chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Influenza like illness, Product preparation error
Clinical narrative: received the entire vial contents (0.45 mL), without dilution; overdose/ received the entire vial contents (0.45 mL), without dilution; flu-like symptoms from the overdose; This is spontaneous report from the two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported 8 similar reports. This is the first one. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for immunization. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the available information, the event "flu-like symptoms" is possibly relate to overdose of vaccine BNT162B2 due to product preparation error. 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-2021032448 same reporter/SD, AE/ different patient;US-PFIZER INC-2021032447 same reporter/SD/AE, different patient;US-PFIZER INC-2021032263 same reporter/SD/AE, different patient;US-PFIZER INC-2021032446 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Influenza like illness
Clinical narrative: Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; This is spontaneous report from two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported similar events for four patients. This is a 2nd of 4 reports. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for immunization. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: The association between the events "received entire vial contents without dilution" and flu-like symptoms with BNT162b2 can not be fully 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-2021032445 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Influenza like illness, Product preparation error
Clinical narrative: received the entire vial contents (0.45 mL), without dilution; overdose/ received the entire vial contents (0.45 mL), without dilution; flu-like symptoms from the overdose; This is spontaneous report from the two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported similar events for four patients. This is 3rd of 4 reports. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for COVID-19 immunisation. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the available information, the event "flu-like symptoms" is possibly relate to overdose of vaccine BNT162B2 due to product preparation error. 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-2021032445 same reporter/SD/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Influenza like illness, Product preparation error
Clinical narrative: received the entire vial contents (0.45 mL), without dilution; Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; This is Spontaneous report from 2 contactable Nurses, 2 contactable physicians and a contactable Pharmacist. These Nurses, physicians and pharmacist reported similar events for 4 patients. This is a 4th of 4 reports.  A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration at single dose (first dose) for unknown indication. Medical history and concomitant medications were not reported. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported Flu-like symptoms was associated with the accidental overdose, received the entire vial contents (0.45 mL) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), without dilution. The case will be reassessed should additional information become 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021032445 same reporter/SD, AE/ different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menorrhagia
Clinical narrative: heavier than normal vaginal bleeding following vaccination 2 weeks before unspecified date; This is a spontaneous report from a contactable Pharmacist reported that a 5 decade (40's) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported. Patient have heavier than normal vaginal bleeding following vaccination 2 weeks before unspecified date, now having vaginal bleeding for 12 days wondering if this was related to the vaccine. The outcome of event was not recovered.  Information on the batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported vaginal bleeding 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.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Injury, Magnetic resonance imaging normal, Tremor
Clinical narrative: wobbling profusely as she walks out of a bathroom/getting even worse; This is a spontaneous report from non-contactable consumers from a Pfizer sponsored program Corporate (Pfizer) Social Media Platforms. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had been injured by the vaccine. She was wobbling profusely as she walked out of a bathroom. She was admitted to the hospital and was cautious about taking the vaccine. She was getting even worse today (11Jan2021) and still did not have any answers from doctors as to how to fix this. The shots cause harm. Injury was real and not rare. She had a bad night last night but today was a little better for her. They still didn't know how to treat this problem. Magnetic resonance imaging (MRI) results came back good today (11Jan2021). She just had another serious episode and she thought it's getting worse when the shakes come. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; This is a spontaneous report from a non-contactable physician (patient) via Pfizer Sales Representative.  A 34-year-old (reported as 34, unit was not provided) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced bells palsy on an unspecified date with outcome of unknown. The event took place after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. 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.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 5-decade-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included insulin dependent diabetic in mid 40s. The patient's concomitant medications were not reported.  The patient experienced TIA (transient ischaemic attack) /mini stroke on same day he received COVID vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Suture insertion, Syncope
Clinical narrative: COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness 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.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide, Computerised tomogram, Concussion, Contusion, Electrocardiogram
Clinical narrative: COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness 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.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Head injury, Loss of consciousness, Myocardial necrosis marker, Skin laceration
Clinical narrative: COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Oropharyngeal pain, Paranasal sinus discomfort
Clinical narrative: can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Loss of consciousness, Throat irritation
Clinical narrative: Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm at 17:15 on 11Jan2021 at single dose for COVID-19 immunization. Medical history included migraine and seizure. Concomitant medication included lamotrigine (LAMICTAL) and zonisamide (ZONEGRAN). Both received within two weeks of vaccination. The patient experienced passed out, chest tightness, dizziness, trouble breathing, and itching throat, all at 17:30 on 11Jan2021. No other vaccines received in four weeks. Facility type vaccine was in hospital. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received salbutamol (ALBUTEROL), steroids, diphenhydramine hydrochloride (BENADRYL), lansoprazole (PREVACID) and IV fluids for treatment. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: Dizziness; Tachycardia; This is a spontaneous report from a contactable other HCP. This other HCP reported for self that the 38-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID-19 Vaccine, Lot#: EL0140, Expiry Date: 31Mar2021), via an unspecified route of administration on 05Jan2021 13:15 on Deltoid, Right at single dose for covid-19 immunisation. Medical history included she did get a monthly allergy injection about 3-4 weeks prior to the COVID-19 Vaccine. She said she did not have any reaction to the allergy shot, clarifying she has always done well with her allergy shots. Concomitant medications were none.  She said she got dizzy for about 30 minutes afterwards, and then was all better. Caller asked if Pfizer has any guidance on how she should proceed with the second COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported she got really dizzy approximately 10 minutes after receiving the COVID-19 Vaccine, and the dizziness lasted for about 30 minutes after that. She said the dizziness completely resolved. Reported she also got a little tachy (clarified as tachycardia) during the time period she was dizzy. She said she wasn't sure if she became tachycardic because she was worried when she became dizzy. She said the tachycardia resolved with the dizziness. No treatment was received. The events stared from 05Jan2021 and considered as Medically significant. The outcome of the events was recovered on 05Jan2021. Vaccination Facility Type was Hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE was require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant tests was none.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of dizziness and tachycardia. 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.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fell out of bed; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient's daughter).  A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown.  After getting shot she fell out of bed and had to be hospitalized. Caller said had nothing to do with shot felt nursing home unsafe and moved to another home once released from hospital. New nursing home not scheduled to give 2nd shots until 28 days and wants to know if ok to wait that extra 8 days. Outcome was unknown. Information on the batch/lot number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Face injury, Fall, Loss of consciousness
Clinical narrative: Passed out; massive diarrhea; fell and hit his face; fell and hit his face; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation.  Medical history included epilepsy from an unknown date and unknown if ongoing (Caller says her father in law hasn't had seizure in years, it was diagnosed when he was a kid, 60-70 years ago).  There were no concomitant medications.  The reporter is calling on behalf of her father in law. She said he had his first dose of the COVID vaccine recently, she pulled this number off of the paperwork today. She says that she believes he had a side effect for it, and also he was rescheduled for his second dose. She says his second dose was supposed to be in 21 days but they rescheduled him for it at 18 days instead. She says he got the first dose on 11Jan, and they rescheduled his next for the 29th. She says she wanted to know if this was correct or ok. The reporter says that the following day he ended up having massive diarrhea, that it caused him while he was on the commode to pass out and he fell and hit his face, the best she can tell he was alone at the time. She says he did not go to the hospital for that, he got up and cleaned himself off and took a nap, and the nurse next door checked on him later on. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Urticaria
Clinical narrative: Anaphylaxis; Persistent cough; This is a literature report were authors reported 21 cases listed in table 1. This is the 20th of the 21 patients.  This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States.   As of 23Dec2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Reporting System. Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours. Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2-150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home.  A 29-year-old female patient who received the 1st dose of the bnt162b2 (BNT162B2 vaccine, unknown lot number) at single dose in Dec2020 for covid-19 immunisation.  Medical history included allergy to sulfa drugs. The patient had no prior history of anaphylaxis. The patient's concomitant medications were not reported.   The patient experienced anaphylaxis (signs and symptoms: generalized urticaria) and persistent cough, 54 min after vaccination, in Dec2020. It was determined to be Brighton level 2 of diagnosis. The patient received treatment at emergency department and received treatment with epinephrine. At the time of the report, the outcome of the events was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-2021043915 same article/drug, different patient;US-PFIZER INC-2021043908 same article/drug, different patient;US-PFIZER INC-2021043909 same article/drug, different patient;US-PFIZER INC-2021043916 same article/drug, different patient;US-PFIZER INC-2021043911 same article/drug, different patient;US-PFIZER INC-2021043910 same article/drug, different patient;US-PFIZER INC-2021043912 same article/drug, different patient;US-PFIZER INC-2021043913 same article/drug, different patient;US-PFIZER INC-2021043914 same article/drug, different patient;US-PFIZER INC-2021043597 same article/drug, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pancytopenia
Clinical narrative: Pancytopenia; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A male patient of an unspecified age received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pancytopenia on an unspecified date with outcome of unknown. It was reported that there was a patient who was hospitalized to had Covid vaccine, number 1, 3 days prior to the hospitalization, he came into the hospital.  The patient had Pancytopenia and the reporter was trying to find out what are Pfizer recommendation for Covid vaccine related Pancytopenia.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Intensive care, Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The pharmacist had an ICU patient that received the COVID vaccine dose 2. On day 3 after the vaccine, the patient was admitted to ICU with pericarditis. It was not a confirmed diagnosis. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The information provided is limited and doesnot allow a full medical assessment.  Considering a temporal relationship, a possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of pericarditis cannot be fully excluded.  The case will be reassessed should additional information become 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: her mother passed away 7-8 days after receiving the vaccine; This is a spontaneous report from a contactable consumer, the daughter of the patient.  A female patient of an unspecified age received the first dose of COVID-19 mRNA VACCINE (MANUFACTURER UNKNOWN), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 19Jan2021 about 7-8 days after receiving the vaccine, the patient passed away. The patient was fine before she received the vaccine and then passed away 7-8 days later.  The cause of death was not reported.   It was not reported if an autopsy was performed. The reporter thought her mother's death had everything to do with the COVID-19 vaccine.  The lot number for the vaccine was not provided and will be requested during follow up.; Reported Cause(s) of Death: Death
Sex: U
Vaccine: COVID19
Symptoms: Death, Immune thrombocytopenia
Clinical narrative: died; acute immune thrombocytopenia; This is a spontaneous report from two contactable consumers. A patient of unspecified age and gender received BNT162B2(lot number and expiration date not provided) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died after receiving the covid vaccine on an unknown date. The patient developed acute immune thrombocytopenia on an unknown date. It was unknown if autopsy was performed. The cause of death was unknown. The outcome of the event "died" was fatal and of the event " acute immune thrombocytopenia" was unknown. The reporter wondered if a platelets blood problem may lead to death and if who have a blood platelets condition like essential thrombocytosis should not risk taking the vaccine.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Died
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site erythema, Injection site inflammation, Injection site pruritus, Pain in extremity
Clinical narrative: After the vaccine on Jan 16, 2021, I had a sore arm with minor inflammation for 3 days.  This subsided without any over the counter medications.  Yesterday at about 5 pm, my arm started to itch slightly at the site of the shot.  Upon waking up this morning, my upper arm has a red circle and is inflamed and it hurts again.  I applied prescription cortisone and will continue to apply throughout the day.   The soreness seems about the same pain level as the first 3 days after receiving the shot.  There is no evidence of bug bite and it would be very strange if I got bit in the exact same location as the shot.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema, Pain
Clinical narrative: Severe pain, edema, erythema, and induration.  Also had a fever of 102 for more than 2 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Diarrhea, loss of appetite, nausea lasting 3 days as of this writing
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: Developed Rhabdomyolysis after working out out on 1/15/21. Was hospitalized on 1/19/20 due to Rhabdomyolysis.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm became red, warm, swollen (size of an avacado) about 7 days after vaccination.  No side effects from vaccine until then.   Pt. worried it is infected so recommended to see primary care provider to evaluate and get treatment if needed.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: chills sore arm
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Throat tightness
Clinical narrative: Patient informed medic while sitting in the observation area that she was experiencing chest pain, difficulty breathing and throat tightness.  Patient was taken to medic area vs=179/89, pulse 121, o@ sat 99%
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache,  chills, body ache, fever
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: Sore arm, and red rash 6x4 inch patch, can see white dot where injection was given.  Rash is flat and light to medium pink.  Denies heat in rash.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Tachycardia
Clinical narrative: PATIENT REPORTS TACHYCARDIA AFTER THE VACCINE ADMINISTRATION. ELECTROCARDIOGRAM COMPLETED WITH NORMAL LIMITS. PATIENT WAS PLACED IN MONITOR FOR A SPACE OF 1HRS. AT NO TIME UNDER OBSERVATION, DID PRESENT TACHYCARDIA.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Visual impairment
Clinical narrative: 2:03PM:  nausea, light headed and visual changes (light became brighter)  2:16PM: Zofran 4mg tab po given.  02:25PM: discharged:  pt no longer experiencing symptoms.   03:05 PM:  contacted pt to let pt know that we will report the adverse effect.  Pt states "am fine".   E. R if symptoms return.  Pt aware.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Lymphadenopathy, Oropharyngeal pain, Tenderness
Clinical narrative: One week post-vaccine, I woke up with a sore throat (that never turned into anything and was gone within 24 hours) and I noticed a hard, tender and swollen lymph node over L bicep.  Swelling has gone down, but remains hard to date of this report (1/25/2021).
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pain
Clinical narrative: I was starting my nursing clinicals in 1991 and was required to get a tetanus vaccine, this was done by my family physician.  The vaccine was given in my left arm. Within a few hours my left arm, from my elbow up to my shoulder, became extremely sore and swollen.  During the night I could not move my arm away from my body because of intense pain upon moving and had to use my right arm to turn myself over and get out of bed.  The swelling was extreme.  I called my physicians office over the period of a few days only to be told that tetanus vaccines cause soreness and some slight swelling (this was not what I was experiencing).  When I saw my fiance (now husband) he was appalled at the pain I was in and described the swelling as the size of a small nerf football. I just showed up at my physicians office (phone calls were not working), the nurse took one look at my arm  and got my doctor, I was still standing at the desk.  He came out and said "This is NOT what we mean by soreness and swelling."  He then took me back and personally injected my arm in at least 4 areas with cortisone injections. The swelling,  pain, soreness, and difficulty of movement were helped by the injections, but continued on a lesser scale for months.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient received vaccine on 12/26/2020; on 1/3/2021 patient experienced rash covering chest and part of back. Patient took a couple of bendaryl capsules for relief.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: 1/22/21 - 6:30 p.m. extreme chills; temp 101.8 - bundled up and went to bed under electric blanket; arm sore and hot 10:00 p.m. sweating, nausea: temp 101.9 - Tylenol 500 mg  1/23/21 - 4:00 a.m. sweating; temp. 101.6 - Tylenol 500 mg -  took lots of naps; arm sore and hot with rash 1/24/21 - 9:00 a.m. felt almost normal - temp 97.8 - which is my normal; arm still sore and hot with rash 1/25/21 - 9:00 a.m. arm still sore and hot with rash
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Hypersensitivity, Intensive care, Joint swelling, Rash
Clinical narrative: Allergic reaction that occurred 7 days after receiving the first vaccination.  Treated for anaphylactic shock at local ER and released.  Anaphylactic shock returned within 24 hours causing second visit to the ER.  I was then transported to  hospital for ICU admission.  Body broke out with hives rash for several days followed by severe joint swelling.  Remained in ICU 3 days and was released to see Allergist.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic reaction that occurred 7 days after receiving the first vaccination.  Treated for anaphylactic shock at local ER and released.  Anaphylactic shock returned within 24 hours causing second visit to the ER.  I was then transported to  hospital for ICU admission.  Body broke out with hives rash for several days followed by severe joint swelling.  Remained in ICU 3 days and was released to see Allergist.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 5x3 in localize redden area at injection site  wildly itching
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Severe pain (unrelieved by Tylenol) at the injection site with accompanying erythema. No fever.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin swelling
Clinical narrative: Itchiness, red spot that got raised, large red spot the size of two palms
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus
Clinical narrative: MODERNA Vaccine results: Headache on day 2,3,4 after administered on Jan. 14; Itchy and red patch appeared on left arm at vaccine site that was about 1 inch square that appeared on day 8 after administerd, on day 9 the red had doubled in size, on day 10 the size had tripled, continuing to be itchy and bright red, with a temp of 99.3 to 99.5.  On day 11, the red was diminishing, no fever noted.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in the Arm at sight of Vaccine. Sore and Warm to touch
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: "I got my second dose around 1pm on 1/22. At 3am I woke up with chills and fever 100.8. I took Tylenol every 6 hours. The highest my temp got was 101.8 on Saturday around 4pm. At that time I had body aches and headache too. Since then I?m been fatigued with a powerful headache, temps ranging 99.1 to 99.8. Taking Tylenol for the headache."
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain, Myalgia, Pyrexia
Clinical narrative: 12 hours late Fever 102-103 , sweats, pain at injection site, myalgia, chills , shivering went away 12 hours later
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: soreness at injection site for 36 hours  pains to joints to fingers, toes and bones in both feet to ankle  headache, sinus pressure, severe nausea for 4 -days, fatigue for 3 days Meds : Tylenol 500 mg -1000 mg every 6 hours as needed, Sinex tabs daily for 3 days, as needed, Zofran 4 mg prescribed by radiology oncologist
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: soreness at injection site for 36 hours  pains to joints to fingers, toes and bones in both feet to ankle  headache, sinus pressure, severe nausea for 4 -days, fatigue for 3 days Meds : Tylenol 500 mg -1000 mg every 6 hours as needed, Sinex tabs daily for 3 days, as needed, Zofran 4 mg prescribed by radiology oncologist
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: 1/22/21, the next morning after shot, left arm at the injection site was a little sore. That lasted two days. No other issues to report after receiving shot #1 of Moderna vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: Low grade temp (100 deg f) beginning about 3 hours after receiving shot.  Became very tired and loss of appetite followed by diarrhea about 8 hours after shot followed by mild headache through the next 24 hours.  I am reporting this mainly because my reaction was unexpected and happened on the first dose.  I have not yet received my second dose.