chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  Diluent was not involved in the temperature excursion.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQU; This spontaneous report was received from a nurse and referred to a 12-month-old-female patient. Concomitant medication included sterile diluent. The patient's has a history of asthma and seasonal allergies. The only medication is seasonal allergy medication (no specific type provided). The patient's concurrent condition was not provided.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was improperly stored during a supported temperature excursion. Temperature was 7 Fahrenheit degree (F). Time frame was 1 hour 37 minutes. Previous temperature excursion did not occur. Sterile diluent was not involved in the temperature excursion. On 16-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (1 dosage form, lot # was reported as W024980, expiration date was reported as 05-FEB-2024 anatomical location was left thigh) intramuscularly for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AEs; HCP confirmed this vaccine was administered on 11MAY2023 after the temperature excursion; This spontaneous report was received from a Registered Nurse (R. N.) regarding to a patient of unspecified age and gender.   The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 11-MAY-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 time dose, lot #1938950, expiration date: 31-MAR-2024 (dosage regimen was not provided) administered orally as prophylaxis (product storage error).  The improperly stored vaccine dose underwent temperature excursions of 1.8 degrees Celsius (C) for 0 hours 9 minutes and 0 seconds, 1.3 C for 1 hour 12 minutes and 0 seconds and 1.2 C for 1 hour 58 minutes and 0 seconds without previous excursions. No other adverse events were reported.; Sender's Comments:  US-009507513-2305USA006001:
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: REGULAR COLD FOR 7 DAYS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced regular cold for 7 days. Laboratory data (dates unspecified) included: COVID-19 virus test false-positive (Binax test). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from regular cold for 7 days. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: REGULAR COLD FOR 7 DAYS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced regular cold for 7 days. Laboratory data (dates unspecified) included: COVID-19 virus test false-positive Bianax test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from regular cold for 7 days. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; 2nd dose on 06Apr2021, 3rd dose on 05May2021, 4th dose on 01Jun2022/patient had 3 booster; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (2nd dose on 06Apr2021, 3rd dose on 05May2021, 4th dose on 01Jun2022/patient had 3 booster) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 036A21A, 017F21A and 037A22A) for COVID-19 prophylaxis.     The patient's past medical history included Magnesium low. Previously administered products included for Whooping cough: TETANUS VACCINE (2-3 years ago); for Hypothyroidism: Synthroid. Past adverse reactions to the above products included No adverse event with Synthroid and TETANUS VACCINE. Concurrent medical conditions included Raynaud's disease (Lupus spectrum), Fibromyalgia, Diabetes, Hypertension, Gene mutation and Clot blood.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced EXTRA DOSE ADMINISTERED (2nd dose on 06Apr2021, 3rd dose on 05May2021, 4th dose on 01Jun2022/patient had 3 booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (2nd dose on 06Apr2021, 3rd dose on 05May2021, 4th dose on 01Jun2022/patient had 3 booster) 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 EXTRA DOSE ADMINISTERED (2nd dose on 06Apr2021, 3rd dose on 05May2021, 4th dose on 01Jun2022/patient had 3 booster).    Concomitant medication was not reported. Patient had a gene mutation which predisposes her to blood clots (prothrombin II). Patient did not receive any other vaccines in the past 4 weeks before the 2nd bivalent dose. Patient administered 5th dose (bivalent) on 10Oct2022, lot number was 053D22A and 6th dose (bivalent) on 17May2023, lot number was AS7172B. Patient had the 2nd bivalent vaccine on 17May2023, and it was administered on the "inner fatty part of her upper shoulder". Patient went to pain management yesterday because she fell out of bed on 02Mar2023. They are prescribing prednisolone 4mg for 6 days.          Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-725233 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2023: Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725233:BIVALENT
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered an vaccine that was 3 days expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F221) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE on 27-Jan-2021, COVID-19 VACCINE on 24-Feb-2021, COVID-19 VACCINE on 04-Nov-2021, COVID-19 VACCINE on 06-May-2022 and COVID-19 VACCINE on 17-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 18-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 18-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired) 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 EXPIRED PRODUCT ADMINISTERED (administered an vaccine that was 3 days expired).    Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy bladder, Bladder cancer, Blood pressure measurement
Clinical narrative: Bladder cancer/ Carcinoma in situ; This spontaneous case was reported by a patient and describes the occurrence of BLADDER CANCER (Bladder cancer/ Carcinoma in situ) in a 67-year-old male patient 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 BLADDER CANCER (Bladder cancer/ Carcinoma in situ) (seriousness criterion medically significant). At the time of the report, BLADDER CANCER (Bladder cancer/ Carcinoma in situ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2023, Biopsy bladder: diagnosed with CIS. On an unknown date, Blood pressure measurement: High.     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 provided. It was reported that bladder cancer was diagnosed with CIS on 04-May-2023, based on the results of a biopsy of bladder. However, since there was a worldwide shortage of BCG, patient will most likely not receive a full BCG dosage during bladder instillations. Plus, patient had the Moderna Covid-19 vaccine, and recently heard that Moderna had good initial results with their pancreatic mRNA vaccine. Patient had high blood pressure other than CIS and was generally good health.The patient states it wasn't  intentional that patient was diagnosed after receiving the Moderna COVID19 Vaccine. The patient explains that cancer was diffused between all the cells. It's not a tumor. It's called carcinoma in situ.  No treatment medication was provided.  Company comment- This is a spontaneous case concerning a 67-year-old male patient with no medical history reported who experienced the unexpected and serious (medically significant) event bladder cancer. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered on an unknown day, hence latency cannot be assessed. It was reported that bladder cancer (carcinoma in situ) was diagnosed, based on the results of a biopsy of bladder. No further details were provided for medical review.  The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Unfortunately, it had been administered to 1 patient on 22May2023. no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.) and NO ADVERSE EVENT (no adverse event) 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. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-May-2023, 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 22-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.) 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 EXPIRED PRODUCT ADMINISTERED (Unfortunately it had been administered to 1 patient on 22May2023.).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Injury, Road traffic accident
Clinical narrative: Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products; Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries; This spontaneous case was reported by a patient and describes the occurrence of INJURY (Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products) and ROAD TRAFFIC ACCIDENT (Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries) 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.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 INJURY (Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products) and ROAD TRAFFIC ACCIDENT (Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries). At the time of the report, INJURY (Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products) and ROAD TRAFFIC ACCIDENT (Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries) 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 provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Patient got Covid after my 3rd or 4th dose of Moderna.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got Covid after my 3rd or 4th dose of Moderna.) 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 fourth 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 COVID-19 (Patient got Covid after my 3rd or 4th dose of Moderna.). At the time of the report, COVID-19 (Patient got Covid after my 3rd or 4th dose of Moderna.) 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 details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 0.5
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 22-May-2023, 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 22-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023) 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 EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023).    No concomitant medications were provided. No treatment medication was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Malaise, Wrong product administered
Clinical narrative: hot flushes; light-headedness/feeling kind of lightheaded; Caller is not feeling that good; Caller only received two total doses of Pfizer Vaccine and the Pfizer Booster was the caller's second dose received; sweating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15May2023 as dose 2, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose: 10Jun2022, lot/NDC/expiration: Unknown, doesn't have that written on the vaccine card. Route of administration: right side of arm), administration date: 10Jun2022, when the patient was 78-year-old, for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 15May2023, outcome "unknown", described as "Caller only received two total doses of Pfizer Vaccine and the Pfizer Booster was the caller's second dose received"; HYPERHIDROSIS (non-serious) with onset May2023, outcome "not recovered", described as "sweating"; MALAISE (non-serious) with onset 16May2023, outcome "unknown", described as "Caller is not feeling that good"; HOT FLUSH (non-serious) with onset 16May2023, outcome "not recovered", described as "hot flushes"; DIZZINESS (non-serious) with onset 16May2023, outcome "recovering", described as "light-headedness/feeling kind of lightheaded". Additional information: Sweating a lot began two or three days after "Mother's Day". Feeling kind of lightheaded began second day after receiving the Pfizer Booster. Doesn't have light headedness that much. Does still have hot flushes. Patient only received two total doses of Pfizer Vaccine and the Pfizer Booster was the patient's second dose received.  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.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Dysgeusia, Insomnia, Pain
Clinical narrative: I am eating but not that much; mouth taste like salty; Its the vagina area, I have like a burning sensation; now everything hurts; dizzy this morning; didn't sleep all night last night; 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 NOS), on 18May2023 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: INSOMNIA (non-serious) with onset 18May2023, outcome "unknown", described as "didn't sleep all night last night "; DIZZINESS (non-serious) with onset 19May2023, outcome "unknown", described as "dizzy this morning"; PAIN (non-serious) with onset 19May2023, outcome "unknown", described as "now everything hurts "; DECREASED APPETITE (non-serious), outcome "unknown", described as "I am eating but not that much"; DYSGEUSIA (non-serious), outcome "unknown", described as "mouth taste like salty"; VULVOVAGINAL BURNING SENSATION (non-serious), outcome "unknown", described as "Its the vagina area, I have like a burning sensation".  Additional Information: Patient did not sleep whole night (previous night), felt dizzy that morning and everything hurts then. Patient was not eating that much. Patient checked the side effects mentioned in the sheet of paper which was given in the Pharmacy where the patient was vaccinated and could not find regarding the mouth taste like salty. Patient wanted to know whether it was normal. Patient got the shot previous day and confirmed it was Pfizer covid shot. Patient also had burning sensation in the vaginal area all of the sudden and salty taste in mouth and wanted to know whether it was normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vulvovaginal burning sensation
Clinical narrative: I am eating but not that much; mouth taste like salty; Its the vagina area, I have like a burning sensation; now everything hurts; dizzy this morning; didn't sleep all night last night; 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 NOS), on 18May2023 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: INSOMNIA (non-serious) with onset 18May2023, outcome "unknown", described as "didn't sleep all night last night "; DIZZINESS (non-serious) with onset 19May2023, outcome "unknown", described as "dizzy this morning"; PAIN (non-serious) with onset 19May2023, outcome "unknown", described as "now everything hurts "; DECREASED APPETITE (non-serious), outcome "unknown", described as "I am eating but not that much"; DYSGEUSIA (non-serious), outcome "unknown", described as "mouth taste like salty"; VULVOVAGINAL BURNING SENSATION (non-serious), outcome "unknown", described as "Its the vagina area, I have like a burning sensation".  Additional Information: Patient did not sleep whole night (previous night), felt dizzy that morning and everything hurts then. Patient was not eating that much. Patient checked the side effects mentioned in the sheet of paper which was given in the Pharmacy where the patient was vaccinated and could not find regarding the mouth taste like salty. Patient wanted to know whether it was normal. Patient got the shot previous day and confirmed it was Pfizer covid shot. Patient also had burning sensation in the vaginal area all of the sudden and salty taste in mouth and wanted to know whether it was normal.   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: Prescribed me Paxlovid and started I taking it; Prescribed me Paxlovid and started I taking it; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 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 "Prescribed me Paxlovid and started I taking it". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  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: 35.0
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) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Lot number: 6h9697) at the age of 35 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 and 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: negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received antiviral covid 19 treatment with Paxlovid from 05May2023 to 10May2023.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: gh9692) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: er8731), in left arm, on 13Apr2021 as dose 2, single (Lot number: er8731), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 32020f0), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Losartan, reaction(s): "Known allergies: Losartan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (May2023) Positive, notes: COVID test came up positive 4-5 days after completing Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event COVID test came up positive 4-5 days after completing Paxlovid course.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Headache; chills; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21May2023 at 12:00 as dose 7 (booster), single (Lot number: GJ3270) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot Number: EL982, Anatomical site: Right Arm), administration date: 23Jan2021, when the patient was 65-year-old, for COVID-19 Immunization; comirnaty (DOSE 2, SINGLE, Lot Number: EN624, Anatomical site: Left Arm), administration date: 13Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE, Lot Number: FF2590, Manufacturer: Unknown), administration date: 15Oct2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Myalgia", "Headache", "Myalgia"; comirnaty (DOSE 3 (BOOSTER), SINGLE, Lot Number: FF2590, Manufacturer: Unknown), administration date: 15Oct2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "Nausea"; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot Number: Unknown, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Lot Number: Unknown, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Lot Number: Unknown, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 22May2023 at 03:30, outcome "recovering"; CHILLS (non-serious) with onset 22May2023 at 03:30, outcome "recovering"; NAUSEA (non-serious) with onset 22May2023 at 03:30, outcome "recovering". Therapeutic measures were taken as a result of headache, chills, nausea.  Additional Information: It was reported that the patient was not diagnosed with COVID prior to vaccination and has not been tested COVID post vaccination. It was also reported that Tylenol 2 tablets was taken as treatment for the events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383789 Same reporter, patient, product, different dose and events;
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: Taking Covid-19 vaccine booster and with 24hrs my arthritis pain are gone and I'm able to walk normally.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  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. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing), notes: I have severe rheumatoid arthritis on right ankle and left knee. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Taking Covid-19 vaccine booster and with 24hrs my arthritis pain are gone and I'm able to walk normally.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had severe rheumatoid arthritis on right ankle and left knee. Taking Covid-19 vaccine booster and with 24hrs patinet arthritis pain are gone and patient was able to walk normally. Patient had medical record shown the medical benefits of Covid-19 vaccine, beyond the treatment of the virus. Patient had always tested negative of Covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
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) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  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 including Paxlovid from 12May2023 to 16May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19 infection detected by at home test kit on 21May2023; Breakthrough COVID-19 infection detected by at home test kit on 21May2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 42 years, 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: "Hypercholesterolemia" (unspecified if ongoing); "Congenital glaucoma" (unspecified if ongoing); "Covid prior vaccination" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21May2023, outcome "recovering" and all described as "Breakthrough COVID-19 infection detected by at home test kit on 21May2023". The event "breakthrough covid-19 infection detected by at home test kit on 21may2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient was treated with Paxlovid. Patient had No Known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300186551 Same patient, different drug, different event;
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) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 May2023, outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 09May2023, stop date: 13May2023).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198809 same patient, different drug/event;
Age: 61.0
Sex: F
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 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 including Paxlovid from 13May2023 to 17May2023.  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: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Why does a magnet stick to my arm where I got the vaccine?"; 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 patient (no qualifiers provided) 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: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "Why does a magnet stick to my arm where I got the vaccine?"".  Additional information: Caller wanted to know "Why does a magnet stick to my arm where I got the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 64 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: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She took Paxlovid (Batch/lot number: 661437) from 18May2023 to 22May2023 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198897 Same patient, different product/event;
Age: 41.0
Sex: F
Vaccine: 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 42-year-old female patient (pregnant) received BNT162b2 (BNT162B2 NOS), on 22Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (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. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11May2023 to 15May2023.  The information on the batch/lot number for [BNT162B2 NOS], has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198915 Same patient, different drug/ events;US-PFIZER INC-202300199883 Same patient/product, different dose/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Gastrointestinal disorder, Illness
Clinical narrative: sick; night sweats; fever; chills; It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach; bowel problem/ Something is going on with her gastrointestinal; not feeling well down there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NIGHT SWEATS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "bowel problem/ Something is going on with her gastrointestinal"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well down there".  Additional information: The patient got the new pfizer 2nd vaccine which is the bivalent. She had been sick for almost 3 weeks getting worse each day. It is pain in left side and stomach fever chills break out in night sweats. Something is going on with her gastrointestinal. The patient was 68 and had no ovaries. It was a stomachs and bowel problem. Please let her know if anyone else has side effects like these and when woukld it go away. Caller had not received the Bivalent vaccine before. Caller has been feeling sick since she received the vaccine. The caller had experienced fever, breaking into sweat at night, stomach pain which she described as soreness in the stomach, trouble with bowels, and not feeling well down there. Caller did not wanted to be transferred. The caller wanted to get more information.  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.