chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent booster for First Primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent booster for First Primary dose).    No concomitant medications were reported.  It was reported that on 29-Nov-2022, the patient walked in telling the staff that she never received the Primary series. She was asking for a 2nd primary dose.  No treatment medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022; No Adverse event; Expired Moderna dose administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022) and NO ADVERSE EVENT (No Adverse event) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to patients) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 21NOV2022, expiration date of 25NOV2022 and administered on 28NOV2022).    No concomitant medication were reported.  HCP stated that 2 patients were administered a dose of the Moderna COVID-19 after the expiration date of 25-NOV-2022. Monovalent vaccine of Individual vial with Unknown vial size  The vial was initially stored in the refrigerator on 21-NOV-2022. The vial did not undergo any temperature excursions. Patients have not reported any adverse reactions to the dose at the time. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out with body rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out with body rashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (broke out with body rashes). At the time of the report, RASH (broke out with body rashes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported the patient took the mRNA vaccine and broke out with body rashes that lasted for over a year.   Treatment information was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus after first three shot / Chirping in my head; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after first three shot / Chirping in my head) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F4A, 001B21A and 031L20A) for COVID-19 prophylaxis.     It was reported that patient had never diagnosed or tested positive with COVID-19. It was reported that patient did not had any acute illness at the time of vaccination and up to one month before. Patient had not experienced any similar event in the past.  Concurrent medical conditions included Blood cholesterol abnormal and Insomnia. Concomitant products included ATORVASTATIN from 2020 to an unknown date for Blood cholesterol abnormal, ZOLPIDEM TARTRATE (AMBIEN) from 2012 to an unknown date for Insomnia.   On 12-Feb-2021 at 12:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced TINNITUS (Tinnitus after first three shot / Chirping in my head). At the time of the report, TINNITUS (Tinnitus after first three shot / Chirping in my head) had not resolved.            Patient stated that if patient was not concentrating on something or distracted patient used to notice the noise. Patient stated that noises started after the vaccinations. Patient had ordered bone conducting headphones to see whether they could help as people claimed they helped in some cases and was a smooth try. Patient had multiple episodes of tinnitus which occurred on 12-Feb-2021, 12-Mar-2021 and 09-Nov-2021. Route and body site for all doses were reported. The event did not caused patient to seek medical case.  Treatment medications were not reported.   This case was linked to MOD-2022-642006 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported Covid symptoms returned after 14 days.  No treatment information was provided.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired 2nd Monovalent primary dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Monovalent primary dose) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Monovalent primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Monovalent primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Monovalent primary dose).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-680248 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER7934), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW2245), in left arm and on 28Jan2022 as dose 3 (booster), single (Lot number: EK9896) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LEVOTIROXINA [LEVOTHYROXINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Haemoptysis, Pericarditis
Clinical narrative: pericarditis; had severe pain in my chest; I was coughing up an alarming amount of blood; chronic fatigue; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 09:00 as dose 1, single (Lot number: FG3527) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies :Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: HAEMOPTYSIS (hospitalization, disability) with onset 13Nov2021, outcome "not recovered", described as "I was coughing up an alarming amount of blood"; FATIGUE (hospitalization, disability) with onset 13Nov2021, outcome "not recovered", described as "chronic fatigue"; CHEST PAIN (hospitalization, disability) with onset 13Nov2021, outcome "not recovered", described as "had severe pain in my chest"; PERICARDITIS (hospitalization, disability, medically significant) with onset 13Nov2021, outcome "not recovered"; DYSPNOEA (hospitalization, disability) with onset 13Nov2021, outcome "not recovered", described as "shortness of breath". The patient was hospitalized for pericarditis, chest pain, haemoptysis, fatigue, dyspnoea (hospitalization duration: 1 day(s)). The events "pericarditis", "had severe pain in my chest", "i was coughing up an alarming amount of blood", "chronic fatigue" and "shortness of breath" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pericarditis, chest pain, haemoptysis, fatigue, dyspnoea. Clinical curse: In less than 24 hours the patient began experiencing symptoms from first dose of the Pfzier vaccine. The patient was coughing up an alarming amount of blood and had severe pain in chest. A Doctor at urgent care informed patient body was reacting to the vaccine and to give it a few days. As the problem persisted, patient was hospitalized. As a result of the vaccine, patient have experienced chronic fatigue, stabbing chest pain, and shortness of breath. The patient had spent the past year struggling with this, in and out of doctor's offices, and was diagnosed with pericarditis. Prior to this, patient was a perfectly healthy 26-year-old with none of these ailments. The vaccine has been detrimental to my health and quality of life. Ae treatment was reported as EKG, bloodwork, etc. The patient had no COVID prior vaccination. It was unknown if COVID tested post vaccination. The patient had no other vaccine in four week.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Autoimmune disorder, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: hair loss; autoimmune disease; covid_test_result=Positive; covid_test_result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 14:30 as dose 1, single (Lot number: Fp4554) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 01Oct2022, outcome "unknown" and all described as "covid_test_result=Positive"; ALOPECIA (disability), outcome "not recovered", described as "hair loss"; AUTOIMMUNE DISORDER (disability), outcome "not recovered", described as "autoimmune disease". The events "covid_test_result=positive", "hair loss" and "autoimmune disease" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Positive, notes: Nasal swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reporter stated that it was not acceptable to approve this vaccine it has caused patient to have Severe hair loss and now being diagnosed with an autoimmune disease and still going to doctors to try and get help for the hair loss, patient noticed this after getting the first COVID vaccine when patient worked in hospital. Patient also know 2 young ladies my age who both just got diagnosed with Miastenia Gravis and giving it to young children is not safe either I hope someone will stop giving this vaccine it is causing more harm than good. The patient had no COVID prior vaccination.; Sender's Comments: A contributory role of BNT162B2 to event covid_test_result=Positive, hair loss and autoimmune disease cannot be excluded based on temporal association and available information. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Decreased appetite, Fatigue, Headache
Clinical narrative: 101 fever; arm site pain; body ache; scratchy throat; chest pain; headache; no appetite; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 17:45 as dose 3 (booster), single (Lot number: GJ6739) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "rheumatoid arthritis fingers" (unspecified if ongoing), notes: rheumatold arthritis fingers; "sickle cell trait" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "allergy to unspecified drug" (unspecified if ongoing), notes: unspecified drug used for nerve pain; "nerve pain" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: unspecified variety of food. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number=EW0181,, Administration time=03:30 PM,, Vaccine location=Left arm), administration date: 16Jun2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number=EW0181,, Administration time=12:30 PM,, Vaccine location=Left arm), administration date: 07Jul2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "101 fever"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "arm site pain"; PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "body ache"; CHEST PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering"; HEADACHE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "no appetite"; THROAT IRRITATION (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "scratchy throat"; FATIGUE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, pain, throat irritation, chest pain, headache, decreased appetite, fatigue. Additional information: other medications in two weeks included blood pressure medicines, multi vitamins and minerals.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Throat irritation, Vaccination site pain
Clinical narrative: 101 fever; arm site pain; body ache; scratchy throat; chest pain; headache; no appetite; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 17:45 as dose 3 (booster), single (Lot number: GJ6739) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "rheumatoid arthritis fingers" (unspecified if ongoing), notes: rheumatold arthritis fingers; "sickle cell trait" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "allergy to unspecified drug" (unspecified if ongoing), notes: unspecified drug used for nerve pain; "nerve pain" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: unspecified variety of food. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number=EW0181,, Administration time=03:30 PM,, Vaccine location=Left arm), administration date: 16Jun2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number=EW0181,, Administration time=12:30 PM,, Vaccine location=Left arm), administration date: 07Jul2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "101 fever"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "arm site pain"; PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "body ache"; CHEST PAIN (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering"; HEADACHE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "no appetite"; THROAT IRRITATION (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "scratchy throat"; FATIGUE (non-serious) with onset 20Nov2022 at 18:00, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, pain, throat irritation, chest pain, headache, decreased appetite, fatigue. Additional information: other medications in two weeks included blood pressure medicines, multi vitamins and minerals.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: reported a positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After a family gathering at them renaissance festival, 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test. The two family members over the age of 50 have been prescribed Paxlovid.   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-202201333384 same product and event, different patient;US-PFIZER INC-PV202200112164 same product and event, different patient;
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19, No apparent symptoms; Tested positive for COVID-19, No apparent symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 26May2021 as dose 1, single (Batch/Lot number: unknown) and on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 15 years 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), ASYMPTOMATIC COVID-19 (medically significant) all with onset 26Nov2022, outcome "unknown" and all described as "Tested positive for COVID-19, No apparent symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Nov2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, asymptomatic covid-19.  Clinical course: Tested positive for COVID-19. No apparent symptoms, he was tested because others in the house with symptoms tested positive.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Covid-19 vaccine associated myocarditis.; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis.".  Clinical course: The mechanism of myocardial injury following mRNA-based vaccination remained uncertain, but it was postulated to reflect overaggressive T-cell activation following host-cell manufacturing of modified mRNA nucleosides of the SARS-CoV-2 virus, subsequently leading to myocardial injury through molecular mimicry. Whether this iatrogenic catalyst of myocardial injury results in a similar duration and cumulative burden of inflammatory injury compared with community-acquired viral myocarditis was previously unknown. A single case series of 5subjects was published casting preliminary insights from convalescent CMR-based findings following mRNA COVID-19 vaccination induced injury.; Sender's Comments: Based on the available information in the case, an association between the reported event Myocarditis and The suspected drug 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.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Covid-19 vaccine associated myocarditis; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis".  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 available information in the case, the causal association between the event myocarditis and the 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: 64.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Balance disorder, Middle ear effusion, Off label use, Product use issue
Clinical narrative: major loss of balance; fluid build up in my right ear behind my eardrum; All joints in my whole body hurt for 6.5 weeks; Dose number:1/Brand:Pfizer CoVid Bival; vaccine received same date: Flucelvax Quad 2022-2023; vaccine received same date: Flucelvax Quad 2022-2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:00 as dose 1, single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 07Oct2022 as dose 1, single (Lot number: 348374) for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Oct2022, outcome "unknown" and all described as "vaccine received same date: Flucelvax Quad 2022-2023"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 07Oct2022 at 10:00, outcome "unknown", described as "Dose number:1/Brand:Pfizer CoVid Bival"; ARTHRALGIA (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "All joints in my whole body hurt for 6.5 weeks"; MIDDLE EAR EFFUSION (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "fluid build up in my right ear behind my eardrum"; BALANCE DISORDER (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "major loss of balance". The events "major loss of balance", "fluid build up in my right ear behind my eardrum" and "all joints in my whole body hurt for 6.5 weeks" required physician office visit. Therapeutic measures were not taken as a result of balance disorder, middle ear effusion, arthralgia.  Additional information: the patient did not receive any other vaccine in four weeks. The patient had not tested for COVID prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Wrong product administered
Clinical narrative: major loss of balance; fluid build up in my right ear behind my eardrum; All joints in my whole body hurt for 6.5 weeks; Dose number:1/Brand:Pfizer CoVid Bival; vaccine received same date: Flucelvax Quad 2022-2023; vaccine received same date: Flucelvax Quad 2022-2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:00 as dose 1, single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 07Oct2022 as dose 1, single (Lot number: 348374) for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Oct2022, outcome "unknown" and all described as "vaccine received same date: Flucelvax Quad 2022-2023"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 07Oct2022 at 10:00, outcome "unknown", described as "Dose number:1/Brand:Pfizer CoVid Bival"; ARTHRALGIA (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "All joints in my whole body hurt for 6.5 weeks"; MIDDLE EAR EFFUSION (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "fluid build up in my right ear behind my eardrum"; BALANCE DISORDER (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "major loss of balance". The events "major loss of balance", "fluid build up in my right ear behind my eardrum" and "all joints in my whole body hurt for 6.5 weeks" required physician office visit. Therapeutic measures were not taken as a result of balance disorder, middle ear effusion, arthralgia.  Additional information: the patient did not receive any other vaccine in four weeks. The patient had not tested for COVID prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Palpitations, Panic attack, Thirst
Clinical narrative: I felt my heart racing like it was going to get out of my chest; my mouth got very dry at that moment I thought I was having a panic attack.; my mouth got very dry at that moment I thought I was having a panic attack.; I try to calm myself got a bottle of water and drank the whole bottle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 32030BD) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 29Mar2021, when the patient was 58-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 08Mar2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "I felt my heart racing like it was going to get out of my chest"; DRY MOUTH (non-serious), PANIC ATTACK (non-serious), outcome "not recovered" and all described as "my mouth got very dry at that moment I thought I was having a panic attack."; THIRST (non-serious), outcome "not recovered", described as "I try to calm myself got a bottle of water and drank the whole bottle". Therapeutic measures were not taken as a result of palpitations, dry mouth, panic attack, thirst.  Additional information: Patient reported that, I felt my heart racing like it was going to get out of my chest crazy, my mouth got very dry at that moment I thought I was having a panic attack. I try to calm myself got a bottle of water and drank the whole bottle. No covid prior vaccination, yes covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337169 same patient/drug, different dose/event;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I felt my heart racing like it was going to get out of my chest; my mouth got very dry at that moment I thought I was having a panic attack.; my mouth got very dry at that moment I thought I was having a panic attack.; I try to calm myself got a bottle of water and drank the whole bottle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 32030BD) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 29Mar2021, when the patient was 58-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 08Mar2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "I felt my heart racing like it was going to get out of my chest"; DRY MOUTH (non-serious), PANIC ATTACK (non-serious), outcome "not recovered" and all described as "my mouth got very dry at that moment I thought I was having a panic attack."; THIRST (non-serious), outcome "not recovered", described as "I try to calm myself got a bottle of water and drank the whole bottle". Therapeutic measures were not taken as a result of palpitations, dry mouth, panic attack, thirst.  Additional information: Patient reported that, I felt my heart racing like it was going to get out of my chest crazy, my mouth got very dry at that moment I thought I was having a panic attack. I try to calm myself got a bottle of water and drank the whole bottle. No covid prior vaccination, yes covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337169 same patient/drug, different dose/event;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Incorrect dose administered, Interchange of vaccine products, Muscle spasms, Pain
Clinical narrative: Headache; all over body ache; muscle cramping; Moderna: 27Nov2022 (1-4 dose); Pfizer Bivalent: 27Nov2022(5th dose); Moderna: 27Nov2022 (1-4 dose); Pfizer Bivalent: 27Nov2022(5th dose); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Nov2022 as dose 1, single (Lot number: 012M20A), in left arm, on 27Nov2022 as dose 2, single (Lot number: 032M20A), in right arm, on 27Nov2022 as dose 3 (booster, single (Lot number: 012H21B), in right arm and on 27Nov2022 as dose 4 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 27Nov2022, outcome "unknown" and all described as "Moderna: 27Nov2022 (1-4 dose); Pfizer Bivalent: 27Nov2022(5th dose)"; HEADACHE (non-serious) with onset 28Nov2022 at 00:30, outcome "recovering"; PAIN (non-serious) with onset 28Nov2022 at 00:30, outcome "recovering", described as "all over body ache"; MUSCLE SPASMS (non-serious) with onset 28Nov2022 at 00:30, outcome "recovering", described as "muscle cramping". Therapeutic measures were not taken as a result of headache, pain, muscle spasms.  Additional information: Age group was reported as elderly (65+ Years).The patient received more than 3 doses.  There were no other vaccine in four weeks. There were no other medications in two weeks. The patient didn't experienced covid prior vaccination. The patient didn't experienced covid tested post vaccination. There were no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; 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 47-year-old male patient received BNT162b2 (COMIRNATY), on 19Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 12Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027), in left arm, all intramuscular 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 28Nov2022, outcome "not recovered", COVID-19 (medically significant) with onset 28Nov2022, outcome "not recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2022) Positive, notes: Nasal Swab. Additional information: No other vaccine in Four week. Tested positive for COVID-19 on 28Nov2022. Sore throat, sneezing, runny nose, congestion, mild cough. In addition, he had been experiencing pain in his left knee and ankle suddenly disappeared. He reported the same thing when he received the first two doses of Cominarty. Now joint pain disappeared at the same time he tested positive for COVID-19. No covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337269 same patient/drug, different dose/event;US-PFIZER INC-202201337387 same patient/drug, different dose/event;US-PFIZER INC-202201337388 same patient/drug, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; 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 47-year-old male patient received BNT162b2 (COMIRNATY), on 19Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 12Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027), in left arm, all intramuscular 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 28Nov2022, outcome "not recovered", COVID-19 (medically significant) with onset 28Nov2022, outcome "not recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2022) Positive, notes: Nasal Swab. Additional information: No other vaccine in Four week. Tested positive for COVID-19 on 28Nov2022. Sore throat, sneezing, runny nose, congestion, mild cough. In addition, he had been experiencing pain in his left knee and ankle suddenly disappeared. He reported the same thing when he received the first two doses of Cominarty. Now joint pain disappeared at the same time he tested positive for COVID-19. No covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337269 same patient/drug, different dose/event;US-PFIZER INC-202201337387 same patient/drug, different dose/event;US-PFIZER INC-202201337388 same patient/drug, different dose/event;
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: pain I had been experiencing in my left knee and ankle suddenly disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE; Lot No: EL3247; Location of injection: Arm Left; Route of Administration: Intramuscular), administration date: 19Feb2021, when the patient was 46-year-old, for Covid-19 immunization, reaction(s): "pain I had been experiencing in my left knee and ankle suddenly disappeared. I reported the same thing when I received the first two doses of Cominarty"; comirnaty (DOSE 2, SINGLE; Lot No: EL3247; Location of injection: Arm Left; Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 46-year-old, for Covid-19 immunization, reaction(s): "pain I had been experiencing in my left knee and ankle suddenly disappeared. I reported the same thing when I received the first two doses of Cominarty". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "pain I had been experiencing in my left knee and ankle suddenly disappeared".  Additional information: It was reported that joint pain disappeared at the same time when tested positive for COVID-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337257 same patient/drug, different dose/event;US-PFIZER INC-202201337388 Same patient/product; different dose/event;
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: pain I had been experiencing in my left knee and ankle suddenly disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE; Lot No: EL3247; Location of injection: Arm Left; Route of Administration: Intramuscular), administration date: 19Feb2021, when the patient was 46-year-old, for Covid-19 immunization, reaction(s): "pain I had been experiencing in my left knee and ankle suddenly disappeared. I reported the same thing when I received the first two doses of Cominarty"; comirnaty (DOSE 2, SINGLE; Lot No: EL3247; Location of injection: Arm Left; Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 46-year-old, for Covid-19 immunization, reaction(s): "pain I had been experiencing in my left knee and ankle suddenly disappeared. I reported the same thing when I received the first two doses of Cominarty". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "pain I had been experiencing in my left knee and ankle suddenly disappeared".  Additional information: It was reported that joint pain disappeared at the same time when tested positive for COVID-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337257 same patient/drug, different dose/event;US-PFIZER INC-202201337388 Same patient/product; different dose/event;