chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 42-year-old non pregnant female physician received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK4176 and expiry date was not reported), via intramuscularly, in Arm Left, on 12Jan2021 at 11:00 AM (age at vaccination: 42-years-old), as dose 2 single for COVID-19 immunization. The patient's medical history included mild asthma. Concomitant medications included LO LOESTRIN FE. The patient was allergic to anesthetic. The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via intramuscularly, in Arm right, on 22Dec2020 at 3:00 PM as dose 1 single for COVID-19 immunization. On 12Feb2021, the patient developed severe right neck/shoulder pain radiated to arm x1.5 weeks, then as pain subsided developed weakness of long thoracic nerve and anterior deltoid, EMG/NC study showed low amplitude of long thoracic nerve. The patient did not receive any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedure which included EMG/NC study showed low amplitude of long thoracic nerve and on 07Apr2021, the patient underwent SARS-CoV-2 test (Nasal Swab) which showed negative results. Outcome of the event was not recovered.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Candida infection
Clinical narrative: Experienced thrush after COVID 19 booster shot; Experienced thrush after COVID 19 booster shot; Experienced thrush after COVID 19 booster shot; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via an unspecified route of administration on unspecified date as dose 3, single for COVID-19 Immunisation. Medical history included kidney transplant from 2020. Patient also had kidney transplant last year and is on immunosuppressants. Patient concomitant medications were not reported. Historical vaccines included dose 1 and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date was not reported) via unspecified route of administration received on unknown dates for COVID-19 immunization. Event took place after use of product. On an unspecified date the patient experienced thrush after COVID 19 booster shot. The Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Off label use
Clinical narrative: Daughter took the second dose again as indication from her doctor.; Daughter took the second dose again as indication from her doctor.; Fatigue; This is a spontaneous report from a contactable consumer (parent) in response to NON-HCP letter sent to consumer via telephonic follow-up activity.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunization. Medical history included lupus from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE. The reporter did not wish to be contacted any further but indicated her daughter (the patient) took the second dose again as indication from her doctor (on an unspecified date). Only adverse event fatigue (on an unspecified date). She will call back if necessary. Information sent to AER Mailbox. At the time of this report, the outcome of fatigue 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: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Inappropriate schedule of product administration, Infection, Pain in extremity
Clinical narrative: Greater than 21 days between first and second doses of the Pfizer Covid Vaccines.; Extreme, debilitating, arm and shoulder pain; Extreme, debilitating, arm and shoulder pain; Fatigue; Caller states that his shoulder pain after the injection wasn't just like a sore arm after an injection; it felt like it spread, like an infection.; This is a spontaneous report from a contactable consumer (patient himself). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FD0809), via an unspecified route of administration, administered in left arm on 26Aug2021 (age at vaccination: 48 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8737) via an unspecified route of administration, administered in left arm on 21Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, the patient had greater than 21 days between first and second doses of the Pfizer covid vaccines. On an unknown date in August2021, the patient experienced extreme, debilitating, arm and shoulder pain, fatigue, reporter stated that his shoulder pain after the injection wasn't just like a sore arm after an injection; it felt like it spread, like an infection. Reporter stated that his arm hurt more on the second day and lasted for about 4 days, on the third day he was about ready to go see his doctor about it if it got any worse. On the fourth day it was starting to get better. Fatigue was during the late morning or early afternoon he has been feeling like he needs to take a nap. The outcome of fatigue was not recovered and all the other events were recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a solicited report from a marketing program 'Facilitated Collect' based on the information received by Pfizer (Mfr. Control No. 21K-163-4068186-00). A contactable consumer (patient) reported that a 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 1, single, and intramuscular on 02Mar2021 (Batch/Lot number was not reported) (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis and moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. In 2021, patient received the 1st dose and on 02Mar2021, patient received the 2nd dose of Pfizer COVID-19 vaccine. In Aug2021, the patient experienced COVID-19. The outcome of the event COVID-19 was recovering/resolving. The reporter's causality for the events of COVID-19 with Humira (Adalimumab) was no reasonable possibility, while for BNT162b2 was possible. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and suspected covid-19 cannot be totally excluded
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Rash macular
Clinical narrative: red splotches on both of his arms; He got the booster, the Pfizer booster vaccine; He got the booster, the Pfizer booster vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine dose 1, and dose 2 (lot numbers and expiry dates was unknown) via unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Reporter stated, "she called for her husband withheld (Not spelled, hence captured as UNKNOWN in the initial tab). He got the booster, the Pfizer booster vaccine and on the 26th and he has these red splotches on both of his arms that appeared after the booster, and he was wondering if you know what this was and what we should do about it?". He got the booster, the pfizer booster vaccine (extra dose administered) on an unspecified date, he got the booster, the pfizer booster vaccine. Name of the Vaccine: Pfizer COVID-19 Vaccine. Reporter was informed about the Role of Pfizer Drug Safety and Pfizer Medical Information Department. Reporter stated, "That was what they gave her, the last person she talked to said here was the number to the Pfizer Medical Department and they gave her this number. Now you are going to be sending her to a third person. All she is getting was the run around. Reporter was informed about Pfizer Medical information department and was provided with the number as withheld. As, reporter abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and further probing could not be done. Limited information available over the call. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immune thrombocytopenia
Clinical narrative: Pt has a DX of ITP, had a platelet drop from 94 to 30 in 28 days post 1st vaccine injection; Pt has a DX of ITP, had a platelet drop from 94 to 30 in 28 days post 1st vaccine injection; This is a spontaneous report from a contactable nurse. A 37-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 (37-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included ITP and Hashimoto thyroiditis. No known allergies. Concomitant medications (Other medications in two weeks) included ergocalciferol (VITAMIN D); ascorbic acid (VITAMIN C); cyanocobalamin (VITAMIN B12). No other vaccine in four weeks. Patient has a DX (diagnosis) of ITP, had a platelet drop from 94 to 30 in 28 days (as reported) post 1st vaccine injection. Adverse event start date was reported as 10Sep2021. Adverse event resulted in Doctor or other healthcare professional office/ clinic visit. Therapeutic measures were taken as a result of the event and included Steroids. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information, the causal association between the events immune thrombocytopenia and condition aggravated and the suspect drug 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 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: Headache, Immunisation, Lymphadenopathy, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer, based on information received by the regulatory authority (manufacturer control no: 20210831000373) for an unknown patient. A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, single dose; and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, single dose, for COVID-19 immunization for COVID-19 immunization. The patient had off-label use of dose 3 booster vaccine. The patient had a headache after the first day and swollen lymph nodes. The outcome of events unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Extra dose administered, Off label use
Clinical narrative: had the third shot two weeks ago; had the third shot two weeks ago; Hair loss; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3182) via an unspecified route of administration on 26Aug2021 (age at vaccination: 67-Years-old) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1284) via unspecified route of administration on 13Jan2021(age at vaccination: 67 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9262) via unspecified route of administration on 03Feb2021(age at vaccination: 67 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced had the third shot two weeks ago on an unspecified date, had the third shot two weeks ago on an unspecified date, hair loss on 02Sep2021. No therapeutic measures were taken for the event alopecia. The outcome of the event alopecia was not recovered, the outcome of the events off label use, extra dose administered was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Pain, Pyrexia, Vaginal ulceration
Clinical narrative: delirium; Vaginal ulcers 48 hours after vaccine with high fever and body aches; Vaginal ulcers 48 hours after vaccine with high fever and body aches; Vaginal ulcers 48 hours after vaccine with high fever and body aches; This is a spontaneous report from a non-contactable consumer. This 33-year-old female consumer (patient) reported for herself that she received a 33 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Aug2021 at 14:30 at left arm for COVID-19 immunisation (age at vaccination: 33 years old). Medical history and concomitant drugs were not provided. The patient had Vaginal ulcers 48 hours after vaccine with high fever and body aches, delirium on 26Aug2021 14:00. Events resulted in Doctor or other healthcare professional office/clinic visit. Steroids were received as treatment. Outcome of the events was resolved in 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Influenza like illness, Myalgia, Off label use
Clinical narrative: had the booster of the Pfizer covid 19 vaccine yesterday; had the booster of the Pfizer covid 19 vaccine yesterday; soreness at the injection site; overall aching; it feels like flu like symptoms; muscle and joint pain/pain is like a muscular and joint pain; muscle aches/pain is like a muscular and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 09Sep2021 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered on 05Feb2021 and 26Feb2021 (at the age of 64-year-old) as dose 1, single and dose 2, single for covid-19 immunisation and did not experienced any adverse effects. On 09Sep2021, the patient experienced had the booster of the pfizer covid 19 vaccine yesterday. On an unspecified date in Sep2021, patient experienced muscle aches/pain is like a muscular and joint pain, soreness at the injection site, overall aching, it feels like flu like symptoms. The outcome of the events muscle aches/pain is like a muscular and joint pain, it feels like flu like symptoms was unknown and outcome of the events soreness at the injection site, overall aching was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: had the booster of the Pfizer covid 19 vaccine yesterday; had the booster of the Pfizer covid 19 vaccine yesterday; soreness at the injection site; overall aching; it feels like flu like symptoms; muscle and joint pain/pain is like a muscular and joint pain; muscle aches/pain is like a muscular and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 09Sep2021 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered on 05Feb2021 and 26Feb2021 (at the age of 64-year-old) as dose 1, single and dose 2, single for covid-19 immunisation and did not experienced any adverse effects. On 09Sep2021, the patient experienced had the booster of the pfizer covid 19 vaccine yesterday. On an unspecified date in Sep2021, patient experienced muscle aches/pain is like a muscular and joint pain, soreness at the injection site, overall aching, it feels like flu like symptoms. The outcome of the events muscle aches/pain is like a muscular and joint pain, it feels like flu like symptoms was unknown and outcome of the events soreness at the injection site, overall aching was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypotension
Clinical narrative: cryptogenic stroke; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Mar2021 16:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation (age at vaccination was 56-year-old).  Medical history included hashimotos. Patient was non-smoker and daily exerciser. Patient received other medications in two weeks. Historical vaccine included 1st dose of BNT162B2 (Lot number: EN6203) on 23Feb2021 at 16:00 for Covid-19 immunisation (age at vaccination was 55-year-old). The patient experienced acryptogenic stroke 4 weeks following 2nd vaccination. No reason found. Normal BMI, no blockages, non-smoker, low blood pressure, daily exerciser. Onset date of acryptogenic stroke was 30Apr2021 at 18:30. Treatment for acryptogenic stroke was unknown. Patient was hospitalized for acryptogenic stroke for 3 days. Outcome of acryptogenic stroke was resolving. Outcome of low blood pressure was unknown. Patient had Nasal Swab Covid test date: 05Jul2021: Negative.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Menstrual disorder, Pain, Paraesthesia
Clinical narrative: Pain, heaviness, and feeling like lower legs were going to buckle underneath me 3 days after receiving vaccine; heaviness,and feeling like lower legs were going to buckle underneath me 3 days after receiving vaccine.; Paresthesia in lower legs, arms, and hands 9 days after vaccination; Started period again 3 days after menstrual cycle ended.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EWO172), via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:45 (age at vaccination 39 years) as Dose 1, Single for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing Known allergies: all nuts except for almonds. The patient concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced paresthesia in lower legs, arms, and hands 9 days after vaccination on an unspecified date in Sep2021.The patient experienced  pain, heaviness, and feeling like lower legs were going to buckle underneath me 3 days after receiving vaccine on 06Sep2021 and started period again 3 days after menstrual cycle ended on an unspecified date in 2021. The patient was not treated for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Extra dose administered, Hypotension, Off label use
Clinical narrative: Blood pressure went down; Booster shot; Booster shot; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 3 via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as a DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a DOSE 2, SINGLE for covid-19 immunisation. On Aug2021, the patient experienced booster shot (extra dose administered and off label use) and on Sep2021 blood pressure went down. She said, stating there was nothing wrong with her she was just wondering. Reporter was reporting on the Pfizer Booster shot for Covid 19 and who explained she had it at the 6-month mark, around there. It was explained that with the first 2 shots she noticed she was tired but with the booster shot, after 4 days, her blood pressure went down to 109/69, 116/63, and 109/66. She was wondering if this is a side effect as it was not listed in the literature she was given. Her previous shot was on 13Feb2021, and her booster was on either the 30Aug2021 or 31Aug2021. She does not state which dose she was referring to for 13Feb2021, the first or second. The patient underwent lab tests and procedures which included blood pressure measurement that was 109/69 on an unspecified date in 2021, blood pressure measurement that was 116/63 on an unspecified date in 2021 and blood pressure measurement that was 109/66 on an unspecified date in 2021. Reporter seriousness for the event was unspecified. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine, Peripheral swelling, Postmenopausal haemorrhage
Clinical narrative: Postmenopausal bleeding; Migraine; Peripheral swelling; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No.: 21K-163-4071912-00). This contactable consumer (patient) reported that a 55-year-old female patient received bnt162b2 (Batch/Lot number was not reported), second dose intramuscular on 25May2021 at the age of 55-year-old as single dose, first dose intramuscular on 04May2021 at the age of 55-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneously from an unspecified date and ongoing, at unspecified dose for psoriatic arthropathy. The patient's medical history and concomitant medications were not reported. No known allergies. The patient experienced postmenopausal bleeding, migraine, peripheral swelling on an unspecified date in 2021. Solicited report by a consumer of a 55 years old female with events of non-serious post menopausal menses onset, migraine and swollen foot, toe and hand with adalimumab (HUMIRA). There was no reported medical history. In 2021, the patient experienced post-menopausal menses onset, migraine and swollen foot, toe and hand. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04May2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 25May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was dose not changed. The outcome of events was not resolved.  The reporter's causality for the events of post-menopausal menses onset, migraine and swollen foot, toe and hand with adalimumab was not provided. The reporter's causality for the events of post-menopausal menses onset, migraine and swollen foot, toe and hand with bnt162b2 was possible.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for events postmenopausal bleeding, migraine, peripheral swelling due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. 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: M
Vaccine: COVID19
Symptoms: Arthralgia, Extra dose administered
Clinical narrative: Booster covid vaccine per MD orders; Booster covid vaccine per MD orders; Pt states an increase in pain mainly in shoulder joints; This is a spontaneous report from a contactable Nurse. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on Sep2021 as DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first and second dose of BNT162B2 on unspecified date. On Sep2021, Patient stated an increase in pain mainly in shoulder joints. Patient stated was off of Xeljanz for 7 days a week ago due to booster covid vaccine per MD orders. Patient stated pain level was now starting to decrease. MD aware. The outcome of the arthralgia was resolving and outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain
Clinical narrative: Hurting; He received his Covid-19 Booster Dose; He received his Covid-19 Booster Dose; This is a spontaneous report from a contactable consumer. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date (at the age of 62-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single (at the age of 62-years-old) for COVID-19 immunization no adverse event reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 2, single (at the age of 62-years-old) for COVID-19 immunization no adverse event reported. The patient experienced hurting, patient received COVID-19 booster dose. 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Mobility decreased, Myalgia
Clinical narrative: Severe Muscle pain in my shoulders, arms and back of thighs; my hand is completely numb; I can not lift anything and have no strength; I can not lift anything and have no strength; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 09Apr2021 (Lot Number: EP6955) as dose 1, single at 53-year-old for COVID-19 immunization. Medical history included no spleen, asthma, arthritis, many broken bones, and Penicillin or anything cillian allergy. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol xinafoate (ADVAIR); and naproxen sodium (ALEVE); all were taken for an unspecified indication, start and stop date were not reported. On 12Apr2021, the patient experienced severe muscle pain in shoulders, arms and back of thighs. It also has attached to her ulna nerve in right arm and his hand was completely numb. The patient cannot lift anything and have no strength, because the pain was so excruciating. The outcome of the events was not recovered. It was unknown if the patient received any treatment for the events. The events were assessed as serious (disability).  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Drug ineffective
Clinical narrative: Colitis ulcerative aggravated; Lack of drug effect/humira not working; This is a solicited report based on the information received by Pfizer from AbbVie. (Manufacturer Control No: 21K-163-3957588-00). A contactable 62-year-old female consumer (patient) reported that:  Solicited report by a consumer of an adult female with events of non-serious ulcerative colitis flare up and humira not working with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced ulcerative colitis flare up and humira not working. PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 19Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 10May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of ulcerative colitis flare up with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of humira not working with humira (Adalimumab) was a reasonable possibility.  Change History: On 07Sep2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of "ulcerative colitis flare-up" was amended to "ulcerative colitis flare up". The event of "humira seems not to be working as well" was amended to "humira not working".  Humira Causality for events 1) Colitis ulcerative aggravated, 2) Lack of drug effect as per reporter (Drug/Vaccine): No reasonable possibility  COVID-19 Vaccine Causality for events 1) Colitis ulcerative aggravated, 2) Lack of drug effect as per reporter (Drug/Vaccine): Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product 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 possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Colitis Ulcerative and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and medications were not reported. The patient had a stroke on 04May2021 and just recently returned to work. HCP stated that he was updating the counts of the Pfizer Covid-19 vaccine and took out a 25 vial box and left it on the counter at room temperature of 69 degrees Fahrenheit for 15 minutes.  HCP was asking if there was stability information of the above Pfizer Covid-19 vaccine. The outcome of the event was unknown. The lot number for [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of stroke cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Extra dose administered, Headache, Myalgia
Clinical narrative: FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine.; FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine.; severe HA's; achy bones/muscles; achy bones/muscles; weak; sleeping for sev days; night sweats; This is a spontaneous report from a contactable other hcp (patient). A 72-year-old (non-pregnant) female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EVV 0217) via an unspecified route of administration, administered in arm left on 08Sep2021 12:00 at dose 3 (booster), single for covid-19 immunisation. Medical history included Hashimoto's, Mast Cell act, High BP, often have adverse reactions to meds (known allergies: Often have adverse reactions to meds). Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); lisinopril (LISINOPRIL) both taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient previously received first and second dose of BNT162B2 for COVID-19 immunization. On 09Sep2021 12:00 the patient experienced had severe HA's, achy bones/muscles, weak, sleeping for sev days, night sweats. Adverse event: FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine. Starting following day I had severe HA's, achy bones/muscles, weak, sleeping for sev days, night sweats. I had no reaction to the 1st two shots, so surprised with reaction. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Off label use, Somnolence
Clinical narrative: FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine.; FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine.; severe HA's; achy bones/muscles; achy bones/muscles; weak; sleeping for sev days; night sweats; This is a spontaneous report from a contactable other hcp (patient). A 72-year-old (non-pregnant) female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EVV 0217) via an unspecified route of administration, administered in arm left on 08Sep2021 12:00 at dose 3 (booster), single for covid-19 immunisation. Medical history included Hashimoto's, Mast Cell act, High BP, often have adverse reactions to meds (known allergies: Often have adverse reactions to meds). Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); lisinopril (LISINOPRIL) both taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient previously received first and second dose of BNT162B2 for COVID-19 immunization. On 09Sep2021 12:00 the patient experienced had severe HA's, achy bones/muscles, weak, sleeping for sev days, night sweats. Adverse event: FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine. Starting following day I had severe HA's, achy bones/muscles, weak, sleeping for sev days, night sweats. I had no reaction to the 1st two shots, so surprised with reaction. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Vaccination site bruising, Vaccination site dermatitis, Vaccination site discolouration
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 50-year-old female patient received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on unspecified date, single dose, for COVID-19 immunisation. The patient's medical history included breast cancer. Concomitant medications not reported. Historical vaccines included dose 1 and dose 2 of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), received on unknown dates, for COVID-19 immunization. Patient experienced injection site reactions for 2 weeks including bruising, blistering, turning to hypopigmentation with dermatitis and itching. Event took place after the 3rd dose of BNT162B2. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 50-year-old female patient received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on unspecified date, single dose, for COVID-19 immunisation. The patient's medical history included breast cancer. Concomitant medications not reported. Historical vaccines included dose 1 and dose 2 of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), received on unknown dates, for COVID-19 immunization. Patient experienced injection site reactions for 2 weeks including bruising, blistering, turning to hypopigmentation with dermatitis and itching. Event took place after the 3rd dose of BNT162B2. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Pustule, Skin weeping
Clinical narrative: It is bubbling with pus bubbles and weeping; It is bubbling with pus bubbles and weeping; Two large patches of itchy skin started day after shot- on left arm/elbow area and right knee/Still itchy and irritated and inflamed/ Skin continued to be itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3182), via an unspecified route of administration in left arm on 08Sep2021 09:30 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. Medical history included none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA7485), via an unspecified route of administration in right arm on 18Aug2021 15:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced two large patches of itchy skin started day after shot- on left arm/elbow area and right knee, skin continued to be itchy and hot on 09Sep2021. Five days later, it is bubbling with pus bubbles and weeping on 13Sep2021. It was Still itchy and irritated and inflamed from 09Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with antibiotic and steroid. Since the vaccination, patient has not been tested for COVID-19. Outcome of events It is bubbling with pus bubbles and weeping was unknown. Outcome of remaining events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Extra dose administered, Headache, Off label use, Pain
Clinical narrative: Vaccination adverse reaction; Headache; Pain; Stomach pain; patient received third dose COVID-19 Vaccine manufactured by Pfizer; patient received third dose COVID-19 Vaccine manufactured by Pfizer; This is a solicited report based on information received by Pfizer (Mfr. Control No. :21K-163-4072509-00). A contactable 59-year-old female consumer (patient) reported.  A 59-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on 01Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on 01Mar2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on unspecified date in 2021 (at the age of 59-year-old) as dose 3, single for COVID-19 immunization. Patient received a co suspect drug Adalimumab (HUMIRA) from unspecified date to unknown ongoing (Lot Number: unknown, Expiration date: unknown) for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. After the vaccination, the patient experienced FOUR days after second Pfizer Covid Vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out with Humira (Adalimumab). There was no reported medical history. On 08Apr2021, the patient experienced four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out. In Apr2021, the four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out resolved. Pfizer BioNTech Covid-19 Vaccine was also considered suspect. The reporter's causality for the event(s) of four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08apr2021, four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08Apr2021, four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08Apr2021 and four days after second Pfizer Covid vaccine felt terrible headache/stabbing stomach pain/ hutting from the inside out onset 08Apr2021 was not provided. The outcome of the events is recovered or resolved.  No follow-up attempts possible. No further information expected.