chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations
Clinical narrative: heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had no past heart conditions. No known allergies.    On 01-Dec-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 01-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was not asked about consent to follow up.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Covid 19 Bivalent vaccine which was administered 16 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine which was administered 16 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine which was administered 16 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine which was administered 16 hours after first puncture) 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 (Moderna Covid 19 Bivalent vaccine which was administered 16 hours after first puncture).    No concomitant medications were reported. No treatment information was provided.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: HPV, Tdap and Meningococci. Past adverse reactions to the above products included No adverse event with HPV, Meningococci and Tdap. Concurrent medical conditions included Penicillin allergy (Taking medicine for allergies: Penicillin, Sulfamethoxazole Trimethoprim), Drug allergy (Taking medicine for allergies: Penicillin, Sulfamethoxazole Trimethoprim) and Drug allergy (Taking medicine for allergies: Penicillin, Sulfamethoxazole Trimethoprim).    On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Jan-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 (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture).    No concomitant medications were reported. Other historical vaccine included Flu. It was reported that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No COVID-19 diagnosis reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) 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 EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 1st of 30 adult patients described by the reporter. Concomitant Medication use information was not provided by reporter. There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date. The batch lot no 022D21A expired on 20 Apr 2022, the Lot number 033F21A expired on 08 Apr 2022 and the Lot number 037C21A expired on 02 Jan 2022. Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704487 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704487:Master case
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 02:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19.  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: The reported COVID-19 positive after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Lot number: 956665) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6207), on 31Mar2021 as dose 2, single (Lot number: ER8737), on 31Oct2021 as dose 3 (booster), single (Lot number: FF2593) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LISINOPRIL; BABY ASPIRIN; CETRIZINE; VITAMIN D3 CALCIUM. Past drug history included: Perfluten lipid microspheres, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Course of events: patient receive treatment with Paxlovid (lot # GG0050) started on 20Jan2023; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Investigation
Clinical narrative: allergic reaction to the first dose (signs and symptoms: rash (injection site,upper chest and neck)); This is a literature report.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), 10 min after the suspect product administration, outcome "recovered", described as "allergic reaction to the first dose (signs and symptoms: rash (injection site, upper chest and neck))". The patient underwent the following laboratory tests and procedures: Brighton score: unknown result, notes: insufficient information to meet case definition. Therapeutic measures were taken as a result of hypersensitivity which included diphenhydramine. Clinical course: Time to symptoms resolution is 1-2 hours. The patient has no atopic history and no anaphylaxis history. Insufficient information to meet case definition was reported for National Institute of Allergy and Infectious Disease and the Food Allergy and Anaphylaxis Network criteria.  A specialized vaccine clinic evaluated patients referred for suspected immediate allergic reactions to the first dose of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine or suspected PEG/polysorbate allergy. All patients were evaluated from May2021 to February 2022. Nine patients were evaluated after experiencing an allergic reaction to the first dose.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-PV202300015137 Same article/ drug and different patient/ event;
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to the first dose (signs and symptoms: raised itchy rash (generalized)); This is a literature report.   A 12-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "food allergy" (unspecified if ongoing), notes: peanut, sesame, egg, hazelnut; "penicillin allergy" (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing), notes: cause is peanut. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), 5 min after the suspect product administration, outcome "unknown", described as "allergic reaction to the first dose (signs and symptoms: raised itchy rash (generalized))". Therapeutic measures were not taken as a result of hypersensitivity. Time to symptoms resolution was several hours. INS (insufficient information to meet case definition) was reported.  A specialized vaccine clinic evaluated patients referred for suspected immediate allergic reactions to the first dose of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine or suspected PEG/polysorbate allergy. All patients were evaluated from May2021 to February 2022. Nine patients were evaluated after experiencing an allergic reaction to the first dose.; Sender's Comments: There is a reasonable possibility that the event hypersensitivity was related to BNT162b2 based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300015137 Same article/ drug and different patient/ event;
Sex: M
Vaccine: COVID19
Symptoms: Cough, Investigation, Throat irritation
Clinical narrative: signs and symptoms: Cough/throat itching; signs and symptoms: Cough/throat itching; This is a literature report.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: tree nuts; "Anaphylaxis" (unspecified if ongoing), notes: tree nuts. The patient's concomitant medications were not reported. The following information was reported: COUGH (medically significant), THROAT IRRITATION (medically significant), outcome "recovered" and all described as "signs and symptoms: Cough/throat itching". The patient underwent the following laboratory tests and procedures: Brighton score: Insufficient information to meet case definition. Therapeutic measures were taken as a result of cough, throat irritation.  A specialized vaccine clinic evaluated patient's referred for suspected immediate allergic reactions to the first dose of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine or suspected PEG/polysorbate allergy. All pt.'s were evaluated from May 2021 to February 2022; their families have provided consent for the publication of clinical data. Nine pt.'s were evaluated after experiencing an allergic reaction to the first dose (average age, 13 years; range, 8-17 years). The vaccine was administered as a single dose without premedications. All patients successfully received the second vaccination with no or minimal symptoms.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events cough, throat irritation and the use of suspect product BNT162b2 cannot be fully excluded.The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300015137 Same article/ drug and different patient/ event;
Age: 60.0
Sex: M
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 (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (batch/lot number: unknown) at the age of 60 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 as dose 2, single (batch/lot number: unknown), in left arm, on 06Apr2022 as dose 3 (booster), single (batch/lot number: unknown), in left arm and on 14Oct2022 as dose 4 (booster), single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin allergies" (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 "recovered with sequelae" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid as COVID 19 treatment with start date 16Dec2022 and stop date 21Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; 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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2010, stop date: 01Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measure such as Paxlovid was 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: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient 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 41 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: "Colon cancer" (unspecified if ongoing); "known allergies: penicillian" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19; treatment with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Moderna Dose Number: 5 / Pfizer / BioNTech Dose Number:4; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: Fk9896) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 as dose 5 (booster), single (Lot number: As7165b), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2022, outcome "unknown", described as "Moderna Dose Number: 5 / Pfizer / BioNTech Dose Number:4"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycilin, reaction(s): "Known allergies: amoxycilin", notes: Known allergies: amoxycilin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) positive, notes: Treatment of COVID-19. 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1  Pfizer,  Dose 2 and 3 Moderna Dose 4 Unk; 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: 1802070) at the age of 32 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 2, single (Lot number: 046C21A), in right arm and on 17May2022 as dose 3 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 27Sep2022 as dose 4 (booster), single (Lot number: A57164B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "Dose 1  Pfizer,  Dose 2 and 3 Moderna Dose 4 Unk"; 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Pityriasis lichenoides et varioliformis acuta
Clinical narrative: Biopsy proven Pityriasis Lichenoides et Varcelliformia Acuta (PLEVA) one week after getting the bivalent booster; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 11-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 immunization; Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization.  The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "Biopsy proven Pityriasis Lichenoides et Varcelliformia Acuta (PLEVA) one week after getting the bivalent booster". The event "biopsy proven pityriasis lichenoides et varcelliformia acuta (pleva) one week after getting the bivalent booster" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: Pityriasis Lichenoides et Varcelliformia Acuta. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta.  Clinical course: The patient received treatment with topical steroids and oral doxycycline for the event. No COVID prior vaccination. Not tested for COVID post vaccination. Other vaccine in four weeks was unknown.  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 current available limited information in the case provided, the causal association between the event Pityriasis Lichenoides et Varioliformis Acuta and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of Vaccine products; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 047A21A), on 09Apr2021 as dose 2, single (Lot number: 008B212A), on 02Nov2021 as dose 3 (booster), single (Lot number: 039F21A) and on 13May2022 as dose 4 (booster), single (Lot number: 004M21A) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jun2022 (unspecified if ongoing), notes: took Paxlovid. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (Manufacture; Unknown, Lot/NDC/Expiry is unknown), administration date: Oct2022, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2023, outcome "recovered" (25Jan2023) and all described as "Tested positive for COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2023) Positive; (20Jan2023) Positive; (25Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Last Thursday, patient tested positive, had runny nose, head congestions, and cough. Patient called doctor and got Paxlovid. She is fully vaccinated with 3 boosters. Her primary series up to the 2nd booster is from Moderna. Her latest booster in Nov2022 was from Pfizer. On Sunday, 22Jan2023, she started Paxlovid, then within 24 hours her COVID symptoms went away. Her COVID symptoms started on Thursday. She sent her information about her symptoms and pictures of her positive COVID tests. She tested herself on 19Jan2023 and 20Jan2023 and both tests were positive for COVID. She was having upper respiratory symptoms which were getting worse; she had a runny nose, sneezing, body aches, and a dry cough. Her symptoms started at 6pm on Thursday, 19Jan2023, and she tested positive at 11pm that night.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Aug2021 as dose 1, single (Lot number: FC3180) and on 07Sep2021 as dose 2, single (Lot number: FF2588) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Cephalosporins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin". Vaccination history included: Pertussis vaccine, reaction(s): "known allergies: Pertussis vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment of COVID-19 from 13Jan2023 to 17Jan2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE, COVID-19 ) and BNT162B2.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Psychiatric symptom, Vitiligo
Clinical narrative: i developed white lesions all over my body (which was diagnosed as vitiligo--autoimmune disorder); sudden traumatic mental shock; have lost my smile/confidence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 at 13:00 as dose 2, single (Lot number: EL3247) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL0142,, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM), administration date: 04Jan2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: PSYCHIATRIC SYMPTOM (disability) with onset 25Jan2021, outcome "not recovered", described as "have lost my smile/confidence"; VITILIGO (disability) with onset 25Jan2021, outcome "not recovered", described as "i developed white lesions all over my body (which was diagnosed as vitiligo--autoimmune disorder)"; MENTAL DISORDER (disability) with onset 25Jan2021, outcome "not recovered", described as "sudden traumatic mental shock". Therapeutic measures were taken as a result of vitiligo, mental disorder, psychiatric symptom.  Clinical course: I developed white lesions all over my body (which was diagnosed as vitiligo autoimmune disorder). I do not have family history of this. My overall health prior to vaccine was excellent. These lesions spread rapidly. This affected me very badly in such a way that I avoided going outside, public meeting/social contacts, hiding the lesions by wearing long sleeves/dresses. This was a sudden traumatic mental shock to me. I was a very cheerful person before but have lost my smile/confidence since then. Sometimes I feel like I would have preferred dying with corona instead of taking this vaccine. The patient was undergoing phototherapy. No COVID prior vaccination. No other vaccine in four weeks and no other medication in two weeks.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result: Positive; COVID test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 08Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Other medical conditions: prediabetes, high cholesterol; "High cholesterol" (unspecified if ongoing). There were no concomitant medications in two weeks. The patient did not receive any other vaccine in four weeks. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2022, outcome "unknown" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2022) Positive.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rashes". The event "rashes" required physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Reporter stated that she has misplaced questionnaire but want to let them know that a number of young women that she knew have had a similar experience with rashes like her. Finally a dermatologist (3rd on, she went to) had her take Pepcid which helped antihistamines did not work at all and caused weight gain for her and others. Anecdotally, this seems to be happening to young women unfortunately. She have been advised by a Dr not to take the most recent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: permanent tingling in both hands and arms/ long term damage; 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), as dose 1, 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: PARAESTHESIA (non-serious), outcome "unknown", described as "permanent tingling in both hands and arms/ long term damage". The events "permanent tingling in both hands and arms/ long term damage" required emergency room visit.  Additional information: Patient got the first one ended up in the ER that night, now have permanent tingling in both hands and arms Tks a lot Now that were finding out the long term damage this untested chemical mixture has caused but no recourse to those affected because the stupid protection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), 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: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "heart attack". The patient date of death was unknown. Reported cause of death: "due to a severe side effect and a heart attack after getting the vaccine". Course of event:  Reporter lost her nephew due to a severe side effect and a heart attack after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: due to a severe side effect and a heart attack after getting the vaccine
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine, Respiratory tract infection
Clinical narrative: gave me respiratory infection took forever to get well; allergic to flu shots; Initial information received on 21-Jan-2023 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced respiratory infection took forever to get well and allergic to flu shots after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious gave me respiratory infection took forever to get well (respiratory tract infection) and allergic to flu shots (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. Patient reported no shots for me.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for both the events.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Vaccination error
Clinical narrative: continued combining Daptacel with ActHib with no reported adverse event; Initial information received on 23-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient where he/she continued combining daptacel with acthib with no reported adverse event while receiving vaccines HIB (prp/t) vaccine [act-HIB] and diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), concomitant medication(s)(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, route, strength, lot/batch number and expiration date : not provided) as prophylactic vaccination and HIB (prp/t) vaccine Powder and solvent for solution for injection (dose, frequency, route, strength, lot/batch number and expiration date : not provided) as prophylactic vaccination.  On an unknown date the patient continued combining daptacel with acthib with no reported adverse event (vaccination error) (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine and HIB (prp/t) vaccine.  Action taken- Not applicable for both suspects.  At time of reporting, the outcome was Unknown for the event continued combining daptacel with acthib with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu two weeks ago while wearing my mask; Initial information received on 23-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got the flu two weeks ago while wearing my mask after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-DEC-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed got the flu two weeks ago while wearing my mask (influenza) (latency: Unknown latency)  I had my flu shot on Dec 1st and got the flu two weeks ago while wearing my mask  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Tenivac that expired yesterday, was given today with no reported adverse event; Initial information received on 23-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that expired yesterday, was given today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) for Immunisation.  On 23-Jan-2023, the patient received ).5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation was unknown, lot U6922AA and expiry date: 22-Jan-2023) via intramuscular route in the right arm for Immunization.  On 23-Jan-2023 the patient developed a non-serious event of tenivac that expired yesterday, was given today with no reported adverse event (expired product administered) (Latency: same day) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  It was not reported if the patient received a corrective treatment for the event .  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.