chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy test
Clinical narrative: I had a positive pregnancy test on 28Sep after my second COVID vaccine. This pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Sep2021 (Batch/Lot Number: 30155BA) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 05Sep2021 (Batch/Lot Number: Fc3183) as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 29-year-old). Medical history included allergies to Penicillin, Sulfa. Concomitant medication(s) included fluoxetine; valacyclovir [valaciclovir]; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). The patient had a positive pregnancy test on 28Sep2021 after the second covid vaccine. this pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was recovering. No treatment received for the event. The patient underwent lab tests and procedures which included pregnancy test: positive on 28Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101449286 similar report from same reporter
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness
Clinical narrative: Bell's Palsy; dizziness; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN5318), intramuscularly administered in left arm on 24Jan2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization at workplace clinic. Medical history and concomitant medications were none. Prior Vaccinations (within 4 weeks) were none. The patient experienced bell's palsy and dizziness on 09Feb2021. Bell's palsy occurred after receiving 1st COVID vaccine and the patient did not guesting it because there was family of bell's palsy. No treatment was received as a result of the events. The outcome of the events was recovered in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: About the site and some burning and pressed the area to find the injection site/ typical symptoms of pain that developed hours later; Tiredness; Feeling lousy; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A 74-year-old male patient received unknown dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that per caller the pharmacist who injected him with Pfizer covid 19 vaccines went what he thought was fairly low with a 1-inch needle. He had amazing pain reaction when she pushed the plunger. He experienced the typical symptoms of pain that developed hours later, tiredness and feeling lousy. The next day he was concerned about the site, some burning and pressed the area to find the injection site about 1-2 days later. Caller voiced that he hoped he didn't cause any damage with the vaccine by pressing the site. He asked how long it takes the Pfizer covid 19 vaccines to disperse from the deltoid muscle. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Thrombosis
Clinical narrative: it might be blood clot; I have a node on my left leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left in Oct2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 48-year-old). Medical history included asthma, ongoing Blood pressure high, allergies, headache. The concomitant medication included cetirizine for High blood pressure (as reported). No Prior vaccinations received Within 4 weeks. In Oct2021 the patient had a node on the left leg, it's like a 'bulb', it had never been there and you can find it, it had never been there, it might be blood clot. No treatment received for the event. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: Severe diarrhea, lasting over 6 days; Lost 5 pounds; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 04Oct2021 at 15:00 (at age of 75 years old, Lot Number: FE3590) as a single dose for covid-19 immunisation. Medical history included osteoporosis, glaucoma, allergies, high blood pressure, high cholesterol; known allergies: penecillin, cephalosporins, demerol, dorzolamide, meperidine, neosporin, polymixin, trimethoprim. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), pantoprazole, losartan, simvastatin. No other vaccine in four weeks. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 administered in right arm on 02Mar2021 (at age of 75 years old, Lot Number: EN6208) and dose 1 administered in left arm on 09Feb2021 (at age of 75 years old, Lot Number: EL9269), both via an unspecified route of administration as a single dose for covid-19 immunisation. The patient not had covid prior vaccination, also not had covid tested post vaccination. On 05Oct2021 at 03:00, the patient experienced Severe diarrhea, lasting over 6 days, despite eating BRATY diet, and upon consultation with pharmacist, taking immodium for the last two days. Lost 5 pounds. The outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Nausea, Pain in extremity, Pruritus
Clinical narrative: feels a little hot; Itching; 2-3 days of fever; nausea; sore arm; Coughing; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FC3184, Expiry date: Unknown) via an unspecified route of administration on 11Oct2021 in the afternoon between 13:00-15:00 (age at vaccination was 78-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date: Unknown) via an unspecified route, administered in left arm on 03Feb2021 and the patient received  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiry date: Unknown) dose 2 via an unspecified route, administered in left arm on 24Feb2021 for COVID-19 immunization and after second dose patient experienced lung disease/ lung disease is Bronchiectasis, a couple days of nausea, arm hardly a sore, GI issues and dermatological issue. 2.5 weeks before the booster patient had the flu shot, had it on 24Sep2021 for immunization, but didn't think it had anything to do with that. Patient previously took histamine (the itching, this happened to her about a year before due to histamine reaction but she hadn't had an issue since then). On an unspecified date in Oct2021 the patient experienced sore arm on the day or 2 after, a week later 3 days of coughing. Patient had about a day of itching, 2-3 days of fever and nausea on 22Oct2021. On 27Oct2021 patient still feels a little hot but she does not registered a normal temper normally. On an unspecified date the patient underwent lab tests and procedures which included body height: shrunk (she use to be 5ft 10.5 inches), influenza: negative, respiratory syncytial virus test: negative and sars-cov-2 test: negative. Therapeutic measures were taken as a result of coughing. The patient remarks that everything that happened could have been related to her previous issues but was not her normal pattern. She experience things similar but each thing was not her normal, they were a little more than her normal. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feels a little hot; Itching; 2-3 days of fever; nausea; sore arm; Coughing; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FC3184, Expiry date: Unknown) via an unspecified route of administration on 11Oct2021 in the afternoon between 13:00-15:00 (age at vaccination was 78-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date: Unknown) via an unspecified route, administered in left arm on 03Feb2021 and the patient received  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiry date: Unknown) dose 2 via an unspecified route, administered in left arm on 24Feb2021 for COVID-19 immunization and after second dose patient experienced lung disease/ lung disease is Bronchiectasis, a couple days of nausea, arm hardly a sore, GI issues and dermatological issue. 2.5 weeks before the booster patient had the flu shot, had it on 24Sep2021 for immunization, but didn't think it had anything to do with that. Patient previously took histamine (the itching, this happened to her about a year before due to histamine reaction but she hadn't had an issue since then). On an unspecified date in Oct2021 the patient experienced sore arm on the day or 2 after, a week later 3 days of coughing. Patient had about a day of itching, 2-3 days of fever and nausea on 22Oct2021. On 27Oct2021 patient still feels a little hot but she does not registered a normal temper normally. On an unspecified date the patient underwent lab tests and procedures which included body height: shrunk (she use to be 5ft 10.5 inches), influenza: negative, respiratory syncytial virus test: negative and sars-cov-2 test: negative. Therapeutic measures were taken as a result of coughing. The patient remarks that everything that happened could have been related to her previous issues but was not her normal pattern. She experience things similar but each thing was not her normal, they were a little more than her normal. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, X-ray
Clinical narrative: Chest pain; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 21Sep2021 13:30 (Lot Number: 30135BA), at the age of 16-year-old, as dose 2, single for COVID-19 immunisation. The patient was not pregnant. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (Lot number: FC3181) on 31Aug2021at 01:00 PM, in left arm for COVID-19 immunization. The patient experienced chest pain and trouble breathing on 21Sep2021 22:00. Still having these issues 5 weeks later. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the events. The patient underwent lab tests and procedures which included EKG, X-ray, Blood work in 2021 with unknown results. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: had flare of RA; This is a spontaneous report based on information received by Pfizer from the Regulatory Authority (Manufacturer control number US-AMGEN-USASP2021072400) from a contactable consumer (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 2021 as DOSE 3 (BOOSTER), SINGLE for Covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication(s) included etanercept (ENBREL) taken 50 mg weekly for rheumatoid arthritis on unspecified date on 2021. On an unknown date in 2021, the patient received the "COVID booster" and had flare of RA (rheumatoid arthritis). The outcome of the event was not recovered.   No follow-up attempts possible. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Nausea, Pneumonia, Pyrexia
Clinical narrative: diarrhea; nausea; fever; Dyspnoea/shortness of breath; pneumonia; This is a spontaneous report from a contactable other health professional (patient's child). A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 08Mar2021 12:00 (Lot Number: unknown) as single dose for covid-19 immunisation at the age of 74-year-old. Medical history included colitis. There was no other vaccine in four weeks. Patient had no known allergies and no covid prior vaccination. Concomitant medications included azathioprine sodium (IMURAN) from an unspecified date and ongoing taken for colitis ulcerosa and steroid etc. The patient experienced diarrhea, nausea, fever, dyspnoea/shortness of breath and pneumonia on 10Mar2021 at 01:00 AM. The patient was hospitalized for events for 4 days.  Events resulted in physician or other hcp office visit, emergency or emergency medicine, hospital treatment and patient died. He had negative COVID test. The patient underwent lab tests and procedures which included nasal swab: negative on 25Mar2021. The patient died on 28Mar2021.  An autopsy was not performed. Patient received oxygen and antibiotics therapy for events. Outcome of events was fatal.   Events occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.; Reported Cause(s) of Death: Pneumonia; Dyspnoea/shortness of breath; fever; nausea; diarrhea
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: diarrhea; nausea; fever; Dyspnoea/shortness of breath; pneumonia; This is a spontaneous report from a contactable other health professional (patient's child). A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 08Mar2021 12:00 (Lot Number: unknown) as single dose for covid-19 immunisation at the age of 74-year-old. Medical history included colitis. There was no other vaccine in four weeks. Patient had no known allergies and no covid prior vaccination. Concomitant medications included azathioprine sodium (IMURAN) from an unspecified date and ongoing taken for colitis ulcerosa and steroid etc. The patient experienced diarrhea, nausea, fever, dyspnoea/shortness of breath and pneumonia on 10Mar2021 at 01:00 AM. The patient was hospitalized for events for 4 days.  Events resulted in physician or other hcp office visit, emergency or emergency medicine, hospital treatment and patient died. He had negative COVID test. The patient underwent lab tests and procedures which included nasal swab: negative on 25Mar2021. The patient died on 28Mar2021.  An autopsy was not performed. Patient received oxygen and antibiotics therapy for events. Outcome of events was fatal.   Events occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.; Reported Cause(s) of Death: Pneumonia; Dyspnoea/shortness of breath; fever; nausea; diarrhea
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: Severe Ice pick headaches followed by Bell's Palsy; Severe Ice pick headaches followed by Bell''s Palsy; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm right on 08Oct2021 11:00 AM (Age at Vaccination: 45 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included known allergies to Penicillin. If other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. device time stamp was 29Oct2021.The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on arm right on 17Sep2021 11:00 AM (at the age of 45 years) as DOSE 1, SINGLE for COVID-19 immunisation. On 19Oct2021 05:00 AM, the patient experienced severe ice pick headaches followed by bells palsy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of events and treatment included Steroids. The outcome of events was not resolved.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Electrocardiogram, Myocardial infarction
Clinical narrative: heart attack; clogged her arteries; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program.   A 63-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0171), dose 2 via an unspecified route of administration on 28Apr2021 as dose 2, single and dose 1 via an unspecified route of administration on 29Mar2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. No PQC was present. Medical history included heart disease (mother's side). The patient concomitant medication was not reported. On 10Oct2021, the patient experienced heart attack, and on an unspecified date in 2021 the patient had clogged her arteries. The patient underwent lab tests and procedures which included electrocardiogram resulted normal. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, SARS-CoV-2 test
Clinical narrative: Blood pressure swings from 155/93 to 91/51. Blood pressure drops after eating.; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: FF2587), via an unspecified route of administration, administered in left arm on 08Oct2021 at 15:00 (at the age of 52-years) as dose 3 (booster), single for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in left arm on 08Feb2021 at 10:00 (at the age of 51-years) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM6203), via an unspecified route of administration, administered in left arm on 01Mar2021 at 10:30 (at the age of 51-years) as dose 2, single for covid-19 immunization. The patient had known allergies to shrimp, Aspirin, ibuprofen, penicillin. The patient had not received any other vaccine within 4 weeks prior to Covid vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included doxycycline (DOXYCYCLINE). On 25Oct2021, the patient had blood pressure swings from 155/93 to 91/51, blood pressure dropped after eating. This resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure measurement: 155/93 on an unspecified date in Oct2021 and 91/51 on an unspecified date in Oct2021. The patient was tested for covid 19 after vaccination with a nasal swab test on 26Oct2021, showed sars-cov-2 test negative. It was unknown if the patient had received any treatment for the event. The outcome of the event was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result=Positive; covid_test_result=Positive; spread body rash all over my arms. Chest, torso, thighs and calves that got worse over time.; developed a wide spread body rash/that got worse over time; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3183) via intramuscular route of administration in right arm on 02Sep2021 as DOSE 2, SINGLE (age at vaccination 41 years) for covid-19 immunisation and dose 1 of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FC3181) via intramuscular route of administration in right arm on 12Aug2021 as DOSE 1, SINGLE (age at vaccination 41 years) for covid-19 immunisation. The patient had no known allergies. The patient concomitant medications were not reported. The patient's other medical history was reported as none. Patient received most recent COVID-19 vaccine at Pharmacy or Drug Store. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks of vaccination. The patient had not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. After 6 days of vaccination on 11Sep2021 patient experienced wide spread body rash all over her arms, chest, torso, thighs and calves that got worse over time. It lasted about 4 weeks. Rash has gotten better but still a little on her thighs. The patient underwent nasal swab test on 18Oct2021 with result positive. Adverse event resulted patient visited Doctor or other healthcare professional office/clinic visit. Patient received treatment for events with multiple medrol dose packs, 5 day course anti viral medication, z pack and topical steroid cream. The outcome of events were recovering.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Burning sensation, Off label use, Product use issue, Pruritus, Rash
Clinical narrative: 8 days after receiving my 3rd booster Pfizer vaccine I developed a severe rash starting under my left breast area which spread to my fingers, arm, stomach, face and back.; started burning then so itchy it was unbearable; started burning then so itchy it was unbearable; other vaccine same date: Flu vaccine; Off-label use; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2590), third dose via an unspecified route of administration, administered in Arm Left on 13Oct2021 12:00 (At the age of 51 year) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and on same day patient also took influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 13Oct2021 (Batch/Lot number was not reported) to 13Oct2021, at DOSE 1, SINGLE for immunization. Medical history included hypertension (other medical history: high blood pressure), asthma (other medical history: Asthma) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 16:00 (At the age of 51 year) as dose 2 single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 16:00 (At the age of 51 year) as dose 1 single for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient experienced eight days after receiving my third booster Pfizer vaccine and developed a severe rash starting under my left breast area which spread to my fingers, arm, stomach, face and back. First started burning then so itchy it was unbearable. Had to see a doctor twice and was put on prednisone to help relieve my itching & spreading. Just started the first dose of antibiotics today seems to be helping. she knew it is the vaccine since she did nothing else out of the ordinary prior to this outbreak. The adverse event resulted in doctor or other healthcare professional office/clinic visit. While treatment received for the adverse events was Prednisone and ketoconazole. Case was considered as non-serious. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, SARS-CoV-2 test, Vitreous floaters
Clinical narrative: huge floaters in my right eye; it disrupted my ability to work at my job; This is a spontaneous report from a contactable consumer(patient). A 60-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30145BA) via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:45 (Age at vaccination 60-years-old) as dose 1, single for covid-19 immunisation. Medical history includes Right shoulder injury and chronic work stress, ADHD primarily Inattentive type from unknown date to unknown if ongoing and Known allergies Penicillin, shrimp, lobster, codeine in Aspirin. Concomitant medication includes bupropion hcl (BUPROPION HCL) taken for an unspecified indication with in 2 weeks of vaccination. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 13Oct2021 at 11:00 am, patient stated that I got huge floaters in my right eye, and it disrupted my ability to work at my job. I had to go to the optometrist to get my eyes examined. Adverse event results in physician office visit. Events leads to Disability. Treatment received for the adverse event with eye exam and need for new glasses. Patient has not diagnosed with COVID-19 prior to vaccination and tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test and result was negative on 28Oct2021 Nasal Swab. Outcome of the was not recovered.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: Tinnitus-ringing in ears; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 30Oct2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 26Feb2021 at 14:00 (at the age of 65-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on an unknown date in 2021 at 14:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 31Oct2021, the next morning of vaccination at 04:00, the patient experienced tinnitus-ringing in ears. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus-ringing in ears was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). This report was received via Pfizer Sales Representative.  A male patient of an unspecified age (approximately 40) received third dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. After 5 days following vaccination on an unspecified date, the patient had sudden onset of bell's palsy. The outcome of the event was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Limb discomfort, SARS-CoV-2 test, Vaccination site mass
Clinical narrative: I had a severe headache; bilateral legs felt heavy; intermittent chest pain for 2 weeks; lump at injection site; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in Arm Right on 17Sep2021 17:30 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Stage 2A cancer left breast, in remission; Lymphedema left axilla, arm, and scapula. Concomitant medication(s) included exemestane 25 mg taken for an unspecified indication, start and stop date were not reported; vitamin d 2,000 IU (vitamin d NOS) taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks and other medications in two weeks included Exemestane 25 mg; Vitamin D 2,000 IU; Folic Acid. The patient experienced a severe headache, bilateral legs felt heavy, intermittent chest pain for 2 weeks, lump at injection site on an unspecified date. Patient did not have covid prior vaccination and covid was tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test (Binax) negative on 01Nov2021 Nasal Swab. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (Pfizer/BionTech COVID-19 Vaccine), dose 1 via an unspecified route of administration administered in left arm on 02Mar2021 13:00 (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included dupilumab (DUPIXENT) taken for asthma and eczema from Oct2019 to Feb2021. The patient experienced diarrhea on 03Mar2021. The seriousness of event was medically significant. Event required visit test: physical office. No treatment received. No prior vaccinations within 4 week. The outcome of event was recovered on 20Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Menstrual disorder, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding off normal menstrual cycle; Vaginal bleeding off normal menstrual cycle; Body chills; Weakness; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 49-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 27Oct2021 (age at vaccination 49-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of dose 1 and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unknown date as dose 1, single and as dose 2, single for covid-19 immunisation. After 3 days, the patient began vaginal bleeding off normal menstrual cycle on 30Oct2021, Bleeding was also darker than normal cycle. The bleeding followed day of body chills and weakness on unspecified date of 2021. The outcome of the events was unknown.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Diarrhoea, Headache
Clinical narrative: Bad headache; Weak / weak but not as much as yesterday / not as weak today; Chills; Ache and pains all over; Today back pain so bad "I" couldn't stand or sit still weak but not as much as yesterday / Today again have back pain and trouble standing and sitting upright; Also have diarrhea/No diarrhea yet; The patient received the third/booster dose of BNT162b2; Arm was sore; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 30Oct2021 at 17:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included control diabetic, previous heart issues and high blood pressure not controlled. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9269) via an unspecified route of administration in the left arm on 18Feb2021 (at the age of 60-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. It was reported that she had got the booster shot on 30Oct2021 (Saturday) and it was so different than the first two shot, from them she had no bad side effects but this booster was kicking her butt. On 30Oct2021, the day of the shot, the patient's arm was sore. On 01Nov2021, the patient experienced bad headache, weak, chills, ache and pains all over. On 02Nov2021, the day of this report, the patient also had back pain which was so bad that she could not stand or sit still, the patient was weak but not as much as the day before (01Nov2021) but then also had diarrhea. On the same day, the patient had back pain again and trouble standing and sitting upright, she was not as weak that day and had no diarrhea yet. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm was sore, bad headache, weak / weak but not as much as yesterday / not as weak today, chills, ache and pains all over, today back pain so bad "I" couldn't stand or sit still / today again have back pain and trouble standing and sitting upright was not resolved and while the outcome of the also had diarrhea/ No diarrhea yet was unknown at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pain in extremity
Clinical narrative: Bad headache; Weak / weak but not as much as yesterday / not as weak today; Chills; Ache and pains all over; Today back pain so bad "I" couldn't stand or sit still weak but not as much as yesterday / Today again have back pain and trouble standing and sitting upright; Also have diarrhea/No diarrhea yet; The patient received the third/booster dose of BNT162b2; Arm was sore; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 30Oct2021 at 17:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included control diabetic, previous heart issues and high blood pressure not controlled. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9269) via an unspecified route of administration in the left arm on 18Feb2021 (at the age of 60-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. It was reported that she had got the booster shot on 30Oct2021 (Saturday) and it was so different than the first two shot, from them she had no bad side effects but this booster was kicking her butt. On 30Oct2021, the day of the shot, the patient's arm was sore. On 01Nov2021, the patient experienced bad headache, weak, chills, ache and pains all over. On 02Nov2021, the day of this report, the patient also had back pain which was so bad that she could not stand or sit still, the patient was weak but not as much as the day before (01Nov2021) but then also had diarrhea. On the same day, the patient had back pain again and trouble standing and sitting upright, she was not as weak that day and had no diarrhea yet. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm was sore, bad headache, weak / weak but not as much as yesterday / not as weak today, chills, ache and pains all over, today back pain so bad "I" couldn't stand or sit still / today again have back pain and trouble standing and sitting upright was not resolved and while the outcome of the also had diarrhea/ No diarrhea yet was unknown at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: diarrhea with blood; This is a spontaneous report from a contactable consumer (patient's husband).   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration (at the age of 61 years) on an unspecified date as dose number unknown (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea with blood on an unspecified date. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Investigation
Clinical narrative: Major Dizziness and Vomiting; Major Dizziness and Vomiting; Continue to get pings throughout body and across the chest; Body Temperature stays 1.5 degree hotter than normal.; Major joint pain mainly in legs and groin; Constant ache and pain and chills; Constant ache and pain and chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26Aug2021 12:00 (Batch/Lot Number: EW1072) as single dose for COVID-19 immunisation (age at vaccination was 52-year-old). Medical history was none. Patient had no known allergies. There were no concomitant medications. The patient experienced major dizziness and vomiting. Patient went to ER and they tested him for heart attack, stroke and ran blood work. No Conclusions sent him home. Body temperature stayed 1.5 degree hotter than normal. Major joint pain mainly in legs and groin. Constant ache and pain and chills. Mainly at night. Continue to get pings throughout body and across the chest. Events onset on 10Sep2021 at 16:45. Patient underwent nasal swab on 15Sep2021: negative. Elected not to get 2nd dose. Doctor advised to wait max weeks and get 2nd dose. Concern that 2nd dose would make the dizziness worse. This really stinks. Patient was 52 years old and had never felt this bad since after the vaccine.   Therapeutic measure was taken as a result of dizziness included medicine to stop the dizziness. Outcome of the events was recovered/resolved with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Joint noise, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Major Dizziness and Vomiting; Major Dizziness and Vomiting; Continue to get pings throughout body and across the chest; Body Temperature stays 1.5 degree hotter than normal.; Major joint pain mainly in legs and groin; Constant ache and pain and chills; Constant ache and pain and chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26Aug2021 12:00 (Batch/Lot Number: EW1072) as single dose for COVID-19 immunisation (age at vaccination was 52-year-old). Medical history was none. Patient had no known allergies. There were no concomitant medications. The patient experienced major dizziness and vomiting. Patient went to ER and they tested him for heart attack, stroke and ran blood work. No Conclusions sent him home. Body temperature stayed 1.5 degree hotter than normal. Major joint pain mainly in legs and groin. Constant ache and pain and chills. Mainly at night. Continue to get pings throughout body and across the chest. Events onset on 10Sep2021 at 16:45. Patient underwent nasal swab on 15Sep2021: negative. Elected not to get 2nd dose. Doctor advised to wait max weeks and get 2nd dose. Concern that 2nd dose would make the dizziness worse. This really stinks. Patient was 52 years old and had never felt this bad since after the vaccine.   Therapeutic measure was taken as a result of dizziness included medicine to stop the dizziness. Outcome of the events was recovered/resolved with sequel.  Follow-up attempts are completed. No further information is expected.