chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 06-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.).    Patient  did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732484 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732484:Linked to Master case MOD-2023-732484, same reporter
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 067H22A and 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, LOT 004M20A) on 28-Jan-2021, Moderna COVID-19 Vaccine (Dose 2, Lot 023M20A ) on 28-Feb-2021, MODERNA COVID-19 VACCINE (Dose 3, LOT 025C21A ) on 01-Sep-2021, Moderna COVID-19 Vaccine (Dose 4 and Lot 041J21A ) on 07-Apr-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 27-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 50 microgram. On 09-May-2023, the patient experienced PAIN IN EXTREMITY (Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Received the Moderna Bivalent booster on the same day at Pharmacy and "my husband's arm is still sore after 2 months/It is very painful) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the pain started about 9-May2-023, besides the usual normal pain on the day of injection. No treatment other than cold compress and Ibuprofen.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough
Clinical narrative: she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not; she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed) and COUGH (she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.   In 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 18-May-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. In December 2022, the patient experienced COVID-19 (she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed). In May 2023, the patient experienced COUGH (she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (she had Covid December of 2022/symptoms were, cough, sore throat, and nasal stuffed) and COUGH (she received her second Moderna Bivalent mid May and about a week later "I had a persistent cough that lasted 3 weeks/sometimes dry and sometime not) 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 medication was reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: no adverse event; They received their first dose last year (06Aug2022) and never got the second dose of the monovalent vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (They received their first dose last year (06Aug2022) and never got the second dose of the monovalent vaccine.) and NO ADVERSE EVENT (no adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     HCP stated they are unaware of any medical hIstory or condition.     On 06-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (They received their first dose last year (06Aug2022) and never got the second dose of the monovalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (They received their first dose last year (06Aug2022) and never got the second dose of the monovalent 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 PRODUCT ADMINISTRATION INTERRUPTED (They received their first dose last year (06Aug2022) and never got the second dose of the monovalent vaccine.).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: Blood disorder, Full blood count
Clinical narrative: Blood count was low; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (Blood count was low) in a 75-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)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    In September 2022, 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 BLOOD DISORDER (Blood count was low). At the time of the report, BLOOD DISORDER (Blood count was low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Low.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.   Reporter did not allow further contact
Age: 1.08
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No Adverse Event) in a 13-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his second dose of the Moderna Covid-19 vaccine on January 6, 2023More than 36 days in between doses of primary series Moderna Covid-19 vaccine.).    No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A patient was administered a dose of the Moderna COVID-19 vaccine bivalent after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose of the Moderna COVID-19 vaccine bivalent after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: VARICELLA VACCINE, MMR and HEPATITIS A. Past adverse reactions to the above products included No adverse event with HEPATITIS A, MMR and VARICELLA VACCINE.    On 20-Jun-2023, 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 20-Jun-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 (A patient was administered a dose of the Moderna COVID-19 vaccine bivalent after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose of the Moderna COVID-19 vaccine bivalent after the published expiration date) 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 (A patient was administered a dose of the Moderna COVID-19 vaccine bivalent after the published expiration date).    No concomitant medication was reported. No symptoms were reported. No additional doses were reported. No treatment medication was reported
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 06-Jul-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 (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.).    No concomitant information was reported. It was reported that patient had no reported symptoms. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732503:Linked to Master case MOD-2023-732484, same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection (confirmed); COVID-19 infection (confirmed); This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease", start date: 1995 (ongoing); "Perianal fistula", start date: 2000 (unspecified if ongoing), notes: Stop date: unspecified; "IR drainage", start date: 2003 (unspecified if ongoing), notes: Illness: IR drainage, Stop date: unspecified; "IR drainage", start date: 2019 (unspecified if ongoing), notes: Illness: IR drainage, Stop date: unspecified; "Hypertension", start date: 2010 (ongoing); "Hyperlipidemia", start date: 2011 (unspecified if ongoing); "Depression", start date: 2007 (unspecified if ongoing); "Osteopenia", start date: 2007 (unspecified if ongoing); "Herpes zoster", start date: 2008 (unspecified if ongoing); "Lyme disease", start date: 2012 (unspecified if ongoing); "Nephrolithiasis", start date: 2005 (unspecified if ongoing); "End stage renal disease requiring kidney transplant", start date: 2009 (unspecified if ongoing), notes: Additional medical history: End stage renal disease requiring kidney transplant (2009); "COVID-19 infection (suspected)", start date: 2020 (unspecified if ongoing), notes: Additional medical history: COVID-19 infection (suspected)(2020); "Non-smoker" (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 25Jan2023, outcome "recovered" (06Feb2023) and all described as "COVID-19 infection (confirmed)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Pathogen was identified as SARS-CoV-2. Clinical course: This subject is a participant in the registry. It has been reported the subject was diagnosed with a confirmed COVID- 19 infection on 25Jan2023. Pathogen was identified as SARS- CoV-2.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) , covid-19 cannot be ruled out.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose
Clinical narrative: While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm; While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm; While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: UNDERDOSE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), outcome "unknown" and all described as "While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm".  Additional information: Pharmacist asking if they will be needing to do another shot of COVID-19 vaccine orange cap to a 5 year-old (patient). Because while they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm. Pharmacist clarified further that after the injection using Pfizer bivalent orange cap, a little bit of the vaccine mixed with blood came out of the injection site.  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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Laboratory test, SARS-CoV-2 test
Clinical narrative: Exactly 10 days later I was in the ER with heart failure.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL8982) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; ALOPURINOL; CALCIUM and daily vitamin (as reported). The following information was reported: CARDIAC FAILURE (hospitalization, disability, medically significant) with onset 26Jan2021 at 12:00, outcome "not recovered", described as "Exactly 10 days later I was in the ER with heart failure.". The patient was hospitalized for cardiac failure (hospitalization duration: 3 day(s)). The event "exactly 10 days later i was in the er with heart failure." required emergency room visit. The patient underwent the following laboratory tests and procedures: Test: (unspecified date) Unknown results; SARS-CoV-2 test: (23Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac failure.  Clinical course: the patient took his first dose of the Pfizer Covid Vaccine on 16Jan2021. Exactly 10 days later he was in the ER with heart failure. He never had any heart issues whatsoever in his entire life up to that point. He was active duty for 25 years and with an agency for almost 20 years after that. He had a physical every year without fail and his heart was always perfect until the reported first shot. Was three days in the hospital and then had a pacemaker and Difibulator put in, in Aug2021. Patient was also on heart meds for the rest of his life (as stated).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247071 Same reporter/patient, same drug/different dose, different AEs;US-PFIZER INC-202300247072 Same reporter/patient, same drug/different dose, different AEs;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: currently has covid again; mild case of Covid; mild case of Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  An 88-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (batch/lot number: unknown) for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown), as dose 3 (booster), single (batch/lot number: unknown) and as dose 4 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "RA, fairly mild" (unspecified if ongoing), notes: has been taking Methotrexate and Plaquenil for over 30 years. Concomitant medications included: METHOTREXATE taken for RA; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] taken for RA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "mild case of Covid"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "not recovered", described as "currently has covid again". The patient underwent the following laboratory tests and procedures: COVID-19 Test: (Nov2022) positive, notes: mild case of Covid; (2023) positive, notes: covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: The patient informed that in Nov2022, had a mild case of Covid and was prescribed Paxlovid. The patient informed that currently has covid again and was taking Paxlovid again. The patient was self quarantining. The patient wanted to know when to get another booster and how long is the self quarantine.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/ BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (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 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: iodine" (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 Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, COVID-19, Drug ineffective
Clinical narrative: COVID; Covid; has a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well]; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID"; COVID-19 (medically significant), outcome "unknown", described as "Covid"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "has a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well]".  Clinical information: Patient had a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well] at an indistinct time period.  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, and the events covid19, drug ineffective, autoimmune disorder cannot be excluded. 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: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2023, 8 months 16 days 11 hrs 30 min after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant) with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 29Jun2023 to 03Jul2023.  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: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GJ6739) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Hypertension" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was treated with Paxlovid from 28Jun2023 to 02Jul2023 for the treatment of Covid-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose number unknown, single (Lot number: FJ1620) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Seafood allergies" (unspecified if ongoing), notes: Known allergies: seafood allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 28Oct2022 at 14:00 as dose 10 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown), as dose 7 (booster), single (Batch/Lot number: unknown), as dose 8 (booster), single (Batch/Lot number: unknown) and as dose 9 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound 3 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: the patient was treated with Paxlovid from 30Jun2023 to 05Jul2023 for Covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 16Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 21May2022 as dose 4 (booster), single (Lot number: 56MZIA), in left arm and on 05Nov2022 at 12:00 as dose 5 (booster), single (Lot number: O/OH22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test 4 days after negative; Negative, notes: positive test 4 days after negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (batch/lot number: unknown) at the age of 45 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (batch/lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (batch/lot number: unknown), in left arm and on 15Oct2021 as dose 3 (booster), single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "allergies to sulfa drugs" (unspecified if ongoing). Concomitant medications included: SYNTHROID, start date: 01Jan2018, stop date: 08Jul2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: on day 7; positive, notes: on day 9 and 10 with substantial return of symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Jun2023 to 03Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive test; COVID positive test; 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), as dose 4 (booster), single (Lot number: FN2908) for 1 day, in left arm, as dose 3 (booster), single (Lot number: 320308D) for 1 day, in left arm, as dose 2, single (Lot number: EM98910) for 1 day, in left arm, on 16Jan2021 as dose 1, single (Lot number: EL8982), in left arm and (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing). Concomitant medications included: ALOPURINOL; CALCIUM; DAILY VITAMINS; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022, outcome "unknown" and all described as "COVID positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive.  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-202300245529 same patient and drug; different dose and event;US-PFIZER INC-202300247071 same patient and drug; different dose and event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have taken the Pfizer Vaccine and booster and I got COVID for the second time; I have taken the Pfizer Vaccine and booster and I got COVID for the second time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I got COVID for the second time. 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 "I have taken the Pfizer Vaccine and booster and I got COVID for the second time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: COPD exacerbation; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 83 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1:, Time: 15:45, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch Lot number: EL3302), administration date: 22Jan2021, when the patient was 83-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2:, Time: 15:45, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch Lot number: EL9261), administration date: 12Feb2021, when the patient was 83-year-old, for Covid-19 Immunization. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 26Sep2022, outcome "recovered" (01Nov2022), described as "COPD exacerbation". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease which included oral prednisone.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026423 same patient/vaccine, different dose and event;
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dermatitis atopic
Clinical narrative: Asthma; Atopic dermatitis; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 5-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2023 as dose 3 (orange cap; booster), single (Lot number: GK1657) at the age of 5 years intramuscular, in right thigh 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 Thigh , Route of administration: Intramuscular , Batch/Lot number: FT9142), administration date: 01Jul2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical site of injection: Left Thigh, Route of administration: Intramuscular , Batch/Lot number: FL8094), administration date: 22Jul2022, when the patient was 5-year-old, for COVID-19 immunization. The following information was reported: ASTHMA (non-serious) with onset 10Feb2023, outcome "unknown"; DERMATITIS ATOPIC (non-serious) with onset 10Feb2023, outcome "unknown", described as "Atopic dermatitis".  Additional Information: The patient did not provide information regarding the reported adverse event. The patient was not vaccinated 4 weeks prior to covid vaccination and was not known if patient was on any concomitant medications. Specific relevant test for thromboembolic events with thrombocytopenia were not performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300161981 Same reporter, patient, product, different dose and events;
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Otitis media, Upper respiratory tract infection
Clinical narrative: Otitis Media; acute upper respiratory infection; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 3-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2023 as dose 2 (maroon cap), single (Lot number: FT9142) at the age of 3 years intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP),SINGLE, Anatomical site of injection: Left thigh, Route of administration: Intramuscular, Batch/Lot number: FX5095), administration date: 24Feb2023, when the patient was 3-year-old, for COVID-19 immunization, reaction(s): "they gave to patients that were used beyond use date/ patient received FX5095 BUD for first vaccine", "they gave to patients that were used beyond use date/ patient received FX5095 BUD for first vaccine"; flu vaccine (DOSE 1, SINGLE, Manufacturer: Sanofi, Batch/Lot#: UT7723MA, Route: Intramuscular, Anatomical site of injection: Left thigh, No. of previous doses: 0), administration date: 24Feb2023, when the patient was 3-year-old. The following information was reported: OTITIS MEDIA (non-serious) with onset 24Mar2023, outcome "unknown"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 24Mar2023, outcome "unknown", described as "acute upper respiratory infection".  Additional information: No specific relevant test for thromboembolic events with thrombocytopenia was done and the patient did not provide information regarding the reported adverse event(s) with the use of the product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152548 Same reporter, patient, product, different dose and events;