chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder pain, Flank pain, Haemorrhage urinary tract, Interchange of vaccine products, Off label use
Clinical narrative: Urinary tract pain and a little bleeding; feeling puncture pain on my right flank and bladder; Urinary tract pain and a little bleeding; feeling puncture pain on my right flank and bladder; Off label use; 1st dose Janssen on 09Apr2021 and 2nd dose Pfizer on 12Nov2021; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received dose of BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FF2593 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Nov2021 at 12:15 hours as dose 2 (booster), single (at the age of 34-years-old) for COVID-19 immunization. Patient had no medical history. It was unknown if patient had any known allergies. The patient concomitant medications were not reported. Historical vaccine included patient received COVID-19 Vaccine (Janssen COVID-19 Vaccine, Batch/Lot number: FF2593 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 09Apr2021 at 00:00 hours as dose 1, single (at the age of 34-years-old) for COVID-19 immunization. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 13Nov2021 at 08:00 hours, patient experienced urinary tract pain and a little bleeding and about 55 hours after the vaccine, patient started feeling puncture pain on right flank and bladder. Patient received no treatment for urinary tract pain and a little bleeding and feeling puncture pain on my right flank and bladder. The outcome of urinary tract pain and a little bleeding and feeling puncture pain on my right flank and bladder was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract pain
Clinical narrative: Urinary tract pain and a little bleeding; feeling puncture pain on my right flank and bladder; Urinary tract pain and a little bleeding; feeling puncture pain on my right flank and bladder; Off label use; 1st dose Janssen on 09Apr2021 and 2nd dose Pfizer on 12Nov2021; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received dose of BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FF2593 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Nov2021 at 12:15 hours as dose 2 (booster), single (at the age of 34-years-old) for COVID-19 immunization. Patient had no medical history. It was unknown if patient had any known allergies. The patient concomitant medications were not reported. Historical vaccine included patient received COVID-19 Vaccine (Janssen COVID-19 Vaccine, Batch/Lot number: FF2593 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 09Apr2021 at 00:00 hours as dose 1, single (at the age of 34-years-old) for COVID-19 immunization. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 13Nov2021 at 08:00 hours, patient experienced urinary tract pain and a little bleeding and about 55 hours after the vaccine, patient started feeling puncture pain on right flank and bladder. Patient received no treatment for urinary tract pain and a little bleeding and feeling puncture pain on my right flank and bladder. The outcome of urinary tract pain and a little bleeding and feeling puncture pain on my right flank and bladder was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Chills, Immunisation, Rheumatoid arthritis
Clinical narrative: booster; Ocassional rheumatoid arthritis flare up; Weak; Chills; This is a solicited report based on information received by Pfizer from a company. MFR Control No.: 21K-163-4147000-00. A contactable 52-year-old male consumer (patient) reporter for himself that:  Solicited report by a consumer of an adult male with events of non-serious occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster with Humira (adalimumab). There was no reported medical history. No known allergies. No Concomitant Drugs Taken. No Relevant Medical History. On unknown dates, the patient experienced occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster. On unknown dates, weak after Pfizer booster and chills after Pfizer booster resolved. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. He received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The patient was treated with Tylenol paracetamol.  The reporter's causality for the events of occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster with Humira (adalimumab) was no reasonable possibility.  The reporter's causality for the events of occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster with Pfizer-BioNTech Covid-19 Vaccine was not reported.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch no. can not be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established. 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: 83.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Rheumatoid arthritis flare up; Swollen, itchy and sore at injection site; Swollen, itchy and sore at injection site; Swollen, itchy and sore at injection site; This is a Solicited report based on the information received by Pfizer from a company manufacture number (21K-163-4148934-00).   A contactable consumer (patient) reported that an 83-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) intramuscular in 2021 (at the age of 83 years old, Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported at unspecified dose for Moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On 01Oct2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer and experienced pain in arm and potassium levels were low. On 25Oct2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. In 2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer. Reported events of non-serious Rheumatoid arthritis flare up and got booster covid vaccine and arm get swollen, itchy and sore at injection site with HUMIRA (ADALIMUMAB). In 2021, the patient experienced Rheumatoid arthritis flare up and got booster covid vaccine and arm get swollen, itchy and sore at injection site. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the events for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was recovering. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of Rheumatoid arthritis flare up and got booster covid vaccine and arm get swollen, itchy and sore at injection site onset in 2021, got booster covid vaccine and arm get swollen, itchy and sore at injection site onset in 2021 and got booster covid vaccine and arm get swollen, itchy and sore at injection site onset in 2021 was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE as per reporter was possible for all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of efficacy of COVID vaccine. Had COVID after vaccination.; Lack of efficacy of COVID vaccine. Had COVID after vaccination.; This is a spontaneous report  from a HCP received from Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced lack of efficacy of covid vaccine: had covid after vaccination  on an unspecified date with outcome of unknown.  Had COVID after vaccination. 2 days of mild symptoms (sinus blocked)  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Pruritus
Clinical narrative: My hand is still itching; The itching started yesterday but it got worse; I had an allergic reaction; I had it broken all over my face, all over my arms and my legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FH8020), dose 1 via an unspecified route of administration, administered in left arm on 11Nov2021 (at age of 58-year-old) as dose 1, single for covid-19 immunization. Medical history included thyroid cancer and blood pressure from an unspecified date and unknown if was ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) for an unspecified indication and amlodipine besilate (NORVASC) taken for blood pressure measurement start and stop dates are not reported for both. The patient did not receive any prior vaccinations within 4 weeks. The patient said, my hand is still itching, the itching started yesterday but it got worse on 12Nov2021, I had an allergic reaction; I had it broken all over my face, all over my arms and my legs (all medically significant) on Nov2021. The patient stated, "Yeah, I got my COVID shot Thursday, my Pfizer COVID shot, first shot Thursday at work and just today, I had been to emergency room. I had an allergic reaction. I had it broken all over my face, all over my arms and my legs and in the emergency room they gave me Benadryl and stuff and 'not clear'. My hand is still itching. That's why I called because I had an allergic reaction when I took the shot." Patient stated, "Yes I took my first. I will take my second 02Dec." Treatment for side effects (Other than Benadryl) was none. Patient stated, " Benadryl; No, they gave me in the emergency room. I don't know how many doses they gave me. They gave it my arm. They gave me an IV, so I don't know how many." For reassurance, patient stated, "No, that's it." Reporter seriousness for the events was unspecified. The outcome of events my hand is still itching, the itching started yesterday but it got worse not recovered, I had an allergic reaction; I had it broken all over my face, all over my arms and my legs was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out; convulsions; This is a spontaneous report from a contactable consumer. A 12-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Nov2021 (Batch/Lot number was not reported) as dose 2, single (at age of 12-years-old) for covid-19 immunisation. No pregnant. There was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. Relevant past drug history was unknown. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Oct2021 (at age of 12-years-old) for COVID-19 immunisation. On 12Nov2021, the patient experienced passed out and had convulsions and was taken to the hospital in ambulance. The patient is fine now. The events result in Emergency room/department or urgent care. There was unknown if the patient was diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. Outcome of the events was recovered on Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest discomfort, Dyspnoea, Immunisation, Myocardial infarction
Clinical narrative: heart attack; Short breaths; My left side of my chest was being stabbed; My left breast I wanted to rip out; pain; the patient received third dose; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: 32030BD), via an unspecified route of administration, administered in arm left on 11Nov2021 at 18:00 (at the age of 38-years-old) as dose 3 (booster), single for covid-19 immunization.  Medical history included allergy to mango and generic depo, endometriosis and autoimmune thyroiditis from an unknown date and unknown if ongoing. The patient previously received other vaccine in four weeks which included flu shot on 28Oct2021. Concomitant medications included unspecified other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. The patient historical vaccines included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number Er8729), via an unspecified route of administration, administered in arm left on 18Mar2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number Er8729), via an unspecified route of administration, administered in arm left on 08Apr2021 as dose 2, single for covid-19 immunization. On 11Nov2021 at 18:00, the patient received third dose of vaccine (coded to booster). On 11Nov2021 at 22:00, the patient thought she was having a heart attack, her left side of chest was being stabbed. She wanted to rip out her left breast. She had short breaths. Next day she could not say full sentences and was still in pain, but better. The patient underwent lab test and procedures which included sars-cov-2 test (nasal swab): negative on 05Sep2021. The patient did not receive any treatment. Device date was reported as 13Nov2021. The outcome of the event pain was recovering and for all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: heart attack; Short breaths; My left side of my chest was being stabbed; My left breast I wanted to rip out; pain; the patient received third dose; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: 32030BD), via an unspecified route of administration, administered in arm left on 11Nov2021 at 18:00 (at the age of 38-years-old) as dose 3 (booster), single for covid-19 immunization.  Medical history included allergy to mango and generic depo, endometriosis and autoimmune thyroiditis from an unknown date and unknown if ongoing. The patient previously received other vaccine in four weeks which included flu shot on 28Oct2021. Concomitant medications included unspecified other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. The patient historical vaccines included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number Er8729), via an unspecified route of administration, administered in arm left on 18Mar2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number Er8729), via an unspecified route of administration, administered in arm left on 08Apr2021 as dose 2, single for covid-19 immunization. On 11Nov2021 at 18:00, the patient received third dose of vaccine (coded to booster). On 11Nov2021 at 22:00, the patient thought she was having a heart attack, her left side of chest was being stabbed. She wanted to rip out her left breast. She had short breaths. Next day she could not say full sentences and was still in pain, but better. The patient underwent lab test and procedures which included sars-cov-2 test (nasal swab): negative on 05Sep2021. The patient did not receive any treatment. Device date was reported as 13Nov2021. The outcome of the event pain was recovering and for all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Near death experience, Pain
Clinical narrative: I feel like I am dying; Muscular pain; Fatigue; I am in so much pain; I feel like I am dying, in a lot of pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: FF2590), via an unspecified route of administration, administered in Arm Left on 06Nov2021 (at the age of 46-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive prior vaccinations within 4 weeks. On Monday, 08Nov2021 the patient experienced i feel like i am dying, muscular pain, fatigue, i am in so much pain; i feel like i am dying, in a lot of pain. It was reported that, patient had muscular pain and fatigue. She was in so much pain. felt like she was dying, in a lot of pain and she could not wait. She was just going to the doctor or a hospital. She went to the doctor Thursday. He said did not take medicine. Drink teas and soup and a lot of liquid. The patient did not receive any treatment. Report was not related to a study or programme. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Off label use, Product use issue
Clinical narrative: vaccine administered to a 11-year-old patient; vaccine administered to a 11-year-old patient; permanently disabled; This is a spontaneous report from a non-contactable consumer. A 11-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date (at the age of 11-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were reported as unknown. Other vaccine in four weeks, covid prior vaccination, covid tested post vaccination, known allergies were reported as unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the covid vaccine or any other medications within 2 weeks of vaccination. On an unspecified date, the patient was permanently disabled. The reporter described that it happened to a granddaughter of her friend. Adverse event resulted in disability or permanent damage. Treatment was reported as unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: miscarriage at 8 weeks; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in arm left on 21Jan2021 (age at vaccination 30 years) as dose 2, single; and first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in arm left on 31Dec2020 (age at vaccination 30 years) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient medical history and concomitant medications were reported none. The patient had no past drug event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has been tested for COVID-19. On 11Sep2021, patient experienced miscarriage at 8 weeks. Seriousness of the event was medically significant. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Nasal Swab, SARS-CoV-2 test: negative on 03Nov2021. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dizziness, Head discomfort, Headache, Pyrexia
Clinical narrative: heart hurt to laugh or at high stress; First 3 days after shot seriously bad headache; slight fever; head pressure; dizzy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 58-years-old), administered in arm right on 04Jun2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included known allergies with shrimp from an unknown date and unknown if ongoing. The patient' concomitant medications were not reported. The facility type vaccine was reported as pharmacy or drug store. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 05Jun2021, the patient experienced heart hurt to laugh or at high stress, first 3 days after shot seriously bad headache, slight fever, head pressure, dizzy. Clinical Course are as follows: First 3 days after shot seriously bad headache slight fever. Then for a month head pressure but no pain, dizzy, heart hurt to laugh or at high stress. Now symptoms only about once or twice a month with same symptoms but not as severe. The treatment was not received for all the adverse events. The clinical outcome for all the events was reported as recovered/resolved with sequel.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Off label use, Product use issue, Pyrexia
Clinical narrative: High fever 104.8; Diarrhea; Dose received 1, Current age 5 years (off label use); Dose received 1, Current age 5 years; This is a spontaneous report from a contactable consumer (parent). A 5-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ik5127) via an unspecified route of administration in left arm on 07Nov2021 at 10:00 (at the age of 5 years-old) as dose 1, single for covid-19 immunization. Medical history included recent infected stye (that child received antibiotic for and recovered from more than 1 week prior). Patient had no known allergies. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medication in two weeks included cefalexin (CEFALEXIN) taken for an unspecified indication, start and stop date were not reported. A 5-year-old patient received the vaccine (coded to off label use and product use in unapproved population). The patient experienced high fever 104.8 and diarrhoea on 08Nov2021 at 15:00. It was reported that seriousness criteria did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. The patient underwent lab test and procedures which include body temperature with results high fever of 104.8 on 08Nov2021. Treatment medication included tylenol, motrin and cool bath. Device timestamp was reported as 14Nov2021. The clinical outcome of the events fever and diarrhoea was recovered in Nov2021 and for all other event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer from a company (MFR Control No. # 21K-163-4138978-00) from a contactable consumer(patient) reported for herself.  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 25Feb2021 (at age of 67 years old, Batch/Lot number was not reported) as single dose, dose 2 intramuscular on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up on an unspecified date. The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of event was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Rheumatoid arthritis flares was not provided. Causality for bnt162b2: The reporter's causality for the event of Rheumatoid arthritis flares was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events RA  and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Bronchial hyperreactivity, Therapeutic response unexpected, Thrombosis
Clinical narrative: reactive airway disease with multiple blood clots; reactive airway disease; After taking my shot I have deceased my need for inhaler; This is a spontaneous report from a contactable consumer (patient). This 64-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included 2020 in the early stage of the Virus patient developed another blood clot and was hospitalized, reactive airway disease. Concomitant medications were not provided. The patient experienced reactive airway disease with multiple blood clots on unspecified date. The clinical course was reported as follows. He/she took the over 6 months ago. He/she also had reactive airway disease with multiple blood clots. 2020 in the early stage of the Virus he/she developed another blood clot and was hospitalized. After taking shot he/she had deceased his/her need for inhaler. The patient asked if think the shot affect more than the virus. Outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Sciatica
Clinical narrative: Booster; severe back and sciatica pain; severe back and sciatica pain; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 32030BD), via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration as dose 2, single both for covid-19 immunization. On an unspecified date in 2021, a couple days after the vaccine, the patient experienced back and sciatica pain. The patient received steroids as therapeutic measure to relieve the pain. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101578115 same reporter/drug, different patients.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Polymenorrhoea, Vaginal haemorrhage
Clinical narrative: intermittent bleeding/ intermittent spotting/ bleeding is very light spotting now; stomach started cramping; she was not expecting her cycle until 16Nov2021; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left deltoid on 02Nov2021 11:05 (batch/lot number: FG3527 and expiration date: 31May2022) at the age of 49 years old, as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at a university vaccination facility.The patient's medical history included very regular menstrual cycle. Patient can tell what day her cycle is supposed to come and has never had intermittent bleeding even when she was pregnant with her children. There is no family medical history relevant to events reported. There were no concomitant medications and no prior vaccinations (within 4 weeks). The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 07Oct2021 (batch/lot number: FE359 and expiration date: 28Feb2022) at the age of 48 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced sore arm, menstrual pain, heavy menstrual bleeding, throwing up, crying, mobility decreased, and sweating profusely. Patient reported that she is one of those people with very regular menstrual cycle and never had intermittent bleeding. She has an appointment to see her doctor next week as she has had intermittent spotting. She has never in her life had spotting. The bleeding began the same date she had the 2nd dose of the vaccine on 02Nov2021, and the bleeding began a few hours after, about 5:00pm. The bleeding was very light, spotting now. When it first began, she thought her cycle was coming. Her stomach started cramping and just started to feel her cycle coming on and her cycle came down and she thought that was odd because she was not expecting her cycle until 16Nov2021. For her to have her cycle on 02Nov2021 really concerned her and she had never been off like that. Patient has had spotting ever since 02Nov2021. She asked herself did this happen because of the vaccine. Her cycle was not due until the 16th of the month and this form of her cycle with spotting was not like a normal cycle and she is not a person to spot. It never happened before, and people need to know so she wanted to report this, and cycles would not necessarily be tested. Some women seemed to have disturbed cycles or issues with it, and she wanted to make sure she was adding to it because it happened to her. The events did not require a visit to the Emergency room and no relevant tests were performed. The outcome of the events was not reported.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Loss of consciousness, Swollen tongue
Clinical narrative: Passing out / same reaction that was on the paperwork his son received; tongue and lips swelled up; tongue and lips swelled up; eyes swelled up; This is a spontaneous report from a contactable consumer (patient's father). This consumer reported same events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Stated that patient father's tongue and lips swelled up and he passed out. One of his eyes swelled up a little bit too, and he kept passing out. Stated that patient father was told it was from shrimp he ate, but it was the same reaction that was on the paperwork his son received when he got his shots so he thought that the reaction was from the vaccine. Outcome of events were unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100975963 same reporter/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Have been sick; Swelling on the face; Dizziness; Weakness; Headaches; Tiredness; Muscle pain; Chills; Joint pain; Nausea; Vomiting; Feeling unwell; Very decreased appetite; Diarrhea; Arm pain; Leg pain; Booster; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 08Nov2021 in left arm, upper as dose 3 (booster), single for COVID-19 immunization. The patient medical history included Blood pressure high. Concomitant medication(s) included hydrochlorothiazide and losartan both taken for an unspecified indication, start and stop date were not reported. Previously patient received dose 1 and dose 2, COVID-19 Vaccine (Primary Immunization series completed but unknown manufacturer), Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. No prior vaccinations within 4 weeks. Patient had received other unspecified products. Consumer stated, she had received her third Pfizer booster last Sunday (later clarified), 08Nov2021 and on unspecified date, patient experienced she have been sick all week long. On unspecified date, Patient experienced swelling on the face, dizziness and weakness, headaches, tiredness, muscle pain, chills, joint pain, nausea and vomiting, feeling unwell, very decreased appetite, diarrhea, arm pain, leg pain. Patient enquired how long, it is going to last like this. The patient did not received the treatment for the events, she had been in her house everyday and could not go out. The outcome for the events was unknown.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Illness, Immunisation
Clinical narrative: Have been sick; Swelling on the face; Dizziness; Weakness; Headaches; Tiredness; Muscle pain; Chills; Joint pain; Nausea; Vomiting; Feeling unwell; Very decreased appetite; Diarrhea; Arm pain; Leg pain; Booster; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 08Nov2021 in left arm, upper as dose 3 (booster), single for COVID-19 immunization. The patient medical history included Blood pressure high. Concomitant medication(s) included hydrochlorothiazide and losartan both taken for an unspecified indication, start and stop date were not reported. Previously patient received dose 1 and dose 2, COVID-19 Vaccine (Primary Immunization series completed but unknown manufacturer), Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. No prior vaccinations within 4 weeks. Patient had received other unspecified products. Consumer stated, she had received her third Pfizer booster last Sunday (later clarified), 08Nov2021 and on unspecified date, patient experienced she have been sick all week long. On unspecified date, Patient experienced swelling on the face, dizziness and weakness, headaches, tiredness, muscle pain, chills, joint pain, nausea and vomiting, feeling unwell, very decreased appetite, diarrhea, arm pain, leg pain. Patient enquired how long, it is going to last like this. The patient did not received the treatment for the events, she had been in her house everyday and could not go out. The outcome for the events was unknown.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Swelling face
Clinical narrative: Have been sick; Swelling on the face; Dizziness; Weakness; Headaches; Tiredness; Muscle pain; Chills; Joint pain; Nausea; Vomiting; Feeling unwell; Very decreased appetite; Diarrhea; Arm pain; Leg pain; Booster; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 08Nov2021 in left arm, upper as dose 3 (booster), single for COVID-19 immunization. The patient medical history included Blood pressure high. Concomitant medication(s) included hydrochlorothiazide and losartan both taken for an unspecified indication, start and stop date were not reported. Previously patient received dose 1 and dose 2, COVID-19 Vaccine (Primary Immunization series completed but unknown manufacturer), Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. No prior vaccinations within 4 weeks. Patient had received other unspecified products. Consumer stated, she had received her third Pfizer booster last Sunday (later clarified), 08Nov2021 and on unspecified date, patient experienced she have been sick all week long. On unspecified date, Patient experienced swelling on the face, dizziness and weakness, headaches, tiredness, muscle pain, chills, joint pain, nausea and vomiting, feeling unwell, very decreased appetite, diarrhea, arm pain, leg pain. Patient enquired how long, it is going to last like this. The patient did not received the treatment for the events, she had been in her house everyday and could not go out. The outcome for the events was unknown.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Have been sick; Swelling on the face; Dizziness; Weakness; Headaches; Tiredness; Muscle pain; Chills; Joint pain; Nausea; Vomiting; Feeling unwell; Very decreased appetite; Diarrhea; Arm pain; Leg pain; Booster; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 08Nov2021 in left arm, upper as dose 3 (booster), single for COVID-19 immunization. The patient medical history included Blood pressure high. Concomitant medication(s) included hydrochlorothiazide and losartan both taken for an unspecified indication, start and stop date were not reported. Previously patient received dose 1 and dose 2, COVID-19 Vaccine (Primary Immunization series completed but unknown manufacturer), Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. No prior vaccinations within 4 weeks. Patient had received other unspecified products. Consumer stated, she had received her third Pfizer booster last Sunday (later clarified), 08Nov2021 and on unspecified date, patient experienced she have been sick all week long. On unspecified date, Patient experienced swelling on the face, dizziness and weakness, headaches, tiredness, muscle pain, chills, joint pain, nausea and vomiting, feeling unwell, very decreased appetite, diarrhea, arm pain, leg pain. Patient enquired how long, it is going to last like this. The patient did not received the treatment for the events, she had been in her house everyday and could not go out. The outcome for the events was unknown.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Cellulitis, Feeling abnormal, Immunisation
Clinical narrative: mind was very foggy; Her arm is throbbing; developed cellulitis at the vaccine site; the cellulitis was traveling down her arm; booster; Body ache; High fever/Temperature went up; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 12Nov2021 (Batch/Lot Number: FD0809) (age at vaccination 52-year-old) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Medical history included was reported as no. Concomitant medications included tamoxifen and propanol taken for an unspecified indication, start and stop date were not reported. The patient received other vaccines within four weeks prior to the vaccination included Flu shot an unspecified route of administration, on 04Oct2021 (Batch/Lot Number: not reported) (age at vaccination 52-year-old) for immunization. The patient received historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: 3247) as dose 1, experienced body aches, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: 3247) as dose 2 single for covid-19 immunisation, experienced body aches. The patient had booster on 12Nov2021, body ache, high fever on Nov2021, developed cellulitis at the vaccine site; the cellulitis was traveling down her arm on 16Nov2021, her arm is throbbing, mind was very foggy on an unspecified date. The patient underwent lab tests and procedures which included blood test: everything is fine on 2021 had blood work done, don't know how recent, in September probably, body temperature: went up this evening 102.5 on 14Nov2021. Therapeutic measures included antibiotics were taken as a result of developed cellulitis at the vaccine site; the cellulitis was traveling down her arm, Ibuprofen for body ache and high fever. The outcome of the event developed cellulitis at the vaccine site; the cellulitis was traveling down her arm was recovering, body ache, high fever not recovered, her arm is throbbing, mind was very foggy was unknown.  Follow-up attempts are completed. No further information is expected.