chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5, (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "High cholesterol" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Anti-viral details: COVID 19 Treatment, brand Pfizer, treatment start date 27Jan2023, treatment stop date 31Jan2023, lot number GF9369, indication Treatment of 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.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FP7135) at the age of 47 years old, administered in the left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Knowm allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: COVID-19 Test (SARS-CoV-2 test): Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.; 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 drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 71.0
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) (Physician).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 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 included: "Other medical history: Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Other medical history: sleep apnea" (unspecified if ongoing), notes: Other medical history: cervical radiculopathy; "Other medical history: cervical radiculopathy" (unspecified if ongoing), notes: Other medical history: cervical radiculopathy. Concomitant medication(s) included: TELMISARTAN oral, start date: 01Sep2022; AMLODIPINE oral, start date: 01Sep2022. Past drug history included: Quinolones, reaction(s): "Known allergies: Quinolones", notes: Known allergies: Quinolones. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment of COVID-19 with Paxlovid, via Oral, treatment start date reported as 28Jan2023 and stop date reported as 01Feb2023.   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 events drug ineffective, COVID-19 and the use of suspect product cannot be fully excluded.
Sex: M
Vaccine: 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 42-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about covid treatment yes, Reporter type patient, If vaccine received yes, No other medication in 2 weeks, Product COVID 19 Treatment start date 25Jan2023, stop date 30Jan2023. vaccine lot unknown reason unable to locate or read the details  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Lot number: 038A21A), on 05May2021 as dose 2, single (Lot number: 006C21A) and on 05Nov2021 as dose 3 (booster), single (Lot number: 071F21A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "mast cell activation syndrome" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023 to 04Feb2023.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 54 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: "Hypothyroidism" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing); "known allergies: seasonal pollens" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. 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 including Paxlovid from 30Jan2023 to 03Feb2023.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID; COVID; Moderna  Dose Number: 2 / Pfizer / BioNTech Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), on 09Sep2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, 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) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Moderna Dose Number: 2 / Pfizer / BioNTech Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; negative, notes: About 7 days after first negative covid test, cold like symptoms returned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 Treatment with Paxlovid, Treatment start date was 25Jan2023, Treatment stop date was 29Jan2023, Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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) 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. 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. Additional information: patient received COVID 19 Treatment, brand: Pfizer, from 30Jan2023 to 03Feb2023.  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.
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax
Clinical narrative: partial collapsed lung; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (177088).  An 86-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "WILD-TYPE TRANSTHYRETIN-RELAT ATTR AMYLOIDOSIS" (unspecified if ongoing), notes: WILD-TYPE TRANSTHYRETIN-RELAT ATTR AMYLOIDOSIS; "ALLERGY TO WASP VENOM TREATMENT KIT" (unspecified if ongoing), notes: ALLERGY TO WASP VENOM TREATMENT KIT; "congestive heart failure", start date: Mar2021, stop date: Mar2021, notes: ended up in the hospital; "atrial fibrillation" (unspecified if ongoing), notes: treated on 12Jul2021. Concomitant medication(s) included: ELIQUIS; FUROSEMIDE; ZOLPIDEM TARTRATE; HYDROXYZINE HCL; LATANOPROST; OMEPRAZOLE; METOPROLOL TARTRATE. Vaccination history included: Moderna covid-19 vaccine (MODERNA COVID (12Y UP)VAC(EUA)), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization. The following information was reported: PNEUMOTHORAX (hospitalization, medically significant), outcome "unknown", described as "partial collapsed lung". The patient was hospitalized for pneumothorax (hospitalization duration: 5 day(s)).  Clinical course: Mar2021 patient got sick from the COVID vaccine and ended up in the hospital for congestive heart failure. 12Jul2021 was treated for atrial fibrillation. Aug2021 she got the COVID booster and went to the hospital for 5 days and had a partial collapsed lung. No additional information available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 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: 73.0
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) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID  19 and BNT162B2.
Age: 58.0
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; Pfizer / BioNTech Dose Number: 3 ; Moderna 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 03Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Apr2022, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 3 ; Moderna Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD; "Sleep Apnea" (unspecified if ongoing), notes: Sleep Apnea; "Bronchiectasis" (unspecified if ongoing); "Controlled Hypertension" (unspecified if ongoing), notes: Controlled Hypertension. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: COVID 19 Treatment; (08Feb2023) Postive, notes: positive antigen test 7 days post last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received and other medication taken in 2 weeks. Anti-viral Paxlovid taken for COVID 19 Treatment, treatment started from 28Jan2023 to 01Feb2023. No known allergies reported. Other medication in 2weeks product was Amlodipine. Symptomatic rebound and positive antigen test 7 days post last dose.  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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Home Ag (Nasal Swab): Positive; Home Ag (Nasal Swab): Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 46-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 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) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "unknown" and all described as "Home Ag (Nasal Swab): Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information : Covid test type post vaccination: Nasal Swab (Home Ag) and was positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of suspect, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5 administration.,Linked Report(s) : US-PFIZER INC-202300060734 same patient different dose/drug/event;
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "POTS" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 05Jan2021; IVABRADINE, start date: 10Oct2022; METHYLPHENIDATE, start date: 07Mar2022; FEXOFENADINE, start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2022 at 14:00, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27Jan2023 to 01Feb2023.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: she tested positive; she tested positive; Moderna Dose Number: 4 ... Pfizer Dose Number 3; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 31 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Exposed to COVID-19", start date: 2023 (unspecified if ongoing), notes: exposed the week before she tested positive. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jun2022, outcome "unknown", described as "Moderna Dose Number: 4 ... Pfizer Dose Number 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Feb2023, outcome "unknown" and all described as "she tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events interchange of vaccine products, drug ineffective, covid-19 and BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Myalgia, Platelet factor 4
Clinical narrative: muscle pain; low grade fever; flu like symtoms; tiredness; 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), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing); "Crohns disease" (ongoing). Concomitant medication(s) included: MESALAMINE oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: pfizer/biontech (1st dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6201), administration date: 11Feb2021, for Covid-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness"; pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), administration date: 04Mar2021, for ovid-19 immunization, reaction(s): "Muscle pain"; pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), administration date: 04Mar2021, for Covid-19 immunization, reaction(s): "Low grade fever", "Tiredness"; Pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), for Covid-19 immunization, reaction(s): "Flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 25Sep2021, outcome "recovered", described as "flu like symtoms"; PYREXIA (non-serious) with onset 25Sep2021, outcome "recovered", described as "low grade fever"; MYALGIA (non-serious) with onset 25Sep2021, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 25Sep2021, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.  Additional information: No prior vaccinations (within 4 weeks). No patient's medical history. No relevant tests. No specific relevant test. Mild reaction to all covid vaccine. Including muscle pain, low grade fever, flue like symptoms, tiredness.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle pain; low grade fever; flu like symtoms; tiredness; 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), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing); "Crohns disease" (ongoing). Concomitant medication(s) included: MESALAMINE oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: pfizer/biontech (1st dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6201), administration date: 11Feb2021, for Covid-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness"; pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), administration date: 04Mar2021, for ovid-19 immunization, reaction(s): "Muscle pain"; pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), administration date: 04Mar2021, for Covid-19 immunization, reaction(s): "Low grade fever", "Tiredness"; Pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), for Covid-19 immunization, reaction(s): "Flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 25Sep2021, outcome "recovered", described as "flu like symtoms"; PYREXIA (non-serious) with onset 25Sep2021, outcome "recovered", described as "low grade fever"; MYALGIA (non-serious) with onset 25Sep2021, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 25Sep2021, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.  Additional information: No prior vaccinations (within 4 weeks). No patient's medical history. No relevant tests. No specific relevant test. Mild reaction to all covid vaccine. Including muscle pain, low grade fever, flue like symptoms, tiredness.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: muscle pain; low grade fever; flu like symptoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 60's received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ6369), in arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6201), administration date: 11Feb2021, for Covid-19 immunization, reaction(s): "Covid-19", "muscle pain", "low grade fever", "flu like symptoms", "tiredness"; BNT162b2 (Dose: 2nd, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6206), administration date: 04Mar2021, for Covid-19 Immunization, reaction(s): "Covid-19", "muscle pain", "low grade fever", "flu like symptoms", "tiredness"; BNT162b2 (Dose: 3rd, Date (dd-Mmm-yyyy): 24Sep2021, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FF2587), administration date: 24Sep2021, for COVID-19 Immunization, reaction(s): "Covid-19", "muscle pain", "low grade fever", "flu like symptoms", "tiredness". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 23Apr2022, outcome "recovered", described as "flu like symptoms"; PYREXIA (non-serious) with onset 23Apr2022, outcome "recovered", described as "low grade fever"; MYALGIA (non-serious) with onset 23Apr2022, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 23Apr2022, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6201) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing); "hyperthyroid" (ongoing); "Fibromyalgia" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot EL9262), administration date: 27Jan2021, when the patient was 77-year-old, for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 24Feb2021, outcome "unknown"; PRESYNCOPE (non-serious) with onset 24Feb2021, outcome "unknown", described as "almost passed out".  Additional Information: The patient had high blood pressure diagnosed long time ago; don't know when this was diagnosed but she went to her doctor on Tuesday for a regular check up and it was low and was 112 over 60 something, thyroid condition hyperthyroid; was diagnosed a long time ago and she has been taking thyroid medicine for quite a while. 2nd shot she got, she had almost an immediate reaction to that but did not realize that is what it was until later and the reaction was that she got dizzy, had to be driven home and was in a chair at the store; she had gone to physical therapy and went and almost passed out and someone had to come get her.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 vaccination; COVID-19 vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 vaccination".  Clinical course: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior and post to the vaccination the patient was diagnosed with COVID-19. If Other vaccine in four weeks: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pemphigoid, Rash
Clinical narrative: Diagnosed with bullous pemphigoid three months later. She had never experienced this before and is concerned that it may have been associated with her COVID-19 vaccination.; She developed a sudden skin rash in Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 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. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: PEMPHIGOID (medically significant) with onset Apr2022, outcome "unknown", described as "Diagnosed with bullous pemphigoid three months later. She had never experienced this before and is concerned that it may have been associated with her COVID-19 vaccination."; RASH (non-serious) with onset Apr2022, outcome "unknown", described as "She developed a sudden skin rash in Apr2022". The events "diagnosed with bullous pemphigoid three months later. she had never experienced this before and is concerned that it may have been associated with her covid-19 vaccination." and "she developed a sudden skin rash in apr2022" required physician office visit. Therapeutic measures were taken as a result of pemphigoid, rash.  Clinical course: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior vaccination the patient was diagnosed with COVID-19. She developed a sudden skin rash in Apr2022 and was diagnosed with bullous pemphigoid three months later. She had never experienced this before and is concerned that it may have been associated with her COVID-19 vaccination. Patient received treatment with prednisone.  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: Cardiac monitoring, Computerised tomogram, Electrocardiogram, Interchange of vaccine products, Ischaemic stroke
Clinical narrative: Moderna; Pfizer Bivalent; Suffered ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (ongoing); "heart bypass", start date: Nov2012, stop date: Nov2012. The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Anatomical Location: Arm, Lot: 013L20A), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Anatomical Location: Arm, Lot: 016M20A), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical Location: Arm, Lot: 002F21A), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical Location: Arm Lot: FP4554), for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. The following information was reported: ISCHAEMIC STROKE (hospitalization, disability, medically significant) with onset 03Jan2023 at 10:00, outcome "recovering", described as "Suffered ischemic stroke"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, disability, medically significant), outcome "unknown", described as "Moderna; Pfizer Bivalent". The patient was hospitalized for interchange of vaccine products, ischaemic stroke (hospitalization duration: 1 day(s)). The event "suffered ischemic stroke" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging and all results was not provided. Therapeutic measures were taken as a result of ischaemic stroke. AE treatment: CT scan, MRI, EKG, neurology visit, heart monitor.  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.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Moderna; Pfizer Bivalent; Suffered ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (ongoing); "heart bypass", start date: Nov2012, stop date: Nov2012. The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Anatomical Location: Arm, Lot: 013L20A), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Anatomical Location: Arm, Lot: 016M20A), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical Location: Arm, Lot: 002F21A), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical Location: Arm Lot: FP4554), for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. The following information was reported: ISCHAEMIC STROKE (hospitalization, disability, medically significant) with onset 03Jan2023 at 10:00, outcome "recovering", described as "Suffered ischemic stroke"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, disability, medically significant), outcome "unknown", described as "Moderna; Pfizer Bivalent". The patient was hospitalized for interchange of vaccine products, ischaemic stroke (hospitalization duration: 1 day(s)). The event "suffered ischemic stroke" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging and all results was not provided. Therapeutic measures were taken as a result of ischaemic stroke. AE treatment: CT scan, MRI, EKG, neurology visit, heart monitor.  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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details: COVID 19 Treatment with Paxlovid from 31Jan2023 till 04Feb2023. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 drug ineffective / COVID-19 cannot be ruled out
Age: 65.0
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 non-contactable reporter(s) (Other HCP) 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 29Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 65 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 included: "some preexisting gi issues" (unspecified if ongoing). There were no concomitant medications. 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.  Clinical course: No vaccine was received. No other medication in 2 weeks given. Anti-viral details includes Paxlovid, treatment started on 23Jan2023 and stopped on 28Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID  19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: he mentioned having back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "he mentioned having back pain".  Additional Information: The person on the line mentioned he received two Pfizer COVID-19 vaccines a year or more ago, and wanted to know if he needed another dose. Caller mentioned he wasn't sure of the lot numbers because the vaccination card had the information close but mentioned the numbers . Additionally, he wanted to know where he could get his vaccine appointment for the booster. Finally, when asked if there was anything else I could assist him, he mentioned having back pain, but that he would go to a clinic to check himself.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.