chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04May2021 17:00 (Lot number: EW0173) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetic and Rheumatoid Arthritis; "Rheumatoid Arthritis" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetic and Rheumatoid Arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: EW0153, Prev dose Lot unknown: False, Prev dose administration date: 12Apr2021, Prev dose administration time: 04:30 PM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 12Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, disability) with onset 06May2021 08:00, outcome "recovering", described as "Guillian Barre symptoms". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 5 day(s)). The event "guillian barre symptoms" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome. Facility type vaccine was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis; booster; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Dec2021 14:30 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLEGRA. Vaccination history included: Moderna (Dose 2, Single,, Dose administration time: 08:30 , Dose brand: Moderna), administration date: 08Apr2021, when the patient was 44 years old, for Covid-19 Immunization; Moderna (Dose 1, Single, Dose administration time: 12:00, Dose brand: Moderna), administration date: Mar2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 03Dec2021 02:00, outcome "recovering", described as "Pericarditis"; IMMUNISATION (non-serious) with onset 02Dec2021 14:30, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 02Dec2021 14:30, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna". The patient was hospitalized for pericarditis (hospitalization duration: 1 day(s)). The event "pericarditis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pericarditis.  Clinical course: The patient has not experienced Covid-19 prior to vaccination. The patient has tested for Covid-19 post vaccination. No known allergies were reported. The patient did not receive other vaccine in four weeks. The patient received NSAIDs as treatment for adverse event. The patient had not covid prior vaccination. The patient was covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Immunisation, Tongue discolouration
Clinical narrative: side effects from booster; Metallic taste of my mouth; discoloration of my tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Dec2021 (Lot number: FE3594) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "side effects from booster"; DYSGEUSIA (non-serious) with onset Dec2021, outcome "unknown", described as "Metallic taste of my mouth"; TONGUE DISCOLOURATION (non-serious) with onset Dec2021, outcome "unknown", described as "discoloration of my tongue".  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain
Clinical narrative: Booster; Chills; Tired; Body aches; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Body aches".  Additional information: Patient felt chills, tired and body aches after receiving Pfizer booster vaccine. 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: 38.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Immunisation, Nasopharyngitis
Clinical narrative: tested positive for Covid-19 today 16Dec21 from an at-home rapid test; tested positive for Covid-19 today 16Dec21 from an at-home rapid test; head cold; minor chills; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old patient received bnt162b2 (BNT162B2), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single 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", COVID-19 (medically significant) with onset 16Dec2021, outcome "unknown" and all described as "tested positive for Covid-19 today 16Dec21 from an at-home rapid test"; IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Booster"; NASOPHARYNGITIS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "head cold"; CHILLS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "minor chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive; (16Dec2021) unknown result. Additional information: The patient reported that she/he had tested positive for Covid-19 today 16Dec21 from an at home rapid test. She/he had a PCR test done today and was awaiting results to confirm his/her positive result. She/he was instructed by the health department to report this positive test result as she/he was fully vaccinated and received a booster shot on 04Nov21. She/he was currently experiencing symptoms of a head cold, minor chills since yesterday 15Dec21. She/he was 38 years old and her/his date of birth was (Withheld). The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 today 16Dec21 from an at-home rapid test; tested positive for Covid-19 today 16Dec21 from an at-home rapid test; head cold; minor chills; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old patient received bnt162b2 (BNT162B2), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single 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", COVID-19 (medically significant) with onset 16Dec2021, outcome "unknown" and all described as "tested positive for Covid-19 today 16Dec21 from an at-home rapid test"; IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Booster"; NASOPHARYNGITIS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "head cold"; CHILLS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "minor chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive; (16Dec2021) unknown result. Additional information: The patient reported that she/he had tested positive for Covid-19 today 16Dec21 from an at home rapid test. She/he had a PCR test done today and was awaiting results to confirm his/her positive result. She/he was instructed by the health department to report this positive test result as she/he was fully vaccinated and received a booster shot on 04Nov21. She/he was currently experiencing symptoms of a head cold, minor chills since yesterday 15Dec21. She/he was 38 years old and her/his date of birth was (Withheld). The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 24 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient reported Covid breakthroughs case, the patient was Covid positive with fever, chills, and aches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101807392 same reporter/patient/product, different dose/event.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Pain in extremity
Clinical narrative: Pain in arm and additional pain in armpit approximately 1 day after 3rd dose; Pain in arm and additional pain in armpit approximately 1 day after 3rd dose; 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF8839) at the age of 39 years 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 Number: 2, Batch/Lot No: EL3248), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "3rd dose"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset 15Dec2021, outcome "not recovered" and all described as "Pain in arm and additional pain in armpit approximately 1 day after 3rd dose". Therapeutic measures were not taken as a result of pain in extremity, axillary pain.  Additional information: Pain in arm and additional pain in armpit approximately 1 day after 3rd dose. Armpit pain was not experienced from the first 2 doses. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Vaccination site pain
Clinical narrative: Slight body acheyness; Arm pain at injection site in left arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FH8027) at the age of 26 years 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 Number: 1, Batch/Lot No: EL3247), administration date: 05Feb2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "Slight body acheyness"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "Arm pain at injection site in left arm". Therapeutic measures were not taken as a result of pain, vaccination site pain. No follow-up attempts are possible. No further information is expected.  Additional information: This is not serious case. It did not meet any of the seriousness criteria. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested positive since the vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blood pressure measurement, Chest pain, Hypertension, Urticaria
Clinical narrative: Hi I have got twice severe allergy after covid shot; vomit every 2 min; hives all over and inside mouth; high bp; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Hi I have got twice severe allergy after covid shot "; VOMITING (non-serious), outcome "unknown", described as "vomit every 2 min"; URTICARIA (non-serious), outcome "unknown", described as "hives all over and inside mouth"; HYPERTENSION (non-serious), outcome "recovered", described as "high bp"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hi I have got twice severe allergy after covid shot; vomit every 2 min; hives all over and inside mouth; high bp; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Hi I have got twice severe allergy after covid shot "; VOMITING (non-serious), outcome "unknown", described as "vomit every 2 min"; URTICARIA (non-serious), outcome "unknown", described as "hives all over and inside mouth"; HYPERTENSION (non-serious), outcome "recovered", described as "high bp"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had both vaccination shots and was hospitalized for six days due to a breakthrough case of covid-19; had both vaccination shots and was hospitalized for six days due to a breakthrough case of covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  A 76 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "AFib" (ongoing). Concomitant medication(s) included: ELIQUIS 5 milligram twice a day, orally. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 20Jul2021, outcome "unknown" and all described as "had both vaccination shots and was hospitalized for six days due to a breakthrough case of covid-19". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 6 day(s)).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pyrexia
Clinical narrative: Fever; headache; Chills; Dose number = 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 26 years 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 Number: 2), administration date: 27Jan2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1), administration date: 04Jan2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Dose number = 3"; PYREXIA (non-serious) with onset 15Dec2021, outcome "recovered" (Dec2021), described as "Fever"; HEADACHE (non-serious) with onset 15Dec2021, outcome "recovered" (Dec2021), described as "headache"; CHILLS (non-serious) with onset 15Dec2021, outcome "recovered" (Dec2021), described as "Chills". Therapeutic measures were not taken as a result of pyrexia, headache, chills.  Additional information:Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Tenderness
Clinical narrative: Had three vaccinations; soreness in his arm; Tenderness in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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 1, his father reported he has had three vaccinations and the only thing that happened to him was soreness and tenderness in his arm), for COVID-19 Immunization, reaction(s): "Soreness in his arm", "Tenderness in his arm"; Bnt162b2 (Dose 2, his father reported he has had three vaccinations and the only thing that happened to him was soreness and tenderness in his arm), for COVID-19 Immunization, reaction(s): "Soreness in his arm", "Tenderness in his arm".  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Had three vaccinations"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his arm"; TENDERNESS (non-serious), outcome "unknown", described as "Tenderness in his arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; fully vaccinated was exposed to a family member with Covid and came down with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "fully vaccinated was exposed to a family member with Covid and came down with symptoms". It was reported that "the patient was fully vaccinated and was exposed to a family member with Covid and came down with symptoms and tested positive for Covid." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid test result; Positive Covid test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 13 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Jun2021 16:00 (Lot number: EP6955) at the age of 13 years as dose 2, single and intramuscular, administered in arm left, administration date 26May2021 16:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; DAILY MULTIVITAMIN. Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021 16:45, outcome "recovering" and all described as "Positive Covid test result". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vitiligo
Clinical narrative: Booster; Developed vitiligo soon after 3rd dose of pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30145BA) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "sjogrens" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG; CEVIMELINE; NP THYROID; LISINOPRIL; XIIDRA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729), administration date: 09Apr2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207), administration date: 19Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Oct2021, outcome "unknown", described as "Booster"; VITILIGO (non-serious) with onset Oct2021, outcome "not recovered", described as "Developed vitiligo soon after 3rd dose of pfizer covid vaccine". The event "developed vitiligo soon after 3rd dose of pfizer covid vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vitiligo.  Additional information: The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event steroid creams. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: sleepiness; Nausea; headache; chills; body aches; runny nose; fatigue; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Dec2021 11:30 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Allergies: Iodine-based dyes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; MELOXICAM. Vaccination history included: Bnt162b2 (Dose 2, Dose product: COVID-19, Dose brand: Pfizer, Lot number: EP6955, Route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Dose product: COVID-19, Dose brand: Pfizer, Lot number: EP6955), administration date: 18Mar2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "Dose number=3"; SOMNOLENCE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "sleepiness"; NAUSEA (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "body aches"; RHINORRHOEA (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "fatigue". Therapeutic measures were taken as a result of somnolence, nausea, headache, chills, pain, rhinorrhoea, fatigue.  Additional information: Patient was not received any other vaccines within 4  weeks. Patient was not diagnosed with covid prior vaccination and also not tested for covid-19 post vaccination. Treatment received for the adverse event was Tylenol.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Somnolence
Clinical narrative: sleepiness; Nausea; headache; chills; body aches; runny nose; fatigue; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Dec2021 11:30 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Allergies: Iodine-based dyes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; MELOXICAM. Vaccination history included: Bnt162b2 (Dose 2, Dose product: COVID-19, Dose brand: Pfizer, Lot number: EP6955, Route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Dose product: COVID-19, Dose brand: Pfizer, Lot number: EP6955), administration date: 18Mar2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "Dose number=3"; SOMNOLENCE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "sleepiness"; NAUSEA (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "body aches"; RHINORRHOEA (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "fatigue". Therapeutic measures were taken as a result of somnolence, nausea, headache, chills, pain, rhinorrhoea, fatigue.  Additional information: Patient was not received any other vaccines within 4  weeks. Patient was not diagnosed with covid prior vaccination and also not tested for covid-19 post vaccination. Treatment received for the adverse event was Tylenol.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Still's disease
Clinical narrative: Adult Onset Stills disease; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Aug2021 (Lot number: EW0202) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: prior vaccination. The patient's concomitant medications were not reported. Past drug history included: Propylene glycol, reaction(s): "Known allergies: Propylene Glycol". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Arm Left), administration date: 27Jul2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: STILL'S DISEASE (hospitalization, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Adult Onset Stills disease". The patient was hospitalized for still's disease (hospitalization duration: 19 day(s)). The event "adult onset stills disease" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Dec2021) negative. Therapeutic; Sender's Comments: The information provided is too limited to make a meaningful medical assessment of the case. However, based on the available information in the case provided, the causal association between the reported event Adult onset Still's disease and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Mass, Tenderness
Clinical narrative: egg shaped lump in muscle; Noticed slightly tender 3"x1.5" egg shaped lump in muscle under left armpit this morning while showering.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 10:15 (Lot number: FF2589) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: Have been under treatment for blood pressure. Concomitant medication(s) included: FENOFIBRAT; EDARBYCLOR; ROSUVASTATIN CALCIUM; EZETIMIBA; ASPRIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3247, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 10:15, outcome "unknown", described as "booster"; MASS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "egg shaped lump in muscle"; TENDERNESS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Noticed slightly tender 3"x1.5" egg shaped lump in muscle under left armpit this morning while showering.". Therapeutic measures were not taken as a result of mass, tenderness.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: aches; Sore right arm; slight headache; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 16:45 (Lot number: FH8028) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: seasonal/indoor allergies; "indoor allergies" (unspecified if ongoing), notes: seasonal/indoor allergies. Concomitant medication(s) included: IUD NOS; NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]; PROBIOTICS NOS; ALLEGRA; B12 [CYANOCOBALAMIN]; FISH OIL; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 30Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 09Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 16:45, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "aches"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "Sore right arm"; HEADACHE (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "slight headache"; FATIGUE (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of pain, pain in extremity, headache, fatigue. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed, Prior to vaccination and has the patient not been test, Since the vaccination for COVID-19. known allergies: No  Follow-Up (21Dec2021): 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: She is vaccinated with Pfizer vaccine, tested positive for Covid.; She is vaccinated with Pfizer vaccine, tested positive for Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "unknown" and all described as "She is vaccinated with Pfizer vaccine, tested positive for Covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive, notes: took the rapid test today and it came back positive. The reporter stated, "She is vaccinated with Pfizer vaccine and received booster on 06Dec2021. She had a tickle in her throat yesterday, and took the rapid test today and it came back positive".   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101809716 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test, Throat irritation
Clinical narrative: She is vaccinated with Pfizer vaccine, tested positive for Covid.; She is vaccinated with Pfizer vaccine, tested positive for Covid.; She had a tickle in her throat yesterday; received booster on Dec 6; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (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:1), for COVID-19 immunization, reaction(s): "Covid-19", "Drug ineffective"; Bnt162b2 (Dose:2), for COVID-19 immunization, reaction(s): "covid-19", "Drug ineffective". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "unknown" and all described as "She is vaccinated with Pfizer vaccine, tested positive for Covid."; IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "received booster on Dec 6"; THROAT IRRITATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "She had a tickle in her throat yesterday". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive, notes: took the rapid test today and it came back positive. The reporter stated that the patient "is vaccinated with Pfizer vaccine and received booster on 06Dec2021. She had a tickle in her throat yesterday, and took the rapid test today and it came back positive".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101809561 same reporter/patient/product, different dose/event.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Shortness of breath; massive multiple pulmonary embolism; 3rd pfizer injection; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 14:45 (Lot number: 30135B) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation in Clinic. The patient had no relevant medical history. Notes: Other medical history: No. Known allergies: No. The patient's concomitant medications were not reported. The patient didn't take other medications in 2 weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 post vaccination. The following information was reported: IMMUNISATION (hospitalization, disability, life threatening) with onset 27Sep2021 14:45, outcome "not recovered", described as "3rd pfizer injection"; DYSPNOEA (hospitalization, disability, life threatening) with onset 04Oct2021(also reported as 7 days after vaccination), outcome "not recovered", described as "Shortness of breath"; PULMONARY EMBOLISM (hospitalization, disability, life threatening) with onset 04Oct2021(also reported as 7 days after vaccination), outcome "not recovered", described as "massive multiple pulmonary embolism". The patient was hospitalized for dyspnoea, pulmonary embolism (hospitalization duration: 6 days). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Oct2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of dyspnoea, pulmonary embolism.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Immunisation, Dyspnoea, Pulmonary embolism and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Connective tissue disorder, Joint dislocation, Ligament disorder, Pain
Clinical narrative: Persistent weakening of connective tissue/ ligaments; Persistent weakening of connective tissue/ ligaments; Persistent weakening of connective tissue/ ligaments; connective tissue laxity; Spontaneous rupture of tendons; chronic pain; dislocation of joints spine, hands, wrists, feet and ankles; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm left, administration date 12Jan2021 (Lot number: El0142) at the age of 45 years 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 Number: 1, Batch/Lot No: Ek5730, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 45 years old, for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: ASTHENIA (disability), CONNECTIVE TISSUE DISORDER (disability), LIGAMENT DISORDER (disability) all with onset 02Feb2021, outcome "not recovered" and all described as "Persistent weakening of connective tissue/ ligaments"; TENDON LAXITY (disability) with onset 02Feb2021, outcome "not recovered", described as "connective tissue laxity"; TENDON RUPTURE (disability) with onset 02Feb2021, outcome "not recovered", described as "Spontaneous rupture of tendons"; PAIN (disability) with onset 02Feb2021, outcome "not recovered", described as "chronic pain"; JOINT DISLOCATION (disability) with onset 02Feb2021, outcome "not recovered", described as "dislocation of joints spine, hands, wrists, feet and ankles". The events "persistent weakening of connective tissue/ ligaments", "persistent weakening of connective tissue/ ligaments", "persistent weakening of connective tissue/ ligaments", "connective tissue laxity", "spontaneous rupture of tendons", "chronic pain" and "dislocation of joints spine, hands, wrists, feet and ankles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures taken included orthopedic splints.; Sender's Comments: The events considered as intercurrent conditions and unrelated to product bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine). This case will be reassessed upon receipt of follow-up information.