chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (no adverse event) in a 23-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 18-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) 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 WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patients received the wrong bivalent Moderna Covid-19 vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received the wrong bivalent Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown 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 WRONG PRODUCT ADMINISTERED (patients received the wrong bivalent Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received the wrong bivalent Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received the wrong bivalent Moderna Covid-19 vaccine).    Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: started having COVID-19 symptoms during the night that same day (sore throat); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (started having COVID-19 symptoms during the night that same day (sore throat)) in an adult male patient 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 if patient had any medical history, allergy, concomitant diseases or risk factor. It was also unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 29-Apr-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 29-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (started having COVID-19 symptoms during the night that same day (sore throat)). The patient was treated with MOLNUPIRAVIR for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (started having COVID-19 symptoms during the night that same day (sore throat)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2023, SARS-CoV-2 test: Positive.     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.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient was concerned that may be the vaccine lost efficacy due to COVID-19 and the treatment and wanted to know if the treatment blunted the vaccine response and diminished the vaccine induced antibodies.   This case was linked to US-MODERNATX, INC.-MOD-2023-724036 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724036:same reporter
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No advese event; HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No advese event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 05-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team). On an unknown date, the patient experienced NO ADVERSE EVENT (No advese event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No advese event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No advese event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Trigger finger
Clinical narrative: She had her trigger thumb 6 weeks ago; This spontaneous case was reported by a patient and describes the occurrence of TRIGGER FINGER (She had her trigger thumb 6 weeks ago) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, lot number 029L20A) on 03-Feb-2021, Moderna COVID-19 Vaccine (2nd dose ,lot number 011A21A) on 03-Mar-2021, Moderna COVID-19 Vaccine (3rd dose  and lot number - 066F21A) on 09-Nov-2021; for Product used for unknown indication: Pfizer (4th dose, lot number FM9992) on 17-May-2022 and Flu (last year) in 2022. Past adverse reactions to the above products included No adverse event with Flu, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Pfizer. Concurrent medical conditions included Hypertension and Hypercholesterolemia.    On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced TRIGGER FINGER (She had her trigger thumb 6 weeks ago). At the time of the report, TRIGGER FINGER (She had her trigger thumb 6 weeks ago) 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.   No concomitant information was reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: After all previous shots, patient had a hard time lifting her arm; After all previous shots, she had a little arm pain; First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (After all previous shots, patient had a hard time lifting her arm), VACCINATION SITE PAIN (After all previous shots, she had a little arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 054A22A and 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (After all previous shots, patient had a hard time lifting her arm) and VACCINATION SITE PAIN (After all previous shots, she had a little arm pain). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (After all previous shots, patient had a hard time lifting her arm), VACCINATION SITE PAIN (After all previous shots, she had a little arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 22-MAR-2021 /2nd Primary monovalent dose on 10-DEC-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-724185 (Patient Link).
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (No Adverse Event) in a 22-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-May-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 06-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) 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 WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.) 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 WRONG PRODUCT ADMINISTERED (Pediatric patient received dose of the monovalent dark pink cup vial instead of dose of the bivalent Moderna COVID19 vaccine.).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724019, US-MODERNATX, INC.-MOD-2023-724088, US-MODERNATX, INC.-MOD-2023-724177, US-MODERNATX, INC.-MOD-2023-724205 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724019:same reporter US-MODERNATX, INC.-MOD-2023-724088:same reporter US-MODERNATX, INC.-MOD-2023-724177:same reporter US-MODERNATX, INC.-MOD-2023-724205:same reporter
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site rash
Clinical narrative: Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise; Patient also had a red rash below the bruise (2"X3") on upper left arm; Patient also had a red rash below the bruise (2"X3") on upper left arm.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise), VACCINATION SITE RASH (Patient also had a red rash below the bruise (2"X3") on upper left arm.) and VACCINATION SITE ERYTHEMA (Patient also had a red rash below the bruise (2"X3") on upper left arm) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 23-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 19-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 13-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 4) on 18-Apr-2022 and PFIZER BIONTECH COVID-19 VACCINE (Dose 5) on 18-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 02-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) 1 dosage form. On 03-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE RASH (Patient also had a red rash below the bruise (2"X3") on upper left arm.). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise) and VACCINATION SITE ERYTHEMA (Patient also had a red rash below the bruise (2"X3") on upper left arm). At the time of the report, VACCINATION SITE BRUISING (Patient reports that within 24 hours after the Moderna Bivalent booster, he developed a very large bruise) and VACCINATION SITE ERYTHEMA (Patient also had a red rash below the bruise (2"X3") on upper left arm) outcome was unknown and VACCINATION SITE RASH (Patient also had a red rash below the bruise (2"X3") on upper left arm.) 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.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. On 28-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine).    No concomitant medications were reported.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 053D22A) 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 WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose).    No concomitant medications were provided. No treatment medication was provided.
Age: 52.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 6 (booster), single (Lot number: GJ665) at the age of 52 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid on 02May2023 for the treatment of Covid-19 and stopped treatment on 06May2023.
Age: 57.0
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 a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FM9992), 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: "Known allergies: Perfume gives me migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 01May2023 to 06May2023.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 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), 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: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "hep c" (unspecified if ongoing), notes: cured. Concomitant medications included: PRILOSEC [OMEPRAZOLE MAGNESIUM]; PAXIL CR; SINGULAIR; ZYRTEC ALLERGY; LOSARTAN; PROBIOTICS. Past drug history included: Demerol, reaction: "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 26Apr2023 to 30Apr2023.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". 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 28Apr2023 to 03May2023.  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 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 62-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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 "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, 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
Symptoms: Arthralgia, Asthenia, Blood pressure measurement, Cold sweat, Dizziness
Clinical narrative: woke up felt faint; Patient woke up this morning throwing up/threw up; cold sweat; joint ache and body ache.; Patient was also very very weak and was unable to sleep well due to the join pain; Patient was also very very weak and was unable to sleep well due to the join pain; sweating profusely; joint ache and body ache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-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 and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "woke up felt faint"; VOMITING (non-serious), outcome "unknown", described as "Patient woke up this morning throwing up/threw up"; COLD SWEAT (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "joint ache and body ache."; ASTHENIA (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "Patient was also very very weak and was unable to sleep well due to the join pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating profusely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Wife of patient called stating that the patient received the Pfizer COVID Vaccine. Patient woke up this morning throwing up and sweating profusely and with joint ache and body ache. Patient had a blood pressure of 126/69mmHg. Patient was also very very weak and was unable to sleep well due to the joint pain. Reporter stated that the patient did not have reactions from the previous doses. Reporter wanted to know if these are side effects from the vaccine and how long they last. Reporter mentioned that his doctor recommended for him to get another dose of the Pfizer COVID Vaccine and asked if this was necessary. Reporter stated, "He received the new COVID Shot (Pfizer COVID-19 Shot) yesterday, that morning he woke up felt faint, he was soaken wet, he broke out in a cold sweat, he threw up. All his joints were hurting him. She was wondering if that's the side effect of the drug. They were aching, every joint in his body were aching." She was ready to take him to emergency room because he was soaken wet, he was sweating profusely."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Pain, Vomiting
Clinical narrative: woke up felt faint; Patient woke up this morning throwing up/threw up; cold sweat; joint ache and body ache.; Patient was also very very weak and was unable to sleep well due to the join pain; Patient was also very very weak and was unable to sleep well due to the join pain; sweating profusely; joint ache and body ache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-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 and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "woke up felt faint"; VOMITING (non-serious), outcome "unknown", described as "Patient woke up this morning throwing up/threw up"; COLD SWEAT (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "joint ache and body ache."; ASTHENIA (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "Patient was also very very weak and was unable to sleep well due to the join pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating profusely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Wife of patient called stating that the patient received the Pfizer COVID Vaccine. Patient woke up this morning throwing up and sweating profusely and with joint ache and body ache. Patient had a blood pressure of 126/69mmHg. Patient was also very very weak and was unable to sleep well due to the joint pain. Reporter stated that the patient did not have reactions from the previous doses. Reporter wanted to know if these are side effects from the vaccine and how long they last. Reporter mentioned that his doctor recommended for him to get another dose of the Pfizer COVID Vaccine and asked if this was necessary. Reporter stated, "He received the new COVID Shot (Pfizer COVID-19 Shot) yesterday, that morning he woke up felt faint, he was soaken wet, he broke out in a cold sweat, he threw up. All his joints were hurting him. She was wondering if that's the side effect of the drug. They were aching, every joint in his body were aching." She was ready to take him to emergency room because he was soaken wet, he was sweating profusely."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: awful rash was reported as worsened/bumps under her stomach and under her breasts; she started to feel a little itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose 5 (booster), single (Lot number: GJ3268) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose: 24Aug2020, Lot: unknown, She reads from vaccine card:  and BT16267-Biontech, Expiration: unknown), administration date: 24Aug2020, when the patient was 77-year-old, for covid-19 immunisation, reaction(s): "terrible headache", "severe diarrhea"; BNT162b2 (Second dose: 15Sep2020, Lot: unknown, she reads and BNT16267-Biontech, Expiration: unknown), administration date: 15Sep2020, when the patient was 77-year-old, for covid-19 immunisation; BNT162b2 (Third dose: 02Sep2021 , Lot: FC3184, Expiration: Oct2021), administration date: 02Sep2021, when the patient was 78-year-old, for covid-19 immunisation; BNT162b2 (Fourth Dose: 17Feb2022, Lot: FJ6369 or FJ6364, thinks its a 4, Expiration: May2022), administration date: 17Feb2022, when the patient was 79-year-old, for covid-19 immunisation, reaction(s): "valve replacement of her heart aortic dissection", "valve replacement of her heart aortic dissection", "stent was also placed during this serious operation on her heart". The following information was reported: RASH (non-serious) with onset 10May2023, outcome "not recovered", described as "awful rash was reported as worsened/bumps under her stomach and under her breasts"; PRURITUS (non-serious) with onset 10May2023, outcome "not recovered", described as "she started to feel a little itchy". Therapeutic measures were taken as a result of rash, pruritus.  Additional information: She wanted to report an adverse reaction to the 5th dose of the covid vaccine, bivalent. The injection was in upper left arm because she was a high-risk person. The nurse gave the covid vaccine, not the doctor. Rash: Next day after the 5th vaccine she started to feel a little itchy, and it was progressing since and sees bumps under her stomach and under her breasts. As a treatment, taking Benadryl and used topical Benadryl lotion. No Investigations, no other Products. She was also a participant in a trial of developing the Pfizer Covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190194 Same reporter/patient, same drug/different dose, different AEs.;
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: severe diarrhea; terrible headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other 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: DIARRHOEA (non-serious), outcome "unknown", described as "severe diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "terrible headache".   Additional information: The report was not related to a study or programme. The reporter had a very bad reaction to the first dose of the Pfizer Covid vaccine, and someone told her that she had similar symptoms, severe diarrhea and terrible headache. It was (name withheld) and she was over the study, that was who reported the same symptoms that the report also experienced.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: severe diarrhea; terrible headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 24Aug2020 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "severe diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "terrible headache".  Additional information: She had a very bad reaction to the first dose severe diarrhea and terrible headache. A lot of people had side effects but they went away. Her husband did not have any side effects, maybe he got a placebo.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190182 Same reporter/patient, same drug/different dose, different AEs.;
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypoacusis
Clinical narrative: she experienced symptoms like having water in her head; which severely affected her hearing.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, 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. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "she experienced symptoms like having water in her head"; HYPOACUSIS (non-serious), outcome "unknown", described as "which severely affected her hearing.".  Additional information: She mentioned after her second dose, she experienced symptoms like having water in her head, which severely affected her hearing. She mentioned she's been contacting the legal department on her own, but that if she did not get a response, she would be contacting a lawyer. She then added that another friend of her had the same problem.  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-202300190787 same reporter/drug/AE, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Well, this is going on going to be two years that I got this ringing in my head; 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 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 and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Well, this is going on going to be two years that I got this ringing in my head".  Additional information: Customer stated, "Well, this is going on going to be two years that he got this ringing in his head."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Parosmia, SARS-CoV-2 test, Skin odour abnormal, Urine odour abnormal
Clinical narrative: my smell changed. Coffee, garlic and cooked meats smelled horrible. I was diagnosed with Parosmia; Also, my body odor, poop and pee smelled chemical.; Also, my body odor, poop and pee smelled chemical.; Also, my body odor, poop and pee smelled chemical.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "herpes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 22Jan2021, when the patient was 67-year-old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL9267, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), for COVID-19 immunization. The following information was reported: SKIN ODOUR ABNORMAL (non-serious), ABNORMAL FAECES (non-serious), URINE ODOUR ABNORMAL (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "Also, my body odor, poop and pee smelled chemical."; PAROSMIA (non-serious) with onset Oct2021, outcome "not recovered", described as "my smell changed. Coffee, garlic and cooked meats smelled horrible. I was diagnosed with Parosmia". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of parosmia, skin odour abnormal, abnormal faeces, urine odour abnormal.  Additional Information: The patient reported that she has been doing smell therapy with essential oils and there has been a slight improvement and she always tested negative for COVID-19. Cortisone princes and theophylline spray was taken a treatment for the reported events. It was reported that the patient was not diagnosed with COVID prior vaccination and was tested for COVID post vaccination. It was reported that the patient received dose 4 (Lot Number:GH9694).
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Shortly after receiving his second dose in Mar/Apr, it spread to the rest of his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 2, 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), administration date: Jun2021, for COVID-19 immunization, reaction(s): "Vitiligo on his hands". The following information was reported: VITILIGO (non-serious), outcome "not recovered", described as "Shortly after receiving his second dose in Mar/Apr, it spread to the rest of his body". The event "shortly after receiving his second dose in mar/apr, it spread to the rest of his body" required physician office visit. It was unknown if therapeutic measures were taken as a result of vitiligo.  Additional information: Recipient told me that he received the vaccine around Jun and by Dec, he started to experience Vitiligo on his hands. Shortly after receiving his second dose in Mar/Apr, it spread to the rest of his body. It was unknown if other vaccine taken in four weeks. It was unknown if any COVID prior to vaccination. It was unknown if COVID tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190379 Same patient/vaccine, different dose, similar event;
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Hypoacusis
Clinical narrative: she experienced symptoms like having water in her head/ She then added that another friend of her has the same problem. which severely affected her hearing.  She then added that another friend of her has the same problem.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division.  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: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "she experienced symptoms like having water in her head/ She then added that another friend of her has the same problem."; HYPOACUSIS (non-serious), outcome "unknown", described as "which severely affected her hearing. She then added that another friend of her has the same problem".  Additional information: Added that another friend of her has the same problem.  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-202300190377 same reporter/drug/AE, different patients.