chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fatigue; Chills; Body Aches; Fever; Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Oct2021 08:30 (Lot number: EN0217) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2 at 15:30 PM, Batch/Lot No: ER5734, Intramuscular in Arm Left), administration date: 07Apr2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1 at 16:30 PM, Batch/Lot No: EN6207, Intramuscular in Arm Left), administration date: 17Mar2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Fatigue"; CHILLS (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Chills"; PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Body Aches"; PYREXIA (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered" (Oct2021), described as "Injection site pain". Therapeutic measures were not taken as a result of fatigue, chills, pain, pyrexia, vaccination site pain.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. Concomitant drugs reported as None, Relevant test were None.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: After her third dose of the COVID-19 Vaccine, she got a fever; not doing well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing), notes: had cancer. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "After her third dose of the COVID-19 Vaccine, she got a fever"; MALAISE (non-serious), outcome "unknown", described as "not doing well".  Additional information: Patient had cancer, she is not in remission and is active. After her third dose of the COVID-19 Vaccine, she got a fever. Reporter was not sure if it's cancer related stuff, also reported that patient was not doing well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: He had fever; Tired; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd), for Covid-19 immunization; Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "He had fever"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: Optional Information:Tired and arm soreness after receiving the booster shot. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever; Body aches; Headache; Chills; 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 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Dec2020 (Lot number: EJ1685, Expiration Date: Mar2021) at the age of 39 years as dose 1, single and administration date 07Jan2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE taken for addison's disease (ongoing); FLUDROCORTISONE taken for addison's disease (ongoing). The following information was reported: PYREXIA (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Low grade fever"; PAIN (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Body aches"; HEADACHE (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Headache"; CHILLS (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Chills".  Additional information: After first dose patient experienced body aches, headache, chills and low grade fever from 19Dec2020 to 20Dec2020. After second dose patient experienced body aches, headache, chills and low grade fever from 08Jan2021 to 09Jan2021. Patient states that she is considered a healthcare professional since she is a registered dietician at a hospital, populated caller as consumer since she does not fit criteria for HCP. Patients other two vaccines she had the normal side effects like body aches, headache, chills and low grade fever. Everything went away in 24 hours, and it was no biggie. She thought that she just had a strong immune system. Her first dose was 18Dec2020 and the side effects started 19Dec2020 and ended 20Dec2020. She had her 2nd dose on 07Jan2021, and the side effects started on 08Jan2021 and then they were gone on 09Jan021. She had her first two at her work and then her third dose she got it at a local grocery store chain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: chills; 97 Fever; aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 10:00 (Lot number: EN6198) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), administration date 12Sep2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Osteoporosis", start date: 2001 (ongoing); "Arthritis" (ongoing); "High cholesterol" (ongoing); "Hypothyroidism" (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased, start date: 2005 (ongoing); LEVOTHYROXIN taken for hypothyroidism, start date: 2005 (ongoing); VITAMIN D2, start date: Jun2021 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: 11 , Anatomical site of injection; Left arm, Batch/Lot no: EN9200), administration date: 20Feb2021, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Sep2021 12:30, outcome "recovered" (14Sep2021), described as "97 Fever"; PAIN (non-serious) with onset 13Sep2021 11:30, outcome "recovered" (14Sep2021), described as "aches and pains"; CHILLS (non-serious) with onset 13Sep2021 13:00, outcome "recovered" (2021), described as "chills". The patient underwent the following laboratory tests and procedures: body temperature: (13Sep2021) 97. Therapeutic measures were taken as a result of pyrexia, pain. Therapeutic measures were not taken as a result of chills.   Additional information: The patient received Tylenol medication for the event pyrexia and pain .    No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Illness, Nasal congestion
Clinical narrative: fever; headaches; body aches; sore throat; cough; congestion; runny nose; fatigue; illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: el3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVAIR. Vaccination history included: Bnt162b2 (Dose Number:01, Pev dose lot number : el3247, Prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "headaches"; PAIN (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "body aches"; OROPHARYNGEAL PAIN (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "sore throat"; COUGH (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "congestion"; RHINORRHOEA (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "runny nose"; FATIGUE (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "fatigue"; ILLNESS (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "illness". The events "fever", "headaches", "body aches", "sore throat", "cough", "congestion", "runny nose", "fatigue" and "illness" were evaluated at the physician office visit.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination.Since the vaccination the patient has not been tested for Covid-19. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Device Date : 08Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: fever; headaches; body aches; sore throat; cough; congestion; runny nose; fatigue; illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: el3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVAIR. Vaccination history included: Bnt162b2 (Dose Number:01, Pev dose lot number : el3247, Prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "headaches"; PAIN (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "body aches"; OROPHARYNGEAL PAIN (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "sore throat"; COUGH (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "congestion"; RHINORRHOEA (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "runny nose"; FATIGUE (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "fatigue"; ILLNESS (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "illness". The events "fever", "headaches", "body aches", "sore throat", "cough", "congestion", "runny nose", "fatigue" and "illness" were evaluated at the physician office visit.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination.Since the vaccination the patient has not been tested for Covid-19. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Device Date : 08Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Malaise, Muscle fatigue, Myalgia
Clinical narrative: Fever; malaise; muscle fatigue; muscle fatigue and pain; joint pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (COMIRNATY, solution for injection), administered in arm left, administration date 05Nov2021 (Lot number: EW0217) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ZYRTEC ALLERGY; LEXAPRO. Vaccination history included: Comirnaty (Product: COVID 19, Brand: Comirnaty, Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Left Arm), administration date: 17Feb2021, when the patient was 28 years old, for COVID-19 Immunization; Comirnaty (Product: COVID 19, Brand: Comirnaty, Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Left Arm), administration date: 27Jan2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021, outcome "recovering", described as "Fever"; MALAISE (non-serious) with onset 06Nov2021, outcome "recovering", described as "malaise"; MUSCLE FATIGUE (non-serious) with onset 06Nov2021, outcome "recovering", described as "muscle fatigue"; MYALGIA (non-serious) with onset 06Nov2021, outcome "recovering", described as "muscle fatigue and pain"; ARTHRALGIA (non-serious) with onset 06Nov2021, outcome "recovering", described as "joint pain"; LYMPHADENOPATHY (non-serious) with onset 06Nov2021, outcome "recovering", described as "swollen lymph nodes". Therapeutic measures were taken as a result of pyrexia.  Additional information: patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. As a treatment patient took ibuprofen for the fever. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; malaise; muscle fatigue; muscle fatigue and pain; joint pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (COMIRNATY, solution for injection), administered in arm left, administration date 05Nov2021 (Lot number: EW0217) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ZYRTEC ALLERGY; LEXAPRO. Vaccination history included: Comirnaty (Product: COVID 19, Brand: Comirnaty, Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Left Arm), administration date: 17Feb2021, when the patient was 28 years old, for COVID-19 Immunization; Comirnaty (Product: COVID 19, Brand: Comirnaty, Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Left Arm), administration date: 27Jan2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021, outcome "recovering", described as "Fever"; MALAISE (non-serious) with onset 06Nov2021, outcome "recovering", described as "malaise"; MUSCLE FATIGUE (non-serious) with onset 06Nov2021, outcome "recovering", described as "muscle fatigue"; MYALGIA (non-serious) with onset 06Nov2021, outcome "recovering", described as "muscle fatigue and pain"; ARTHRALGIA (non-serious) with onset 06Nov2021, outcome "recovering", described as "joint pain"; LYMPHADENOPATHY (non-serious) with onset 06Nov2021, outcome "recovering", described as "swollen lymph nodes". Therapeutic measures were taken as a result of pyrexia.  Additional information: patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. As a treatment patient took ibuprofen for the fever. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported, no further information provided; the patient was vaccinated expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II); This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 02-FEB-2021, the patient was vaccinated expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Lot# T003385 and expiration date 28-JAN-2022) (frequency were not reported) as prophylaxis. (Expired product administered). The vaccine not have any temperature excursion. No additional adverse event reported, no further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Dizziness, Ear discomfort, Hypoacusis
Clinical narrative: acute viral sensorineural hearing loss of left ear; acute viral sensorineural hearing loss of left ear; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 16-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden onset of decreased hearing in left ear with tinnitus, ear fullness, minimal dizziness and occasional pulsating-like sensation and was diagnosed with acute viral sensorineural hearing loss of left ear (deafness neurosensory, viral infection). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events acute viral sensorineural hearing loss of left ear was considered as not recovered. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events acute viral sensorineural hearing loss of left ear to be disability. Upon internal review, deafness neurosensory was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss, Tinnitus, Viral infection
Clinical narrative: acute viral sensorineural hearing loss of left ear; acute viral sensorineural hearing loss of left ear; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 16-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden onset of decreased hearing in left ear with tinnitus, ear fullness, minimal dizziness and occasional pulsating-like sensation and was diagnosed with acute viral sensorineural hearing loss of left ear (deafness neurosensory, viral infection). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events acute viral sensorineural hearing loss of left ear was considered as not recovered. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events acute viral sensorineural hearing loss of left ear to be disability. Upon internal review, deafness neurosensory was determined to be medically significant.
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered Bexsero instead of Menactra; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a female patient who received Men B NVS (Bexsero) (batch number ABxb58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that a patient was inadvertently administered Bexsero instead of Menactra, which led to wrong vaccine administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was sick of corona for four days (suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 1). Patient stated, "I've been sick of corona for four days you have scammed me JNJ pfizer". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported (dose number in series 1). The patient additionally received BNT 162 (Pfizer vaccine) (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with BNT 162 (dose number in series 2). This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000217345.; Sender's Comments: V0:20220231913-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious. This case, from the same reporter was linked to 20220237069 and 20220236731.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; low fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 16:00 (Lot number: ER8377) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low fever".  Additional information: Patient had vaccination at Pharmacy or Drug store, no prior vaccinations (within 4 weeks) were taken. No relevant tests reported. Events resolved in 3-4 days.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Pyrexia
Clinical narrative: Fever; Ache; under arm ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 23:15 (Lot number: F63527) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN4204, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 23:00, outcome "recovered" (Nov2021), described as "Fever"; PAIN (non-serious) with onset 06Nov2021 23:00, outcome "recovered" (Nov2021), described as "Ache"; AXILLARY PAIN (non-serious) with onset 06Nov2021 23:00, outcome "recovered" (Nov2021), described as "under arm ache". Therapeutic measures were taken as a result of pyrexia, pain, axillary pain.  Additional information: No other medications received in two weeks. No other vaccine received in four weeks. Fever, ache, and under arm ache started after 10h following booster. Treatment received for events was advil. No covid present prior vaccination. Covid was not tested post vaccination. No known allergies. No other medical history was present. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pain, Pyrexia, Swelling
Clinical narrative: Fever; chill; aches; underarm swelling and ache; underarm swelling and ache; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 11:00 (Lot number: F63527) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 21:00, outcome "recovered" (09Nov2021), described as "Fever"; CHILLS (non-serious) with onset 06Nov2021 21:00, outcome "recovered" (09Nov2021), described as "chill"; PAIN (non-serious) with onset 06Nov2021 21:00, outcome "recovered" (10Nov2021), described as "aches"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 06Nov2021 21:00, outcome "recovered" (09Nov2021) and all described as "underarm swelling and ache". Therapeutic measures were taken as a result of pyrexia, chills, pain, swelling, axillary pain.  Additional information:Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not received other medications the patient received within 2 weeks of vaccination Patient received treatment with Advil (took every 6-8 hr) for the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination .no name of the drug and allergic reaction was reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: bit of fever; headache; chills; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An 8-year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "bit of fever"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Experiencing a slight fever/Experiencing like a fever, it is low, it is a 100.4; I am not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FH8088) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Nov2021, outcome "unknown", described as "Experiencing a slight fever/Experiencing like a fever, it is low, it is a 100.4"; MALAISE (non-serious) with onset 10Nov2021, outcome "unknown", described as "I am not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent lab tests and procedures which included Body temperature: 100.4.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  An adult patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller would like to know if after the 2nd dose the patient had a high fever would that be a reason to not get the booster dose.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 15:00 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 12Nov2021 15:00, outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of pyrexia.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: fever; vomiting; nauseua; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 18:00 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "fever"; VOMITING (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "vomiting"; NAUSEA (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "nauseua". Therapeutic measures were not taken as a result of pyrexia, vomiting, nausea.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: fever; headache; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had COVID-19 last fall or earlier this year and was just now getting her first dose of PFIZER COVID-19 vaccine. She had a fever for several days getting to as high as 103.5 for a day, then dropped down. She did missed two days of work and also experienced headache and nausea. Reporter told her that she needed to report her side effects and she agreed but did not want to be contacted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: Fever up to 102F; Swollen lymph nodes in left armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: ff2587) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN. Vaccination history included: Bnt162b2 (Dose Number: 1, product: COVID 19, brand: Pfizer, lot number: ff2589, administration date: 25Oct2021 , vaccine location: Left arm, 1st dose- no sx), administration date: 25Oct2021, when the patient was 25 years old, for covid 19 immunization. The following information was reported: PYREXIA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Fever up to 102F"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021, outcome "recovering", described as "Swollen lymph nodes in left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, lymphadenopathy. Additional information- It was reported that patient administer vaccine at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks and Other medications in two weeks was acetaminophen. Patient did not suffer from covid before vaccination and did not underwent covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: APIXABAN taken for cerebrovascular accident prophylaxis; DILTIAZEM HCL taken for hypertension; LOSARTAN taken for hypertension; HYDROCHLORIDE B1; PREVACID; AMBIEN. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: This patient developed pancreatitis after receiving apixaban therapy. Based on the etiopathogenesis of pancreatitis, the reported event is considered not related to apixaban. Pfizer is a marketing authorization holder of Thiamine HCl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Thiamine HCl has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: mild fever; chills; This is a spontaneous report received from a contactable reporter(s) (Physician) this physician reported for a female (patient).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Oct2021 13:00 (Lot number: 301558A) at the age of 58 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "osteoarthritis" (ongoing); "prediabetes" (ongoing); "Allergic reactions" (ongoing); "hypercholesterolemia" (ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); ALLEGRA taken for hypersensitivity (ongoing). The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills".  Additional Information: Did the patient provide information to you regarding the reported adverse event (s) with the use of the product was reported as yes. If Yes above, do you consider the Pfizer product had a causal effect to the adverse event was reported as yes. Patient received the first single dose of vaccine on 19Oct2021 13:00 as dose 1single Anatomical Site of injection: Left upper arm. The night of the second vaccine she reported she had mild fever and chills which is the same side effects she had after the first dose. Had mild fever, chills, night of vaccine administration. These symptoms will similar to what site had experienced after first dose of Pfizer covid vaccine one month earlier symptoms resolved next day.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Uncontrollable body shake; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "Uncontrollable body shake".  Additional information: The nurse has sent 7 kids home with severe cardiac and neurological ae, some have gone to the hospital with cardiac with myocarditis diagnosis and PVC (premature ventricular contraction 6 years old) some of them are experiencing crushing chest pain, bilateral arm and finger numbness, bilateral leg numbness, one girl yesterday was suffering from all over body shakes, incontrollable that she cant control, what the nurse was seeing over the past week; first kid sent home, right sidedness weakness, numbing and tingling in her arms and legs and she couldn't feel the right side of her face or her tongue with crushing stomach pain, other kid that couldn't feel both of her arms and fingers and terrible stomach pain, kid that was sent to hospital on Saturday, crushing chest pain, diagnosed with myocarditis and PVC, kid yesterday, had uncontrollable body shake and couldn't stop them sent to the doctor, today was a crushing chest pain, bilateral weakness of the hands and arms weakness on the legs and extreme exhaustion, hemiparesis on the right side she couldn't feel the entire side of her body including tongue her face and her nose. The nurse said that this happened in just one tiny school, all female. Age from 6-10.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 09:15 (Lot number: EN6206) at the age of 61 years as dose 1, single and administered in arm left, administration date 31Mar2021 09:15 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "little fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient was an adult. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for Covid-19 since the vaccination. The patient had no known allergies. The patient had no medical history.  No follow-up attempts are possible. No further information is expected.