chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.  On 19-JAN-2023, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# was reported as W02294, and expiration date was 13-JUL-2024; strength and route were unknown) for prophylaxis after temperature excursion (product storage error).  Temperature excursion of this vaccine was 6.9 Fahrenheit degrees (F) for 15 minutes. Previous temperature excursion was reported as 7.1 F for 30 minutes and 11.6 F for 1. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; Inbound call from medical assistant who reports VARIVAX that expired 4/1/2023 was administered to one patient today 4/12/2023.; This spontaneous report has been received from a medical assistant, referring a patient of unknown sex and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 12-APR-2023, the patient was vaccinated with and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number U010398 has been verified to be a valid lot number, expiry date 01-APR-2023) (strength, dose, frequency, and administration route were not provided) (expired product administered) concomitantly with sterile diluent (manufacturer unknown), both indicated as prophylaxis  No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Given 4 Year Old Child a Dose of Heplisav-B; Initial Report Received on 23-Feb-2023.  A registered nurse reported that a 4-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported.  Allergies were unknown.  On 27-Jan-2023, the 4-year-old patient received a dose of HEPLISAV-B vaccine (Lot # 941060, expiration date 02-Dec-2024; NDC # and route not reported) in the left deltoid at a pharmacy. No adverse effects were reported.  No further information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 01Apr2023 to 05Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: She got anaphylactic shock from it/She was allergic to the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown", described as "She got anaphylactic shock from it/She was allergic to the first dose". Clinical course: She got anaphylactic shock from it. Yet no one told her from the first time it happened not to get the second one.   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-202300156967 Same reporter/drug, different patient/event;US-PFIZER INC-202300156966 Same reporter/drug, different patient/event;US-PFIZER INC-202300156965 Same patient, Same product (DOSE 2), different events;
Sex: F
Vaccine: COVID19-2
Symptoms: Morphoea
Clinical narrative: morphea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A 71-year-old female patient 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. 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: MORPHOEA (non-serious), outcome "unknown", described as "morphea".  Additional Information: On an incoming call from the patient she stated "She was prescribed Eucrisa for morphea which is off label". The patient also stated "this occurred after her fifth Pfizer vaccine just so you know."  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-PV202300068455 Same reporter/patient, different drug/AE.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefixime, reaction(s): "Known allergies: Cefixime". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "recovering"; COVID-19 (medically significant) with onset 12Apr2023, outcome "recovering"; DRUG INEFFECTIVE (medically significant) with onset 12Apr2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2023) Negative; (11Apr2023) Negative; (12Apr2023) Positive; (13Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300156338 same reporter/patient with different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: she totally got her insides ripped up/ she got the Pfizer Covid shot and now has heart problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-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 and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "she totally got her insides ripped up/ she got the Pfizer Covid shot and now has heart problems". Therapeutic measures were taken as a result of cardiac disorder.  Additional information:Caller stated that patient got the Pfizer Covid shot and now has heart problems. You couldn't pay her a million dollars to take it again. She now has to be on Eliquis for the rest of her life. Her son is worried something is going to happen to him too. More and more people are getting heart problems and you really don't know how people are going to be afterward. All Pfizer cares about is making money, whether that's off shots or making money off Estring and not letting anyone know when the patent ends. She wanted to let Pfizer know that senior citizens cannot afford Estring because health insurance won't cover it and its much cheaper to go to (country withheld) to purchase.  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-202300156709 same patient and different drug/events.;US-PFIZER INC-202300156131 same patient and different drug/events.;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: She stated a girl in her orthopedic office also dealt Joint pain this for 6 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 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: ARTHRALGIA (non-serious), outcome "recovered", described as "She stated a girl in her orthopedic office also dealt Joint pain this for 6 months".  Additional information: Reporter knows for a fact she was not the only person that was dealing with the joint pain. She stated a girl in her orthopedic office also dealt with it for 6 months and it went away for her.  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-202300156123 same reporter/drug, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Photosensitivity reaction
Clinical narrative: a friend did Pfizer and now has a skin condition, an autoimmune problem, that cannot be out in the sun anymore because of Pfizer.; a friend did Pfizer and now has a skin condition, an autoimmune problem, that cannot be out in the sun anymore because of Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: AUTOIMMUNE DISORDER (medically significant), PHOTOSENSITIVITY REACTION (medically significant), outcome "unknown" and all described as "a friend did Pfizer and now has a skin condition, an autoimmune problem, that cannot be out in the sun anymore because of Pfizer.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Basal cell" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid treatment (start date: 31Mar2023 and stop date: 04Apr2023). Other medication in 2weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known Allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral Paxlovid for the treatment of Covid-19 which started on 03Apr2023 and stopped on 07Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, 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). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 30 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0162), on 06May2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757) for covid-19 immunisation. The patient's relevant medical history included: "undifferentiated connective tissue disease (that's why I take plaquenil)" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] taken for undifferentiated connective tissue disease, start date: 01Jan2022, stop date: 04Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests: Body temperature: (13Apr2023) 99.9; SARS-CoV-2 test: (04Apr2023) Positive, notes: Initial positive test: April 4 in the morning; (10Apr2023) Negative, notes: morning of 10Apr and morning of 11Apr; (11Apr2023) Negative, notes: morning of 10Apr and morning of 11Apr; (13Apr2023) Positive, notes: Positive test (rebound). Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID rebound. Initial positive test: 04Apr2023 in the morning. Paxlovid: 04Apr2023 evening until morning of 09Apr2023 (lot number: GG4908). During this time, patient did not take his normal Plaquenil, per guidance from his PCP. He restarted Plaquenil a few days after finishing his Paxlovid course. Negative tests: morning of 10Apr2023 and morning of 11Apr2023. Positive test (rebound): evening of 13Apr2023. Symptoms: very running nose (gross), exhaustion (he got really tired grating a carrot. The carrot was not that good), slightly elevated temp (99.9).  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, SARS-CoV-2 test
Clinical narrative: COVID-19 positive after receiving Pfizer COVID-19 Vaccinations; COVID-19 positive after receiving Pfizer COVID-19 Vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ3275) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart issue" (unspecified if ongoing), notes: he's a heart patient; "immunocompromised" (unspecified if ongoing), notes: she is immunocompromised. 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 positive after receiving Pfizer COVID-19 Vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: back in Dec (date incomplete); Negative, notes: Tested negative after a couple days. Therapeutic measures were 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.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "DMEK corneal transplant" (unspecified if ongoing), notes: resulting from a diagnosis of Fuchs Dystrophy; "Fuchs Dystrophy" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 03Apr2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient tested negative on days 6 and 7 from the date he started 5 day course on Paxlovid. During the time he used Paxlovid, he was symptom-free from COVID except for an afternoon on the 3rd day when he felt fatigued. Today is day 13 from the date of symptom onset and the only symptom the patient currently has is a cough and some mild upper respiratory congestion.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She got COVID; She got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 6 (booster), single (Lot number: GJ3275) at the age of 70 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN5318), in arm, on 25Mar2021 as dose 2, single (Lot number: EN6199), in arm, on 03Sep2021 as dose 3 (booster), single (Lot number: FC3182), in arm, on 17Mar2022 as dose 4 (booster), single (Lot number: FK9895), in arm and on 17Aug2022 as dose 5 (booster), single (Lot number: FP7150), in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: 1983 (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "heart patient" (unspecified if ongoing); "cough" (unspecified if ongoing); "got three replacement joints" (unspecified if ongoing); "surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Apr2023, outcome "unknown" and all described as "She got COVID". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 4ft 11in, notes: Lost a couple of inches stating 4ft 11in is probably correct; Body temperature: (unspecified date) 100, notes: she got a low grade fever of 100-100.1; (unspecified date) 100.1, notes: she got a low grade fever of 100-100.1; SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative after a couple days; (11Apr2023) Positive, notes: She was positive for COVID again on 11Apr2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Symptoms started evening of 10Apr2023. First day she could go out with the mask on was 10Apr2023 and she felt a little bit of symptoms that night. She was positive for COVID again on 11Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157613 Same product and event, different patient;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: I began having electric shocks all over my body so my Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 17:00 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Since that time I have also been diagnosed with PsA, Fibromyalgia" (unspecified if ongoing); "Since that time I have also been diagnosed with PsA, Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; LISINOPRIL; LANSOPRAZOLE; OXYBUTIN. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6200, Vaccine Administration Time: 05:00 PM), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: SMALL FIBRE NEUROPATHY (disability) with onset 30Apr2021 at 13:00, outcome "not recovered", described as "I began having electric shocks all over my body so my Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy". The event "i began having electric shocks all over my body so my dr did skin biopsy because she believed i have small nerve fiber neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: (30Apr2021) Positive, notes: Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy. Both locations came back positive; SARS-CoV-2 test: (05Jan2022) Positive. Therapeutic measures were taken as a result of small fibre neuropathy.Clinical course: Patient took daily medicines for the symptoms caused. Patient began having electric shocks all over her body so her Dr did skin biopsy because she believed she had Small nerve Fiber Neuropathy. Both locations came back positive. she began having numbness and pins and needles.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I began having electric shocks all over my body so my Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 17:00 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Since that time I have also been diagnosed with PsA, Fibromyalgia" (unspecified if ongoing); "Since that time I have also been diagnosed with PsA, Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; LISINOPRIL; LANSOPRAZOLE; OXYBUTIN. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6200, Vaccine Administration Time: 05:00 PM), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: SMALL FIBRE NEUROPATHY (disability) with onset 30Apr2021 at 13:00, outcome "not recovered", described as "I began having electric shocks all over my body so my Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy". The event "i began having electric shocks all over my body so my dr did skin biopsy because she believed i have small nerve fiber neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: (30Apr2021) Positive, notes: Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy. Both locations came back positive; SARS-CoV-2 test: (05Jan2022) Positive. Therapeutic measures were taken as a result of small fibre neuropathy.Clinical course: Patient took daily medicines for the symptoms caused. Patient began having electric shocks all over her body so her Dr did skin biopsy because she believed she had Small nerve Fiber Neuropathy. Both locations came back positive. she began having numbness and pins and needles.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Factor VIII inhibition
Clinical narrative: Developed a factor VIII inhibitor; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FN2908) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "MI with stent" (unspecified if ongoing); "CKD" (unspecified if ongoing); "gout" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "MI with stent" (unspecified if ongoing), notes: MI with stent. Concomitant medication(s) included: ALLOPURINOL; NORVASC; LIPITOR; JARDIANCE; COZAAR; METOPROLOL; OXYBUTIN. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, is bivalent=False, lot number=EW0161, lot unknown=False, administrator route=Intramuscular, dose number=1), for Covid-19 immunization; Bnt16b2 (product=Pfizer, Other vaccine same date lot number=EW0172, dose number=2), for Covid-19 immunization; Bnt16b2 (product=Pfizer, Other vaccine same date lot number=FE3594,  dose number=3), for Covid-19 immunization. The following information was reported: FACTOR VIII INHIBITION (hospitalization, medically significant, life threatening) with onset 08Jul2022, outcome "recovering", described as "Developed a factor VIII inhibitor". The patient was hospitalized for factor viii inhibition (hospitalization duration: 14 day(s)). The event "developed a factor viii inhibitor" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of factor viii inhibition. Clinical course: The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested COVID post vaccination. The patient had none known allergies. Other vaccine same date dose number=4. Adverse event resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Adverse event treatment: FEIBA, DDAVP, Advate, high dose steroids IV.; Sender's Comments: Based on the information provided, a causal relationship between suspect drug BNT162b2 and the reported event Factor VIII inhibition cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: CT contrast" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing); "HBP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient treated with Paxlovid with start date as 30Mar2023 and stop date as 04Apr2023.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna and Pfizer vaccines administered-dose number unknown; Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old 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), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna and Pfizer vaccines administered-dose number unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: COVID rebound after testing negative for four straight days; (Apr2023) Negative; (Apr2023) Negative; (Apr2023) Negative, notes: COVID rebound after testing negative for four straight days including a negative PCR test on day 3. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157745 same patient/product, different dose/event;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 20Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 13Aug2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 11Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Marginal zone lymphoma" (unspecified if ongoing); "levaquin Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; NORTRIPTYLINE; LATANOPROST; RHOPRESSA; TIMOLOL. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157708 same reporter/patient, different drug/event;
Sex: M
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: Made him incredibly sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 83-year-old 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 included: "Unspecified types of Non-Hodgkin Lymphoma" (ongoing). Concomitant medication(s) included: IMBRUVICA taken for non-hodgkin's lymphoma (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ILLNESS (hospitalization), outcome "recovered", described as "Made him incredibly sick". Therapeutic measures were taken as a result of illness. Clinical course: Reporter (patient care coordinator) reported as adverse event based on a conversation he had with his patient. Caller called regarding Imbruvica shipment but patient mentioned that he had Pfizer COVID-19 Booster shot and that made him incredibly sick, and he would not like to take any more Booster shots from Pfizer. Patient was discharged on an unknown date from hospital.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: 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) all with onset Apr2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Apr2023 to 11Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: After two negative Ag tests 48 hours apart; (Apr2023) Negative, notes: After two negative Ag tests 48 hours apart; (15Apr2023) Positive, notes: tested positive again; (2023) Positive, notes: symptoms plus positive Ag tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient took the full Paxlovid treatment after first COVID infection (symptoms plus positive Ag tests) from 05Apr2023 to 10Apr2023. Then the patient had two negative Ag tests 48 hours apart.  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-202300157934 Same patient, different product;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 013M20A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 012A21A), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: 069F21A), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: Turkey" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: May1997; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2000; LIPITOR, start date: Jan2000, stop date: 27Feb2023; PROZAC, start date: Apr2000; FLONASE [FLUTICASONE PROPIONATE], start date: May2004; LOPRESSOR, start date: May2009; THORNE, start date: May2011; BREO ELLIPTA, start date: Mar2012; COZAAR, start date: Feb2014; SINGULAIR, start date: Jan2015. Past drug history included: Septra, reaction(s): "Allergy", notes: known allergies: Septra; Bactrim, reaction(s): "Allergy", notes: known allergies: Bactrim. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Patient took Paxlovid from 28Feb2023 to 04Mar2023 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157746 same reporter/patient, different drug/event;
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 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: "Hypertrophic cardiomyopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Floroquinolones, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157983 same patient, different drug and AE.;
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).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: could not take meds. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The 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-202300158016 Same patient/reporter, different dose/events;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "gall stones" (unspecified if ongoing); "Known allergies: 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as COVID 19 Treatment from 01Apr2023 to 06Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300158076 same patient, different drug/event;
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID_test_result=Positive/15Apr2023; COVID_test_result=Positive/15Apr2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Dec2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020) intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: 031A21A), in left arm and on 23Apr2021 as dose 2, single (Lot number: 039B21A), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2023, outcome "unknown" and all described as "COVID_test_result=Positive/15Apr2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) Positive, notes: Nasal Swab.  Clinical information: No other vaccine in four weeks. No other medications in two weeks. The patient experienced sore throat and body aches on 15Apr2023 12:30 am. AE resulted in emergency room/department or urgent care. Outcome of the events was recovering. No treatment received. COVID prior vaccination: No. COVID tested post vaccination: yes.