chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (I've got muscle soreness in my left arm /muscle soreness in my left arm /Pain has been consistent since the first dose/ache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (I've got muscle soreness in my left arm /muscle soreness in my left arm /Pain has been consistent since the first dose/ache). At the time of the report, VACCINATION SITE PAIN (I've got muscle soreness in my left arm /muscle soreness in my left arm /Pain has been consistent since the first dose/ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received 3rd dose of the vaccine in his left arm. and still dealing with a side effect from some time ago patient had gotten 3 shots
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date/lot 042J21A should have been reported with a BUD of Feb 17, 2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medication was not provided.   It was reported that there was a mistake given during my phone call regarding lot 012H21B. That lot was not affected, but lot 042J21A should have been reported with a BUD of Feb 17, 2022.  Treatment information was not reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: joint pain / Specifically migrating joint pain; injection site arm soreness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (injection site arm soreness) and ARTHRALGIA (joint pain / Specifically migrating joint pain) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE, ROSUVASTATIN, MELOXICAM, PANTOPRAZOL [PANTOPRAZOLE] and HYDROXYCHLOROQUINE for an unknown indication.    On 21-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ARTHRALGIA (joint pain / Specifically migrating joint pain). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm soreness). At the time of the report, VACCINATION SITE PAIN (injection site arm soreness) had resolved and ARTHRALGIA (joint pain / Specifically migrating joint pain) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  It was reported that, the patient had injection site arm soreness after his dose lasted for 2 days. In Oct-2022, the patient developed joint pain, specifically migrating joint pain. The patient has had a series of blood tests to rule out rheumatoid arthritis. Patient was still waiting for a final diagnosis of rheumatoid arthritis from his Rheumatologist.  No treatment medications were reported.   This case was linked to MOD-2023-705996 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date,vaccines were administered July 13 to 21 of 2022/vaccines used by date was July 14 2022).    No concomitant medications were provided. No treatment medications were provided. It was reported that the office was aware of 3 patients that had received mention vaccine vials.
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site movement impairment
Clinical narrative: I can't use my arms at all; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I can't use my arms at all) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can't use my arms at all). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I can't use my arms at all) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site movement impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I cannot use my right arm ever since I got your vaccination) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I cannot use my right arm ever since I got your vaccination). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I cannot use my right arm ever since I got your vaccination) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient cannot use right arm ever since getting the vaccination.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Mobility decreased
Clinical narrative: jacked up my arm, I cannot use my arm anymore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (jacked up my arm, I cannot use my arm anymore) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (jacked up my arm, I cannot use my arm anymore). At the time of the report, MOBILITY DECREASED (jacked up my arm, I cannot use my arm anymore) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Pruritus
Clinical narrative: got red splots as well all over her body; More than 35 days in between Primary Series vaccines; itching all over/Adverse Reactions of continued itching; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching all over/Adverse Reactions of continued itching), ERYTHEMA (got red splots as well all over her body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Primary Series vaccines) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 041B21A and 939904) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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. In March 2021, the patient experienced PRURITUS (itching all over/Adverse Reactions of continued itching). On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Primary Series vaccines). On an unknown date, the patient experienced ERYTHEMA (got red splots as well all over her body). At the time of the report, PRURITUS (itching all over/Adverse Reactions of continued itching) had not resolved and ERYTHEMA (got red splots as well all over her body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Primary Series vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: running a fever of 103; The initial case was missing the following minimum criteria: ICH - Unspecified AE. Upon receipt of follow-up information on 25an2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "R/A", start date: Jan2017 (ongoing), notes: rheumatoid arthritis; "Polymyalgia rheumatica", start date: Jan2017 (ongoing); "B/P" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); WARFARIN taken for thrombosis, start date: Aug2019 (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); MONTELUKAST taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: FM9810, Administration time: 10:57 AM, Anatomical site of injection: Left arm), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: EN6200, Administration time: 10:44 AM, Anatomical site of injection: Left arm), administration date: 04Mar2021, when the patient was 74-year-old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 at 16:00, outcome "recovered" (Oct2021), described as "running a fever of 103". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The event pyrexia lasted for 4 days. Patient did not go to hospital or family doctor.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Athsma" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN, start date: 14Jan2023, stop date: 20Jan2023; GUAIFENESIN taken for cough, start date: 14Jan2023, stop date: 20Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 13Jan2023 and stopped on 19Jan2023.  Clinical course was reported as, Paxlovid side effects metal taste in mouth, drowsiness, Diarrhoea, Gas, dry mouth on 15Jan2023. Patient not recovered from symptoms. Patient did not get treatment for AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE, start date: 25Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks was Prednisone. Anti viral details included COVID 19 Treatment, brand was Paxlovid started on 25Jan2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dyspnoea" (unspecified if ongoing), notes: other medical history: shortness of breath. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Other medication in 2 weeks: Yes. No known allergies. Other medical history: shortness of breath  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate, Heart rate abnormal
Clinical narrative: Chest pain; abnormal heartbeat; shortness of breath; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose 3 (booster), single (Lot number: GJ6743) at the age of 42 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: possibly Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "known allergies Tetracycline"; Doxycycline, reaction(s): "known allergies Doxycycline". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Lot #FF8839, Route of Administration: Intramuscular), administration date: 27Sep2021, when the patient was 40-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Lot #EW0178, Route of Administration: Intramuscular), administration date: 01Sep2021, when the patient was 40-year-old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 25Jan2023, outcome "not recovered"; HEART RATE ABNORMAL (non-serious) with onset 25Jan2023, outcome "not recovered", described as "abnormal heartbeat"; FATIGUE (non-serious) with onset 25Jan2023, outcome "not recovered"; DYSPNOEA (non-serious) with onset 25Jan2023, outcome "not recovered", described as "shortness of breath". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There was no other vaccine in four weeks. There was no other medications in two weeks. There as no covid prior vaccination. There was no covid tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Pain, Swelling face
Clinical narrative: body aches; Shivering; Swollen eyes; face is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: EYE SWELLING (non-serious) with onset 25Jan2023, outcome "unknown", described as "Swollen eyes"; SWELLING FACE (non-serious) with onset 25Jan2023, outcome "unknown", described as "face is swollen"; PAIN (non-serious), outcome "recovering", described as "body aches"; CHILLS (non-serious), outcome "recovering", described as "Shivering". Therapeutic measures were taken as a result of pain, chills. Additional information: caller got the Pfizer COVID booster vaccine and had a reaction last night and this morning, which caller stated is normal, always has this reaction, which caller clarified is that caller always has body aches and shivering for a little bit. When caller took medicine, no product name provided, the body aches and shivering reduced. Woke up with swollen eyes this morning, under eyes, on top of eyes, and face is swollen, really swollen around eyes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test positive; COVID test positive; COVID test positive; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), on 11Feb2021 as dose 2, single (Lot number: EM9810), on 30Aug2021 as dose 3 (booster), single (Lot number: EW0186) and on 02Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 78 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Aug2022, outcome "unknown" and all described as "COVID test positive"; DISEASE RECURRENCE (medically significant) with onset 01Oct2022, outcome "unknown", described as "COVID test positive". The event "covid test positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Aug2022) Positive; (01Oct2022) Positive; (unspecified date) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of disease recurrence.  Clinical course: Clarified that they had to get another booster because they were going on a cruise and flew to visit family. Husband got sick first and tested positive on 24Aug2022. Apparently, the dose they got on 02Aug2022 was the Monovariant. Thinking, probably they had the Omicron variant when they were in withheld. Since patient got sick after he had the second booster, should he now get the Bivariant booster. No treatment was given, cousin was physician, they did not give out Paxlovid. Test results: Yes, when they came back from vacation in Sep2022, patient tested positive for COVID again, 01Oct2022 and was then put on Paxlovid. No prior vaccinations within 4 weeks. No family medical history relevant to adverse events. Was feeling terrible, did home test that was negative, was really feeling lousy. Went to local, free-standing ER, they did another COVID test that was positive and he was prescribed the Paxlovid. Clarified he was not admitted to hospital.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  vaccination failure/ COVID 19  disease recurrence and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300038437 same reporter/drug/event, different patient;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "some arthritis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Jan2023 to 18Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 02Dec2022, stop date: 08Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Received other medication in 2 weeks. No known allergies. Received anti-viral product Paxlovid for COVID-19 on start date 10Jan2023 and treatment stop date on 15Jan2023.   The information on the batch/lot number for BNT162b2 NOS has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6198), on 25Mar2021 as dose 2, single (Lot number: ER8732), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 04Nov2022 as dose 5 (booster), single (Lot number: FM9992) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recently treated for recurrent prostatitis-UTI" (unspecified if ongoing); "UTI" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Known allergies: Fish" (unspecified if ongoing); "Known allergies: Sesame" (unspecified if ongoing); "Known allergies: Cumin" (unspecified if ongoing); "Known allergies: Turmeric" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; CLARITINE, stop date: 19Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "severe neutropenia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Jan2023, Treatment stop date: 20Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Severe illness; This is a spontaneous report received from a non-contactable Consumer. A female patient received BNT162b2 (BNT162B2 NOS), 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 consumer was calling about the Pfizer COVID-19 vaccine. She mentioned that she completed her shots and never had COVID because she takes vitamins. She added that she lost her twin nephews due to a severe side effect and a heart attack after getting the vaccine (AER# AER#202300045329 and PV202300017123) and her niece got a severe illness from taking bad shots of the vaccine. She also said why we are giving this to people and it's having side effects because it was not tested. Outcome of the event was unknown.   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-PV202300017123 same reporter, drug and different patient, event;
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EW0172) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose on 19May2021 Lot#EW0164), administration date: 19May2021, when the patient was 14-year-old, for Covid-19 immunization, reaction(s): "headache", "chills". The following information was reported: HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown". Additional information: The patient's mother stated that after the first three doses everything was ok, aside from headache and chills.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039503 same product, event and patient, different dose;
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot#EW0164), administration date: 19May2021, when the patient was 14-year-old, for Covid-19 immunization, reaction(s): "headache", "chills"; BNT162b2 (DOSE 2, SINGLE, Lot#EW0172), administration date: 09Jun2021, when the patient was 14-year-old, for Covid-19 immunization, reaction(s): "headache", "chills". The following information was reported: HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown".   Additional information: The mother calling on behalf of her daughter (patient) who received Pfizer covid-19 vaccines; the mother stated that after the first three Pfizer doses everything was ok, aside from headache and chills. Fourth dose on 24Jan2023 Lot#GK1337: Pfizer bivalent.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039503 same product, event and patient, different dose;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 43 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER2613), on 20Apr2021 as dose 2, single (Lot number: ER8735) and on 20Oct2021 as dose 3 (boostre), single (Lot number: FF2590) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Other medical history: peripheral venous insufficiency" (unspecified if ongoing), notes: Other medical history: peripheral venous insufficiency; "Other medical history: plantar fasciitis" (unspecified if ongoing), notes: Other medical history: plantar fasciitis; "Other medical history: dermatofibroma" (unspecified if ongoing), notes: Other medical history: dermatofibroma; "Known allergies: KNDA" (unspecified if ongoing), notes: Known allergies: KNDA. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (14Jan2023) Positive, notes: Rebound COVID 19 URI. positive PCR 14Jan2023; SARS-CoV-2 test: (unspecified date) Negative, notes: Negative rapid Ag on days 8; (unspecified date) Positive, notes: 10 Positive rapid Ag; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid on 14Jan2023 to 19Jan2023.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: severe illness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "severe illness".  Additional information: Caller was calling about the Pfizer COVID-19 vaccine. She mentioned that she completed her shots and never had COVID because she takes vitamins. She added that she lost her nephew due to a severe side effect and a heart attack after getting the vaccine and her niece got a severe illness from taking bad shots of the vaccine. She also said why we are giving this to people and it's having side effects because it was not tested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid early January/taking Paxlovid; got Covid early January/taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient 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; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset Jan2023, outcome "unknown" and all described as "got Covid early January/taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: The patient has had all the Pfizer shots and boosters, just got Covid early January.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4, Pfizer / BioNTech; Dose Number: 5, Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset May2022, outcome "unknown", described as "Dose Number: 4, Pfizer / BioNTech; Dose Number: 5, Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment drug included paxlovid from 13Jan2023 to 18Jan2023.  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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures, Paxlovid from 10Jan2023 to 15Jan2023, were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Primary immunization series of Pfizer and dose 3 of Moderna; COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vestibular migraine" (unspecified if ongoing); "low back pain" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Primary immunization series of Pfizer and dose 3 of Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Negative, notes: antigen testing after 6 days of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid, treatment start date=16Jan2023, treatment stop date=21Jan2023, Lot number=2692144, Indication=treatment of covid-19. Adverse event: rebound of symptoms. Negative by antigen testing after 6 days of paxlovid.  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 events INTERCHANGE OF VACCINE PRODUCTS, COVID-19, DRUG INEFFECTIVE and the suspect drug BNT162B2 cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: left side chest pain arising 2 days following vaccination. Ongoing for about 3 months.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 25Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 27Nov2022 at 20:00, outcome "not recovered", described as "left side chest pain arising 2 days following vaccination. Ongoing for about 3 months.". The event "left side chest pain arising 2 days following vaccination. ongoing for about 3 months." required physician office visit and emergency room visit.  Additional information: Left side chest pain arising 2 days following vaccination. Ongoing for about 3 months. Patient had no history of health issues. Patient did not have covid prior vaccination and covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib".  Clinical course: Caller said she received an email saying about another booster shot for the Pfizer covid vaccine. Caller says she got 2 of the original doses and got a booster dose back on 21Sep2022. Caller was asking if Pfizer has another booster shot available. Caller says the email mentioned it being the BA4/BA5 variant for the omicron virus. Caller says she has Afib and was 76 years old and that if she were to take it this would be her 2nd booster dose or 4th dose of the Pfizer covid vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.