chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: he received his booster dose; he received his booster dose; constant fatigue/ tired all day; This is a spontaneous report from a contactable consumer (patient himself). A 63-years-old male patient received BNT162B2 (COMIRNATY mRNA vaccine, formulation: Solution for injection, Lot Number: ec3181, Expiry Date was not reported), via an unspecified route of administration, administered in Arm Left on 14Aug2021 as dose 3 (booster), single for COVID-19 immunisation (Age at Vaccination was 63 years). The patient medical history was not reported. The patient concomitant medications included Avostatin (medications received within 2 weeks of vaccination). No known allergies were reported. It was reported that, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19, Prior to vaccination and has been tested for COVID-19 Since the vaccination. The patient previously received BNT162B2 (COMIRNATY mRNA vaccine, formulation: Solution for injection, Lot Number: ec9269), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as dose 2, single (Age at Vaccination was 63 years) and received BNT162B2 (COMIRNATY mRNA vaccine, formulation: Solution for injection, Lot Number: ec9262), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunisation. On 14Aug2021, the patient received his booster dose. On an unspecified date in Aug2021, the patient experienced constant fatigue/ tired all day ever morning even after a full night's sleep (sleeps 8 to 9 hours). The patient has visited physician office as result of events, and they said it is unexplained fatigue on their end. There was no prolonged hospitalization, and no therapeutic measures were taken as a result of events. The patient underwent lab tests and procedures which included blood test: okay/ nothing is abnormal, COVID test: Nasal Swab: unknown result on an unspecified date in 2021 (Post vaccination). The outcome of the event constant fatigue/ tired all day was not recovered.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Infection parasitic
Clinical narrative: I started getting ''parasites''; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration in Jun2021 as single dose (dose number unknown) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In July2021, the patient started getting parasites. The patient stated that must have got like a bad dose because of some rumor species which was never ever seen before. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (01Nov2021) follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Arm tenderness/ arm tenderness was in her left arm; Arm tenderness/ arm tenderness was in her left arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 05Mar2021 at 12:00 (batch/lot number: EN6205 and expiry date: Jun2021) at the age of 58 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine on 05Mar2021, and she was fine and didn't really have any symptoms, "just the usual, like you get after you get the flu shot where you have arm tenderness or whatever." The patient reported that the arm tenderness was in her left arm and does not remember when it began, but it began a couple of hours after the vaccine on 05Mar2021 and resolved probably in a day or so. The patient recovered from the event "arm tenderness/ arm tenderness was in her left arm" on Mar2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Palatal swelling, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Allergic reaction; Swelling of tongue, roof of mouth; Swelling of tongue, roof of mouth; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 59-year-old (age at vaccination) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Oct2021 13:00 (Batch/Lot Number: FE3590) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included known allergies: Shellfish, Iodine. Concomitant medications included losartan and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. On 23Oct2021 13:30, the patient experienced allergic reaction-swelling of tongue, roof of mouth and shortness of breath. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Oct2021 Nasal Swab. Therapeutic measures were taken as a result of the events which included treatment with EPIPEN. The patient did not recover from the events. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site infection, Vaccination site pain, Vaccination site swelling
Clinical narrative: i caught a deep tissue infection in my arm where the injections site was; deep tissue infection in his arm where the injections site was and experienced swelling, redness and pain was excruciating; deep tissue infection in his arm where the injections site was and experienced swelling, redness and pain was excruciating; deep tissue infection in his arm where the injections site was and experienced swelling, redness and pain was excruciating; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in arm on 18Oct2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced couple of days later a deep tissue infection in his arm where the injections site was and experienced swelling, redness and pain was excruciating. Patient was wondering if anyone ever heard of this happening before to anyone else. The outcome of the events was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Guillain-Barre syndrome
Clinical narrative: two weeks ago I got covid; two weeks ago I got covid; I got GBS; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE; and then dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE,  for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had both shots ending in Mar2021. He got GBS on an unspecified date in 2021 and two weeks ago (Oct2021) from the time of report, he got COVID. It does not protect 100% and no one seems to care that those getting GBS are suffering still. It is brutal and life changing. The outcome of the event GBS was not recovered; while for the other events, it was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Heavy menstrual bleeding, Vaginal haemorrhage
Clinical narrative: eventually required hospitalization for hemoglobin of 5.7; Flow following January dose lasted longer than 10 days; Menorrhagia following both doses; I am still having abnormal bleeding to this day; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient, non-pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration, administered in left arm on 11Jan2021 07:15 (at the age of 38-years-old) as single dose for COVID-19 immunization. The patient's medical history included migraines and known allergies to cephalosporins. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration, administered in left arm on 21Dec2020 07:15 as single dose for COVID-19 immunization and experienced menorrhagia following both doses and noticeably heavier flow after December dose that eventually stopped on its own. Facility type vaccine was hospital. The patient did not received other vaccine in four weeks and other medications in two weeks. On Feb2021, the patient experienced menorrhagia following both doses. Noticeably heavier flow after December dose that eventually stopped on its own. Flow following January dose lasted longer than 10 days and eventually required hospitalization for hemoglobin of 5.7. The patient received 2 blood transfusions, IV venofer infusions, oral TXA, and had to be started on birth control for the first time in her life in order to control the bleeding. She was still having abnormal bleeding to this day. The events resulted in emergency room/department or urgent care visit, and hospitalization for 3 days. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The patient underwent lab tests and procedures which included haemoglobin: 5.7 on Feb2021. Therapeutic measures were taken as a result of the events and included treatment with blood transfusion, IV venofer and lysteda. The outcome of the event vaginal haemorrhage was not recovered and the outcome of the events were recovered with sequelae.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101491088 same reporter/pt/drug, different dose/event
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Fibromyalgia, Hidradenitis
Clinical narrative: Crohn's disease; Fibromyalgia; Hidradenitis suppurativa; This is a solicited report received from a contactable consumer (patient) from a non-interventuonal study, Facilitated Collect, based on information by Pfizer from Abbvie, (Manufacturer control number: 21k-163-4136236-00).   A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Jul2021 (at the age of 42 years) (Batch/Lot number was not reported) as a single dose and dose 2 intramuscular on 23Jul2021 (at the age of 42 years) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; and adalimumab (HUMIRA, solution for injection in pre-filled syringe), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced Crohn's disease, fibromyalgia, and hidradenitis suppurativa on an unspecified date with outcome of unknown. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The action taken in response to the events for adalimumab was unknown.  Causality for Humira (adalimumab): The reporter's causality for the events of Crohn's disease, hidradenitis suppurativa and fibromyalgia was not provided.  Drug: Humira Causality: Crohn's disease, Hidradenitis suppurativa, Fibromyalgia Causality as per reporter (drug/vaccine): not reported  Drug: Pfizer Biontech COVID-19 vaccine (tozinameran), (tozinameran) Causality: Crohn's disease, hidradenitis suppurativa, fibromyalgia Causality as per reporter (drug/vaccine):  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 the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: The mother gave birth to a premature baby; The mother gave birth to a premature baby; This is a spontaneous report from a contactable consumer (mother). This consumer reported information for both mother and fetus/baby.  This is a baby report. A female patient of an unspecified age was exposed to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental on 11Mar2021 (Lot Number: EN6204) as dose 1, single, and transplacental on 08Apr2021 (Lot Number: ER8734) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the mother gave birth to a premature baby (the patient) via vaginal delivery with epidural anaesthesia. The patient was hospitalized and stayed in intensive care for 19 days. The patient weighed 5.9 lbs ozs and measured 50 cm long. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021416982 mother case
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Weakness in left arm 18 hours after vaccine administration; Also tingling pain and numbness with excessive sensitivity in left hand; Also tingling pain and numbness with excessive sensitivity in left hand; Also tingling pain and numbness with excessive sensitivity in left hand; Also tingling pain and numbness with excessive sensitivity in left hand; This is a spontaneous report from a contactable consumer. This 67-year-old male consumer (patient) received 2nd dose of BNT162B2 (Lot # EN6203), on 24Feb2021 09:30 AM, vaccine location in Left arm for covid-19 immunization (at the age of 66 years old). Medical history included osteoarthritis, osteoporosis, prostate cancer, cancer in remission. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Historical vaccine was 1st dose of BNT162B2 (LOT # EL9264), on 03Feb2021 12:00 PM, vaccine location in Left arm for covid-19 immunization. Patient experienced Weakness in left arm 18 hours after vaccine administration. Also tingling pain and numbness with excessive sensitivity in left hand which has not subsided from 25Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Outcome of the event was Not recovered.  No follow-up attempts possible. No further information expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hip fracture
Clinical narrative: broken hip; shingles; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 02Nov2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from the Pfizer sponsored program, via two contactable consumers. A 94-year-old female patient received the first dose of BNT162B2 at 93-year-old, via an unspecified route of administration on 05Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced broken hip, and shingles on an unspecified date. Patient just came out of rehab for broken hip and shingles. Reporter was trying to arrange for an in home shot for patient and would like to know if the series had to start over or she could just get her second dose. Reporter wanted to know since it was over six months would they give the second dose or the first one again. Treatment was none. Outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Monoplegia, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for husband) from a Pfizer sponsored program. A 73-years-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration at age of 73-years-old on 21Oct2021 in the afternoon around 3:00 to 4:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included parkinson's from 2011 and ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 72-years-old on 10Jan2021 and second dose of bnt162b2 at age of 72-years-old on 31Jan2021 for Covid-19 immunization and both experienced no reactions. The patient experienced paralysis or loss of function in right hand on 23Oct2021. He thought that he slept on his hand funny because it was not working right. He had the head nurse at the home look at it and there was no swelling and he was in no pain. Physical therapy looked at it and they couldn't find anything but they gave him a hand brace and he keeps taking it off because it was not comfortable. So there has been no change for 2 weeks and his hand was still dead. She has been watching and it was not better. The patient underwent lab tests and procedures which included x-ray: normal in Oct2021 they found nothing abnormal. Outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Drug ineffective, Nervous system disorder, Pulmonary mass, Suspected COVID-19
Clinical narrative: I almost died from the COVID.; I almost died from the COVID.; I had a little tiny patch in my lungs; it attached my heart and nervous system; it attached my heart and nervous system; This is a spontaneous report. A contactable female consumer (patient) reported for herself that a female patient of an unspecified age received BNT162B2(COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history included 300 allergic reactions to medications, gave her mono. The patient's concomitant medications were not reported. The patient previously received DSK Shingrix vaccine and experienced lymphoedema, received another vaccine which gave her mono. The patient wanted to know how Pfizer COVID-19 vaccine metabolizes in our system. She knew certain vaccines/ drugs are eliminated through urine or sweat. She also wanted to know the elimination process of the vaccine. She had some genetic metabolizing issues with certain drugs. She received DSK Shingrix vaccine and developed lymphoedema. She developed a reactive lymph node. It's been 5 to 6 years it has not gone away. The doctor started to think it's a tumor. She received another vaccine which gave her mono. She had 10 000 after another vaccine. (She couldn't understand or interpret what the caller was saying, even after having her repat the information and listening to the recording 2-3 times.) She never had mono, but this vaccine gave her that. Unclear which vaccine she was referring to. She had over 300 allergic reactions to medications. She was going to see her allergist, but her doctor did not want to give she the vaccine caused of her genetic issue. She almost died from the COVID. It didn't even attack her lungs. She had a little tiny patch in her lungs it attached her heart and nervous system. It didn't attack my lungs. She had no ventilator. She was still having other issues. She still had those issues. She believed the information on the metabolism of the Pfizer biotech COVID-19 vaccine was still not available. The doctors were not even taking the time to fill out a 15-minute adverse report. She wanted you to know and pass on this message. She had a reaction from the vaccine which was three months later. The doctors didn't believe it was related to the vaccine because they'd believe such a delayed response. However, doctors finally believed it was related to the vaccine. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Palpitations
Clinical narrative: Heart fluttering; Chest pain when exercising 3 days after shot/ continued sporadic chest pain; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old female patient (pregnant: no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on 20Oct2021 (Batch/Lot Number: FF8841) as dose 1, single for covid-19 immunisation. Medical history included polycystic ovarian syndrome from an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; colecalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took erythromycin and experienced allergy. The patient experienced heart fluttering on 23Oct2021 at 14:00, chest pain when exercising 3 days after shot/ continued sporadic chest pain on 23Oct2021 at 14:00, heart palpitations on 23Oct2021 at 14:00. Reported Event: Sharp chest pain when exercising 3 days after shot, continued sporadic chest pain, heart palpitations and heart fluttering still continuing 10 days after initial AE. The adverse event resulted in emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Loss of consciousness
Clinical narrative: She passed out after receiving the vaccine; Her BP is been affected.; This is a spontaneous report from a Pfizer-Sponsored Program. A contactable consumer (patient mother) reported that a female patient (reporter's daughter) of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported, and concomitant medications included "DepoVera" a birth control pills every three months. patient passed out after receiving the vaccine. Her BP is been affected. It's been four weeks. The doctor thinks its age related because she's 15. 52% percent of females will have this type of reaction. The doctor blames it on something else. She had received been receiving DepoVera a birth control pills every three months. She never passed out from that. The doctor doesn't want to report anything because they think the adverse events are not related to the vaccine. Outcome of the events was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events  and the suspect drug BNT162B2  cannot be ruled out. 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: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: got an infection; This is a spontaneous report from a non-contactable consumer or other non hcp for a male patient (reporter's father). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported, Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported, Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced "got an infection". The reporter wanted to know if her elderly father can get the 3rd dose of the Covid-19 vaccine. She said that her father got 2 doses of the covid-19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Immunisation, Investigation
Clinical narrative: Dose number=3; Pericarditis; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female non-pregnant patient received bnt162b2 (BNT162B2), third single dose intramuscularly, administered in arm left on 09Oct2021 (Batch/Lot Number: FF2587) for covid-19 immunisation at age of 26-year-old. The patient was not pregnancy at time of vaccination. There was no medical history and no known allergies. Concomitant medications included influenza vaccine (FLU) third single dose at right arm for an unspecified indication from 09Oct2021 to 09Oct2021 and birth control medication within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (Batch/Lot No: EH9899) on 20Dec2020 intramuscularly at left arm and second dose of bnt162b2 (Batch/Lot No: EL3248) on 10Jan2021 intramuscularly at left arm for covid-19 immunisation, both at age of 25-year-old. Prior to vaccination, the patient didn't diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pericarditis on 09Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. Patient received EKG, chest X-rays, NSAIDS, echo, lab work as treatment for the event. Outcome of the event was not recovered.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Pericarditis and immunization cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Dose number=3; Pericarditis; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female non-pregnant patient received bnt162b2 (BNT162B2), third single dose intramuscularly, administered in arm left on 09Oct2021 (Batch/Lot Number: FF2587) for covid-19 immunisation at age of 26-year-old. The patient was not pregnancy at time of vaccination. There was no medical history and no known allergies. Concomitant medications included influenza vaccine (FLU) third single dose at right arm for an unspecified indication from 09Oct2021 to 09Oct2021 and birth control medication within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (Batch/Lot No: EH9899) on 20Dec2020 intramuscularly at left arm and second dose of bnt162b2 (Batch/Lot No: EL3248) on 10Jan2021 intramuscularly at left arm for covid-19 immunisation, both at age of 25-year-old. Prior to vaccination, the patient didn't diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pericarditis on 09Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. Patient received EKG, chest X-rays, NSAIDS, echo, lab work as treatment for the event. Outcome of the event was not recovered.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Pericarditis and immunization cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mental impairment, Vaccination site mass, Vaccination site swelling
Clinical narrative: Headache; the medicine size feels bigger and it swelled; Had a little bit of a lump where it was injected.; Is also losing her mind, cannot think straight anymore/Brain just not working; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 78-year-old female patient received the first dose of BNT162B2 on 02Mar2021 (lot number: EN6205) (at the age of 78-years-old) via unknown route of administration in arm at single dose; the second dose of BNT162B2 on 31Mar2021 (lot number: EP7534) via unknown route of administration in arm at single dose for COVID-19 immunisation. Medical history included: a little bit hard of hearing, which started before the COVID-19 Vaccine and concomitant medications were reported as standard vitamins. Patient previously took flu shot for little bit of a lump on unknown date. Headache began after the first dose COVID-19 Vaccine, 02Mar2021. Patient was also losing her mind, could not think straight anymore. Patient Had a little bit of a lump where it was injected. The medicine in her arm stayed quite a while like her husband's did. It was a lump. When she got the COVID-19 Vaccine, the medicine size felt bigger and it swelled. Felt a little tiny lump like the medicine was still there. The second shot was awful and did the same thing. She was stabbed in the arm for a while. It felt a little hard, did not know how many days later, but still had a lump. Now she did not have the lumps in her arm, but it stayed for quite a while. Weight was Around 100lbs, she did not change much. Her brain was just not working, it was terrible and she hated it. She could sit down and cry. About the Headache, there was not a time when it was better. Patient did not feel it when she slept. From the minute she opened her eyes, headache started, Stayed on, Constant pain. Probably had pain when she's sleeping, but did not feel it. About Brain just not working: patient did not know exactly when it started, did not know if it had to do with the COVID-19 Vaccine, the headache, or that she was an old lady. Right now, she was trying to get her brain to function. She was taking over the counter vitamins, Focus Factor. She would go through days that were worse than before. Told that when you got old, you lost some memories and so on. Patient was forgetting so many things now. Patient wanted to get quicker than other people, had a weak lung, heard coronavirus attacks the lungs first. In her age, she was healthy. When she had a headache, her doctor gave her a pill and she would take it. The outcome of the event headache was not recovered. The outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Rapid test and she was positive/ Covid Quantitative Ab's were positive; Rapid test and she was positive/ Covid Quantitative Ab's were positive; not feeling well; This is a spontaneous report from a contactable physician. A 13-year-old female patient received BNT162B2(COMIRNATY), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient who had the vaccine series a month prior to this report. She was not feeling well at school and they did a Rapid test and she was positive in 2021. Saw her in the office and she had no fever and a mild cough. Her Covid Quantitative Ab's were positive in 2021. This at least indicates she had a response to the vaccine as this positive rapid test indicating infection is too soon to trigger a response and she has not had prior Symptoms suggestive of Covid. The outcome of event was unknown.  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, a possible causal association 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.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Pruritus
Clinical narrative: Her skin is itchy; She is having some kind of allergic reaction; booster; This is a spontaneous report from a contactable consumer or other non hcp reported for herself (patient). A 70-years-old female patient received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient reported her skin is itchy, she is having some kind of allergic reaction, booster. Clinical course was reported as she was not sure if she had some kind of allergic reaction because her skin was itchy and wanted to know if that was a side effect. She also stated she was currently not taking Xeljanz. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Swelling
Clinical narrative: Off-label use; booster; swelling; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program 002591. A 57-year-old female patient received a booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose on an unspecified date (lot number unknown) for COVID-19 immunization. The patient previously received COVID-19 Vaccine on unspecified date (Primary Immunization series complete but unknown manufacturer). The patient had history included ongoing stage 3 kidney failure and ongoing auto-immune disease. Concomitant medications included tofacitinib citrate (XELJANZ 5 mg tablet) and ongoing Amoxicillin. The patient took Covid booster shot and was off Xeljanz for a week. She was experienced swelling. The event onset date, details, and outcome were not reported.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: I have discovered I miscarried 2 weeks after my second dose of the Pfizer vaccine; at that time I was 4-5 weeks pregnant; This is a spontaneous report from a contactable consumer (patient). A 28-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH, solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in the left arm on 20Sep2021 12:00 (at the age of 28 years old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient medical history included allergies to Bananas. The patient concomitant medication included prenatal vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH, solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in the left arm on 03Sep2021 12:00 (at the age of 28 years old) as dose 1, single for COVID-19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 27Oct2021 09:15, the patient experienced I have discovered I miscarried 2 weeks after my second dose of the Pfizer vaccine, and at that time I was 4-5 weeks pregnant. The mother reported she became pregnant while taking BNT162B2. The mother was 11 Weeks pregnant (Gestational period: 5) at the onset of the event. Last menstrual date was on 06Aug2021. All events resulted in physician office visit. Therapeutic measures were taken as a result of I have discovered I miscarried 2 weeks after my second dose of the pfizer vaccine, at that time I was 4-5 weeks pregnant and included with treatment DNC. The clinical outcome of the events was reported as recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101502504 same reporter/patient/product, different dose/event.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Syncope, Weight decreased
Clinical narrative: experienced covid vaccine made patient faint; Lost weight; This is a solicited report from a Study (FACILITATED COLLECT) based on information received by Pfizer from AbbVie, manufacturer control number:21K-163-4138882-00). A contactable 41-year-old male consumer (patient) reported that:  Solicited report by a consumer of a 41-year-old male with events of non-serious covid vaccine made patient faint and lost weight with HUMIRA(ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced lost weight. On 01Jun2021, the patient experienced covid vaccine made patient faint. On an unknown date, covid vaccine made patient faint resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Jun2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 22 Jun 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of covid vaccine made patient faint and lost weight was not provided.  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. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: booster dose of BNT162B2; off label use; Postive COVID test 01Nov2021; Postive COVID test 01Nov2021; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 47-year-old non-pregnant female patient received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: 301308A, Expiry date: unknown), (age at the time of vaccination was 47 years, patient was non-pregnant at the time of vaccination) via intramuscular administered in Arm Left on 07Oct2021 at 18:00 as dose 3, booster single for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medication included biotin, vitamin d, Iron and Vegan Omega 3 daily. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247) (age at the time of vaccination was 46 years), via intramuscular, administered in Arm Left on 23Feb2021 at 14:00 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203) (age at the time of vaccination was 46 years), via intramuscular, administered in Arm Left on 16Mar2021 at 14:15 as dose 2, single for COVID-19 immunization. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and tested positive with COVID post vaccination. No known allergies. The patient underwent lab tests and procedures, which included nasal swab real time PCR: positive on 01Nov2021. Treatment received no. The patient visited the physician office. The outcome of the events was resolving at the time of the report.  Follow-up attempts were completed. No further information was expected.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Fatigue, Feeling abnormal, Hypothyroidism
Clinical narrative: I'm not sleeping or able to even think because of the brain fog and fatigue; My thyroid blood work shows a 0.005 level of the needed hormone, prior to the shot I was at 3.6; My hair is falling out and creating bald spots; I'm not sleeping or able to even think because of the brain fog and fatigue; I'm not sleeping or able to even think because of the brain fog and fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old unspecified gender patient received the second dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration in Sep2021 (Lot Number: FF8839) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history included hashimotos, allergy to dairy, soy and yeast. The patient didn't received 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 hadn't been tested for COVID-19. Concomitant medication included thyroid hormone, antibiotics for tooth infection. The patient previously received gluten and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration in Sep2021 (Lot Number: Fc3182) as single dose for COVID-19 immunization. The patient stated:"My thyroid blood work shows a 0.005 level of the needed hormone, prior to the shot I was at 3.6. This has been devastating to my health and condition, I have been living in a constant flare since the shots whereas before I was managing my condition well with the medicine and diet. My hair is falling out and creating bald spots. I'm not sleeping or able to even think because of the brain fog and fatigue." The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.