chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Product storage error; Poor quality vaccine administered; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-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 an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided    The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 96 of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 100th out of 100 patients.  No concomitant medication was provided by reporter.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:case
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Eczema, Laboratory test
Clinical narrative: Severe eczema; Atopic dermatitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose number unknown (booster), single (Lot number: FH8027) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Primary Immunization series complete; dose number unknown.), administration date: 16Feb2021, for covid-19 immunization. The following information was reported: DERMATITIS ATOPIC (non-serious) with onset Jan2022, outcome "not recovered", described as "Atopic dermatitis"; ECZEMA (non-serious) with onset Jan2022, outcome "not recovered", described as "Severe eczema". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, dermatitis atopic.  Additional information: NDC number, UPC number, expiry date of covid vaccine, Clobetasol: Unknown. The patient reported that after he had first booster covid shot Pfizer he developed severe eczema, atopic dermatitis, severe case and the only way he was able to control it is to put him on Pfizer Cibinqo and his insurance company wanted him to pay  a lot of money every month for Cibinqo to cure the severe eczema that he had and he was sure it was the result of the covid booster from Pfizer. This one has the original vaccination and the first booster he got. EN6200, that was for the second shot. Site of vaccine administration: arm. Start date of event: Consumer stated, Jan2022, he doesn't know the exact date 15Jan. Outcome of the event: Consumer stated, probably worsened. Treatment: Consumer stated, yes, topical cortisone (clarified as Clobetasol) and because that did not work, they put him on Cibinqo. Clobetasol: Dose: 0.5 percent. Frequency: Consumer stated, On the affected area twice a day.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: FEVER up to 103 F; Chills; Aches; headache; congestion in chest; nauseous; strong ache in left arm; Rash on arm of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 13:45 as dose 3 (booster), single (Lot number: GJ6742) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: adhesive on some band aids" (unspecified if ongoing), notes: known allergies: adhesive on some band aids. Concomitant medication(s) included: ATORVASTATIN; MIRTAZAPINE. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: PFIZER, SARS-COV2 (COVID-19) VACCINE, Batch/Lot No: Lot number: #EW0151, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Lot number: #EN6207, Location of injection: Leg Left), administration date: 18Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: PAIN (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "Aches"; CHILLS (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered"; PYREXIA (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "FEVER up to 103 F"; VACCINATION SITE RASH (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "Rash on arm of injection"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "congestion in chest"; HEADACHE (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered"; NAUSEA (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "nauseous"; VACCINATION SITE PAIN (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "strong ache in left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, respiratory tract congestion, nausea, vaccination site pain, vaccination site rash.  Additional information: No other vaccines reported to have administered in four weeks. Medications in two weeks included mirtazapine 15 mg /atorvastatin 10 mg. Patient did not had covid prior vaccination nor tested positive post vaccination but reported known allergies to adhesive on some band aids.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Vaccination site pain, Vaccination site rash
Clinical narrative: FEVER up to 103 F; Chills; Aches; headache; congestion in chest; nauseous; strong ache in left arm; Rash on arm of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 13:45 as dose 3 (booster), single (Lot number: GJ6742) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: adhesive on some band aids" (unspecified if ongoing), notes: known allergies: adhesive on some band aids. Concomitant medication(s) included: ATORVASTATIN; MIRTAZAPINE. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: PFIZER, SARS-COV2 (COVID-19) VACCINE, Batch/Lot No: Lot number: #EW0151, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Lot number: #EN6207, Location of injection: Leg Left), administration date: 18Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: PAIN (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "Aches"; CHILLS (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered"; PYREXIA (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "FEVER up to 103 F"; VACCINATION SITE RASH (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "Rash on arm of injection"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "congestion in chest"; HEADACHE (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered"; NAUSEA (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "nauseous"; VACCINATION SITE PAIN (non-serious) with onset 13Jan2023 at 19:30, outcome "not recovered", described as "strong ache in left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, respiratory tract congestion, nausea, vaccination site pain, vaccination site rash.  Additional information: No other vaccines reported to have administered in four weeks. Medications in two weeks included mirtazapine 15 mg /atorvastatin 10 mg. Patient did not had covid prior vaccination nor tested positive post vaccination but reported known allergies to adhesive on some band aids.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; dose 4:Pfizer/ Dose3,2: Moderna/ Dose 1: Janssen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 10Oct2022 as dose 4 (booster), single (Lot number: GH96935) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 2, single (Lot number: 048F21A), in left arm and on 11Jul2022 as dose 3 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "cic" (unspecified if ongoing), notes: cic. Concomitant medication(s) included: LEXAPRO, start date: 01Jun2021; TRULANCE, start date: 01Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022, outcome "unknown", described as "dose 4:Pfizer/ Dose3,2: Moderna/ Dose 1: Janssen"; 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.
Age: 66.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 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: "OSA" (unspecified if ongoing), notes: OSA; "known allergies: Sulfa and all sulfa products" (unspecified if ongoing), notes: known allergies: Sulfa and all sulfa products; "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received covid-19 treatment with anti-viral product, brand Pfizer from 28Dec2022 till 01Jan2023. Increased nasal congestion progressing to fever, chills with severe headache. Tested positive for COVID-19 for second time.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 38.0
Sex: M
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: test negative for COVID-19 on day 4 of the treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 04Jan2023 to 09Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: if covid tested post vaccination Yes; if covid tested post vaccination Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: Ew0169), on 18Jun2021 as dose 2, single (Lot number: Ew0187), on 25Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 23Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol at that time only, minor other unrelated health concerns; "known allergies: New stings" (unspecified if ongoing), notes: known allergies: New stings. The patient's 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 "if covid tested post vaccination Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result, notes: COVID test type post vaccination: Nasal Swab.  Clinical Information: if COVID prior vaccination was Yes. if COVID tested post vaccination was Yes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis C virus test, Hepatitis C virus test positive
Clinical narrative: positive for Hepatitis C/wife's sister also had the same thing happen to her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HEPATITIS C VIRUS TEST POSITIVE (non-serious), outcome "unknown", described as "positive for Hepatitis C/wife's sister also had the same thing happen to her". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter had been vaccinated with the Pfizer COVID-19 vaccine and boosters and recently reporter was tested and found to be positive for Hepatitis C (which to the best of his knowledge, he has never had). Reporter wife's sister (the patient) also had the same thing happen to her. The reporter thought this was rather strange.  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: Linked Report(s) : US-PFIZER INC-PV202300009747 same reporter/drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: He had nothing but heart problems, He had to go to the hospital (Further clarifications unknown) Arrythmia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: ARRHYTHMIA (hospitalization, medically significant), outcome "recovering", described as "He had nothing but heart problems, He had to go to the hospital (Further clarifications unknown) Arrythmia".  Clinical course: He had to get all three shots (Clarified as COVID-19 vaccine). The third shot he got he had nothing but heart problems since then. He had to go to the hospital (Further clarifications unknown) Arrythmia and he had to go to the hospital twice. There was about 4 weeks maybe or so between he had to get shot and heart had to get paddled to get it back in rhythm again. Once he got it back in rhythm, he said he felt just fine now but did not know how long that's going to last. He was 45 years old. In response to probe safety report for son: Reporter stated, "reporter's son may have already filed one cause he was still in the navy and then he was still part of the navy so what he had done, Reporter did not know. Reporter just know he said 'thank god the hospital was only 2 miles away because he drove himself to hospital'.  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, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment/Got COVID; COVID 19 Treatment/Got COVID; Moderna_ dose 4 and Pfizer BioNTech_dose 5 - 19Sep2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Mantle cell lymphoma" (unspecified if ongoing). No known allergies. There were no concomitant medications. No other medication in 2weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown", described as "Moderna_ dose 4 and Pfizer BioNTech_dose 5 - 19Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "recovered" (13Jan2023) and all described as "COVID 19 Treatment/Got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had a COVID 19 Treatment of Paxlovid, started on 28Dec2022, stopped on 03Jan2023. Reportedly non-serious report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2014, stop date: 28Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Dec2022 to 02Jan2023.  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: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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. Therapeutic measures, Paxlovid from 06Jan2023 to 10Jan2023, were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 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 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 "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.  Clinical course: No known allergies. Other medication in 2 weeks. Paxlovid started on 04Jan2023 and stopped on 08Jan2023 for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Stenosis
Clinical narrative: stenosis; arthritis; Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots; Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots; 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 69-year-old female patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Lot number: EW0172) and on 11Jun2021 as dose 2, single (Lot number: EW0176) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2023, outcome "not recovered" and all described as "Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots"; STENOSIS (non-serious), outcome "unknown"; ARTHRITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) They found stenosis and arthritis., notes: Had recent MRI of lower back, because of back pain. They found stenosis and arthritis; SARS-CoV-2 test: (13Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: stenosis; arthritis; Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots; Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots; 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 69-year-old female patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Lot number: EW0172) and on 11Jun2021 as dose 2, single (Lot number: EW0176) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2023, outcome "not recovered" and all described as "Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots"; STENOSIS (non-serious), outcome "unknown"; ARTHRITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) They found stenosis and arthritis., notes: Had recent MRI of lower back, because of back pain. They found stenosis and arthritis; SARS-CoV-2 test: (13Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). 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 21Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 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: "atopic dermatitis" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (15Jan2023) Positive, notes: tested positive on home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023 Clinical course: COVID-19 was back to normal and then 4 days after last Paxlovid dose developed mild runny nose and cough and tested positive on home test.; 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 drug BNT162B2 (COMIRNATY) to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). 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 21Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 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: "atopic dermatitis" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (15Jan2023) Positive, notes: tested positive on home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023 Clinical course: COVID-19 was back to normal and then 4 days after last Paxlovid dose developed mild runny nose and cough and tested positive on home test.; 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 drug BNT162B2 (COMIRNATY) to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ew0169), in right arm, on 07May2021 as dose 2, single (Lot number: ew0171), in right arm and on 08Dec2021 as dose 3 (booster), single (Lot number: 330308d) at the age of 46 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Sep2022 as dose 4 (booster), single (Lot number: as7145b), in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Dec2021, outcome "unknown"; 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: (Jan2023) Positive, notes: tested a strong positive on rapid tests after days of testing faint positives and symptoms clearing up; (Jan2023) Positive, notes: tested a strong positive on rapid tests after days of testing faint positives and symptoms clearing up; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 08Jan2023 to 12Jan2023.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Malaise, Pyrexia, Somnolence
Clinical narrative: really not feeling well; really lethargic; and slept the whole day; 102 fever/temperatures have been 102, 101, and 100.4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose number unknown (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: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 14Jan2023, outcome "not recovered", described as "102 fever/temperatures have been 102, 101, and 100.4"; SOMNOLENCE (non-serious) with onset 14Jan2023, outcome "unknown", described as "and slept the whole day"; LETHARGY (non-serious) with onset 14Jan2023, outcome "unknown", described as "really lethargic"; MALAISE (non-serious), outcome "unknown", described as "really not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was calling about the COVID-19 Vaccine Booster. Her and her husband both got the latest COVID-19 Vaccine booster on Friday. Friday was fine but then Saturday morning, her husband had a fever and slept the whole day and was really lethargic and then running 102 fever. Sunday running her husband was still running a fever and has one this morning again. The temperatures have been 102, 101, and 100.4. Her husband was really not feeling well. She needs some guidance on what to do.   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: 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) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing), notes: Other medical history: Migraines; "osteoporosis" (unspecified if ongoing), notes: Other medical history: osteoporosis; "hx colonic polyps" (unspecified if ongoing), notes: Other medical history: hx colonic polyps. The patient's concomitant medications were not reported.  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, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: As per the available information the causality of the events vaccination failure, covid-19 with the suspect can not be ruled out completely.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine administration date=28Oct2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date=02Apr2022,; vaccine brand other=Moderna, vaccine administration date=28Oct2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date=02Apr2022,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6206), on 04Apr2021 as dose 2, single (Lot number: EW0151), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8835), in right arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 as dose 5 (booster), single (Lot number: 059F22A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Codine intolerance, reaction(s): "Known allergies: Codine intolerance". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "vaccine brand other=Moderna, vaccine administration date=28Oct2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date=02Apr2022,"; VACCINATION FAILURE (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. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neoplasm malignant, Pain in extremity
Clinical narrative: have cancer; ever since I received the vaccine my legs hurt so bad; I can't walk; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose number unknown (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: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset Jan2023, outcome "unknown", described as "I can't walk"; PAIN IN EXTREMITY (non-serious) with onset Jan2023, outcome "unknown", described as "ever since I received the vaccine my legs hurt so bad"; NEOPLASM MALIGNANT (medically significant) with onset Jan2023, outcome "unknown", described as "have cancer". The patient asked wanted to know when this will go away. She have cancer, and many problems, and ever since  she received the vaccine, her legs hurt so bad and she can't walk. She wanted to know if this is one of the side effects and if it will go away. The patient mentioned that she can't go anywhere. She received a Pfizer Booster Vaccine 8 days ago. She also mentioned her Health Care Provider just retired so she is having a tough time.   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: Fatigue
Clinical narrative: just had some tiredness; 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 62-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 and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "just had some tiredness".  Additional information included Reporter states he took the Pfizer-BioNTech COVID-19 Vaccine primary series 1 and 2. He states he" just had some tiredness" and then received his first Pfizer booster dose and "got a headache for 4-5 days, 2nd booster had no side effects. Patient got "3rd Pfizer booster dose last week on 05Jan2023, I felt very bad after 3 hours my shoulders, arms ached and I had headaches and at night I got a fever and woke up at night with chills and fever and took Tylenol and then I was sweating." caller states he Got up in morning. "Just tired and had a little pain over my left chest and 3rd or 4th day my heart was beating very fast and then went away. Yesterday, the chest pain came back and lasted all day and my BP (Blood pressure) was 179/96 and last night the pain went away at 12:00 and at 3am I went to (Withheld) and for an hour or so I had chest pain. I just wanted to call and see if anyone else had these symptoms, then I wouldn't worry so much."   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024856 same patient and reporter, different dose and event;US-PFIZER INC-202300024855 same patient and reporter, different dose and event;US-PFIZER INC-202300024857 same patient and reporter, different dose and event;