chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Illness, Lymphadenopathy, Pyrexia
Clinical narrative: COVID; COVID; 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 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose 4 (booster), single (Lot number: GJ6796) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8729), as dose 2, single (Lot number: EW0172) and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history included: "cold induced asthma" (unspecified if ongoing); "upper respiratory it moves to her chest/upper respiratory thing", start date: Jun2019 (unspecified if ongoing). Concomitant medication(s) included: DULERA taken for asthma, respiratory disorder; LEVALBUTEROL [LEVOSALBUTAMOL] taken for respiratory disorder, start date: Jun2019; PRILOSEC [OMEPRAZOLE] (ongoing); PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Lab test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300072419 same patient, different vaccine dose/events.;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: 012A21A), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of cancer" (unspecified if ongoing), notes: History of cancer with chemotherapy 13 years before this report; "Chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Jun2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with PF-07321332, ritonavir (PAXLOVID), from 08Feb2023 (Lot number: GF5593) to 12Feb2023. Therapeutic measures were not taken as a result of interchange of vaccine products.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: The reporter is the patient.  A 77-year-old female 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; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy" (unspecified if ongoing), notes: had a Hysterectomy when she was 27-28 years old; "really weak", start date: Sep2022 (unspecified if ongoing); "cough", start date: Sep2022 (unspecified if ongoing); "RSV", start date: Sep2022 (unspecified if ongoing). Concomitant medication(s) included: PREMARIN taken for hormone replacement therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: Body height: 5' 1.5", notes: States she used to be 5' 1.5" but as a normal part of again she lost height; lost height, notes: States she used to be 5' 1.5" but as a normal part of again she lost height; SARS-CoV-2 test: Positive, notes: Tested Positive for Covid 19 after 3 Pfizer Covid Vaccines. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: RSV was in Sep2022. The doctor said he was not going to send her out to get a test for RSV, he was just going to treat her for it, so she didn't really have a test but had the symptoms and the treatment was the same. She states it hasn't bothered her since. Reporter states she was just really weak and had a cough. Covid was in Oct2022. States it didn't last very long either. She reports she was really tired again. States she even had a total of 3 Pfizer Covid Vaccines.    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. Sender's Comments: The causal association of reported event lack of efficacy and Covid 19 illness is assessed as probably related to suspected Vaccine BNT162B2 based on temporal exposure and disease occurrence as reported. Case will be reassess once new information such as date of vaccination will be reported
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She had her COVID 19 shots, but she doesn't know how many she had. She would guess they were all Pfizer/tested positive for COVID; She had her COVID 19 shots, but she doesn't know how many she had. She would guess they were all Pfizer/tested positive for COVID; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had her COVID 19 shots, but she doesn't know how many she had. She would guess they were all Pfizer/tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient reported that her age was probably close to 60. She stated that she had diarrhea so bad that she had permanently discontinued to taking treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 (BNT162B2 NOS) and the reported events drug ineffective, COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain assessment, Pneumonia, Rheumatoid arthritis
Clinical narrative: RA flare; COVID; COVID; Sick Last Year with Pneumonia; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non-HCP), Program ID:  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (ongoing); "arthritis pain" (ongoing). Concomitant medication(s) included: XELJANZ XR oral taken for rheumatoid arthritis, start date: Jul2021 (ongoing); VOLTAREN [DICLOFENAC SODIUM] taken for arthritis; ADVIL [IBUPROFEN]; FOLIC ACID; METHOTREXATE. Past drug history included: Penicillin vk, reaction(s): "allergy", notes: 500 mg tablet; Hydroxychloroquine sulfate, reaction(s): "allergy". The following information was reported: PNEUMONIA (medically significant) with onset Apr2022, outcome "recovered", described as "Sick Last Year with Pneumonia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "COVID"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA flare". The patient underwent the following laboratory tests and procedures: Pain assessment: 5.  Clinical course: Patient had Covid Oct2022. Patient Stated that prescriber was aware and  she did not take Xeljanz Xr For 3.5 weeks. Resolved. No Additional Details Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. The event "RA flare" is not considered related to the suspect vaccine BNT162B2 but more likely related to aggravation of the underlying medical condition of ongoing "Rheumatoid Arthritis". The other event "Sick Last Year with Pneumonia" is more likely a coincidental event so that is not likely considered related to the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. This case will be reassessed once additional information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 infection (confirmed); COVID-19 infection (confirmed); This is a spontaneous report received from a contactable reporter (healthcare professional). A 63-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single and on 15Feb2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis-Spondyloarthritis", start date: 2013 (ongoing); "Sinusitis", start date: 2011 (unspecified if ongoing); "Thyroid Problem" (unspecified if ongoing); "Back or Spine problem" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Upper respiratory infection", start date: 2015 (unspecified if ongoing); "Gastroenteritis", start date: 2017 (unspecified if ongoing); "Hemorrhage (non-serious bleed)", start date: 2017 (unspecified if ongoing); "Conjunctivitis", start date: 2018 (unspecified if ongoing); "Atypical chest pain", start date: 2018 (unspecified if ongoing); "Non-Smoker" (unspecified if ongoing). Concomitant medications included: AZULFIDINE oral, start date: 23Jan2020, stop date: 01Nov2022; NSAIDs, oral (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 infection (confirmed)".   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The contributory role of BNT162b2 to the reported drug ineffective event cannot be excluded since a lack of effect can generally be expected for any medicinal product as a 100% success rate cannot be reasonably assumed in every patient treated.
Age: 66.0
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 67-year-old male patient received BNT162b2 (BNT162B2), on 27May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient has no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: Reinfected with positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; GUANFACINE; HYDROXIZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Feb2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Positive test six days after testing. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: Positive test six days after testing. Minor symptoms of sniffling and sneezing prompted test. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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: "high cholesterol" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". After testing positive on 03Feb2023, the patient was started on PAXLOVID on the same day.Minor symptoms, some fatigue and depressive thoughts. Clear headed again by 07Feb2023. The patient took last dose of PAXLOVID on 08Feb2023. The patient tested negative (rapid antigen) on 10Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 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". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "MVP-  Endocarditis", start date: 1996 (unspecified if ongoing); "MVP-  Endocarditis", start date: 1996 (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LYRICA, start date: 20Jun2018; METOPROLOL; SERTRALINE; NORTRIPTYLINE; EVENITY [ROMOSOZUMAB]. Past drug history included: Minocine, reaction(s): "known allergies: minocine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Feb2023) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 07Feb2023 to 11Feb2023.  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: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing); "Drug Allergy; Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 31Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ2524), 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: "Atrial Fibrulation" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Covid test was strongly  positive again in 3 days after end of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing), notes: more than 20 years ago; "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: States she got covid 19 infection in 2022 and then now. Mentions that she received pfizer covid vaccine primary series and booster; States she got covid 19 infection in 2022 and then now. Mentions that she received pfizer covid vaccine primary series and booster; States she got covid 19 infection in 2022 and then now. Mentions that she received pfizer covid vaccine primary series and booster; 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 61-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Caller states she has diabetes but it is controlled with diet and exercise. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "States she got covid 19 infection in 2022 and then now. Mentions that she received Pfizer covid vaccine primary series and booster"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "unknown", described as "States she got covid 19 infection in 2022 and then now. Mentions that she received Pfizer covid vaccine primary series and booster". The patient specified that at the time of this report it was her 2nd time getting covid. The first time was only sniffles. She stated she got covid 19 infection in 2022 and then at the time of this report (e.g. 2023). The patient stated that this was the 4th day since her symptoms started. She will be picking up her prescription for Paxlovid today.  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: COVID-19, SARS-CoV-2 test, 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 72-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 14:00 as dose 1, single (Lot number: en5318), in right arm, on 01Mar2021 as dose 2, single (Lot number: fn6200), in right arm, on 27Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 30145ba), in right arm and on 22Jul2022 as dose 4 (booster), single (Lot number: fj4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type II" (unspecified if ongoing), notes: Other medical history: Diabetes type II. The patient's concomitant medications were not reported. Past drug history included: Ciproflaxin, reaction(s): "Known allergies: Ciproflaxin", notes: Known allergies: Ciproflaxin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive; (10Feb2023) Negative; (14Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZATHIOPRINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive rapid test 48 hours after a negative test; Positive, notes: positive rapid test 48 hours after a negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Interchange of vaccine products, Weight
Clinical narrative: Diarrhea; however caller's 3 prior doses were the Moderna COVID-19 vaccine.; 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 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Feb2023 at 14:00 as dose 4 (booster), single (Lot number: GJ3270) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 3), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Feb2023, outcome "unknown", described as "however caller's 3 prior doses were the Moderna COVID-19 vaccine."; DIARRHOEA (non-serious) with onset 16Feb2023 at 04:00, outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea  Additional information: No other conditions, investigations, other products. Initially stated calling because caller got the 4th shot, whatever the shot is called, and is experiencing some diarrhea. Calling Pfizer because caller is looking to get disposable panties for only a couple of days for discomfort and is looking for a recommendation for women's bowel incontinence or diarrhea. Patient weight: Probably 150ish pounds. Started around 4PM then at 4AM got up with uncontrollable diarrhea. Since 4AM hasn't done anything, is in bed, that is why caller thought caller may have a product around just in case diarrhea does come back.Upon attempting to clarify specific product name, caller stated it is either the Pfizer BioNTech COVID-19 vaccine mRNA, but caller thinks the last dose, 4th shot, caller got was the bivalent, is that the latest one, Caller then located vaccination card and clarified and confirmed caller received the Pfizer COVID-19 vaccine bivalent for caller's 4th dose. Confirmed this was caller's 4th dose total. 3 prior doses were the Moderna COVID-19 vaccine. Stated does caller have to go for a 2nd dose. Was on and off about whether caller was going to take the vaccine or not, then caller's sister had Covid so caller ended up getting the vaccine. Anatomical Site of injection: Left upper shoulder. Patient has no Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas); Advanced or untreated HIV infection; Use of medications that suppress the immune system (e.g., high-dose corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept). Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None.
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Pruritus, Rash
Clinical narrative: rash on his shoulder all the way to his elbow, that broke out; when he took the shot it hurt real bad; itching inside of his body, then all over arm where he has been scratching and scratching/ itching on left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 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: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "rash on his shoulder all the way to his elbow, that broke out"; LIMB INJURY (non-serious), outcome "not recovered", described as "when he took the shot it hurt real bad"; PRURITUS (non-serious), outcome "not recovered", described as "itching inside of his body, then all over arm where he has been scratching and scratching/ itching on left arm". The events "rash on his shoulder all the way to his elbow, that broke out", "when he took the shot it hurt real bad" and "itching inside of his body, then all over arm where he has been scratching and scratching/ itching on left arm" required physician office visit. Therapeutic measures were taken as a result of rash, limb injury, pruritus.  Additional course: caller had called regarding the Pfizer booster shot. Caller confirmed he was a patient that had a rash on his shoulder all the way to his elbow, that broke out. Caller needs to know what was going on in his body the same way. Caller stated he took Benadryl like they told him and he was still having itching in his skin. Caller states he did not know what was going on but he understands he has itching inside of his body, then all over his arm where he has been scratching and scratching. Caller stated it was itching on his left arm. Caller stated when he took the shot it hurt real bad and when they shot him the rash came up the next day. Caller starts on his left side he had itching going down his leg. Caller states his doctor told him to contact Pfizer.  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: Hypoaesthesia
Clinical narrative: complained of numbness on one side of his face, used to be severe but is now milder, but still there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Batch/Lot No: Unknown., Site of administration: Unknown), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered with sequelae", described as "complained of numbness on one side of his face, used to be severe but is now milder, but still there". The event "complained of numbness on one side of his face, used to be severe but is now milder, but still there" required physician office visit. It was unknown if therapeutic measures were taken as a result of hypoaesthesia.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Reactive depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive; (10Feb2023) Negative; (12Feb2023) Negative; (17Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 06Feb2023 to 11Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: body aches; a low grade fever; chills; fatigue; was falling asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000150 (Novavax).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 19Mar2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Feverish", "she had a severe headache", "nausea", "body aches", "chills", "did not eat for 2 days". The following information was reported: PYREXIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "a low grade fever"; PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 08Apr2021, outcome "unknown"; FATIGUE (non-serious) with onset 08Apr2021, outcome "unknown"; SOMNOLENCE (non-serious) with onset 08Apr2021, outcome "unknown", described as "was falling asleep". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: body aches; a low grade fever; chills; fatigue; was falling asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000150 (Novavax).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 19Mar2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Feverish", "she had a severe headache", "nausea", "body aches", "chills", "did not eat for 2 days". The following information was reported: PYREXIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "a low grade fever"; PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 08Apr2021, outcome "unknown"; FATIGUE (non-serious) with onset 08Apr2021, outcome "unknown"; SOMNOLENCE (non-serious) with onset 08Apr2021, outcome "unknown", described as "was falling asleep". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Basedow's disease
Clinical narrative: diagnosed with Graves; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (14Feb2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 12Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 23Oct2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: BASEDOW'S DISEASE (hospitalization, medically significant) with onset 21Dec2022, outcome "not recovered", described as "diagnosed with Graves". The event "diagnosed with graves" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of basedow's disease.  Clinical course: Patient received her vaccines; 3 total. She had just been diagnosed with Graves and her research says it may be from the vaccine. No, medical inquiry was not forwarded. The reported issue occur after use of a Pfizer product. She had many symptoms. Finally diagnoses with Graves on 21Dec2022 by endocrinologist. Date started (or best estimated period): Oct2022. Admission to hospital due to the event (Does not include emergency room visit without further admission): Yes. She was still experiencing the event. They sent her to primary Dr, who sent her to endocrinologist. No surgical treatment needed for the event. On Dec2022 Propranlol and Methimazole 10 mg 2x's day 10 mg (ongoing) were given as treatment drugs. No other product(s) that were taken together with those indicated above. Patient was always healthy. Covid 19 vaccines taken: 22Jan2021, 12Feb2021, 23Oct2021 and 13Sep2022-Felt bad, then got worse. Symptoms got worse. Finally diagnoses.  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: Interchange of vaccine products, Monoplegia
Clinical narrative: interchange of vaccine products; leg paralysis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alzheimers" (unspecified if ongoing), notes: Yes,I placed her in a nursing home with Alzheimers approx. a month+ or - B4 pandemic hit. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant), outcome "unknown"; MONOPLEGIA (disability, medically significant), outcome "unknown", described as "leg paralysis".  Clinical course: I thank Pfizer, Moderna, etc. for the complete immunization of wife, (name-withheld), and my remaining lives. Yes, I placed her in a nursing home with Alzheimers approx. a month+ or - B4 pandemic hit, however, (name-withheld) does not deserve her leg paralysis & resulting wheel chair confinement following vaccination.  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: COVID-19, Drug ineffective
Clinical narrative: Caller got the vaccinations and he went to the doctor today and told him that he has Covid; Caller got the vaccinations and he went to the doctor today and told him that he has Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller got the vaccinations and he went to the doctor today and told him that he has Covid". The events "caller got the vaccinations and he went to the doctor today and told him that he has covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: Patient was asked if this is the same as the vaccinations shot but only in a pill form. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Caller clarifies that she still has long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female 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; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: Had COVID in 2020 prior to the COVID vaccines; was hospitalized for Covid virus. The patient's concomitant medications were not reported.  The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Caller clarifies that she still has long Covid".  Additional information: Caller states she also has long COVID. Had COVID in 2020 prior to the COVID vaccines; was hospitalized for COVID virus. Caller clarifies that she still has long COVID; but she has different symptoms than her husband. Neurological. She also had Moderna COVID vaccine primary doses; two Moderna COVID boosters; and her third booster was Pfizer COVID booster. Reporter details: Reporter type: documented as Consumer; She mentions that she was a home health aide and a dental assistant in the past; specifically calling about herself.  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-202300066918 Same patient/vaccine, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Somebody died on 10Feb in his family; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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. The following information was reported: DEATH (death) with onset 10Feb2023, outcome "fatal", described as "Somebody died on 10Feb in his family". The patient date of death was 10Feb2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Somebody died on 10Feb in his family