chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
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) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "shellfish" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Losartin, reaction(s): "allergies: Losartin". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 17Nov2023 to 21Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414678 same patient, different drug;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 15Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 15Nov2023 to 19Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414890 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had covid in January of this year; I had covid in January of this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 74-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: I have a lot of allergies; "allergic to citric acid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "I had covid in January of this year". Clinical course: Had all of the Pfizer COVID-19 vaccines, did get Covid in January of this year. Clarified and confirmed had not gotten Comirnaty vaccine yet, had just had prior Pfizer COVID-19 vaccines. 30Nov2022 got COVID bivalent vaccine and then a month later in Jan2023 got Covid, so was protected, was at peak of protection.  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-202300418789 same patient/reporter different event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Hypersensitivity
Clinical narrative: I had covid in January of this year; I had covid in January of this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 74-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: I have a lot of allergies; "allergic to citric acid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "I had covid in January of this year". Clinical course: Had all of the Pfizer COVID-19 vaccines, did get Covid in January of this year. Clarified and confirmed had not gotten Comirnaty vaccine yet, had just had prior Pfizer COVID-19 vaccines. 30Nov2022 got COVID bivalent vaccine and then a month later in Jan2023 got Covid, so was protected, was at peak of protection.  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-202300418789 same patient/reporter different event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Caller had little mini flares after the vaccine but nothing bad; autoimmune disease; 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 74-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: I have a lot of allergies; "allergic to citric acid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed.), for COVID-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Jan2023, outcome "unknown", described as "autoimmune disease"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller had little mini flares after the vaccine but nothing bad". Clinical Course: Caller calling in about the ingredients of the new covid vaccine and which variant shes gonna get. patient had all Pfizer covid 19 vaccines, she chose Pfizer because of the ingredients in it.  Patient had a lot of allergies." When patient called the pharmacy, she ask if they have Pfizer, what am she getting  what was the difference. Caller stated caller's 1st problem is allergic reaction, caller doesn't get flu vaccine or pneumonia vaccine, nothing with adjuvant in it and various things since caller is allergic to citric acid, that's why caller chose Pfizer. Caller's main concern is that the inactive ingredients are the same. Caller had little mini flares after the vaccine but nothing bad, made it through Covid. Couldn't take Paxlovid, but stated Covid wasn't real bad. Clarified and confirmed caller has not gotten the Comirnaty vaccine yet, caller has just had the prior Pfizer COVID-19 vaccines. 30Nov2022 caller got COVID bivalent vaccine and then a month later in Jan2023 got Covid, so was protected, was at peak of protection.  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-202300414938 same patient/vaccine, different events/suspect doses;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Hypersensitivity
Clinical narrative: Caller had little mini flares after the vaccine but nothing bad; autoimmune disease; 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 74-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: I have a lot of allergies; "allergic to citric acid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed.), for COVID-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Jan2023, outcome "unknown", described as "autoimmune disease"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller had little mini flares after the vaccine but nothing bad". Clinical Course: Caller calling in about the ingredients of the new covid vaccine and which variant shes gonna get. patient had all Pfizer covid 19 vaccines, she chose Pfizer because of the ingredients in it.  Patient had a lot of allergies." When patient called the pharmacy, she ask if they have Pfizer, what am she getting  what was the difference. Caller stated caller's 1st problem is allergic reaction, caller doesn't get flu vaccine or pneumonia vaccine, nothing with adjuvant in it and various things since caller is allergic to citric acid, that's why caller chose Pfizer. Caller's main concern is that the inactive ingredients are the same. Caller had little mini flares after the vaccine but nothing bad, made it through Covid. Couldn't take Paxlovid, but stated Covid wasn't real bad. Clarified and confirmed caller has not gotten the Comirnaty vaccine yet, caller has just had the prior Pfizer COVID-19 vaccines. 30Nov2022 caller got COVID bivalent vaccine and then a month later in Jan2023 got Covid, so was protected, was at peak of protection.  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-202300414938 same patient/vaccine, different events/suspect doses;
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: developed PMR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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; Bnt162b2 (Dose 2, Single), for Covid-19 Immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "developed PMR". Clinical course: Caller was calling on behalf of her 71 year old sister and was asking if Pfizer vaccines can develop PMR, her sister got 3 pfizer vaccines and then developed PMR also stated that her sister was the 11th case in the privacy.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 24Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 18May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Non-Alcoholic Fatty Liver Disease" (unspecified if ongoing); "PCN Allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Biaxin Allergy" (unspecified if ongoing); "Cipro allergy" (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 Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Nov2023 to 17Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414869 same patient, different drug and event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 65 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 23Feb2021 at 12:00 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 at 12:00 as dose 2, single (Lot number: EN6208), in left arm, on 10Nov2021 at 12:00 as dose 3 (booster), single (Lot number: EW0172), in left arm and on 01Jun2022 at 12:00 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "RNY Gastric bypass surgery", start date: 2008 (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE, start date: 05Apr2021, stop date: 26Nov2023. 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 38-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 16Nov2023 to 20Nov2023. Clinical course: Patient had no known allergies,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300418435 Same patient, different drug/ AE;
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder
Clinical narrative: 8 yr old boy has autism and new symptom onset started shortly after receiving Covid vaccines; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An 8-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "8 yr old boy has autism and new symptom onset started shortly after receiving Covid vaccines". Therapeutic measures were not taken as a result of autism spectrum disorder.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known disease pathophysiology, the event autism spectrum disorder is assessed as not related to BNT162B2 OMI XBB.1.5, and more likely due to underlying medical condition of autism.
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 11:00 as dose 4 (booster), single (Lot number: 6H9703) at the age of 47 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS], start date: 01Jan2018; VITAMIN C [ASCORBIC ACID], start date: 01Sep2021; ZINC, start date: 01Sep2021; ESOMEPRAZOLE MAGNESIUM, start date: 09May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Nov2023, outcome "recovered" (25Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Nov2023) Positive; (25Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19 from 19Nov2023 to 23Nov2023. Patient stated that she first tested positive for Covid on 19Nov2023, and started taking Paxlovid on the same day. She took the full prescription all 5 days. On 25Nov2023 she tested negative. Patient also took Estyrella on 01Feb2021.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency. However, a contributory role of bnt162b2, bnt162b2 omi ba.4-5  to the events Drug ineffective and Covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300414984 same patient, different drug and event;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer /BioNTech dose 1,2 and vaccine brand other=Moderna dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 11Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Dec2021, outcome "unknown", described as "vaccine brand=Pfizer /BioNTech dose 1,2 and vaccine brand other=Moderna dose 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 14Nov2023 to 19Nov2023. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300418378 Same patient, different drug and different AE;US-PFIZER INC-202300418496 Same patient/vaccine, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: confirmed that all of the COVID vaccines she received were from Pfizer/Caller stated that she got COVID; confirmed that all of the COVID vaccines she received were from Pfizer/Caller stated that she got COVID; 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 54-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (ongoing); "only has one lung" (ongoing), notes: only has one lung. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "confirmed that all of the COVID vaccines she received were from Pfizer/Caller stated that she got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Caller stated that she was immunocompromised and only had one lung. Caller stated that she didn't had the latest booster of the COVID shot. Caller later confirmed that all of the COVID vaccines she received were from Pfizer, however she did not receive the last couple of boosters. Caller stated that she got COVID and was prescribed Paxlovid, however she had a hard time swallowing larger pills. Caller provided that "today had been the 5th day, however she had not taken the medication at that time and stated it was her last day to try and take it.  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-202300411050 same patient, different drug/event;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 5 (booster), single (Lot number: GLO446) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN9581), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 08Jun2022 as dose 4 (booster), single (Lot number: FM7553), in right arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic Rhinitis" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Mint, Ginger Reaction: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Inulin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 02Nov2023 to 07Nov2023. Clinical course: Patient was healthy and in good aerobic condition prior to covid. Upon all the shots, had latest booster 1 month prior to illness. Resting heart rate 73 bpm prior to illness. Average walking 4 mile/day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300365991 Same patient, different product/event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took Paxlovid from 17Nov2023 to 21Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Product lot number issue, Rash, Visual impairment
Clinical narrative: It is too small for her to read, even with her glasses, she cannot see it. The patient stated she did do not see anything; When asked about lot number, the patient stated she did not see the number whatever number is here. It is too small for her to read, even with her glasses, she cannot see it; Legs are breaking out in a rash/Slight rash knees down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 at 11:45 as dose 1, single (Lot number: HG7557) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; DOPAMINE. The following information was reported: RASH (non-serious) with onset 28Nov2023 at 13:45, outcome "unknown", described as "Legs are breaking out in a rash/Slight rash knees down"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "It is too small for her to read, even with her glasses, she cannot see it. The patient stated she did do not see anything"; PRODUCT LOT NUMBER ISSUE (non-serious), outcome "unknown", described as "When asked about lot number, the patient stated she did not see the number whatever number is here. It is too small for her to read, even with her glasses, she cannot see it". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash. Additional information: Consumer stated that she just received a Pfizer booster vaccine (Later clarified as Comirnaty) about 3 hours ago and her legs were breaking out in a rash, a slight rash knees down, no place else on her body just on her legs. When asked about lot number, the patient stated she did not see the number whatever number is here. It is too small for her to read, even with her glasses, she cannot see it. The patient stated she did do not see anything. The patient also mentioned that she was taking a lot of medication on daily basis.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 29-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 08:30 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "Known allergies: All nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 15Nov2023 to 20Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300421156 Same reporter/ patient; different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash macular
Clinical narrative: broke out in a shingles rash; having soreness and pain across his abdomen; still has faded blotches where the lesions were but no nerve pain; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 90-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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "broke out in a shingles rash"; PAIN (non-serious), outcome "unknown", described as "having soreness and pain across his abdomen"; RASH MACULAR (non-serious), outcome "unknown", described as "still has faded blotches where the lesions were but no nerve pain".  Additional information: Retired nurse stated her husband has had 3 covid vaccines and is due for the 4th.  He broke out in a shingles rash on September 3rd (he was having soreness and pain across his abdomen 4-5 days before).  He still has faded blotches where the lesions were but no nerve pain. Is it safe to get the Pfizer covid 19 vaccine now? His doctor said it was okay but the pharmacist called someone and then told them he should wait until it was completely healed. She is wondering if there is more info on this since she is getting conflicting information.      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: Near death experience
Clinical narrative: he's probably dead sooner because of the Pfizer vaccine he got; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "he's probably dead sooner because of the Pfizer vaccine he got". Clinical course: He also stated that he's probably dead sooner because of the Pfizer vaccine he got and based on the studies, people dying suddenly because of the vaccine and that was not safe.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Malaise, Suspected COVID-19
Clinical narrative: contracted covid; contracted covid; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Clinical course: Caller said at the last part of the call that he contracted covid and he was not feeling well and he was on his way to the clinic form because the caller was not feeling well and might had Pfizer shots.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug Efficacy; Drug Efficacy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Drug Efficacy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX, UNK
Symptoms: Body temperature, Eye inflammation, Eye pruritus, Fatigue, Headache
Clinical narrative: Fever; Frequent urination; Itch in her left eye; Eye inflammation and had to take antibiotics; Lower back pain is getting better; Fatigue; Covid and flu vaccines and not feeling well after; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). Other Case identifier(s): 2023US005747.  A 54-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; abaloparatide (TYMLOS), since 06Aug2023 (Lot number: D03869B, Expiration Date: 28Feb2025) at 80 ug daily, subcutaneous for osteoporosis. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; ROSUVASTATIN CALCIUM; METOPROLOL SUCCINATE; ASPIRIN EC. Past drug history included: Amoxicillin, reaction(s): "Allergy to antibiotic". The following information was reported: MALAISE (non-serious) with onset 06Aug2023, outcome "unknown", described as "Covid and flu vaccines and not feeling well after"; EYE INFLAMMATION (non-serious) with onset 06Aug2023, outcome "unknown", described as "Eye inflammation and had to take antibiotics"; FATIGUE (non-serious) with onset 06Aug2023, outcome "unknown"; PYREXIA (non-serious) with onset 06Aug2023, outcome "unknown", described as "Fever"; POLLAKIURIA (non-serious) with onset 06Aug2023, outcome "unknown", described as "Frequent urination"; HEADACHE (non-serious) with onset 06Aug2023, outcome "unknown"; EYE PRURITUS (non-serious) with onset 06Aug2023, outcome "unknown", described as "Itch in her left eye"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 06Aug2023, outcome "unknown", described as "Lower back pain is getting better". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was 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, FLUX, UNK
Symptoms: Malaise, Pollakiuria, Pyrexia, Therapeutic response unexpected
Clinical narrative: Fever; Frequent urination; Itch in her left eye; Eye inflammation and had to take antibiotics; Lower back pain is getting better; Fatigue; Covid and flu vaccines and not feeling well after; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). Other Case identifier(s): 2023US005747.  A 54-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; abaloparatide (TYMLOS), since 06Aug2023 (Lot number: D03869B, Expiration Date: 28Feb2025) at 80 ug daily, subcutaneous for osteoporosis. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; ROSUVASTATIN CALCIUM; METOPROLOL SUCCINATE; ASPIRIN EC. Past drug history included: Amoxicillin, reaction(s): "Allergy to antibiotic". The following information was reported: MALAISE (non-serious) with onset 06Aug2023, outcome "unknown", described as "Covid and flu vaccines and not feeling well after"; EYE INFLAMMATION (non-serious) with onset 06Aug2023, outcome "unknown", described as "Eye inflammation and had to take antibiotics"; FATIGUE (non-serious) with onset 06Aug2023, outcome "unknown"; PYREXIA (non-serious) with onset 06Aug2023, outcome "unknown", described as "Fever"; POLLAKIURIA (non-serious) with onset 06Aug2023, outcome "unknown", described as "Frequent urination"; HEADACHE (non-serious) with onset 06Aug2023, outcome "unknown"; EYE PRURITUS (non-serious) with onset 06Aug2023, outcome "unknown", described as "Itch in her left eye"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 06Aug2023, outcome "unknown", described as "Lower back pain is getting better". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was unknown. 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: Neoplasm malignant
Clinical narrative: her brother is dying due to the Covid-19 vaccine and cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: NEOPLASM MALIGNANT (life threatening), outcome "unknown", described as "her brother is dying due to the Covid-19 vaccine and cancer". Reporter stated that Pfizer was a criminal organization which was not effective for its use, Vaccines should be one time only why it needed to have booster, her brother was dying due to the Covid-19 vaccine and cancer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: shortness of breath; chest pain; This is a spontaneous report received from a contactable reporter(s) (Lawyer) from legal division.  A 23-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (death, medically significant) with onset Nov2021, outcome "fatal"; DYSPNOEA (death, medically significant) with onset Nov2021, outcome "fatal", described as "shortness of breath". The events "shortness of breath" and "chest pain" required emergency room visit. The patient date of death was 25Nov2021. Reported cause of death: "shortness of breath", "chest pain". It was not reported if an autopsy was performed. Clinical course: The attached lawsuit was filed on 27Nov in state court in (City withheld), (State withheld) by the estate of a 23-year-old (State withheld). Student who allegedly died after administration of a COVID-19 vaccine. Plaintiff admits that he does not yet know which vaccine was administered to his son, and has therefore named Pfizer, BNT, Moderna, and J&J (but not AZ), and states that he will dismiss the other manufacturers once he knows which vaccine his son took. Plaintiff alleges his son was an intern at (Company name withheld) and (Institution withheld) and was forced to get vaccinated in Nov2021, and died on 25Nov2021 after suffering chest pains and shortness of breath. Most of the allegations focus on the Pfizer/BioNTech vaccine, which he acknowledges was produced for the Department - allegations helpful to a removal. Plaintiff alleges claims under (State withheld) product liability statute, failure to warn, breach of warranty, negligence, wantonness, fraud (misrepresentation and suppression), invasion of privacy, battery, breach of contract, conspiracy, and wrongful death. Plaintiff acknowledges the rules but claims that the rules in that it does not provide Due Process, among other alleged constitutional infirmities.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Reported Cause(s) of Death: chest pain; shortness of breath
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Death, Dyspnoea, Respiratory distress
Clinical narrative: shortness of breath; chest pain; This is a spontaneous report received from a contactable reporter(s) (Lawyer) from legal division.  A 23-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (death, medically significant) with onset Nov2021, outcome "fatal"; DYSPNOEA (death, medically significant) with onset Nov2021, outcome "fatal", described as "shortness of breath". The events "shortness of breath" and "chest pain" required emergency room visit. The patient date of death was 25Nov2021. Reported cause of death: "shortness of breath", "chest pain". It was not reported if an autopsy was performed. Clinical course: The attached lawsuit was filed on 27Nov in state court in (City withheld), (State withheld) by the estate of a 23-year-old (State withheld). Student who allegedly died after administration of a COVID-19 vaccine. Plaintiff admits that he does not yet know which vaccine was administered to his son, and has therefore named Pfizer, BNT, Moderna, and J&J (but not AZ), and states that he will dismiss the other manufacturers once he knows which vaccine his son took. Plaintiff alleges his son was an intern at (Company name withheld) and (Institution withheld) and was forced to get vaccinated in Nov2021, and died on 25Nov2021 after suffering chest pains and shortness of breath. Most of the allegations focus on the Pfizer/BioNTech vaccine, which he acknowledges was produced for the Department - allegations helpful to a removal. Plaintiff alleges claims under (State withheld) product liability statute, failure to warn, breach of warranty, negligence, wantonness, fraud (misrepresentation and suppression), invasion of privacy, battery, breach of contract, conspiracy, and wrongful death. Plaintiff acknowledges the rules but claims that the rules in that it does not provide Due Process, among other alleged constitutional infirmities.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Reported Cause(s) of Death: chest pain; shortness of breath
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: experience of chronic hives for about 8 times; 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 NOS), as dose number unknown,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "experience of chronic hives for about 8 times". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received. Additional information: Caller is in a dilemma trying to decide whether to get another booster for covid because she's been having experience of chronic hives for about 8 times. And she wanted to know if the covid shot will make it worse. Created Manual AE form because the caller has a pre existing condition.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.