| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Dyspnea (1816); Fatigue (1849); Headache (1880); Nausea (1970); Pneumonia (2011); Blurred Vision (2137); Dizziness (2194); No Code Available (3191)
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| Event Date 10/24/2020 |
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Event Type
Injury
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Event Description
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Diagnosed with ground glass pneumonia [pneumonia] ([exhaustion], [shortness of breath]).Could not work or drive [inability to work].Could not work or drive [impaired driving ability].Trying to read the paperwork and noted blurred vision [blurred vision].Developed a headache and was treated for migraine [migraine headache].Labs showed elevated d-dimer [fibrin d dimer increased].Super sick [sickness].Intense headache [headache].Dizziness [dizziness].Nausea [nausea].Right arm and lips felt tingly [tingling lips].Right arm and lips felt tingly [paraesthesia upper limb].Synvisc one given for post knee surgery pain [product use in unapproved indication].Case narrative: initial information from united states received on 24-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a (b)(6) years old female patient who was diagnosed with ground glass pneumonia, could not work or drive, trying to read the paperwork and noted blurred vision, developed a headache and was treated for migraine, labs showed elevated d-dimer, super sick, intense headache, dizziness, nausea, right arm and lips felt tingly, while using the medical device hylan g-f 20, sodium hyaluronate (synvisc one) for post knee surgery pain.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had used this product for the first time.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection once (dose, route and batch number unknown) for post knee surgery pain (product use in unapproved indication).On the same day in less than 10 minutes after her injection her right arm (paraesthesia) and lips felt tingly (paraesthesia oral).On the same day, patient was trying to read the paperwork from hcp (healthcare professional) and noted blurred vision (vision blurred).The patient developed a headache then went to ed (emergency department) where she was treated for migraine (migraine headache).On (b)(6) 2020, the next day after latency of 1 day, patient was super sick (illness), had intense headache (headache), dizziness, nausea.Patient could not work or drive (impaired work ability and impaired driving ability; seriousness criteria: disability).On an unknown date in 2020, after unknown latency, patient felt exhausted (fatigue) and had shortness of breath (dyspnoea).With further follow-up from hcp her labs showed elevated d-dimer (fibrin d dimer increased) and ct (computerized tomogram) with contrast was done (results not reported).She was diagnosed with ground glass pneumonia (pneumonia) (seriousness criteria: medically significant) (onset: 2020 and latency unknown) and was started on an antibiotic twice to treat it.The patient asked if there was any information on similar adverse events and treatment.Action taken: not applicable for all events.Corrective treatment: started on an antibiotic twice to treat pneumonia; unspecified for migraine headache; not reported for rest events.Outcome: not applicable for product use in unapproved indication; unknown for all other events.
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Event Description
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Diagnosed with ground glass pneumonia [pneumonia] ([exhaustion], [shortness of breath]).Could not work or drive [inability to work].Could not work or drive [impaired driving ability].Trying to read the paperwork and noted blurred vision [blurred vision].Developed a headache and was treated for migraine [migraine headache].Labs showed elevated d-dimer [fibrin d dimer increased].Super sick [sickness].Intense headache [headache].Dizziness [dizziness].Nausea [nausea].Right arm and lips felt tingly [tingling lips].Right arm and lips felt tingly [paraesthesia upper limb].Synvisc one given for post knee surgery pain [product use in unapproved indication].Case narrative: initial information from united states received on 24-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a 59 years old female patient who was diagnosed with ground glass pneumonia, could not work or drive, trying to read the paperwork and noted blurred vision, developed a headache and was treated for migraine, labs showed elevated d-dimer, super sick, intense headache, dizziness, nausea, right arm and lips felt tingly, while using the medical device hylan g-f 20, sodium hyaluronate (synvisc one) for post knee surgery pain.The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.Patient had used this product for the first time.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection once (dose, route and batch number unknown) for post knee surgery pain (product use in unapproved indication).On the same day in less than 10 minutes after her injection her right arm (paraesthesia) and lips felt tingly (paraesthesia oral).On the same day, patient was trying to read the paperwork from hcp (healthcare professional) and noted blurred vision (vision blurred).The patient developed a headache then went to ed (emergency department) where she was treated for migraine (migraine headache).On (b)(6) 2020, the next day after latency of 1 day, patient was super sick (illness), had intense headache (headache), dizziness, nausea.Patient could not work or drive (impaired work ability and impaired driving ability; seriousness criteria: disability).On an unknown date in 2020, after unknown latency, patient felt exhausted (fatigue) and had shortness of breath (dyspnoea).With further follow-up from hcp, her labs showed elevated d-dimer (fibrin d dimer increased) and ct (computerized tomogram) with contrast was done (results not reported).She was diagnosed with ground glass pneumonia (pneumonia) (seriousness criteria: medically significant) (onset: 2020 and latency unknown) and was started on an antibiotic twice to treat it.The patient asked if there was any information on similar adverse events and treatment.Action taken: not applicable for all events.Corrective treatment: started on an antibiotic twice to treat pneumonia; unspecified for migraine headache; not reported for rest events.Outcome: not applicable for product use in unapproved indication; unknown for all other events.A product technical complaint (ptc) was initiated on 24-nov-2020 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa was required.Investigation complete date: 01-dec-2020.Additional information was received on 24-nov-2020 from other healthcare professional: global ptc number was added to the case.Text amended accordingly.Additional information was received on 01-dec-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.
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Event Description
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Diagnosed with ground glass pneumonia [pneumonia] ([chest tightness], [chest pain], [exhaustion], [shortness of breath]), could not work or drive [inability to work], could not work or drive [impaired driving ability], trying to read the paperwork and noted blurred vision [blurred vision], developed a headache and was treated for migraine [migraine headache], labs showed elevated d-dimer [fibrin d dimer increased], super sick [sickness], intense headache / headaches (recurrent) [headache], dizziness / light headed / dizzy [light headedness], nausea/ nauseous within 10-15 minutes of injection (recurrent) [nausea], right arm and lips felt tingly / tingling in r arm and lips [tingling lips], no energy (recurrent) [loss of energy], right arm and lips felt tingly / tingling in r arm and lips [paraesthesia upper limb], synvisc one given for post knee surgery pain [product use in unapproved indication].Case narrative: initial information from united states received on 24-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a 59 years old female patient who was diagnosed with ground glass pneumonia, could not work or drive, trying to read the paperwork and noted blurred vision, developed a headache and was treated for migraine, labs showed elevated d-dimer, super sick, right arm and lips felt tingly, no energy , right arm and lips felt tingly / tingling in r arm and lips, dizziness / light headed / dizzy, nausea / nauseous within 10-15 minutes of injection (recurrent), intense headache / headaches (recurrent), had shortness of breath (recurrent) while using the medical device hylan g-f 20, sodium hyaluronate (synvisc one) for post knee surgery pain.The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.Patient had used this product for the first time.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection once (dose, route and batch number unknown) for post knee surgery pain (product use in unapproved indication).On the same day in less than 10 minutes after her injection her right arm (paraesthesia) and lips felt tingly (paraesthesia oral) and the patient was nauseous within 10-15 minutes of injection.On the same day, patient was trying to read the paperwork from hcp (healthcare professional) and noted blurred vision (vision blurred) and the patient developed a headache then went to ed (emergency department) where she was treated for migraine (migraine headache) and the symptoms went away after 7 hours in the er (emergency room) treatment with prescription of intravenous rizatriptan and ondansetron.On (b)(6) 2020, the patient had low energy (asthenia) also.On (b)(6) 2020, the next day after latency of 1 day, patient was super sick (illness), had intense headache (headache), dizziness / dizzy, nausea and light-headed.The patient would wake up at night and / or was hard to sleep.The symptoms came back first thing in the morning with shortness of breath.The events went on and off throughout day and night.Patient could not work or drive (impaired work ability and impaired driving ability; seriousness criteria: disability).On (b)(6) 2020, after 7 days latency, patient felt exhausted (fatigue) which was on and off throughout the day and antibiotics.The patient was diagnosed with groundglass pneumonia (pneumonia) (seriousness criteria: medically significant) (onset: on (b)(6) 2020 and latency unknown) and was started the patient went to hospital er and was treated with antibiotic twice, torodal shot for headache and nausea shot.The patient asked if there was any information on similar adverse events and treatment.On (b)(6) 2020, the patient still had on and off going shortness of breath, tight chest, dizzy, exhausted and bad headaches throughout the day and the antibiotics were changed with rizatriptan when patient went to urgent care.The patient was referred to pulmonary doctor.The patient was had 4 covid19 tests since on (b)(6) 2020.Most recent test was on (b)(6) 2020 and all tests had come back negative.With further follow-up from hcp, her labs showed elevated d-dimer (fibrin d dimer increased) and ct (computerized tomogram) with contrast was done (results not reported).Action taken: not applicable for all events.Corrective treatment: started on an antibiotic twice to treat pneumonia; unspecified for migraine headache; ondansetron for nausea / nauseous within 10-15 minutes of injection (recurrent); rizatriptan for intense headache / headaches (recurrent, dizziness / light headed / dizzy no energy, fatigue,symptom of chest discomfort, dyspnea; antibiotics, torodal shot for headache and nausea shot, change of antibiotics for headache, dizziness, fatigue, symptom of chest discomfort, dyspnea; not reported for rest events.Outcome: not applicable for product use in unapproved indication; recovered for blurred vision, paraesthesia; not recovered for dizziness / light headed / dizzy, nausea / nauseous within 10-15 minutes of injection (recurrent), intense headache / headaches (recurrent), had shortness of breath (recurrent) and diagnosed with ground glass pneumonia, unknown for all other events.A product technical complaint (ptc) was initiated on 24-nov-2020 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa was required.Investigation complete date: 01-dec-2020.Additional information was received on 24-nov-2020 from other healthcare professional: global ptc number was added to the case.Text amended accordingly.Additional information was received on 01-dec-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Additional information was received on 05-dec-2020 from other healthcare professional.Event added for no energy and symptoms of chest tightness (recurrent), chest pain (recurrent) added.Verbatim updated for right arm and lips felt tingly / tingling in r arm and lips, dizziness/ light headed / dizzy, nausea / nauseous within 10-15 minutes of injection (recurrent), intense headache / headaches (recurrent), had shortness of breath (recurrent).Event outcome updated for dizziness / light headed / dizzy, nausea / nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent) and diagnosed with ground glass pneumonia, right arm and lips felt tingly / tingling in r arm and lips, blurred vision.Treatment updated.Clinical course was updated.Text amended accordingly.
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Event Description
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Diagnosed with ground glass pneumonia [pneumonia] ([chest tightness], [chest pain], [exhaustion], [shortness of breath]).Could not work or drive [inability to work].Could not work or drive [impaired driving ability].Trying to read the paperwork and noted blurred vision [blurred vision].Developed a headache and was treated for migraine [migraine headache].Labs showed elevated d-dimer [fibrin d dimer increased].Super sick [sickness].Intense headache/headaches (recurrent) [headache].Dizziness/light headed/ dizzy [light headedness].Nausea/nauseous within 10-15 minutes of injection (recurrent) [nausea].Right arm and lips felt tingly/tingling in r arm and lips [tingling lips].No energy (recurrent) [loss of energy].Right arm and lips felt tingly/tingling in r arm and lips [paraesthesia upper limb].Synvisc one given for post knee surgery pain [product use in unapproved indication].Case narrative: this case is deleted following an incorrect worldwide id.The new case (b)(4) will be submitted with the same information.Initial information from united states received on 24-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a 59 years old female patient who was diagnosed with ground glass pneumonia, could not work or drive, trying to read the paperwork and noted blurred vision, developed a headache and was treated for migraine, labs showed elevated d-dimer, super sick, right arm and lips felt tingly, no energy, right arm and lips felt tingly/tingling in r arm and lips, dizziness/light headed/ dizzy, nausea/nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent) while using the medical device hylan g-f 20, sodium hyaluronate (synvisc one) for post knee surgery pain the patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.Patient had used this product for the first time.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection once (dose, route and batch number unknown) for post knee surgery pain (product use in unapproved indication).On the same day in less than 10 minutes after her injection her right arm (paraesthesia) and lips felt tingly (paraesthesia oral) and the patient was nauseous within 10-15 minutes of injection.On the same day, patient was trying to read the paperwork from hcp (healthcare professional) and noted blurred vision (vision blurred) and the patient developed a headache then went to ed (emergency department) where she was treated for migraine (migraine headache) and the symptoms went away after 7 hours in the er (emergency room) treatment with prescription of intravenous rizatriptan and ondansetron.On (b)(6) 2020, the patient had low energy (asthenia) also.On (b)(6) 2020, the next day after latency of 1 day, patient was super sick (illness), had intense headache (headache), dizziness/ dizzy, nausea and light-headed.The patient would wake up at night and/ or was hard to sleep.The symptoms came back first thing in the morning with shortness of breath.The events went on and off throughout day and night.Patient could not work or drive (impaired work ability and impaired driving ability; seriousness criteria: disability).On (b)(6) 2020, after 7 days latency, patient felt exhausted (fatigue) which was on and off throughout the day and antibiotics.The patient was diagnosed with groundglass pneumonia (pneumonia) (seriousness criteria: medically significant) (onset: (b)(6) 2020 and latency unknown) and was started the patient went to hospital er and was treated with antibiotic twice, torodal shot for headache and nausea shot.The patient asked if there was any information on similar adverse events and treatment.On (b)(6) 2020, the patient still had on and off going shortness of breath, tight chest, dizzy, exhausted and bad headaches throughout the day and the antiobiotics were changed with rizatriptan when patient went to urgent care.The patient was referred to pulmonary doctor.The patient was had 4 covid19 tests since (b)(6) 2020.Most recent test was (b)(6) 2020 and all tests had come back negative.With further follow-up from hcp, her labs showed elevated d-dimer (fibrin d dimer increased) and ct (computerized tomogram) with contrast was done (results not reported).Action taken: not applicable for all events.Corrective treatment: started on an antibiotic twice to treat pneumonia; unspecified for migraine headache; ondansetron for nausea/nauseous within 10-15 minutes of injection (recurrent); rizatriptan for intense headache/headaches (recurrent, dizziness/light headed/ dizzy no energy, fatigue,symptom of chest discomfort, dyspnea; antibiotics, torodal shot for headache and nausea shot, change of antibiotics for headache, dizziness, fatigue, symptom of chest discomfort, dyspnea; not reported for rest events outcome: not applicable for product use in unapproved indication; recovered for blurred vision, paraesthesia; not recovered for dizziness/ light headed/dizzy, nausea/nauseous within 10-15 minutes of injection (recurrent), intense headache/headaches (recurrent), had shortness of breath (recurrent) and diagnosed with ground glass pneumonia, unknown for all other events.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one.Batch number: unknown; global ptc number: 100083968.The product lot number was not provided; therefore, a batch record review was not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa was required.Investigation complete date: (b)(6) 2020.Additional information was received on 24-nov-2020 from other healthcare professional: global ptc number was added to the case.Text amended accordingly.Additional information was received on 01-dec-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Additional information was received on 05-dec-2020 from other healthcare professional.Event added for no energy and symptoms of chest tightness (recurrent), chest pain (recurrent) added.Verbatim updated for right arm and lips felt tingly/tingling in r arm and lips, dizziness/ light headed/ dizzy, nausea/nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent).Event outcome updated for dizziness/light headed/ dizzy, nausea/nauseous within 10-15 minutes of injection (recurrent), intense headache/headaches (recurrent), had shortness of breath (recurrent) and diagnosed with ground glass pneumonia, right arm and lips felt tingly/ tingling in r arm and lips, blurred vision.Treatment updated.Clinical course was updated.Text amended accordingly.
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Event Description
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Diagnosed with ground glass pneumonia [pneumonia] ([chest tightness], [chest pain], [exhaustion], [shortness of breath]) could not work or drive [inability to work] could not work or drive [impaired driving ability] trying to read the paperwork and noted blurred vision [blurred vision] developed a headache and was treated for migraine [migraine headache] labs showed elevated d-dimer [fibrin d dimer increased] super sick [sickness] intense headache/ headaches (recurrent) [headache] dizziness/ light headed/ dizzy [light headedness] nausea/ nauseous within 10-15 minutes of injection (recurrent) [nausea] right arm and lips felt tingly/ tingling in r arm and lips [tingling lips] no energy (recurrent) [loss of energy] right arm and lips felt tingly/ tingling in r arm and lips [paraesthesia upper limb] synvisc one given for post knee surgery pain [product use in unapproved indication] case narrative: this case is submitted following an incorrect worldwide id in case id ((b)(4)) which will be deleted.This report contains no new information.Initial information from united states received on (b)(6) 2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a 59 years old female patient who was diagnosed with ground glass pneumonia, could not work or drive, trying to read the paperwork and noted blurred vision, developed a headache and was treated for migraine, labs showed elevated d-dimer, super sick, right arm and lips felt tingly, no energy , right arm and lips felt tingly/ tingling in r arm and lips, dizziness/ light headed/ dizzy, nausea/ nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent) while using the medical device hylan g-f 20, sodium hyaluronate (synvisc one) for post knee surgery pain.The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.Patient had used this product for the first time.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection once (dose, route and batch number unknown) for post knee surgery pain (product use in unapproved indication).On the same day in less than 10 minutes after her injection her right arm (paraesthesia) and lips felt tingly (paraesthesia oral) and the patient was nauseous within 10-15 minutes of injection.On the same day, patient was trying to read the paperwork from hcp (healthcare professional) and noted blurred vision (vision blurred) and the patient developed a headache then went to ed (emergency department) where she was treated for migraine (migraine headache) and the symptoms went away after 7 hours in the er (emergency room) treatment with prescription of intravenous rizatriptan and ondansetron.On (b)(6) 2020, the patient had low energy (asthenia) also.On (b)(6) 2020, the next day after latency of 1 day, patient was super sick (illness), had intense headache (headache), dizziness/ dizzy, nausea and light-headed.The patient would wake up at night and/ or was hard to sleep.The symptoms came back first thing in the morning with shortness of breath.The events went on and off throughout day and night.Patient could not work or drive (impaired work ability and impaired driving ability; seriousness criteria: disability).On (b)(6) 2020, after 7 days latency, patient felt exhausted (fatigue) which was on and off throughout the day and antibiotics.The patient was diagnosed with groundglass pneumonia (pneumonia) (seriousness criteria: medically significant) (onset: (b)(6) 2020 and latency unknown) and was started the patient went to hospital er and was treated with antibiotic twice, torodal shot for headache and nausea shot.The patient asked if there was any information on similar adverse events and treatment.On (b)(6) 2020, the patient still had on and off going shortness of breath, tight chest, dizzy, exhausted and bad headaches throughout the day and the antiobiotics were changed with rizatriptan when patient went to urgent care.The patient was referred to pulmonary doctor.The patient was had 4 covid19 tests since (b)(6) 2020.Most recent test was (b)(6) 2020 and all tests had come back negative.With further follow-up from hcp, her labs showed elevated d-dimer (fibrin d dimer increased) and ct (computerized tomogram) with contrast was done (results not reported).Action taken: not applicable for all events.Corrective treatment: started on an antibiotic twice to treat pneumonia; unspecified for migraine headache; ondansetron for nausea/ nauseous within 10-15 minutes of injection (recurrent); rizatriptan for intense headache/ headaches (recurrent, dizziness/ light headed/ dizzy no energy, fatigue,symptom of chest discomfort, dyspnea; antibiotics, torodal shot for headache and nausea shot, change of antibiotics for headache, dizziness, fatigue, symptom of chest discomfort, dyspnea; not reported for rest events outcome: not applicable for product use in unapproved indication; recovered for blurred vision, paraesthesia; not recovered for dizziness/ light headed/ dizzy, nausea/ nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent) and diagnosed with ground glass pneumonia, unknown for all other events a product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa was required.Investigation complete date: (b)(6) 2020 additional information was received on (b)(6) 2020 from other healthcare professional: global ptc number was added to the case.Text amended accordingly.Additional information was received on (b)(6) 2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2020 from other healthcare professional.Event added for no energy and symptoms of chest tightness (recurrent), chest pain (recurrent) added.Verbatim updated for right arm and lips felt tingly/ tingling in r arm and lips, dizziness/ light headed/ dizzy, nausea/ nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent).Event outcome updated for dizziness/ light headed/ dizzy, nausea/ nauseous within 10-15 minutes of injection (recurrent), intense headache/ headaches (recurrent), had shortness of breath (recurrent) and diagnosed with ground glass pneumonia, right arm and lips felt tingly/ tingling in r arm and lips, blurred vision.Treatment updated.Clinical course was updated.Text amended accordingly.
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