chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose number unknown, single (Lot number: el9267), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that the patient did not have known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose number unknown, single (Lot number: el9267), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that the patient did not have known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. Follow-up attempts are completed. No further information is expected.
Sex: F
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired PROQUAD administered.; Dose: 0.5 ml IM; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 18-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) dose of 0.5 mL, lot number: T032148 was confirmed to be valid, expiration date: 20-MAR-2022, administered intramuscularly (anatomical location was not reported) for prophylaxis (expired product administered, incorrect route of product administration). The vaccine was reconstituted with sterile diluent (STERILE DILUENT), dose of 0.5 mL, lot number: U008044, expiration date: 06-JUL-2023. No additional information was provided. No additional adverse events (AEs) or product quality complaints (PQC) reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other issues or concerns noted.; Patient was giving PROQUAD on April 18, 2022 and the patient had already had doses of MMRII and VARIVAX.; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On unknown dates, the patient was vaccinated with doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (strengths, doses, dose numbers, formulations, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for both) for prophylaxis.  On 18-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) lot number: U039957, expiration date: 14-JUN-2023 (dose, strength, formulation, route of administration and anatomical location were not reported) for prophylaxis (extra dose administered). No other issues or concerns were noted (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox, shingles (Family History) (oldest sister had recurring shingles 3 times in her adult life) and chickenpox (Family History).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that Day 7 and last night before reporting had to be the worst for pain. The patient found out a day before reporting that her oldest sister had recurring shingles 3 times in her adult life. The patient had chickenpox when she was quite young. The patient went and got the 1 time 2 doses shingles shot years ago and had shingles, the patient never thought she would have to deal with shingles. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick for a week; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-APR-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient got the single shot and was sick for a week Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have the shingles shots,but I just got them again/suspected vaccination failure; just got them again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (several years before the date of reporting).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-APR-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received the Shingles shots, but the patient just got them (shingles) again. According to the patient's doctor, it could had been worse if the patient had not got the shingles shots. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for herpes zoster were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Infanrix; Patient receiving Boostrix, 2 years old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: The advisory service reported that a patient received dose of Boostrix vaccine instead of Infanrix. The HCP (health care professional) stated another advisory service reported the AE (adverse event), so did not provide any information about the situation, only wanted to know how to proceed.  Additional Supportive Information: The health care professional reported that a patient received Boostrix vaccine instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. Follow up was not asked to HCP (health care professional). This case is linked with case US2022068741 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068741:Same reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech; Pain in the arm for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech) and PAIN IN EXTREMITY (Pain in the arm for couple of days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 031B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (drug induced), Pneumonia (he was overdosed with antibiotics and had Pneumonia 5 times in last 10 years), Drug overdose (Antibiotics overdose), Drug overdose (Pharmaceutical products overdose) and Prostate surgery. Concurrent medical conditions included Gout, Hypertension, Immunocompromised and Grover's disease. Concomitant products included FEBUXOSTAT (ULORIC) for Gout, LOSARTAN and AMLODIPINE for Hypertension, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Prostate surgery.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech) and PAIN IN EXTREMITY (Pain in the arm for couple of days). At the time of the report, TINNITUS (The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech) had not resolved and PAIN IN EXTREMITY (Pain in the arm for couple of days) had resolved.            The patient was immunocompromised which qualified him for 3rd dose. Patient stated many years ago he was overdosed with antibiotics and had Pneumonia 5 times in last 10 years, which made him immunocompromised. Patient reported that 15 years ago he was in surgery, where they overdosed him with pharmaceutical products which caused tinnitus. He states tinnitus was drug induced. But after the 3rd dose, the volume of tinnitus tripled and the pitch has changed from annoying screaming to high pitch screech.  Treatment information was not reported.   This case was linked to MOD-2022-550540 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022; Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 031A21A and 039A21A) for COVID-19 vaccination.     Patient was not allergic to medications, food and other products. It was unknown whether the patient ever had COVID + test or diagnosis. Acute and Chronic illnesses at the time of vaccination was reported as not applicable.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022/Date(s) of administration of vaccine: 25Apr2022) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator: 25Apr2022/ Date(s) of administration of vaccine: 25Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was initially stored in the refrigerator on 25 Apr 2022. The vial did not  undergo any temperature excursions.   This case was linked to MOD-2022-551003 (Patient Link).; Sender's Comments:  :MOD-2022-551003 Patient 2
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient feels hands really swollen after receiving the Moderna booster; Patient feels hands really achy after receiving the Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Patient feels hands really swollen after receiving the Moderna booster) and PAIN IN EXTREMITY (Patient feels hands really achy after receiving the Moderna booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     The patient never had any COVID-19 test or diagnosis previously.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy, Drug allergy (Morphine allergy), Drug allergy (Fentanyl allergy), Drug allergy (Bactrim allergy) and Arthritis (many years ago, before vaccines). Concomitant products included LOSARTAN for Blood pressure, OMEPRAZOLE for Prophylaxis, METOPROLOL, METAXALONE and HYDROCODONE for an unknown indication.    On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2022, the patient experienced PERIPHERAL SWELLING (Patient feels hands really swollen after receiving the Moderna booster) and PAIN IN EXTREMITY (Patient feels hands really achy after receiving the Moderna booster). At the time of the report, PERIPHERAL SWELLING (Patient feels hands really swollen after receiving the Moderna booster) and PAIN IN EXTREMITY (Patient feels hands really achy after receiving the Moderna booster) outcome was unknown.            It was reported that patient received Pfizer for the primary series and Moderna COVID-19 vaccine for the booster dose.  Concomitant drug Omeprazole was used for protect stomach and Losartan for maintained blood pressure.  After two days of Moderna vaccine patient experienced hands really achy and swollen.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Suspected COVID-19
Clinical narrative: received the vaccine (did not specify the manufacturer) and got sick git COVID; got sick git COVID after that; she is really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "received the vaccine (did not specify the manufacturer) and got sick git COVID"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "got sick git COVID after that"; ILLNESS (non-serious), outcome "unknown", described as "she is really sick".  Clinical information included as During the call patient mentioned that her girlfriend (70 years) received the vaccine (did not specify the manufacturer) and got sick git COVID after that and patient is really sick.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Regulatory Authority report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); agency report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immuno compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "agency report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". Therapeutic measures were taken as a result of suspected covid-19. Patient received treatment with Paxloid for Covid 19, treatment start date, stop date: 22Apr2022 via oral route. Other medication in 2 weeks: Unknown. Adverse event: Wonderful result. Within two hours the patient's symptoms began to subside, and she was able to perform activities impossible hours before (as reported). Adverse event start date: 22Apr2022 (as reported). Adverse event start time: 02:30 PM (as reported). If treatment ae: No (as reported). Known allergies: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF3590) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing); "Allergy: Scallops" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jul2002 (ongoing); DICLOFENAC, start date: Jul2021 (ongoing); ALIGN, start date: Sep2020 (ongoing). 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient received Anti-viral treatment product COVID 19 Treatment, treatment start date on 19Apr2022, treatment stop date on Apr2022, lot number FR7229, indication Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Swelling
Clinical narrative: Experienced light fever; Left arm pit is still swollen and puffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer) for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset Apr2022, outcome "not recovered", described as "Left arm pit is still swollen and puffy"; PYREXIA (non-serious) with onset 22Apr2022, outcome "recovered" (2022), described as "Experienced light fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller received the booster dose Pfizer COVID 19 Vaccine on Thursday, 21Apr2022, The caller experienced a light fever on Friday, 22Apr2022. The light fever went away. The caller's left arm pit is still swollen and puffy. The caller is assuming the left arm pit being swollen and puffy is a lymph node. The caller read on the Pfizer website that it would take 24-48 hours for the swollen armpit to go away. However, the caller's left armpit is still swollen. The caller would like advice or to know when the left armpit swelling will go away?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral palsy, Cerebrovascular accident, Visual impairment
Clinical narrative: stroke; cerebral palsy; low vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "deaf" (unspecified if ongoing), notes: Caller is deaf, and using a speech relay service. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; CEREBRAL PALSY (medically significant), outcome "unknown"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "low vision".  Clinical course: Caller is deaf, and using a speech relay service, she had a massive stroke, she had the first dose of the Pfizer vaccine sometime in mid of Feb2022, she would like to know if she could still take the 2nd dose or had to start over. She had Cerebral Palsy as well and low vision.  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: Myocardial infarction, Swelling, Vitreous floaters
Clinical narrative: heart attack- like symptoms; Diagnosis was severe reaction to the shot which later led to vision problems such as floaters, swelling etc.; Diagnosis was severe reaction to the shot which later led to vision problems such as floaters, swelling etc.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 27-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. If other vaccine in four weeks and other medications in two weeks were reported as unknown. If covid prior vaccination Unknown. If covid tested post vaccination Unknown. Known allergies unknown. Other medical history unknown. Facility type vaccine Pharmacy or Drug Store. The following information was reported: VITREOUS FLOATERS (hospitalization, disability), SWELLING (hospitalization, disability) all with onset May2021, outcome "not recovered" and all described as "Diagnosis was severe reaction to the shot which later led to vision problems such as floaters, swelling etc."; MYOCARDIAL INFARCTION (hospitalization, disability, medically significant) with onset May2021, outcome "not recovered", described as "heart attack- like symptoms". The events "heart attack- like symptoms" and "diagnosis was severe reaction to the shot which later led to vision problems such as floaters, swelling etc." required emergency room visit. It was unknown if therapeutic measures were taken as a result of myocardial infarction, vitreous floaters, swelling. It was reported that, adverse event the family lives in (place withheld) and the son received the vaccine from (name withheld) in (place withheld) last year and then proceeded to have heart attack- like symptoms. The father was summoned and took his son to the hospital. Diagnosis was severe reaction to the shot which later led to vision problems such as floaters, swelling etc. The hospital people were perplexed and not really sure why this happened and could only attend to symptoms. The son lives with the parents and is not able to work and still has symptoms. Adverse event resulted in [Emergency room/department or urgent care, Disability or permanent damage]. If treatment adverse events unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: deathly sick from the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent (patient's mother).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "deathly sick from the booster".  Additional information: Reporter was the mother of the patient. Reporter was stated that her daughter was deathly sick from the booster and she was on the Pfizer vaccine and reporter was asked for patient information, lots, expiry dates, NDC numbers and dates of her daughter's Pfizer Covid vaccines and declined and states she has none of that information to provide.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Palpitations, Paraesthesia, Presyncope
Clinical narrative: light headed; palpitations; tingling/numbing in both legs and arms; tingling/numbing in both legs and arms; a near syncope episodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Lot number: EW0185) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peniccilin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed"; PALPITATIONS (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "tingling/numbing in both legs and arms"; PRESYNCOPE (non-serious), outcome "unknown", described as "a near syncope episodes". The events "light headed", "palpitations", "tingling/numbing in both legs and arms" and "a near syncope episodes" required physician office visit and emergency room visit.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Patient was put on steriods and nerve meds. No covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Compulsive lip biting, Dysarthria
Clinical narrative: Lip-chewing; slurring; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PYRIDOSTIGMINE; PREDNISONE; AZITHROMYCIN [AZITHROMYCIN DIHYDRATE]. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary immunization, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary immunization, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (1st booster , manufacturer unknown), for COVID-19 immunization. The following information was reported: COMPULSIVE LIP BITING (non-serious), outcome "unknown", described as "Lip-chewing"; DYSARTHRIA (non-serious), outcome "unknown", described as "slurring". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, Drug ineffective, Fatigue
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Congestion; Aches; Coughing; Fatigue; lost her sense of taste; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19"; SINUS CONGESTION (non-serious), outcome "unknown", described as "Congestion"; PAIN (non-serious), outcome "unknown", described as "Aches"; COUGH (non-serious), outcome "unknown", described as "Coughing"; FATIGUE (non-serious), outcome "unknown"; AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19.  Clinical Information: Reporter stated he learned 24Apr2022 that his friend, F50, tested positive for COVID-19. The patient symptoms included congestion, fatigue, aches, coughing. She had received the Pfizer vaccine and booster (27Feb2021, 20Mar2021 and 26Oct2021).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Congestion; Aches; Coughing; Fatigue; lost her sense of taste; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19"; SINUS CONGESTION (non-serious), outcome "unknown", described as "Congestion"; PAIN (non-serious), outcome "unknown", described as "Aches"; COUGH (non-serious), outcome "unknown", described as "Coughing"; FATIGUE (non-serious), outcome "unknown"; AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19.  Clinical Information: Reporter stated he learned 24Apr2022 that his friend, F50, tested positive for COVID-19. The patient symptoms included congestion, fatigue, aches, coughing. She had received the Pfizer vaccine and booster (27Feb2021, 20Mar2021 and 26Oct2021).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Accident, Ecchymosis, Hand fracture, Limb discomfort
Clinical narrative: Second booster of Covid: Terrible accident; Second booster of Covid: Right leg not being right; black and blue marks; Second booster of Covid: Fractured thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN, First booster), for COVID-19 Immunization. The following information was reported: ACCIDENT (non-serious) with onset 07Apr2022, outcome "unknown", described as "Second booster of Covid: Terrible accident"; HAND FRACTURE (medically significant) with onset Apr2022, outcome "unknown", described as "Second booster of Covid: Fractured thumb"; LIMB DISCOMFORT (non-serious) with onset Apr2022, outcome "unknown", described as "Second booster of Covid: Right leg not being right"; ECCHYMOSIS (non-serious) with onset Apr2022, outcome "unknown", described as "black and blue marks". The clinical course was reported as that the Ibrance and Faslodex are the 2 things keeping her alive. If not for the effect of the second booster of COVID which were all Pfizer, all her medicine has been Pfizer, she wouldn't have been in the terrible accident she had on 07Apr, she is lucky with all the black and blue marks and her right leg not being right, fractured thumb. This Pfizer program situation has her aggravated and anxious every time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: First dose: Chills; First dose: nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 09:00 as dose 1, single (Lot number: EN6202) at the age of 74 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Triple Bypass", start date: 04Oct2014 (unspecified if ongoing), notes: Triple Bypass He was on a ventilator relative to this.; "COVID", start date: Jan2021 (unspecified if ongoing), notes: COVID Before the first shot he had COVID, a mild case, no fever, no cough. His wife had it a long time long hauler lost her sense of smell for a time.; "blood pressure" (unspecified if ongoing), notes: blood pressure medication Furosemide; "cancer" (unspecified if ongoing), notes: his mother died at 45 from cancer, father had cancer (family medical history). Concomitant medication(s) included: FUROSEMIDE taken for blood pressure abnormal. Vaccination history included: Gamma globulin (Manufacturer/Lot/NDC/Expiry: Unknown, caller did not have this information to provide., Adverse Event: Quite a reaction), administration date: 1968, reaction(s): "Quite a reaction"; Cholera (Manufacturer/Lot/NDC/Expiry: Unknown, caller did not have this information to provide., Adverse Event: Reaction), reaction(s): "Reaction"; Yellow fever (Manufacturer/Lot/NDC/Expiry: Unknown, caller did not have this information to provide.). The following information was reported: CHILLS (non-serious) with onset 27Feb2021 at 01:00, outcome "recovered" (27Feb2021), described as "First dose: Chills"; NAUSEA (non-serious) with onset 27Feb2021 at 01:00, outcome "recovered" (27Feb2021), described as "First dose: nausea".
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext; numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext; had some diziness; first dose on 29Jul2021, 2nd dose on 01Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2022 as dose 2, single (Lot number: FM0698) at the age of 42 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand=PZIFER, prev dose brand unknown=False, prev dose lot number=EW0185, prev dose lot unknown=False, prev dose administration date=29Jul2021 , prev dose number=1), administration date: 29Jul2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "LIGHT HEADED", "PALPITATIONS", "Tingling/numbing in both legs and arms", "Syncope Episodes". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Mar2022, outcome "unknown", described as "first dose on 29Jul2021, 2nd dose on 01Mar2022"; DIZZINESS (non-serious) with onset 03Mar2022 at 08:00, outcome "not recovered", described as "had some diziness"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 03Mar2022 at 08:00, outcome "not recovered" and all described as "numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext". The events "numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext" and "had some diziness" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness.  Additional information: If other vaccine in four weeks: No. Other medications in two weeks: No. If covid prior vaccine: No. If covid tested post vaccination: no. First vaccine patient experienced light headed, palpitations, tingling/numbing in both legs and arms and a near syncope episodes, second vax developed numbness/tingling burning sensation that started on feet that gradually spread to upper ext/ had some dizziness. Patient was put on steroids and nerve meds.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm soreness at the injection site; redness at the injection site; mild headache; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (ongoing), notes: Hyperlipidemia, Did not have symptoms just had bloodwork that diagnosed this.; "Uveitis", start date: 2020 (ongoing), notes: Uveitis, Onset date about 2 years ago. Uveitis relapse on day 4 of this last reaction, around 19Apr2022.; "Lupus" (ongoing), notes: Lupus Onset date: Probably had all her life, but started having complications about 5 years ago; "It asks are you allergic to gelatin and she is if it is bovine" (unspecified if ongoing), notes: It asks are you allergic to gelatin and she is if it is bovine. Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for lupus-like syndrome, start date: 2017; ZETIA taken for hyperlipidaemia; PREDNISOLONE taken for uveitis, start date: 2020. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Dec2020 at 12:00, outcome "recovered" (25Dec2020), described as "arm soreness at the injection site"; HEADACHE (non-serious) with onset 23Dec2020 at 12:00, outcome "recovered" (25Dec2020), described as "mild headache"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Dec2020 at 12:00, outcome "recovered" (25Dec2020), described as "redness at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that with the first dose she experienced arm soreness at the injection site, redness at the injection site, and may have had a mild headache; all of which started about 24 hours after first dose was administered. She had recovered completely after about 1.5 days after onset of these events. Prior Vaccinations patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via agency.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 as dose 3 (booster), single (Lot number: FK9729) 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: moderna (Dose Number: 2, Batch/Lot No: 076C2117, Manufacturer: Moderna), administration date: 23Sep2021, when the patient was 68-year-old, for Covid-19 Immunization; moderna (Dose Number: 1, Batch/Lot No: 939906, Manufacturer: Moderna), administration date: 26Aug2021, when the patient was 68-year-old, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19".  Clinical information: If vaccine received: Yes. Known allergies and other medical history were unknown. Other medication in 2 weeks were unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 31Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "IBS" (unspecified if ongoing); "long standing anxiety disorder" (unspecified if ongoing); "Sulfa based medications" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for depression, start date: Aug2019; FIBER; PROBIOTICS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. Additional information: Paxlovid (Lot number- FX2740) Antiviral medication in 2weeks for COVID 19 Treatment from 22Apr2022 to 24Apr2022   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.