chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information about patient 7th out of 18 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 8 out of 18 (12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    No concomitant medications was reported. No treatment drug details was reported. This case contains information of 9th out of 18 patients (12 patients initial dose) as described by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723715, US-MODERNATX, INC.-MOD-2023-723704, US-MODERNATX, INC.-MOD-2023-723715 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723715:9 Out of 18(12 Patients-Initial Dose) US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case) US-MODERNATX, INC.-MOD-2023-723715:9 Out of 18(12 Patients-Initial Dose)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 12th of 18th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 13th patient out of 18 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information about patient 15th out of 18 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 16 Out of 18(6 Patients-2nd dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 second 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    No concomitant medications was reported. No treatment drug details was reported. This case contains information of 17th out of 18 patients as described by the reporter. (6 patients-dose 2).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    No concomitant medication details was reported. It was reported that patient first dose was a Moderna Monovalent dose. No treatment medication details was reported.  This case was reported for 14 Out of 18(6 Patients-2nd dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Age: 4.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap) and NO ADVERSE EVENT (No adverse event) in a 4-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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 09-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap) 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 reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap).    No concomitant medications were reported.  No treatment medications were reported.
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 10-May-2023 at 11:56 AM, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)) 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 (Nurse is calling to report that a 7-month-old patient received First dose Bivalent Moderna COVID-19 vaccine 0.2 ml from a vial with Pink Cap (Lot no.215K22A & Exp. Date: 19AUG2023)).    No concomitant drug information was provided. The patient had not received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (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 25Apr2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2023) positive; (02May2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She tested positive for covid on 25Apr2023, received paxlovid on 26Apr2023, tested negative for covid on 02May2023, after not having symptoms from 30Apr2023 to 02May2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5 and the reported events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300182348 same reporter/patient, different product/AE;
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at injection site; symptoms of swelling at the injection site and a ring around the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse and Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GM9409, Expiration Date: 31Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "symptoms of swelling at the injection site and a ring around the injection site". Additional information: It was reported that two patients had symptoms of swelling at the injection site and a ring around the injection site, also redness at injection site in the same batch of Prevnar 20.  No follow-up attempts are possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300082584 same drug and AE, different patient;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Granuloma, Laboratory test, Rash, Skin lesion
Clinical narrative: Skin lesions; skin rash; granulomas; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 as dose number unknown (booster), single (Lot number: Gj3277) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF8839), administration date: 08Oct2021, when the patient was 44-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: SKIN LESION (non-serious), outcome "not recovered", described as "Skin lesions"; RASH (non-serious), outcome "not recovered", described as "skin rash"; GRANULOMA (non-serious), outcome "not recovered", described as "granulomas". The events "skin lesions", "skin rash" and "granulomas" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin lesion, rash, granuloma.  Additional information: No covid prior vaccination nor tested positive post vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been not tested for COVID-19. Treatment includes medication, biopsy, lab work.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: A home COVID-19 antigen test result was positive; A home COVID-19 antigen test result was positive; This is a literature report for the following literature source(s).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "coronary artery bypass graft" (unspecified if ongoing); "hypertension" (ongoing); "diabetes" (ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN; ASPIRINE; DAPAGLIFLOZIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "A home COVID-19 antigen test result was positive". The patient underwent the following laboratory tests and procedures: Blood creatinine: unknown results; normal limits; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Case report: A 72-year-oldmancalled his primary care physician (PCP) after2days of throat pain, myalgia, mild shortness of breath, and fever. A home COVID-19 antigen test result was positive. He had received 3 doses of the BNT162b2 vaccine (Pfizer-BioNTech COVID-19 vaccine); the most recent dose was 6 months prior. Considering a history of recent coronary artery bypass graft, hypertension, diabetes, and the patient's age, his PCP prescribed nirmatrelvir and ritonavir (Paxlovid) for 5 days. The patient called his PCP after 2 days with active complaints of worsening myalgia. On medication review, the patient's active medications included atorvastatin, 80mg daily; metformin, 1000mg twice a day; aspirin, 81mg daily; and dapagliflozin, 10mg daily. The patient was advised to stop nirmatrelvir-ritonavir use, hold atorvastatin use, and have his creatinine kinase levels checked. The patient's creatinine kinase levels came back   with in normal limits. With rest and over-the-counter analgesics, the patient's symptoms improved without further interventions. HisCOVID-19-related symptoms resolved within 5 days. He was restarted on atorvastatin therapy 1week after finishing nirmatrelvir-ritonavir treatment, with no recurrence of myalgias.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event vaccination failure and covid-19 cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown"; COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Apr2023 to 04Apr2023.  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-202300186522 same patient/product, different dose/event;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9694), in left arm and on 08Apr2023 at 15:00 as dose 5 (booster), single (Lot number: GS3268) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 08Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "fibroids" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Cipro allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300186692 same patient, different drug and event.;
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:00 as dose 3 (booster), single (Lot number: 049D22A) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 01Nov2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment was with Paxlovid, treatment start date was 29Apr2023 and treatment stop date was 03May2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300186678 same patient, different drug/event;
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The first 4 were associated with a left axillary enlarged lymph node that developed within a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 72 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose: covid-19, Product name and manufacturer lot number: Pfizer EN6201, Date: 11Feb2021, Healthcare professional or clinic site: (withheld)), administration date: 11Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days"; BNT162b2 (2nd dose: covid-19, Product name and manufacturer lot number: Pfizer EN6201, Date: 04Mar2021, Healthcare professional or clinic site: (withheld)), administration date: 04Mar2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days".  Additional information: All of the injections were in the left deltoid and all were provided by in (City name and State name withheld). The first 4 were associated with a left axillary enlarged lymph node that developed within a few days and caused no problems and which resolved within several weeks.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The first 4 were associated with a left axillary enlarged lymph node that developed within a few days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 72 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, SINGLE, Anatomical Site of injection: Left Deltoid, Batch/Lot number: EN6201), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days"; BNT162b2 (Dose 2, SINGLE, Anatomical Site of injection: Left Deltoid, Batch/Lot number: EN6201), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days"; BNT162b2 (Dose 3 (BOOSTER), SINGLE, Anatomical Site of injection: Left Deltoid, Batch/Lot number: 301558A), administration date: 28Sep2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days".  Additional information: Reported as, the first 4 were associated with a left axillary enlarged lymph node that developed within a few days and caused no problems and which resolved within several weeks.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took COVID Vaccine; I took Pfizer; tested positive today; I took COVID Vaccine; I took Pfizer; tested positive today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2023, outcome "unknown" and all described as "I took COVID Vaccine; I took Pfizer; tested positive today". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; Blood thyroid stimulating hormone: (unspecified date) Unknown results; SARS-CoV-2 test: (10May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient's last dose was, he didn't know but hardly 8 months ago now probably 7 to 8 months ago. Now, he tested positive today, just he tested like 3 hours ago, it came positive. For COVID-19, he took Tylenol, one Tylenol about for 5 to 6 hours ago.  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-202300187320 Same product, patient, different AEs, different dose;
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: high blood pressure; also have a little headache too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 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: HEADACHE (non-serious) with onset 10May2023, outcome "unknown", described as "also have a little headache too"; HYPERTENSION (non-serious) with onset 10May2023, outcome "unknown", described as "high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension, headache.  Additional information: The patient took some TYLENOL but that didn't really touch it.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, White blood cell count, White blood cell count decreased
Clinical narrative: WBC was 2.0; no taste; no smell; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 2, single, Lot number: EN6201), administration date: 12Feb2021, when the patient was 75-year-old, for COVID-19 immunization, reactions: "WBC was 3.4 and has been dropping since", "no taste", "no smell", "very sick", "tiredness", "anemic"; BNT162b2 (dose 1, single, Lot number: EL9262), administration date: 22Jan2021, when the patient was 75-year-old, for COVID-19 immunization, reactions: "no taste", "no smell". The following information was reported: ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "no smell"; AGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "no taste"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 17Mar2022, outcome "recovered" (27Jun2022), described as "WBC was 2.0". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of white blood cell count decreased.  Additional information: On 17Mar2022 white blood cell (WBC) 2.0. On 06Apr2022 WBC 2.2. On 26Apr2022 WBC 2.06. On 08Jun2022 WBC 2.19 (13Jun2022 started prednisone 20 mg). On 27Jun2022 WBC 4.9.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037577 same patient/vaccine, diff dose/event;