chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 18C22A) for COVID-19 prophylaxis. The patient did not have information about previous COVID-19 vaccination doses.     On 25-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023) 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 (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine on 25-Mar-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was stated that no other adverse reactions were reported. No treatment information was provided.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; patient received 2 Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 043H22A and 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (patient received 2 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 EXTRA DOSE ADMINISTERED (patient received 2 Bivalent Moderna COVID-19 vaccine).    On 01-FEB-2021, patient received first Primary monovalent dose (Lot 042L20A and Exp. Date: 05-JUL-2021).  On 01-MAR-2021, patient received 2nd Primary monovalent dose (Lot 022M20A and Exp. Date: 08-AUG-2021). On 15-APR-2022, patient received First Monovalent Booster dose (Lot 065K21A and  Exp. Date: 05-JUL-2022). Dosage text of fifth dose was reported as additional booster.  No concomitant medications was reported.  Patient received bivalent vaccine in a shortened suggested time frame.  No treatment medications was reported.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1417B) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they accidentally administered a patient with an expired dose of the Moderna Covid 19 vaccine.).    No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: Illness, Palpitations, Vertigo
Clinical narrative: vertigo; palpitations; sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick). At the time of the report, VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The reporter reported that her husband ended up with vertigo and heart palpitations. They were in the hospital. He got sick.  No treatment medications were reported.
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.; no adverse event; Patient was administered 0.5ml on 3/24, over 30 days passed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed), PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.) and NO ADVERSE EVENT (no adverse event) in a 59-year-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. 047c22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed), PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed) and PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed).    No concomitant medications were reported. 1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed. No symptoms were reported. No treatment information was reported.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 25-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent 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 a Moderna Monovalent vaccine instead of a Moderna bivalent 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 (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine).    No concomitant medications was reported.  Dosage text of suspect Moderna vaccine was reported Additional Booster.  No other adverse reactions are reported.  No treatment medications was reported.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary series ), PFIZER BIONTECH COVID-19 VACCINE (Booster dose) and PFIZER BIONTECH COVID-19 VACCINE (Primary series ). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 25-Mar-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent 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 (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine).    Concomitant medication was not provided.   Treatment information was not provided.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent 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 (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine).    No concomitant medications were reported.  No other adverse reactions were reported.  No treatment medications were reported.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023) 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 (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023).    No concomitant medications were reported.  Patient Initially received First Primary monovalent dose on 26-Sep-2022, Lot no was AR9236B and Expiry date was reported as 11-Feb-2023, then Second Primary monovalent dose on 28-Oct-2022 with Lot no. AR9236B and Expiry date was reported as 11-Feb-2023. 30 Day beyond use date for Bivalent drug was 26-Mar-2023.  There was Individual vial inside opened carton with vial size 0.4 ml. Date the vial was initially stored in the refrigerator was Unknown. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and had other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with influenza vaccine.   On 27-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.).    Concomitant drugs were not reported.  It was reported that patient had no AEs reported.  Treatment medications were not provided.
Age: 12.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Dehydration, Diarrhoea, Fatigue, Headache, Vomiting
Clinical narrative: Severe vomiting and diarrhea, insomnia, night following vaccination per Mom's report.  Mom chose not to take student for medical evaluation as she looked up vaccine side effects and felt this was likely related, but symptoms were severe enough that had she not found this info on-line she would've taken her to ER.
Age: 12.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Diarrhoea, Insomnia, Vomiting
Clinical narrative: Severe vomiting and diarrhea, insomnia, night following vaccination per Mom's report.  Mom chose not to take student for medical evaluation as she looked up vaccine side effects and felt this was likely related, but symptoms were severe enough that had she not found this info on-line she would've taken her to ER.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Experienced covid rebound starting on 19Mar2023; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 03 (booster) single (Batch/Lot number: unknown), as dose 02, single (Batch/Lot number: unknown) and as dose 01, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 3 booster, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose number: 1 & 2, Primary series immunization complete, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 19Mar2023, outcome "recovering", described as "COVID-19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 19Mar2023, outcome "recovering", described as "Experienced covid rebound starting on 19Mar2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptoms 3/23 = coughing, back ache, leg discomfort, sore throat, congestion, fatigue. Mild to moderate + 3/24; Symptoms 3/23 = coughing, back ache, leg discomfort, sore throat, congestion, fatigue. Mild to moderate. Home AG + 3/24; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 38-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), sngle (Lot number: GJ6742) at the age of 38 years intramuscular, 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), sngle (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 23Mar2023, outcome "recovering" and all described as "Symptoms 3/23 = coughing, back ache, leg discomfort, sore throat, congestion, fatigue. Mild to moderate.+ 3/24". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Mar2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship.
Age: 64.0
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 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 64 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EP7534), in left arm and as dose 2, single (Lot number: EW0151), in left arm for covid-19 immunization. The patient's relevant medical history included: "Adhesives, some fruits" (unspecified if ongoing), notes: Adhesives, some fruits; "Adhesives, some fruits" (unspecified if ongoing), notes: Adhesives, some fruits. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 21Jan2021.  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. Paxlovid taken as treatment for covid 19 from 14Mar2023 to 18Mar2023.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Lot number: 023M20A), in left arm, on 23Mar2021 as dose 2, single (Lot number: 013M20A), in left arm, on 04Dec2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 22Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 10Mar2023 to 15Mar2023 as COVID 19 Treatment.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: having 4 days of negative tests; Positive, notes: just the positive test results; negative, notes: having 4 days of negative tests; positive, notes: just the positive test results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took 'Paxlovid' for treatment of COVID-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130564 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body mass index, 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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: None known; "BMI 38.9" (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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 38.9; SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was used from 15Mar2023 to 20Mar2023 for treatment of COVID-19. Tested positive after 4 days of negative home tests.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER / BIONTECH COVID-19 VACCINE), on 17Sep2022 as dose 5 (booster), single (Lot number: gj532) at the age of 72 years, in right arm for covid-19 immunisation; 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: "Hypertension" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). No known allergies. 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 and included treatment with Paxlovid from 13Mar2023 to 18Mar2023.
Age: 0.33
Sex: M
Vaccine: PNC13, DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Crying, Laboratory test, Magnetic resonance imaging, Seizure
Clinical narrative: patient developed seizures after the vaccine; Crying abnormally; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 4-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 07Mar2023 as dose 1, single (Lot number: FP2144, Expiration Date: 30Sep2024) at the age of 4 months intramuscular, in left thigh for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CRYING (non-serious) with onset 08Mar2023, outcome "recovered" (10Mar2023), described as "Crying abnormally"; SEIZURE (hospitalization, medically significant) with onset 11Mar2023, outcome "unknown", described as "patient developed seizures after the vaccine". The patient was hospitalized for seizure (start date: 13Mar2023, discharge date: 17Mar2023, hospitalization duration: 5 day(s)). The event "patient developed seizures after the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: lab work: Unknown results, notes: the patient had lab work; Magnetic resonance imaging: Unknown results, notes: the patient had multiple MRI's while he was hospitalized. Therapeutic measures were taken as a result of seizure. Caller states that the patient developed seizures after the vaccine. The patient had no fever. The mom reported that the patient was crying abnormally on 08Mar2023 until 10Mar2023. The seizures started for the patient on 11Mar2023. The patient had 3-4 seizures on the 11th. Then the patient had 4 seizures that Sunday, 6 that Monday. The patient was taken to the Emergency Room that Monday and was admitted to the hospital on 13Mar2023. The patient was discharged from the hospital on 17Mar2023. Caller states that sometime during the patient's hospitalization for the seizures, the patient was started on Keppra, 100mg/mL, 2mL by mouth twice a day. Caller does not know the date that the patient was started on the Keppra but states that it was after the seizures that started on 11Mar2023, the patient was started on Keppra somewhere between 13Mar2023 and 17Mar2023 when the patient was in the hospital.; Sender's Comments: There is a reasonable possibility that the events crying and seizure were related to PREVNAR 13 based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 0.33
Sex: M
Vaccine: PNC13, DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Blood culture, Computerised tomogram head normal, Culture urine, Electroencephalogram abnormal, Infant irritability
Clinical narrative: patient developed seizures after the vaccine; Crying abnormally; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 4-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 07Mar2023 as dose 1, single (Lot number: FP2144, Expiration Date: 30Sep2024) at the age of 4 months intramuscular, in left thigh for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CRYING (non-serious) with onset 08Mar2023, outcome "recovered" (10Mar2023), described as "Crying abnormally"; SEIZURE (hospitalization, medically significant) with onset 11Mar2023, outcome "unknown", described as "patient developed seizures after the vaccine". The patient was hospitalized for seizure (start date: 13Mar2023, discharge date: 17Mar2023, hospitalization duration: 5 day(s)). The event "patient developed seizures after the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: lab work: Unknown results, notes: the patient had lab work; Magnetic resonance imaging: Unknown results, notes: the patient had multiple MRI's while he was hospitalized. Therapeutic measures were taken as a result of seizure. Caller states that the patient developed seizures after the vaccine. The patient had no fever. The mom reported that the patient was crying abnormally on 08Mar2023 until 10Mar2023. The seizures started for the patient on 11Mar2023. The patient had 3-4 seizures on the 11th. Then the patient had 4 seizures that Sunday, 6 that Monday. The patient was taken to the Emergency Room that Monday and was admitted to the hospital on 13Mar2023. The patient was discharged from the hospital on 17Mar2023. Caller states that sometime during the patient's hospitalization for the seizures, the patient was started on Keppra, 100mg/mL, 2mL by mouth twice a day. Caller does not know the date that the patient was started on the Keppra but states that it was after the seizures that started on 11Mar2023, the patient was started on Keppra somewhere between 13Mar2023 and 17Mar2023 when the patient was in the hospital.; Sender's Comments: There is a reasonable possibility that the events crying and seizure were related to PREVNAR 13 based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 0.33
Sex: M
Vaccine: PNC13, DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Metabolic function test, Seizure, Urine analysis
Clinical narrative: patient developed seizures after the vaccine; Crying abnormally; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 4-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 07Mar2023 as dose 1, single (Lot number: FP2144, Expiration Date: 30Sep2024) at the age of 4 months intramuscular, in left thigh for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CRYING (non-serious) with onset 08Mar2023, outcome "recovered" (10Mar2023), described as "Crying abnormally"; SEIZURE (hospitalization, medically significant) with onset 11Mar2023, outcome "unknown", described as "patient developed seizures after the vaccine". The patient was hospitalized for seizure (start date: 13Mar2023, discharge date: 17Mar2023, hospitalization duration: 5 day(s)). The event "patient developed seizures after the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: lab work: Unknown results, notes: the patient had lab work; Magnetic resonance imaging: Unknown results, notes: the patient had multiple MRI's while he was hospitalized. Therapeutic measures were taken as a result of seizure. Caller states that the patient developed seizures after the vaccine. The patient had no fever. The mom reported that the patient was crying abnormally on 08Mar2023 until 10Mar2023. The seizures started for the patient on 11Mar2023. The patient had 3-4 seizures on the 11th. Then the patient had 4 seizures that Sunday, 6 that Monday. The patient was taken to the Emergency Room that Monday and was admitted to the hospital on 13Mar2023. The patient was discharged from the hospital on 17Mar2023. Caller states that sometime during the patient's hospitalization for the seizures, the patient was started on Keppra, 100mg/mL, 2mL by mouth twice a day. Caller does not know the date that the patient was started on the Keppra but states that it was after the seizures that started on 11Mar2023, the patient was started on Keppra somewhere between 13Mar2023 and 17Mar2023 when the patient was in the hospital.; Sender's Comments: There is a reasonable possibility that the events crying and seizure were related to PREVNAR 13 based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number: 1, 2, 3, 4; Pfizer, Dose Number: 5; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER / BIONTECH COVID-19 VACCINE), on 07Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: 039D21A), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: 003J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). No known allergies. Concomitant medication included: METFORMIN HCL, start date: 01Jan2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Oct2022, outcome "unknown", described as "Moderna, Dose Number: 1, 2, 3, 4; Pfizer, Dose Number: 5"; 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 and included treatment with Paxlovid.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Renal function test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/Positive for COVID-19 after receiving 5 Pfizer COVID-19 Vaccines; Treatment of COVID-19/Positive for COVID-19 after receiving 5 Pfizer COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 16Feb2021 as dose 2, single (Lot number: EL9265), on 18Aug2021 as dose 3 (booster), single (Lot number: FC3180) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698), all unknown for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing), notes: had HIV for 32 years; "Mild kidney disease" (unspecified if ongoing), notes: Diagnosed a long time ago, but it's stable. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Positive for COVID-19 after receiving 5 Pfizer COVID-19 Vaccines". The event "treatment of covid-19/positive for covid-19 after receiving 5 pfizer covid-19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: 101; Renal function test: kidney function was improving; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clincal course: His viral load was suppressed. He stated that he was good with suppressing things in his body. This was his first time having COVID in 3 years. He had 5 COVID-19 Vaccines and the latest one, the bivalent. Had very mild COVID-19 symptoms. Initially tested positive Saturday evening. Sunday he only had an elevated temperature of 101. Since then, has had no temperature. He started Paxlovid on 19Mar2023 after testing positive the first day. All 5 vaccine was administered in the morning, around 9AM. Was told to not take his simvastatin with Paxlovid because of a potential interaction. He stopped taking Simvastatin for the 5 days he took Paxlovid. The doctor checked all of his other medications and those were ok to take with Paxlovid. He went to the urgent care with a mask on and explained he took a home test that was positive for COVID-19. He was not retested for COVID-19 at the urgent care. At that time, he didn't have a fever, had no symptoms but a little scratchy throat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130658 same reporter/patient, different product/AE;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Knee arthroplasty
Clinical narrative: She had a knee replacement surgery on 03Oct2022; 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 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy to sulfa" (ongoing), notes: had to do with medication for knee replacement. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Batch/lot number: EP7533), administration date: 01Apr2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot: EW0173), administration date: 29Apr2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Lot: FF2593), administration date: 12Nov2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose: 4, Lot: Either FJ4489 or FJ4989), administration date: 12Apr2022, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: KNEE ARTHROPLASTY (hospitalization) with onset 03Oct2022, outcome "unknown", described as "She had a knee replacement surgery on 03Oct2022". The patient was hospitalized for knee arthroplasty (start date: 03Oct2022, discharge date: 05Oct2022, hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of knee arthroplasty. Clinical course included: The product was Comirnaty, Gray cap, Original/Omicron BA.4/BA.5 (Bivalent) She stated she had the Pfizer COVID vaccine in Apr2021 and never had a problem. Then Pfizer recommended that 5 months later it was recommended to get a booster so she had her boosters (all Pfizer) since 2021 and 2022. The last booster was 17Sep2022 (Lot# could be 6J2524 or GJ2524 but she thinks it is GJ2524 based on how they wrote other 6's on her card). She had a knee replacement surgery on 03Oct2022 and they were putting her in a nursing home after for 2 weeks because she had no help at home. Her doctor told them to stay home because this is a major surgery and she did exactly what he said. Patient was hospitalized for knee replacement surgery from 03Oct2022 to 05Oct2022 and sent to nursing home after hospital discharge for recovery, due to living situation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300131331 same patient/drug, different dose number/event;