chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; They gave the vaccine more than 12 hours post 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They gave the vaccine more than 12 hours post 1st puncture).    No concomitant medications were reported.   It was reported that, on 21-Oct-2022 (at 9:00-9:30 AM) nurse gave a Moderna COVID-19 bivalent booster vaccine from a vial which had been first punctured on 20-Oct-2022 at 10:20 AM. They gave the vaccine more than 12 hours post 1st puncture. Vial size reported was 2.5 milliliter. The vial was initially stored in refrigerator on 20-Oct-2022 at 17:03 PM. The vial was stored at room temperature post puncture, and it did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 23 hours and some minutes.  No treatment details were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Blood disorder, Fall, Gait disturbance, Gait inability, Muscular weakness
Clinical narrative: had a terrible blood disease; can hardly walk; legs are all weak, legs just give way; Some days cannot walk; collapse for no reason, falling down for no reason; feet are all swollen, legs and feet were swelling; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk) and FALL (collapse for no reason, falling down for no reason) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk), FALL (collapse for no reason, falling down for no reason) and PERIPHERAL SWELLING (feet are all swollen, legs and feet were swelling). At the time of the report, BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk), FALL (collapse for no reason, falling down for no reason) and PERIPHERAL SWELLING (feet are all swollen, legs and feet were swelling) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication were reported.  The reporter stated that patient was in his 60s alive. Patient had the same thing as the other patient of falling down for no reason. Patient could hardly walk. Some days patient was ok and some days patient could not walk. Patient doctor knew nothing about this, so the reporter told to check with the doctor if it was from the Moderna's shot and so the doctor was doing blood work. But the doctor did not seem to know that. The doctor did not even think to see if it was related to the shot.  It was reported that the doctor was doing blood work, however, the results of the tests were not provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: had a terrible blood disease; can hardly walk; legs are all weak, legs just give way; Some days cannot walk; collapse for no reason, falling down for no reason; feet are all swollen, legs and feet were swelling; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk) and FALL (collapse for no reason, falling down for no reason) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk), FALL (collapse for no reason, falling down for no reason) and PERIPHERAL SWELLING (feet are all swollen, legs and feet were swelling). At the time of the report, BLOOD DISORDER (had a terrible blood disease), GAIT DISTURBANCE (can hardly walk), MUSCULAR WEAKNESS (legs are all weak, legs just give way), GAIT INABILITY (Some days cannot walk), FALL (collapse for no reason, falling down for no reason) and PERIPHERAL SWELLING (feet are all swollen, legs and feet were swelling) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication were reported.  The reporter stated that patient was in his 60s alive. Patient had the same thing as the other patient of falling down for no reason. Patient could hardly walk. Some days patient was ok and some days patient could not walk. Patient doctor knew nothing about this, so the reporter told to check with the doctor if it was from the Moderna's shot and so the doctor was doing blood work. But the doctor did not seem to know that. The doctor did not even think to see if it was related to the shot.  It was reported that the doctor was doing blood work, however, the results of the tests were not provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Developed Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Developed Covid-19). At the time of the report, COVID-19 (Developed Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.         Concomitant medications were not provided.  Patient had developed Covid-19 on an unspecified date and was suggested to take Paxlovid. The patient was not hospitalized.  Treatment information was reported as the patient was suggested to take Paxlovid.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: local pain in the site of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (local pain in the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose-1) on 01-Mar-2021, Pfizer COVID-19 Vaccine (Dose 2, Lot number-EN6200) on 21-Mar-2021, Pfizer COVID-19 Vaccine (!st booster dose and Lot number- SF2588) on 22-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine. Concurrent medical conditions included Hypercholesteraemia (Recent change in status such as improvement or worsening: no) since 2005, GERD (Recent change in status such as improvement or worsening: improved since 2 years ago) and Osteoarthritis (Recent change in status such as improvement or worsening: no). Concomitant products included SIMVASTATIN for High cholesterol, ESTRADIOL, AMMONIUM LACTATE, CALCIUM and VITAMIN D NOS for an unknown indication.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE PAIN (local pain in the site of injection). On 16-Apr-2022, VACCINATION SITE PAIN (local pain in the site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Ammonium Lactate for elbows.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-662810 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID/tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID/tested positive) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (tested positive for COVID/tested positive). At the time of the report, COVID-19 (tested positive for COVID/tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive. On 19-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.  The patient stated she received previous COVID19 vaccinations, but she didn't know exactly when. Then she got COVID.  She wanted to know how long she needs to wait before getting the next booster.  Patient took medication on 20-OCT-2022. She was better then.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent).    No concomitant medications were reported.  It was unknown if patient experienced any AE.  Total 7 patients received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-663474, US-MODERNATX, INC.-MOD-2022-663502, US-MODERNATX, INC.-MOD-2022-663552, US-MODERNATX, INC.-MOD-2022-663563, US-MODERNATX, INC.-MOD-2022-663577, US-MODERNATX, INC.-MOD-2022-663578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663474:same reporter US-MODERNATX, INC.-MOD-2022-663502:same reporter US-MODERNATX, INC.-MOD-2022-663552:same reporter US-MODERNATX, INC.-MOD-2022-663563:same reporter US-MODERNATX, INC.-MOD-2022-663577:same reporter US-MODERNATX, INC.-MOD-2022-663578:same reporter
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: myocarditis after coronavirus disease 2019 vaccination; This is a literature report.  A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "myocarditis after coronavirus disease 2019 vaccination". Presenting symptoms 2-5 days after second dose of mRNA COVID-19 vaccination included burning chest pain and shortness of breath for 24 h.The patient underwent the following laboratory tests and procedures: C-reactive protein (2.69-47.75): unknown results, notes: elevated; Echocardiogram: 62 %, notes: No RWMA (regional wall motion abnormality), normal diastolic function; Transthoracic echocardiograms on presentation; 67 %, notes: No RWMA, normal diastolic function; Follow up Transthoracic echocardiograms; Electrocardiogram: ST elevations in antereolateral leads, notes: on presentation; Early repolarization changes, notes: Follow-up ECG; Magnetic resonance imaging heart: Edema, patchy sub epicardial late gadolinium, notes: enhancement; on presentation; Resolved edema, no late gadolinium, notes: enhancement Follow-up cardiac magnetic resonance (CMR); Troponin (1094-2126): unknown results. Patient underwent CMR during acute hospitalization. Therapeutic measures were taken as a result of myocarditis. Treatment comprised ibuprofen for 2 weeks with complete resolution of symptoms at hospital discharge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event myocarditis and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: myocarditis after coronavirus disease 2019 vaccination; This is a literature report.  A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "myocarditis after coronavirus disease 2019 vaccination". Presenting symptoms 2-5 days after second dose of mRNA COVID-19 vaccination included burning chest pain and shortness of breath for 24 h.The patient underwent the following laboratory tests and procedures: C-reactive protein (2.69-47.75): unknown results, notes: elevated; Echocardiogram: 62 %, notes: No RWMA (regional wall motion abnormality), normal diastolic function; Transthoracic echocardiograms on presentation; 67 %, notes: No RWMA, normal diastolic function; Follow up Transthoracic echocardiograms; Electrocardiogram: ST elevations in antereolateral leads, notes: on presentation; Early repolarization changes, notes: Follow-up ECG; Magnetic resonance imaging heart: Edema, patchy sub epicardial late gadolinium, notes: enhancement; on presentation; Resolved edema, no late gadolinium, notes: enhancement Follow-up cardiac magnetic resonance (CMR); Troponin (1094-2126): unknown results. Patient underwent CMR during acute hospitalization. Therapeutic measures were taken as a result of myocarditis. Treatment comprised ibuprofen for 2 weeks with complete resolution of symptoms at hospital discharge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event myocarditis and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Investigation
Clinical narrative: Acute onset chest pain for 24 h/diagnosed with myocarditis; This initial case was considered invalid since the suspect drug was an unspecified product. Upon follow up review case was considered as valid.   This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination".  A 15-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Imunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovered", described as "Acute onset chest pain for 24 h/diagnosed with myocarditis". The patient underwent the following laboratory tests and procedures: C-reactive protein: 10.65 mg/dl; Echocardiogram (18-38): 63 %; LVEF 63 percent with No RWMA borderline abnormal, notes: diastolic dysfunction lateral E velocity of 0.6m/s; LVEF 64, notes: no RWMA, normal diastolic function; Ejection fraction: 63 %; 64 %, notes: Follow-up; Electrocardiogram: ST elevations in antereolateral leads; Resolved ST-T wave changes; diastolic function: abnormal; normal, notes: Follow-up; Magnetic resonance imaging heart: Edema, patchy subepicardial late gadolinium, notes: enhancement; Resolved edema,, notes: small focal areas of subepicardial late gadolinium enhancement; Troponin (1094-2126): 1502 ng/ml.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Myocarditis and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201253393 Same article/drug/event; Different patient;US-PFIZER INC-202201253394 Same article/drug/event; Different patient;US-PFIZER INC-202201253395 Same article/drug/event; Different patient;US-PFIZER INC-202201253396 Same article/drug/event; Different patient;US-PFIZER INC-202201253397 Same article/drug/event; Different patient;
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: Acute onset chest pain for 24 h/diagnosed with myocarditis; This initial case was considered invalid since the suspect drug was an unspecified product. Upon follow up review case was considered as valid.   This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination".  A 15-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Imunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovered", described as "Acute onset chest pain for 24 h/diagnosed with myocarditis". The patient underwent the following laboratory tests and procedures: C-reactive protein: 10.65 mg/dl; Echocardiogram (18-38): 63 %; LVEF 63 percent with No RWMA borderline abnormal, notes: diastolic dysfunction lateral E velocity of 0.6m/s; LVEF 64, notes: no RWMA, normal diastolic function; Ejection fraction: 63 %; 64 %, notes: Follow-up; Electrocardiogram: ST elevations in antereolateral leads; Resolved ST-T wave changes; diastolic function: abnormal; normal, notes: Follow-up; Magnetic resonance imaging heart: Edema, patchy subepicardial late gadolinium, notes: enhancement; Resolved edema,, notes: small focal areas of subepicardial late gadolinium enhancement; Troponin (1094-2126): 1502 ng/ml.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Myocarditis and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201253393 Same article/drug/event; Different patient;US-PFIZER INC-202201253394 Same article/drug/event; Different patient;US-PFIZER INC-202201253395 Same article/drug/event; Different patient;US-PFIZER INC-202201253396 Same article/drug/event; Different patient;US-PFIZER INC-202201253397 Same article/drug/event; Different patient;
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 30 patients received FLUZONE HIGH DOSE QIV after the vaccine experienced a temperature excursion with no reported adverse event; vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event; Initial information on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA435111(CLUSTER).  This case involves 30 unknown age and unknown gender patients who received fluzone high dose qiv after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event (product storage error).  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, dose, route not reported; lot UT7714AA) for prophylactic vaccination.  On an unknown date, the 30 patients received fluzone high dose qiv after the vaccine experienced a temperature excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Muscular weakness
Clinical narrative: Left upper extremity weakness.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Carditis, Chest pain, Dyspnoea
Clinical narrative: First one was fine but the 2nd caused what we believe was likely myo or pericarditis. I had pretty extreme SOB, chest pain, exhaustion and collapsed on the floor several times because I was too weak to make it around the house. It started with bizarre heart rate and blood pressure spikes and drops immediately after the vaccine and the carditis like symptoms started about 3 days after that. To this day I have not regained my cardio capacity. I only returned about 60% of what I used to have despite a year of trying, I saw a cardiologist 4 months after this happened (soon as I could get in) and he told me I probably had a small amount of permanent damage and there would be no telling what I may ever recover.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate abnormal, Immediate post-injection reaction, Laboratory test, Syncope
Clinical narrative: First one was fine but the 2nd caused what we believe was likely myo or pericarditis. I had pretty extreme SOB, chest pain, exhaustion and collapsed on the floor several times because I was too weak to make it around the house. It started with bizarre heart rate and blood pressure spikes and drops immediately after the vaccine and the carditis like symptoms started about 3 days after that. To this day I have not regained my cardio capacity. I only returned about 60% of what I used to have despite a year of trying, I saw a cardiologist 4 months after this happened (soon as I could get in) and he told me I probably had a small amount of permanent damage and there would be no telling what I may ever recover.
Age: 0.75
Sex: F
Vaccine: DTAPIPV, DTPPVHBHPB, PNC13
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: diaphoretic, low BP 90/50s-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Lethargy, Nausea
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: diaphoretic, low BP 90/50s-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Additional Details: counseled patient to use ice packs and take tylenol, and a claratin to help with swelling. will check back in 1-2 days
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient had a sever form of vasovagal syncopy with fainting
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient had a sever form of vasovagal syncopy with fainting
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Additional Details: Influenza shot given high than usual on left arm in deltoid. Patient states she could feel "needle penetrating and breaking through". Patient felt resistance from needle injection.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Lymphadenopathy, Nausea, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Additional Details: Influenza shot given high than usual on left arm in deltoid. Patient states she could feel "needle penetrating and breaking through". Patient felt resistance from needle injection.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Nausea, Syncope, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient came to the pharmacy and received both flu and moderna vaccines. While patient was waiting after vaccination, she became unresponsive for less than a minute upon which I intervened. Patient said she was hung over from drinking alcohol. Epipen was not administered because she regained consciousness as sson as I got to the vaccination area and she refused epipen.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient came to the pharmacy and received both flu and moderna vaccines. While patient was waiting after vaccination, she became unresponsive for less than a minute upon which I intervened. Patient said she was hung over from drinking alcohol. Epipen was not administered because she regained consciousness as sson as I got to the vaccination area and she refused epipen.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Malaise, Myalgia, SARS-CoV-2 test positive
Clinical narrative: 09/03/22 presents to ED for "cough and overall malaise myalgias". PMHx of "chronic left lower extremity thrombosis not on anticoagulation"
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Said after around 15min that he was dizzy. Wasn't getting better after sitting a bit longer and said he felt like it was sort of a fog in his head. His wife was also there. They waited a bit longer and then the wife wanted a wheel chair from store. They brought him one and he and his wife wanted to leave and did not want to wait any longer. He got into the electric wheel chair himself and seemed to be doing better. He operated the wheel chair himself with his wife next to him.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis, Panic attack, Presyncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient appeared to have a panic attack which almost turned into a fainting spell right after vaccination was given. EMS was called, all her vitals were normal and she recovered. did not go to the hospital. no signs of allergy to the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient appeared to have a panic attack which almost turned into a fainting spell right after vaccination was given. EMS was called, all her vitals were normal and she recovered. did not go to the hospital. no signs of allergy to the vaccine.
Age: 4.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Inappropriate schedule of product administration, Injection site pain, No adverse event
Clinical narrative: There has been no adverse reaction to date.  This dose was given too soon.  Instead of 8 weeks between the 2nd and 3rd dose there was only 4 weeks.  Only symptom experienced was soreness at the site.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Mobility decreased
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Additional Details: patient report generalized myalgia, fevers, severe fatigue, severe headahe, dizziness. says feels like a bad flu. unable to get out bed since day of administration and he is generally very active.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Additional Details: patient report generalized myalgia, fevers, severe fatigue, severe headahe, dizziness. says feels like a bad flu. unable to get out bed since day of administration and he is generally very active.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Throat and tongue  hives hours later
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Peripheral swelling, Skin irritation, Urticaria
Clinical narrative: Patient's leg swollen, large welt at least 3 inches in width, red & irritated. Bruising
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Chapped lips, Condition aggravated, Disturbance in attention, Eye pruritus
Clinical narrative: My Long-COVID symptoms have progressed. My chronic fatigue has worsened, I get migraine headaches that I've never before had in my entire life, I experience word-finding difficulty, inability to concentrate, and brain-fog, I have chronic pain and aches that disrupt my daily life,  I experience post-exertional fatigue to a high degree. I developed Mast Cell Activation Syndrome and Oral Allergy Syndrome which causes me to experience allergic reactions to most foods that manifests symptoms in my skin and GI tract. I started seeing a Naturopath MD over the summer of 2022 and am on a regimen of prescription medications and herbal supplements to try and get the MAST cells under control, but have experienced very little improvement so far.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Eyelid infection, Fatigue, Feeling abnormal, Food allergy
Clinical narrative: My Long-COVID symptoms have progressed. My chronic fatigue has worsened, I get migraine headaches that I've never before had in my entire life, I experience word-finding difficulty, inability to concentrate, and brain-fog, I have chronic pain and aches that disrupt my daily life,  I experience post-exertional fatigue to a high degree. I developed Mast Cell Activation Syndrome and Oral Allergy Syndrome which causes me to experience allergic reactions to most foods that manifests symptoms in my skin and GI tract. I started seeing a Naturopath MD over the summer of 2022 and am on a regimen of prescription medications and herbal supplements to try and get the MAST cells under control, but have experienced very little improvement so far.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal disorder, Herpes zoster, Hypersensitivity, Infection, Lip pruritus
Clinical narrative: My Long-COVID symptoms have progressed. My chronic fatigue has worsened, I get migraine headaches that I've never before had in my entire life, I experience word-finding difficulty, inability to concentrate, and brain-fog, I have chronic pain and aches that disrupt my daily life,  I experience post-exertional fatigue to a high degree. I developed Mast Cell Activation Syndrome and Oral Allergy Syndrome which causes me to experience allergic reactions to most foods that manifests symptoms in my skin and GI tract. I started seeing a Naturopath MD over the summer of 2022 and am on a regimen of prescription medications and herbal supplements to try and get the MAST cells under control, but have experienced very little improvement so far.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Loss of personal independence in daily activities, Mast cell activation syndrome, Migraine, Oral allergy syndrome
Clinical narrative: My Long-COVID symptoms have progressed. My chronic fatigue has worsened, I get migraine headaches that I've never before had in my entire life, I experience word-finding difficulty, inability to concentrate, and brain-fog, I have chronic pain and aches that disrupt my daily life,  I experience post-exertional fatigue to a high degree. I developed Mast Cell Activation Syndrome and Oral Allergy Syndrome which causes me to experience allergic reactions to most foods that manifests symptoms in my skin and GI tract. I started seeing a Naturopath MD over the summer of 2022 and am on a regimen of prescription medications and herbal supplements to try and get the MAST cells under control, but have experienced very little improvement so far.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Post-acute COVID-19 syndrome, Skin disorder
Clinical narrative: My Long-COVID symptoms have progressed. My chronic fatigue has worsened, I get migraine headaches that I've never before had in my entire life, I experience word-finding difficulty, inability to concentrate, and brain-fog, I have chronic pain and aches that disrupt my daily life,  I experience post-exertional fatigue to a high degree. I developed Mast Cell Activation Syndrome and Oral Allergy Syndrome which causes me to experience allergic reactions to most foods that manifests symptoms in my skin and GI tract. I started seeing a Naturopath MD over the summer of 2022 and am on a regimen of prescription medications and herbal supplements to try and get the MAST cells under control, but have experienced very little improvement so far.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast, Breast cancer recurrent, Condition aggravated, Pathology test
Clinical narrative: Reoccurrence of breast cancer.  Previously diagnosed and treated in 2014.  Clean bill of health since then.  Until localized reoccurrence of same cancer in September 2022.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 2/10/21  015M20A dose 2 Moderna 3/10/21  030A21A dose 3 Moderna 11/16/21  005C21A
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Ringing in my ears (Tinnitus)
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received a second Moderna Bivalent booster 1 month and 12 days after his first bivalent booster. This was a clerical oversight, staff has been retrained. Patient was monitored and shows no adverse reaction.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Fatigue, Feeling abnormal, Oropharyngeal pain
Clinical narrative: On the evening of the 21st I had sore throat and tightness in chest. On October of 22 went to urgent care and tested positive for COVID-19. They prescribed PAXLOVID and I began taking it around noon on the 22nd. On the 22nd I also began having fatigue and brain fog. After beginning PAXLOVID I haven't noticed significant improvements in my symptoms.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On the evening of the 21st I had sore throat and tightness in chest. On October of 22 went to urgent care and tested positive for COVID-19. They prescribed PAXLOVID and I began taking it around noon on the 22nd. On the 22nd I also began having fatigue and brain fog. After beginning PAXLOVID I haven't noticed significant improvements in my symptoms.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: 09/03/22 presents to EC ED for "altered mentation". PMHx of " seizures on Depakote, hypertension, bradycardia"
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Diarrhoea
Clinical narrative: Chills, weakness, diarrhea
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given the pediatric vaccine instead of the adult vaccine, there was no adverse reaction at the time of the vaccine.
Age: 97.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Acute respiratory failure, COVID-19, Chest X-ray abnormal, General physical health deterioration, Hyporesponsive to stimuli
Clinical narrative: Discharge Provider: DO Primary Care Provider: NP Admission Date: 10/16/2022 Discharge Date: Oct 20, 2022   PRESENTING PROBLEM: Severe sepsis Pneumonia of right lower lobe due to infectious organism Sepsis with acute hypoxic respiratory failure, due to unspecified organism, unspecified whether septic shock present    HOSPITAL COURSE: Patient is a 97-year-old gentleman, resident of long-term facility who has been declining over the past several weeks and has become less responsive.  He was diagnosed with COVID-19 and August of 2022.  Past medical history includes chronic atrial flutter, chronic obstructive pulmonary disease, coronary artery disease.  Patient was treated for sepsis and at admission is chest x-ray revealed hazy infiltrate and airspace disease of the right lower lung.  Patient wishes to be made comfortable, no aggressive treatments, no vasopressors cardiac resuscitation, no CPR no BiPAP and no intubation/ventilation were respected.  Patient's family agreed with his wishes to be kept comfortable and allow a natural death. The patient was treated with antibiotics for healthcare associated pneumonia.  He was placed in appropriate isolation precautions.  He was seen by appropriate therapies and care management.  It was felt difficult to advance his antibiotics due to inability to safely swallow.  It was suspected current issues were at least in part related aspiration pneumonia.  Wishes to generally proceed in a comfort oriented treatment plan were respected. The patient was seen by hospice on 10/19/2022 and the outcome of this meeting with family was the desire to return to his place of residence under the care of hospice.  Roxanol was added to his medical regimen.  Arrangements for return to long-term facility under hospice care were made today.  Antibiotics will be discontinued.  Code status at discharge is do not resuscitate.  Prognosis is poor/terminal, family aware.