chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: then two positive tests 21Feb with slight dry throat; then two positive tests 21Feb with slight dry throat; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FF2589) at the age of 58 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Feb2022, outcome "unknown" and all described as "then two positive tests 21Feb with slight dry throat".The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive; (21Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with covid prior to vaccination. The patient had been tested for Covid-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported LOE events and the suspect drug BNT162B2 cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR positive same day/exposed at dinner event; PCR positive same day/exposed at dinner event; Congestion; Dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single, administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Feb2022, outcome "unknown" and all described as "PCR positive same day/exposed at dinner event"; NASAL CONGESTION (non-serious) with onset 20Feb2022, outcome "unknown", described as "Congestion"; COUGH (non-serious) with onset 20Feb2022, outcome "unknown", described as "Dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) negative, notes: Other; (21Feb2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19, nasal congestion, cough.  Clinical course: 17Feb2022 Exposed at dinner event and then SX started 20Feb2022 congestion and dry cough and HA then Ag neg 21Feb2022 but PCR positive same day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 with reported vaccination failure & covid-19 cannot be excluded based on provided information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Ag test Feb2022 was exposed to someone at 1/17 event/test result:positive; Ag test Feb2022 was exposed to someone at 1/17 event/test result:positive/Dry and nasal congestion; Ag test Feb2022 was exposed to someone at 1/17 event/test result:positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Feb2022, outcome "unknown", SARS-COV-1 TEST POSITIVE (medically significant) with onset 22Feb2022, outcome "unknown" and all described as "Ag test Feb2022 was exposed to someone at 1/17 event/test result:positive/Dry and nasal congestion"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Feb2022, outcome "unknown", described as "Ag test Feb2022 was exposed to someone at 1/17 event/test result:positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Feb2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, sars-cov-1 test positive, exposure to sars-cov-2.  Clinical Course: sx ST dry and nasal congestion mild late Feb2021 and then + Ag test Feb2022 was exposed to someone at 1/17 event. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis has been flaring; fatigue; congestion; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "rheumatoid arthritis has been flaring"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; COUGH (non-serious), outcome "unknown", described as "cough". Clinical course: Patient reported Xeljanz held when she received COVID vaccinations, did not reported adverse effects during holds. she was sick with other things after vaccinations and Xeljanz was held, did not provide names of illnesses, dates, or adverse effects during holds. Xeljanz was held 1 week before and 2 weeks after booster shot on 12Dec2021. reports about 3 weeks after re-starting Xeljanz, she was diagnosed with COVID infection with antiviral treatment, no hospitalization. Xeljanz on hold since the week of 24Jan2022. stated she has long COVID affecting her lungs and md advised her to wait for lungs to heal before re-starting Xeljanz. during hold her rheumatoid arthritis has been flared with fatigue, congestion, cough, her prednisone and lupus medication is also on hold. MD aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Contracted COVID; Contracted COVID; She was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 20 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Contracted COVID"; ILLNESS (hospitalization, medically significant), outcome "unknown", described as "She was sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: This is the second case out of 2 cases in which reporter is reporting for her grand-daughter (Consumer). Reporter stated, has had some kind of severe reaction to the Pfizer (COVID-19 Vaccine) and one week back but originally got my shot (COVID-19 Vaccine). I have got my last shot in Aug2021, got my second shot, relocated in Sep. My grand-daughter got corona in Dec or Jan and the health department called us and asked me questions in my name and told us to quarantine because I probably had it too COVID and my brother who lived here had it (further clarifications unknown) anyways I developed since then a severe case of hives and its going on two months. I had the Pfizer shot, yes and I have developed hives, severe case of hives, yes. I don't know the exact date. It had to be in Dec when the health department called us but let me look it. It had to be in Dec or Jan when I have had my doctor's appointment here, I think my doctor in January. So, it had to be in December sometime around the Jan around the beginning of Jan or second week of Jan it sounds like that. I am not talking for sure but yes (voice overlapping) whenever my granddaughter they had to look at her name withheld contracted COVID and some seconds I might had it too. Yes, she did, she experienced we both had the same shot and she experienced COVID in Dec I believe or Jan somewhere in Dec and Jan. Nope, she is not on anything. She is completely healthy. She only did the test when she, they diagnosed her with COVID in hospital in December or January (Further clarifications unknown hence tab was left unchecked). They send her in quarantine together (Further clarifications unknown).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Investigation, Suspected COVID-19
Clinical narrative: I probably had it too COVID; I probably had it too COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: EW0217, Expiration Date: 30Sep2021) at the age of 54 years as dose 2, single and administered in arm left, administration date 10Jun2021 (Lot number: EW0179, Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing), notes: Additional Information for Concomitant Products Tizanidine: Consumer stated, "At the time the only medication that I was taking is the muscle relaxer, it's called Tizanidine.". Concomitant medication(s) included: TIZANIDINE taken for muscle relaxant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I probably had it too COVID". The patient underwent the following laboratory tests and procedures: investigation: unknown results. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Inappropriate schedule of product administration, Laboratory test, Mental disorder
Clinical narrative: I probably had it too COVID; I probably had it too COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: EW0217, Expiration Date: 30Sep2021) at the age of 54 years as dose 2, single and administered in arm left, administration date 10Jun2021 (Lot number: EW0179, Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing), notes: Additional Information for Concomitant Products Tizanidine: Consumer stated, "At the time the only medication that I was taking is the muscle relaxer, it's called Tizanidine.". Concomitant medication(s) included: TIZANIDINE taken for muscle relaxant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I probably had it too COVID". The patient underwent the following laboratory tests and procedures: investigation: unknown results. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: I probably had it too COVID; I probably had it too COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: EW0217, Expiration Date: 30Sep2021) at the age of 54 years as dose 2, single and administered in arm left, administration date 10Jun2021 (Lot number: EW0179, Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing), notes: Additional Information for Concomitant Products Tizanidine: Consumer stated, "At the time the only medication that I was taking is the muscle relaxer, it's called Tizanidine.". Concomitant medication(s) included: TIZANIDINE taken for muscle relaxant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I probably had it too COVID". The patient underwent the following laboratory tests and procedures: investigation: unknown results. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: ADAMTS13 activity assay, Blood lactate dehydrogenase, Blood smear test, Contusion, Haptoglobin
Clinical narrative: This is a literature report. A 28 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "iTTP", start date: 2019 (unspecified if ongoing), notes: late 2019; "fatigue" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "rash" (unspecified if ongoing); "ecchymosis" (unspecified if ongoing); "petechiae" (unspecified if ongoing); "scant vaginal bleeding" (unspecified if ongoing); "mild headaches" (unspecified if ongoing); "microangiopathic hemolytic anemia" (unspecified if ongoing), notes: On the peripheral blood smear; "admitted" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rituximab for Immune-mediated thrombotic thrombocytopenic purpura, reaction(s): "she developed recurrent thrombocytopenia and suffered an exacerbation of iTTP"; Caplacizumab for exacerbation of iTTP, reaction(s): "but did not achieve an ADAMTS-13 activity remission". The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), outcome "recovered", described as "iTTP relapse"; CONTUSION (non-serious), outcome "unknown", described as "bruising on her arms". The patient was hospitalized for thrombotic thrombocytopenic purpura (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: adamts13 activity assay: a diagnosis of iTTP; less than 2.5, notes: %; blood lactate dehydrogenase (normal high range 190): 205 IU/l; normalized; 216 IU/l; normalized, notes: on day 3; blood lactate dehydrogenase: normalized; 216 IU/l; blood smear test: she was found to be severely thrombocytopenic, notes: (platelets,17x 109/L) with evidence of microangiopathic hemolytic anemia; schistocytes; haptoglobin: undetectable; platelet count: 17 x10 9/l; 84 x10 9/l, notes: thrombocytopenia; 159 x10 9/l; 57 x10 9/l; normal, notes: on day 3. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events Thrombotic thrombocytopenic purpura 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombotic thrombocytopenic purpura
Clinical narrative: This is a literature report. A 28 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "iTTP", start date: 2019 (unspecified if ongoing), notes: late 2019; "fatigue" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "rash" (unspecified if ongoing); "ecchymosis" (unspecified if ongoing); "petechiae" (unspecified if ongoing); "scant vaginal bleeding" (unspecified if ongoing); "mild headaches" (unspecified if ongoing); "microangiopathic hemolytic anemia" (unspecified if ongoing), notes: On the peripheral blood smear; "admitted" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rituximab for Immune-mediated thrombotic thrombocytopenic purpura, reaction(s): "she developed recurrent thrombocytopenia and suffered an exacerbation of iTTP"; Caplacizumab for exacerbation of iTTP, reaction(s): "but did not achieve an ADAMTS-13 activity remission". The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), outcome "recovered", described as "iTTP relapse"; CONTUSION (non-serious), outcome "unknown", described as "bruising on her arms". The patient was hospitalized for thrombotic thrombocytopenic purpura (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: adamts13 activity assay: a diagnosis of iTTP; less than 2.5, notes: %; blood lactate dehydrogenase (normal high range 190): 205 IU/l; normalized; 216 IU/l; normalized, notes: on day 3; blood lactate dehydrogenase: normalized; 216 IU/l; blood smear test: she was found to be severely thrombocytopenic, notes: (platelets,17x 109/L) with evidence of microangiopathic hemolytic anemia; schistocytes; haptoglobin: undetectable; platelet count: 17 x10 9/l; 84 x10 9/l, notes: thrombocytopenia; 159 x10 9/l; 57 x10 9/l; normal, notes: on day 3. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events Thrombotic thrombocytopenic purpura 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date: 15Jan2022 / covid test result: Positive; covid test date: 15Jan2022 / covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jun2021 15:00 (Lot number: EW0183) at the age of 43 years as dose 2, single and administered in arm left, administration date 21May2021 13:30 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "covid test date: 15Jan2022 / covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive, notes: Nasal swab.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: reduced immunity; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single; lot number: unknown; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant) with onset Feb2021, outcome "unknown", described as "reduced immunity".  Clinical course: No adverse reaction to booster shot (3Innoculation).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Near death experience
Clinical narrative: She almost passed away; She got depressed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "She almost passed away"; DEPRESSION (non-serious), outcome "unknown", described as "She got depressed". The consumer reported that there was a death in family, and she got depressed. The patient never took any vaccine before. Reporter further stated, she took this vaccine and was hospitalized for a week. She almost passed away.  The reporter considered "she got depressed" not related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the event of Depression is assessed as unrelated to bnt162b2 and more likely due to death in family as reported in narrative .
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infection; Breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Lot number: Ew0196) at the age of 45 years as dose 3 (booster), single, administration date 24Mar2021 (Lot number: Ep6955) as dose 2, single and administration date 04Mar2021 (Lot number: El3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NAPROXEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Feb2022, outcome "recovering" and all described as "Breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: Covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: Binaxnow, covid test date: 23Feb2022, covid test result: Positive. The patient was not tested positive prior vaccination and got tested after vaccination. The patient did not had any other vaccine in four weeks.  No other vaccine in four weeks. No covid prior vaccination. Patient was tested covid positive post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, Pulmonary pain, Suspected COVID-19
Clinical narrative: received Pfizer vaccine as booster;Janssen as initial dose; received Pfizer vaccine as booster;Janssen as initial dose; contracted the covid-19 virus; lungs are still hurting; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "received Pfizer vaccine as booster;Janssen as initial dose"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "contracted the covid-19 virus"; PULMONARY PAIN (non-serious), outcome "not recovered", described as "lungs are still hurting". Therapeutic measures were taken as a result of suspected covid-19, pulmonary pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200321927 Same reporter/Patient, Different event/Drug
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Cardiomegaly, Echocardiogram, Ejection fraction, Ejection fraction abnormal
Clinical narrative: heart failure; stated that his resting heart rate is 160; ejection fraction is still only at 20%; grossly enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "stated that his resting heart rate is 160"; EJECTION FRACTION ABNORMAL (medically significant), outcome "unknown", described as "ejection fraction is still only at 20%"; CARDIOMEGALY (non-serious), outcome "unknown", described as "grossly enlarged heart". The patient underwent the following laboratory tests and procedures: ejection fraction: 20 %; heart rate: 160, notes: his resting heart rate is 160; echocardiogram: unknown results. Therapeutic measures were taken as a result of cardiac failure, heart rate increased, ejection fraction abnormal, cardiomegaly.  The wife reported that her husband experiencing heart issues shortly after his second dose of Pfizer vaccine. Her husband had it and her daughter when it was appropriate for their age group and her husband had been battling this since then. His resting heart rate was 160 which caused his heart to be grossly enlarged. He had heart failure for a few months from continued rapid heart rate. He had to have a defibrillator to control it and that he had been placed on Entresto. He had another echocardiogram last week and he went to see the cardiology surgeon to get the results. His ejection fraction was still only at 20% and they were saying that there was no other viable treatment other than putting him on the transplant list. She heard that it was mostly in younger men and she had her entire family vaccinated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart failure; stated that his resting heart rate is 160; ejection fraction is still only at 20%; grossly enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "stated that his resting heart rate is 160"; EJECTION FRACTION ABNORMAL (medically significant), outcome "unknown", described as "ejection fraction is still only at 20%"; CARDIOMEGALY (non-serious), outcome "unknown", described as "grossly enlarged heart". The patient underwent the following laboratory tests and procedures: ejection fraction: 20 %; heart rate: 160, notes: his resting heart rate is 160; echocardiogram: unknown results. Therapeutic measures were taken as a result of cardiac failure, heart rate increased, ejection fraction abnormal, cardiomegaly.  The wife reported that her husband experiencing heart issues shortly after his second dose of Pfizer vaccine. Her husband had it and her daughter when it was appropriate for their age group and her husband had been battling this since then. His resting heart rate was 160 which caused his heart to be grossly enlarged. He had heart failure for a few months from continued rapid heart rate. He had to have a defibrillator to control it and that he had been placed on Entresto. He had another echocardiogram last week and he went to see the cardiology surgeon to get the results. His ejection fraction was still only at 20% and they were saying that there was no other viable treatment other than putting him on the transplant list. She heard that it was mostly in younger men and she had her entire family vaccinated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Pruritus, Rash, Swelling
Clinical narrative: rash all over her body; swelling; itchiness; shortness of breath; diarrhoea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash all over her body"; SWELLING (non-serious), outcome "unknown", described as "swelling"; PRURITUS (non-serious), outcome "unknown", described as "itchiness"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea".  Additional information: Reporter stated that she had her first dose for the Pfizer Covid-19 vaccine on 15Feb2022, and caller mentioned that she is experiencing severe allergic reaction now, she has a rash all over her body, swelling, itchiness and shortness of breath. She's afraid of taking the 2nd dose, but she said that she already has an appointment with the doctor. The doctor recommended she take a test, and once the result is out she can have the Johnson and Johnson vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: exposed at a dinner party and tested Ag positive 24Feb2022 but no sx so far; exposed at a dinner party and tested Ag positive 24Feb2022 but no sx so far; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 25 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 16Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Feb2022, outcome "unknown" and all described as "exposed at a dinner party and tested Ag positive 24Feb2022 but no sx so far". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (24Feb2022) positive, notes: covid test type post vaccination=Unknown. Additional information: Exposed at a dinner party and tested Ag positive 24Feb but no sx so far. Facility type vaccine was Workplace clinic. Sequiris vaccine administered in vaccine 4 weeks on 16Nov2021. Unknown if Covid prior vaccination. Tested Covid post vaccination. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Vaccination failure , covid 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Test: Home Ag/Result: Positive; Test: Home Ag/Result: Positive; fever; fatigue; rhinorrhea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 48 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EL3247) as dose 2, single and administration date 02Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 23Feb2022, outcome "unknown" and all described as "Test: Home Ag/Result: Positive"; PYREXIA (non-serious) with onset 21Feb2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 21Feb2022, outcome "unknown", described as "fatigue"; RHINORRHOEA (non-serious) with onset 21Feb2022, outcome "unknown", described as "rhinorrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, pyrexia, fatigue, rhinorrhoea. Clinical course includes that, SX 21Feb2022 after ice hockey event with known exposure then family members in household got covid and so did he mild SX fever fatigue and rhinorrhea. Covid prior vaccination was unknown. Other vaccination in four weeks was unknown. Post vaccination covid was tested positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events 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 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.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Test: Home Ag/Result: Positive; Test: Home Ag/Result: Positive; fever; fatigue; rhinorrhea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 48 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EL3247) as dose 2, single and administration date 02Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 23Feb2022, outcome "unknown" and all described as "Test: Home Ag/Result: Positive"; PYREXIA (non-serious) with onset 21Feb2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 21Feb2022, outcome "unknown", described as "fatigue"; RHINORRHOEA (non-serious) with onset 21Feb2022, outcome "unknown", described as "rhinorrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, pyrexia, fatigue, rhinorrhoea. Clinical course includes that, SX 21Feb2022 after ice hockey event with known exposure then family members in household got covid and so did he mild SX fever fatigue and rhinorrhea. Covid prior vaccination was unknown. Other vaccination in four weeks was unknown. Post vaccination covid was tested positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events 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 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test, Vaccination failure
Clinical narrative: develops Covid19 confirmed by nasal swab test 'Covid rapid test'.; develops Covid19 confirmed by nasal swab test 'Covid rapid test'.; she got sick in 2021; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group and a sales representative. The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05May2021 (Lot number: EW0167) at the age of 29 years as dose 2, single and administration date 14Apr2021 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism, for which she takes Levothyroxine.; "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", COVID-19(medically significant) with onset Feb2022, outcome "recovered" and all described as "develops Covid19 confirmed by nasal swab test 'Covid rapid test'."; MALAISE (non-serious) with onset 2021, outcome "recovered", described as "she got sick in 2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) positive, notes: Nasal Swab test.AE treatment:10 day course of cephALEXin 500 MG.Patient should have received the 3rd dose, however with dose 1 and dose 2 she got sick in 2021, and for that reason she did not want to receive the third dose.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes left arm pit and left side of neck; This is a spontaneous report from a contactable reporter (healthcare professional). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Feb2022 at 15:45 (Lot number: unknown) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: tree nuts and "Latex allergy" (unspecified if ongoing). Concomitant medication included blood pressure medications (unspecified). Past drug history included: Benzoyl peroxide, reaction: "Drug allergy", notes: Known allergies: Benzoyl Peroxide. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm; Administration time: 14:00), administration date: 02Jun2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm; Administration time: 14:00), administration date: 23Jun2021, when the patient was 45 years old, for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2022 at 16:00, outcome "recovering", described as "Swollen lymph nodes left arm pit and left side of neck". The event "Swollen lymph nodes left arm pit and left side of neck " was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included anti inflammatory medications over the counter (OTC) and warm packs for lymphadenopathy.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got Covid after receiving both vaccines; Got Covid after receiving both vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 87 year-old male patient received bnt162b2 (BNT162B2), administration date 11May2021 (Lot number: EW0169) at the age of 86 years as dose 2, single and administration date 20Apr2021 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "Got Covid after receiving both vaccines". The patient was hospitalized for vaccination failure, covid-19 (start date: 19Dec2021, discharge date: 22Dec2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  Clinical course: Caller (patient) clarified that he got two shots, he ended up in the hospital for two weeks with a blood clot, he couldn't walk, then he went through months of rehab. Stated then he got Covid.   No follow-up attempts are possible. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Osteoarthritis
Clinical narrative: Severe dermatitis and osteoarthritis started a month after first injection; Osteoarthritis started a month after first injection; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Apr2021 at 13:00 (Lot number: EN6201) at the age of 58 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medications. The following information was reported: DERMATITIS (non-serious) with onset 02May2021, outcome "not recovered", described as "Severe dermatitis and osteoarthritis started a month after first injection"; OSTEOARTHRITIS (non-serious) with onset 02May2021, outcome "not recovered", described as "Osteoarthritis started a month after first injection". The events "Severe dermatitis and osteoarthritis started a month after first injection" and "Osteoarthritis started a month after first injection" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dermatitis and osteoarthritis.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported she had no health insurance but had paid to go to 8 different doctors. Reacts due to weather or stress. Patient reported this was not in family history and never had before. Treatment received for dermatitis and osteoarthritis included Cortisone. Since the vaccination, the patient had not been tested for COVID-19. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 21Apr2021 at 13:00 (Lot number: EO7533) at the age of 58 years as dose 2, single for COVID-19 immunisation and bnt162b2 (BNT162B2), administered in left arm, administration date 01Feb2022 at 13:00 (Lot number: FJ6369) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation.