chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Barrett's oesophagus, Eating disorder, Gastric disorder, Headache, Hot flush
Clinical narrative: Barrett's esophagus; Muscle shoulder and left arm are aching; Left arm are aching/arm was a little sore; Throat is tightening up; Nauseous; Gastric problems; Headache; Hands and feet are cold/extremely cold in her hands and feet and cannot get warm; Hot flashes; Achalasia; Breaking out in sweat; Cannot eat; Really sick; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had Barrett's esophagus; muscle shoulder and left arm were aching; arm was a little sore; throat was tightening up; nauseous; gastric problems; headache; hands and feet were cold/extremely cold in her hands and feet, and could not get warm; had hot flashes; achalasia; was breaking out in sweat; could not eat; and was really sick. The outcome of the events was unknown. The patient was supposed to get the second dose of vaccination on 14Apr2021.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Myalgia, Nausea, Oesophageal achalasia
Clinical narrative: Barrett's esophagus; Muscle shoulder and left arm are aching; Left arm are aching/arm was a little sore; Throat is tightening up; Nauseous; Gastric problems; Headache; Hands and feet are cold/extremely cold in her hands and feet and cannot get warm; Hot flashes; Achalasia; Breaking out in sweat; Cannot eat; Really sick; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had Barrett's esophagus; muscle shoulder and left arm were aching; arm was a little sore; throat was tightening up; nauseous; gastric problems; headache; hands and feet were cold/extremely cold in her hands and feet, and could not get warm; had hot flashes; achalasia; was breaking out in sweat; could not eat; and was really sick. The outcome of the events was unknown. The patient was supposed to get the second dose of vaccination on 14Apr2021.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Throat tightness
Clinical narrative: Barrett's esophagus; Muscle shoulder and left arm are aching; Left arm are aching/arm was a little sore; Throat is tightening up; Nauseous; Gastric problems; Headache; Hands and feet are cold/extremely cold in her hands and feet and cannot get warm; Hot flashes; Achalasia; Breaking out in sweat; Cannot eat; Really sick; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had Barrett's esophagus; muscle shoulder and left arm were aching; arm was a little sore; throat was tightening up; nauseous; gastric problems; headache; hands and feet were cold/extremely cold in her hands and feet, and could not get warm; had hot flashes; achalasia; was breaking out in sweat; could not eat; and was really sick. The outcome of the events was unknown. The patient was supposed to get the second dose of vaccination on 14Apr2021.  Information on lot number/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Lethargy, Pain in extremity, Unresponsive to stimuli
Clinical narrative: Minimally responsive; Severe left arm pain; systemic weakness and lethargy resulting in 5 falls within the week after the shot; systemic weakness and lethargy resulting in 5 falls within the week after the shot; systemic weakness and lethargy resulting in 5 falls within the week after the shot; This is a spontaneous report from a contactable nurse. An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 86-year-old, via an unspecified route of administration, administered in left arm on 24Mar2021 (Lot Number: ER2613) as single dose for COVID-19 immunisation. Medical history included cerebrovascular disease, HTN, DMII, dementia. Concomitant medications included metformin, glimepiride, amlodipine, acetylsalicylic acid (ASPIRIN (E.C.)), senna alexandrina leaf, and vitamin D. The patient was not diagnosed with COVID-19 prior vaccination and was not tested post vaccination. The patient has no known allergies. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6206) at the age of 86-year-old, on 03Mar2021 11:00 AM, intramuscular at the left arm for COVID-19 immunisation. On 25Mar2021 06:00 AM, the patient experienced severe left arm pain, systemic weakness and lethargy. This resulted in 5 falls within the week after the shot on 24Mar2021. Minimally responsive on 05Apr2021 and transferred with full assist to hospital bed. Gathered family for goodbyes on 06Apr2021 as appeared terminal. On 07Apr2021 some alertness in afternoon and strength has been slowly improving as of today 12Apr2021. No treatment was received for the events. The patient was hospitalized due to the event minimally responsive on 05Apr2021. The outcome of the events was recovering.; Sender's Comments: Based on the available information, the Company considers the reported event minimally responsive is unrelated to BNT162B2 vaccination but more likely an inter-current medical condition in this 86-year-old male patient with medical history of cerebrovascular disease, HTN, DMII, dementia. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis perforated, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: experience appendicitis like pain in abdomen/diagnosed with a perforated appendicitis; This is a spontaneous report from a contactable consumer (who is also the patient). A 61-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm, on 31Mar2021 12:30, as single dose, for covid-19 immunisation. Medical history included known allergy to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). On 01Apr2021 at 13:30 (reported as "24 hours after the first Pfizer jab on 31Mar2021"), the patient experienced appendicitis like pain in abdomen. She was diagnosed on 04Apr2021 at the emergency room (ER) with a perforated appendicitis. This resulted to hospitalization for 3 days in Apr2021. Treatment for the events included "CT scans and IV antibiotics". The patient underwent lab tests and procedures which included computerised tomogram (CT scans): perforated appendicitis; and COVID nasal swab: negative, both on 04Apr2021. The patient was recovering from the event.  Information on the lot/ batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, C-reactive protein, Crying, Investigation, Mobility decreased
Clinical narrative: Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to move without screaming and crying; Unable to move without screaming and crying; Lost 7.8 lbs in 6 days; This is a spontaneous report from a contactable physician. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (received at 64-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included refractory lymphocytic microcolitis. The patient was not pregnant. She had no COVID prior to vaccination. Concomitant medication(s) included budesonide (BUDESONIDE) taken for an unspecified indication from 01Apr2021 to an unspecified stop date; vedolizumab (ENTYVIO) taken for an unspecified indication from 09Mar2021 to an unspecified stop date. The patient previously took diflucan, nitrofurantoin, flagyl [metronidazole] and experienced allergies (known allergies). On 05Apr2021 06:00 AM, the patient had an acute onset of unspeakable back pain 10/10. She was unable to move without screaming and crying. The patient received Flexeril and was hospitalized 5 days. The patient underwent laboratory test and procedures which included: CRP (C-reactive protein) =170, Sedimentation rate=34. She had no cardio or pulmonary issues. She lost 7.8 lbs in 6 days (weight 103). It was reported that all adverse events occurred on 05Apr2021 06:00 AM. The patient was tested for COVID post vaccination via nasal swab on 02Apr2021 and 07Apr2021 with results of negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient received corrective treatment in response to the adverse events, which included Dilaudid and Valium and hold still in bed. Outcome of the events was recovering.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, SARS-CoV-2 antibody test, Screaming, Weight, Weight decreased
Clinical narrative: Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to move without screaming and crying; Unable to move without screaming and crying; Lost 7.8 lbs in 6 days; This is a spontaneous report from a contactable physician. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (received at 64-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included refractory lymphocytic microcolitis. The patient was not pregnant. She had no COVID prior to vaccination. Concomitant medication(s) included budesonide (BUDESONIDE) taken for an unspecified indication from 01Apr2021 to an unspecified stop date; vedolizumab (ENTYVIO) taken for an unspecified indication from 09Mar2021 to an unspecified stop date. The patient previously took diflucan, nitrofurantoin, flagyl [metronidazole] and experienced allergies (known allergies). On 05Apr2021 06:00 AM, the patient had an acute onset of unspeakable back pain 10/10. She was unable to move without screaming and crying. The patient received Flexeril and was hospitalized 5 days. The patient underwent laboratory test and procedures which included: CRP (C-reactive protein) =170, Sedimentation rate=34. She had no cardio or pulmonary issues. She lost 7.8 lbs in 6 days (weight 103). It was reported that all adverse events occurred on 05Apr2021 06:00 AM. The patient was tested for COVID post vaccination via nasal swab on 02Apr2021 and 07Apr2021 with results of negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient received corrective treatment in response to the adverse events, which included Dilaudid and Valium and hold still in bed. Outcome of the events was recovering.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cough, Heart rate
Clinical narrative: 107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 °F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 °F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82.  The outcome was recovering.  Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender's Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperpyrexia, Nasopharyngitis, Palpitations
Clinical narrative: 107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 °F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 °F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82.  The outcome was recovering.  Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender's Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally 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: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Immediate mid section itching and hives; Immediate mid section itching and hives; Extremely swollen left arm and hand within two days; Hives turned to water blisters; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient had no prior COVID vaccination, no COVID test post vaccination and no other vaccine in the last four weeks. The patient had unspecified concomitant medications for the last two weeks. The patient experienced immediate mid-section itching and hives. Extremely swollen left arm and hand within two days. Hives turned to water blisters, unaffected by prednisone. Blisters first appeared on arms, back and stomach and advanced to underarms and groin area. Hospitalization for five days was necessary. The events started on 09Feb2021. Intravenous steroids and antibiotics were given as treatment. The second dose of BNT162B2 was given on 18Feb2021 11:00 on the left arm. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope two hours after the vaccine.; This is a spontaneous report from a contactable other hcp (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ew0151), via an unspecified route of administration, administered in Arm Right on 11Apr2021 13:00 (at 35-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant.  Vaccination facility type was Pharmacy or Drug Store. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. Patient had no known allergies. The patient experienced syncope two hours after the vaccine on 11Apr2021 15:00, she never had any history of syncope before. No treatment was received. The outcome of the event was recovered in Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: a minor attack of vertigo; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the second of three reports. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient had a minor attack of vertigo (hospitalization) on an unspecified date with outcome of unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021400449 same drug, different patient, similar AE;US-PFIZER INC-2021402493 same drug, different patient, similar AE
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: had a minor attack of vertigo; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had a minor attack of vertigo (hospitalization) on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402492 same drug, different patient, similar AE;US-PFIZER INC-2021400449 same drug, different patient, similar AE
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Diarrhoea, SARS-CoV-2 test
Clinical narrative: upper stomach pain; chills; vomiting all night and diarrhea; vomiting all night; severe back ache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021 at 12:00 as a single dose for COVID-19 immunization.  Medical history included colitis from an unknown date and unknown if ongoing. Concomitant medication included mesalamine (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks. The patient was tested for COVID-19 with a nasal swab on 04Apr2021 with a result of negative. On 01Apr2021 at 06:00 PM, the patient started to have severe back ache. The patient took Aleve and it didn't go away. The patient then had dinner and took Tylenol extra strength and tried to sleep. The patient took Benadryl to go to sleep as the pain was unbearable. The next day, 02Apr2021, the patient was fine until 09:30 PM. The unbearable backpain came back and the patient also had upper stomach pain. The patient had chills, no fever, vomiting all night and diarrhea. The pain never went away. By Sunday, 04Apr2021, the patient went to the hospital in the emergency room and her gallbladder was removed. The patient was hospitalized on 04Apr2021, for two days, due to the events. The outcome of the events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: upper stomach pain; chills; vomiting all night and diarrhea; vomiting all night; severe back ache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021 at 12:00 as a single dose for COVID-19 immunization.  Medical history included colitis from an unknown date and unknown if ongoing. Concomitant medication included mesalamine (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks. The patient was tested for COVID-19 with a nasal swab on 04Apr2021 with a result of negative. On 01Apr2021 at 06:00 PM, the patient started to have severe back ache. The patient took Aleve and it didn't go away. The patient then had dinner and took Tylenol extra strength and tried to sleep. The patient took Benadryl to go to sleep as the pain was unbearable. The next day, 02Apr2021, the patient was fine until 09:30 PM. The unbearable backpain came back and the patient also had upper stomach pain. The patient had chills, no fever, vomiting all night and diarrhea. The pain never went away. By Sunday, 04Apr2021, the patient went to the hospital in the emergency room and her gallbladder was removed. The patient was hospitalized on 04Apr2021, for two days, due to the events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypotension
Clinical narrative: rapid heart beat; Low blood pressure; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 (Batch/Lot number and Expiry date were not reported) as a single dose for COVID-19 immunization. The patient's medical history included that he was an ongoing heart patient (unspecified). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced rapid heart beat and low blood pressure. The patient was hospitalized for rapid heart beat and low blood pressure on an unspecified date and stayed in the hospital for about 3 days. The patient further stated he racked up quite a bill and had asked his doctors before he took the vaccine if they thought it would be safe and they didn't know for sure. The patient was just calling to let Pfizer know and avoid it happening to other patients. The patient was wondering if Pfizer felt somewhat responsible for his bills. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Productive cough, Pulmonary congestion
Clinical narrative: My lungs also got congested; fatigue; cough up phlegm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 29Mar2021 15:45 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma, high blood pressure and ongoing MS (multiple sclerosis). Concomitant medications included atenolol;chlorthalidone, methylphenidate hydrochloride (RITALIN) and escitalopram oxalate (LEXAPRO). On 29Mar2021 16:30, the patient experienced lungs also got congested after she got the vaccine. They sound like they do after she have had an asthma attack, and she could actually cough up phlegm. She had MS previously and ever since she got the vaccine, her fatigue had increased exponentially and hasn't gotten any better since she got the shot two weeks ago. No treatment was received for the events. The facility where the vaccine was administered was in a school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: My lungs also got congested; fatigue; cough up phlegm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 29Mar2021 15:45 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma, high blood pressure and ongoing MS (multiple sclerosis). Concomitant medications included atenolol;chlorthalidone, methylphenidate hydrochloride (RITALIN) and escitalopram oxalate (LEXAPRO). On 29Mar2021 16:30, the patient experienced lungs also got congested after she got the vaccine. They sound like they do after she have had an asthma attack, and she could actually cough up phlegm. She had MS previously and ever since she got the vaccine, her fatigue had increased exponentially and hasn't gotten any better since she got the shot two weeks ago. No treatment was received for the events. The facility where the vaccine was administered was in a school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: every 15-30 minutes, patient's heart seems to flutter and feel almost like jello, almost like a hiccup or something; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 12:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included known allergies to drugs: sulfa drugs and food: hazelnut, apple, peach. The patient was not pregnant at the time of report and vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ethinylestradiol, norgestimate (TRI-SPRINTEC); colecalciferol (VIT D3); and cobamamide (VITAMIN B12 [COBAMAMIDE]). Patient had no COVID prior to vaccination and was not tested for COVID post vaccination. It was reported that every 15-30 minutes, patient's heart seems to flutter and feel almost like jello, almost like a hiccup or something. Patient began to notice this on Sunday, the day after she was vaccinated, but it's possible that it could have been happening on Saturday as well. The patient did not receive treatment for the event. Event start date was reported as 11Apr2021 at 12:00. Outcome of the event was not recovered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: Fever; nightsweats; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), gout, and lung cancer (remission). Patient has no COVID-19 prior to vaccination. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever and nightsweats on 01Apr2021. The patient was hospitalized for fever and nightsweats for 3 days. The outcome of the events was recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: consumer reported that the patient in the hospital bed next to her had the same shot and on the same day and was hospitalized at the same time has her with the same diagnosis and surgery which is appendicitis requiring appendectomy; This is a spontaneous report from a contactable consumer reporting for a patient. This consumer reported similar events for two patients. This is the second of two reports. This is a spontaneous report from a contactable consumer reporting for a patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The reporting consumer reported that the patient in the hospital bed next to her had the same shot and on the same day and was hospitalized at the same time has her with the same diagnosis and surgery which is appendicitis requiring appendectomy. Event onset date was reported as 31Mar2021. Hospitalization date was unknown. Outcome of the event was unknown.  Information on the lot number has been requested.; Sender's Comments: Linked Report(s) : 2021401328 same reporter, drug and event, different patient
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Vulvovaginal pain
Clinical narrative: extreme pain in the vaginal area and noticed I had some bumps; vaginal area noticed had some bumps/ herpes; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) via unspecified route on right arm single dose for COVID-19 immunisation on 08Apr2021, 05:30 PM, at 20-year-old. Medical history included: allergies: sulfamethoxazole, trimethoprim (BACTRIM). Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) on right arm for COVID-19 immunization on 20Mar2021, 10:30 AM, at 20-year-old. Two days after having second shot (10Apr2021, 08:00 PM), the patient started to experience extreme pain in the vaginal area and noticed had some bumps. The patient went to the hospital and the doctors believed it to be herpes. No test results have not come back yet. They Believed the virus had been asymptomatic prior and getting the vaccine triggered an outbreak. Emergency room/department or urgent care visited and was reported as hospitalized. Treatment received included: antiviral medication and pain medications. Outcome of the events was not resolved.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Death, Seizure
Clinical narrative: increased body temperature, seizure, death
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme, Full blood count, Rash
Clinical narrative: Erythema Multiforme Major - Severe rash on right inner thigh and pubic region .
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Fever Bodyaches Chills Cough Runny nose Fatigue
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Fever Bodyaches Chills Cough Runny nose Fatigue
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis, Investigation, Pain in extremity, Thrombosis
Clinical narrative: Approximately 2 weeks after the vaccine, inexperienced deep leg pain.  3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain.  3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain.  3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; This is a spontaneous report from a contactable consumer.  A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later, the patient went to the hospital and was diagnosed with a blood clot/DVT. AE resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events: Vitals taken, blood work, prescribed blood thinner. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date ae treatment= Vitals taken, blood work , investigation: blood clot/dvt on 08Apr2021 3 days later I went to the hospital and  was diagnosed with a blood clot/DVT, investigation: unknown result on an unspecified date ae treatment= Vitals taken, blood work.  The outcome of the event was recovering. The patient does not have COVID prior vaccination, and was not COVID tested post vaccination. The patient has no known allergies.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a rash on my arms and legs.  Pink bumps that whenever I scratch them turn dark.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Rash
Clinical narrative: Blood clots in stool, weird bloody stringy thing, rash on left arm that appeared days earlier and hasn't gone away.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Paraesthesia
Clinical narrative: The night after the second injection, she started feeling tingling on the left hand fingers tips and pain in the left knee and ankle. After one to two days the pains subsided but the knee keeps warbling and shakes when she try to walk or stand on it.  Up to now, the tingling is not severe as at first but warbling is almost the same.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Electrocardiogram, Headache, Heart rate irregular, Influenza like illness
Clinical narrative: Following the first dose, I was referred for an EKG by my primary physician. My heartbeat was irregular and the doctors said it was probably from the vaccination. I had severe arm pain and flu-like symptoms. Dose 2, I had intense lymph node swelling and pain of vaccination site, a three-day continuous fever between 99 and 102 degrees, no sleep and horrible body/head pain.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Lymph node pain, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Following the first dose, I was referred for an EKG by my primary physician. My heartbeat was irregular and the doctors said it was probably from the vaccination. I had severe arm pain and flu-like symptoms. Dose 2, I had intense lymph node swelling and pain of vaccination site, a three-day continuous fever between 99 and 102 degrees, no sleep and horrible body/head pain.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Following the first dose, I was referred for an EKG by my primary physician. My heartbeat was irregular and the doctors said it was probably from the vaccination. I had severe arm pain and flu-like symptoms. Dose 2, I had intense lymph node swelling and pain of vaccination site, a three-day continuous fever between 99 and 102 degrees, no sleep and horrible body/head pain.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Fever (101)  around 16 hours after second dose, fatigue, headache, swollen lymph nose on left side,  pain at injection site
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, hot, hard, itchy area at injection site
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tenderness
Clinical narrative: Soreness, chills
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Thrombosis
Clinical narrative: Swelling underneath my left arm pit which may be a possible blood clot; Swelling underneath my left arm pit which may be a possible blood clot; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 08Apr2021 (16:15) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (05:45), the patient had swelling underneath my left armpit which may be a possible blood clot. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 12 days after receiving the vaccine, I noticed a red oval/circle mark around the injection site. (otherwise known as "covid arm") I also noticed that my left arm was a little itchy as well. The redness went away after 4-5 days.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: bloody stool; Severe stomach pains; fever(103 degrees); diarrhea; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 (Batch/Lot Number: EN6208) at the age of 35-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications, no other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Severe stomach pains, diarrhea, fever (103 degrees), bloody stool on 24Mar2021 06:00. Adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment included Antibiotics, pain meds and colonoscopy for adverse events of Severe stomach pains, fever and bloody stool. Covid test post vaccination (Nasal Swab) on 02Apr2021: Negative. The outcome of the events was recovering. The patient received second dose of bnt162b2 (lot number: ER8737) on 02Apr2021 at Left arm for covid-19 immunisation.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event haematochezia, abdominal pain and pyrexia and the suspect drug.  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.