chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Overdose, Product preparation error, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Injection site pain; It was a pediatric dose. It required the dilution and it was given without dilution/one dose was inadvertently administered without dilution to a 6 years old; It was a pediatric dose. It required the dilution and it was given without dilution/one dose was inadvertently administered without dilution to a 6 years old; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 6 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Mar2022 (Lot number: FL0007) 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, date: 12Feb2022, Route of administration: Intramuscular, Anatomical location: Right deltoid Arm, Lot number: FL0007/Diluent Lot#2315BDK, Expired date: 01Nov2022), administration date: 12Feb2022, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 05Mar2022, outcome "unknown" and all described as "It was a pediatric dose. It required the dilution and it was given without dilution/one dose was inadvertently administered without dilution to a 6 years old"; PYREXIA (non-serious) with onset 06Mar2022, outcome "recovered" (09Mar2022), described as "Fever"; CHILLS (non-serious) with onset 06Mar2022, outcome "recovered" (09Mar2022), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 06Mar2022, outcome "recovered" (09Mar2022), described as "Injection site pain". Therapeutic measures were not taken as a result of pyrexia, chills, vaccination site pain.  Additional Information: Patient did not receive any other vaccines were within 4 weeks prior to the COVID vaccine. No specific relevant test were done. Reporter clarified regarding the type of medication error that no diluent was used, resulting in higher than authorized dose for pediatric Pfizer vaccine. The stage of medication error (e.g., prescribing, dispensing, preparation, and administration) was during vaccine preparation step, it was drawn from the pediatric Pfizer vial without dilution. Contributing factors to the medication error was inadequate training/forgetfulness. They had Informed the recipient's guardian of the vaccine administration error. Patient experienced fever, chills, injection site pain (Nothing outside of the expected side effect profile). Patients mother was informed to monitor 5x and if anything.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mucosal ulceration, Tongue ulceration
Clinical narrative: Chronic ulcers mostly on the tongue, some other places on the mucosa areas; Chronic ulcers mostly on the tongue, some other places on the mucosa areas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Leg Left), administration date: 28May2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "Location of injection: Leg Left"; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Leg Left), administration date: 07May2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: TONGUE ULCERATION (non-serious), MUCOSAL ULCERATION (non-serious) all with onset 03Dec2021, outcome "not recovered" and all described as "Chronic ulcers mostly on the tongue, some other places on the mucosa areas". Therapeutic measures were taken as a result of tongue ulceration, mucosal ulceration.  Additional information: Patient had no known allergies. No other vaccine in four weeks. Patient had no covid prior to vaccination and not tested for covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: arm pain; severe headaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Jul2021 (Batch/Lot number: unknown) at the age of 15 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: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovered", described as "arm pain"; HEADACHE (non-serious) with onset Jul2021, outcome "recovered", described as "severe headaches"; NAUSEA (non-serious) with onset Jul2021, outcome "recovered", described as "nausea". Therapeutic measures were not taken as a result of pain in extremity, headache, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. Patient had no Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Dizziness, Fatigue, Head discomfort
Clinical narrative: heavy left arm; Arm pain; head aid; diarrhea; cold sweet; dizzy; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2022 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Fabriomalgya" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "heavy left arm"; PAIN IN EXTREMITY (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "Arm pain"; HEAD DISCOMFORT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "head aid"; DIARRHOEA (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "diarrhea"; COLD SWEAT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "cold sweet"; DIZZINESS (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "fatigue". The events "heavy left arm", "arm pain", "head aid", "diarrhea", "cold sweet", "dizzy" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of limb discomfort, pain in extremity, head discomfort, diarrhoea, cold sweat, dizziness, fatigue.  Additional information: Pharmacy or Drug Store was reported as facility type vaccine. There was no other vaccine administered in four weeks. The patient did not receive any other medications within four week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: heavy left arm; Arm pain; head aid; diarrhea; cold sweet; dizzy; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2022 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Fabriomalgya" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "heavy left arm"; PAIN IN EXTREMITY (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "Arm pain"; HEAD DISCOMFORT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "head aid"; DIARRHOEA (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "diarrhea"; COLD SWEAT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "cold sweet"; DIZZINESS (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "fatigue". The events "heavy left arm", "arm pain", "head aid", "diarrhea", "cold sweet", "dizzy" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of limb discomfort, pain in extremity, head discomfort, diarrhoea, cold sweat, dizziness, fatigue.  Additional information: Pharmacy or Drug Store was reported as facility type vaccine. There was no other vaccine administered in four weeks. The patient did not receive any other medications within four week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: my neck was itchy; hives on my left forearm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 20:00 (Lot number: EN6205) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Strawberries, reaction(s): "Allergy"; Ciprofloxacin, reaction(s): "Allergy"; Gadolinium, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (COVID 19, brand=Pfizer, lot number=EN6198, administration date=20Feb2022, administration time=08:00 PM, dose number=1 vaccine location=Left arm), administration date: 20Feb2021, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "recovering", described as "my neck was itchy"; URTICARIA (non-serious), outcome "recovering", described as "hives on my left forearm". Therapeutic measures were not taken as a result of pruritus, urticaria.  Additional Information: It was reported that, after getting the second dose of pfizer, I immediately started to get hives on my left forearm and my neck was itchy. My left arm also broke out in pimples for about 3 months.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: menstrual cycle was delayed by 2-3 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 18:30 (Lot number: FJ8757) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: strawberries" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin", notes: ciprofloxacin; Gadolinium, reaction(s): "Known allergies: Gadolinium", notes: Gadolinium. Vaccination history included: Bnt162b2 (Dose: 2, lot number: EN6205, administration time: 08:00 AM, at Left arm), administration date: 13Mar2021, when the patient was 25 years old, for covid-19 immunization, reaction(s): "my neck was itchy"; Bnt162b2 (Dose: 2, lot number: EN6205, administration time: 08:00 , at Left arm), administration date: 13Mar2021, when the patient was 25 years old, for Covid-19 immunization, reaction(s): "hives on my left forearm"; Bnt162b2 (DOSE: 1, lot number: EN6198, administration time: 08:00 PM, dose vaccine location: Left arm), administration date: 20Feb2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 01Jan2022, outcome "recovering", described as "menstrual cycle was delayed by 2-3 weeks". Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: The patient had not receive any other vaccine in four weeks. The patient was not on other medication in past two weeks. No Covid prior vaccination. No Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Blood test
Clinical narrative: excessive amount of hair coming off of my head every time I washed my hair. 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 43 year-old patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, 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, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "excessive amount of hair coming off of my head every time I washed my hair.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned, never had any issues before the vaccine and now left with less than half of used to have. (abusive language).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in the armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2022 11:45 (Lot number: FF2589) 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, Brand : Pfizer/BioNTech,, Lot_number: EL3247,, Route of administration: Intramuscular,, Administration time: 09:30 AM, Location: Left arm), administration date: 22Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose number: 1, Brand : Pfizer/BioNTech,, Lot_number: EL3247,, Route of administration: Intramuscular, Administration time: 09:30 AM, Location: Left arm), administration date: 01Mar2021, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Mar2022 09:00, outcome "not recovered", described as "Swollen lymph nodes in the armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: No covid prior vaccination and not tested for covid post vaccination. No other vaccines in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test, Tendonitis
Clinical narrative: Severely sore joints all over; Achilles tenden pain; 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 left (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), when the patient was 48 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Severely sore joints all over"; TENDONITIS (non-serious) with onset 10Nov2021, outcome "not recovered", described as "Achilles tenden pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, tendonitis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: In the end of Jan2022 I developed on my left hand a lesion that looks like Zoster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 15:00 (Lot number: FD0809) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I had chicken pox as a child" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 26Mar2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198,, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 05Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 24Jan2022, outcome "not recovered", described as "In the end of Jan2022 I developed on my left hand a lesion that looks like Zoster". It was unknown if therapeutic measures were taken as a result of herpes zoster.  Additional information: Patient had PFE booster on 22Dec2021 (left arm) and in the end of Jan2022  developed on my left hand a lesion that looks like Zoster (I had chicken pox as a child), which doesn't go away. Patient had no other vaccine in four weeks. Patient had not no covid prior vaccination  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 13:15 (Lot number: FH8030) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "Dose Number 1: Moderna/ Dose Number 2: Moderna/ Dose Number 2: Pfizer booster" (unspecified if ongoing); "If Covid Prior Vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (prev_dose_product: COVID19,, prev dose brand:Moderna,, prev dose brand unknown:False,, prev dose lot number:006M20A,, prev dose lot unknown :False,, prev dose administration date:19Feb2021,, prev dose administration time:02:30PM, prev dose dose number:1,, prev dose vaccine location:Left arm), administration date: 19Feb2021, when the patient was 74 years old, for Covid-19 immunization; Moderna (Prev dose product:COVID 19,, Prev dose brand:Moderna,, Prev dose brand unknown:False,, Prev dose lot number:0061321A,, Prev dose lot unknown:False,, Prev dose administration date=19Mar2021,, Prev dose administration time=01:45PM, Prev dose dose number:2,, Prev dose vaccine location:Left arm,), administration date: 19Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 25Nov2021 12:00, outcome "not recovered", described as "diarrhea". The event "diarrhea" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional information: No other vaccine in four weeks. Prior vaccination had covid. Covid was tested post vaccination. Nasal swab test type post vaccination.15 Minute test. Patient stated he got diarrhea soon after taking the Pfizer booster (22Nov2021) and still have it (13Mar2022). Treatment for adverse event with Anti-Diarrhea Medication & Scheduled For Colonosc  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Deafness, Malignant melanoma, Tinnitus
Clinical narrative: hearing loss; melanoma on arm; basal cell on face; Tinnitus; 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 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 (Dose number Unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "melanoma on arm"; BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "basal cell on face"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Deafness, Malignant melanoma, SARS-CoV-2 test, Tinnitus
Clinical narrative: hearing loss; melanoma on arm; basal cell on face; Tinnitus; 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 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 (Dose number Unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "melanoma on arm"; BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "basal cell on face"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: hearing loss; melanoma on arm; basal cell on face; Tinnitus; 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 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 (Dose number Unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "melanoma on arm"; BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "basal cell on face"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: fatigue; headache; nausea; lightheadedness upon standing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2022 16:00 (Lot number: Fm0698) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: FERROUS SULFATE; ATORVASTATIN [ATORVASTATIN CALCIUM]; LORATADINE; AIRBORNE. The following information was reported: FATIGUE (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "fatigue"; HEADACHE (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "lightheadedness upon standing". Therapeutic measures were not taken as a result of fatigue, headache, nausea, dizziness.  Additional information: No other vaccine in four weeks. Other medications in two weeks: ferrous sulfate, atorvastatin,loratadine, airborn.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Palpitations
Clinical narrative: palpitations; upper body aches (arms, shoulders, chest, upper back); "reactive" lymph node under left axillary/left chest area; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; calcium (VIACTIV [CALCIUM]) (Batch/Lot number: unknown). Relevant medical history included: "Eczema" (unspecified if ongoing); "Acne" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 19Oct2021; VIT B COMPLEXE [VITAMINS NOS]; VIT D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 13Jan2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL5730, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 07Nov2021, outcome "recovered" (Nov2021), described as "palpitations"; PAIN (non-serious) with onset 07Nov2021, outcome "not recovered", described as "upper body aches (arms, shoulders, chest, upper back)"; LYMPHADENOPATHY (non-serious) with onset 07Nov2021, outcome "not recovered", described as ""reactive" lymph node under left axillary/left chest area". Therapeutic measures were not taken as a result of palpitations, pain, lymphadenopathy.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Headache, Hypertension
Clinical narrative: Tremors; headache; heart palpitations; shortness of breath; chest tightness; nausea; anxiety; high blood pressure; feeling unwell and doomed; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2022 12:00 (Lot number: FE 3594) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE [PREDNISONE ACETATE]. The following information was reported: TREMOR (non-serious) with onset 19Feb2022, outcome "not recovered", described as "Tremors"; HEADACHE (non-serious) with onset 19Feb2022, outcome "not recovered", described as "headache"; PALPITATIONS (non-serious) with onset 19Feb2022, outcome "not recovered", described as "heart palpitations"; DYSPNOEA (non-serious) with onset 19Feb2022, outcome "not recovered", described as "shortness of breath"; CHEST DISCOMFORT (non-serious) with onset 19Feb2022, outcome "not recovered", described as "chest tightness"; NAUSEA (non-serious) with onset 19Feb2022, outcome "not recovered", described as "nausea"; ANXIETY (non-serious) with onset 19Feb2022, outcome "not recovered", described as "anxiety"; HYPERTENSION (non-serious) with onset 19Feb2022, outcome "not recovered", described as "high blood pressure"; MALAISE (non-serious) with onset 19Feb2022, outcome "not recovered", described as "feeling unwell and doomed". The events "tremors", "headache", "heart palpitations", "shortness of breath", "chest tightness", "nausea", "anxiety", "high blood pressure" and "feeling unwell and doomed" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, headache, palpitations, dyspnoea, chest discomfort, nausea, anxiety, hypertension, malaise.  Additional Information: No other vaccine in four weeks. Covid prior to vaccination and covid tested post vaccination. Pfizer have permission to contact the reporter about this event. Pfizer have permission to contact your/the patient's healthcare provider about this report. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Palpitations, SARS-CoV-2 test, Tremor
Clinical narrative: Tremors; headache; heart palpitations; shortness of breath; chest tightness; nausea; anxiety; high blood pressure; feeling unwell and doomed; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2022 12:00 (Lot number: FE 3594) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE [PREDNISONE ACETATE]. The following information was reported: TREMOR (non-serious) with onset 19Feb2022, outcome "not recovered", described as "Tremors"; HEADACHE (non-serious) with onset 19Feb2022, outcome "not recovered", described as "headache"; PALPITATIONS (non-serious) with onset 19Feb2022, outcome "not recovered", described as "heart palpitations"; DYSPNOEA (non-serious) with onset 19Feb2022, outcome "not recovered", described as "shortness of breath"; CHEST DISCOMFORT (non-serious) with onset 19Feb2022, outcome "not recovered", described as "chest tightness"; NAUSEA (non-serious) with onset 19Feb2022, outcome "not recovered", described as "nausea"; ANXIETY (non-serious) with onset 19Feb2022, outcome "not recovered", described as "anxiety"; HYPERTENSION (non-serious) with onset 19Feb2022, outcome "not recovered", described as "high blood pressure"; MALAISE (non-serious) with onset 19Feb2022, outcome "not recovered", described as "feeling unwell and doomed". The events "tremors", "headache", "heart palpitations", "shortness of breath", "chest tightness", "nausea", "anxiety", "high blood pressure" and "feeling unwell and doomed" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, headache, palpitations, dyspnoea, chest discomfort, nausea, anxiety, hypertension, malaise.  Additional Information: No other vaccine in four weeks. Covid prior to vaccination and covid tested post vaccination. Pfizer have permission to contact the reporter about this event. Pfizer have permission to contact your/the patient's healthcare provider about this report. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: my arm, the site is little swollen and sore; my arm, the site is little swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2022 (Lot number: FL3198) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Verbatim:Diabetes; "COPD" (ongoing), notes: Verbatim:COPD; "defibrillator" (unspecified if ongoing), notes: Verbatim: I have a defibrillator; "asthmatic" (ongoing), notes: Verbatim: Iam asthmatic. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Mar2022, outcome "recovering" and all described as "my arm, the site is little swollen and sore". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling.  Additional information: The patient stated that she got her first Pfizer shot on Friday and her arm, the site is little swollen and sore and she had been putting alcohol on it but it feels like going down. About the prior vaccination (within 4 weeks) the patient stated that she got injection for her blood sugar (Further clarifications unknown) on Thursday, when probed to clarify if it was a vaccine the patient stated no. The patient stated Just rubbed it with alcohol regarding the treatment received. The patient stated that she had diabetes, COPD, she had a defibrillator (further not clarified) and she was asthmatic. Regarding concomitant medication the patient stated it was a long list of names.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Pain
Clinical narrative: Temp of 104; body aches; chills; Diarrhea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2022 10:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Shrimp" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR. The following information was reported: PYREXIA (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "Temp of 104"; PAIN (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, diarrhoea, decreased appetite.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Known allergies: Shrimp. Other medical history: Asthma  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temp of 104; body aches; chills; Diarrhea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2022 10:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Shrimp" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR. The following information was reported: PYREXIA (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "Temp of 104"; PAIN (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 12Mar2022 10:15, outcome "recovering", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, diarrhoea, decreased appetite.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Known allergies: Shrimp. Other medical history: Asthma  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I've been really sick since I had the COVID shot last year; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: ILLNESS (non-serious), outcome "unknown", described as "I've been really sick since I had the COVID shot last year".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Guillain-Barre syndrome, SARS-CoV-2 test
Clinical narrative: diagnosis of Guillain-Barre syndrome/ right hand paresthesias/ progressive lower extremity weakness; This is a spontaneous report received from a contactable reporter (physician).  A 51 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 30Jan2022 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Vitamin D deficiency" (unspecified if ongoing); "remote history of Breast cancer" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication included: ERGOCALCIFEROL. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization,Medically Significant ) with onset 28Feb2022, outcome "recovering", described as "diagnosis of Guillain-Barre syndrome/ right hand paresthesias/ progressive lower extremity weakness". The patient was hospitalized for Guillain-Barre syndrome (start date: 08Mar2022, discharge date: 15Mar2022, hospitalization duration: 7 days). The patient underwent the following laboratory tests and procedures: CSF test: (08Mar2022) negative, notes: diagnosis of Guillain-Barre syndrome based on CSF analysis, negative imaging findings, and examination; SARS-CoV-2 test: (08Mar2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of Guillain-Barre syndrome. Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ergocalciferol within 2 weeks of vaccination. The patient reported an onset of right hand paresthesias on 2/28/22, with progressive lower extremity weakness, leading to hospitalization on 3/8/22 and diagnosis of Guillain-Barre syndrome based on CSF analysis, negative imaging findings, and examination. The patient received treatment of intravenous immunoglobulin (IVIG) for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination and the patient has been tested for COVID-19 since the vaccination.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: full body rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 25 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 11Feb2022 14:00 (Lot number: FL3198, Expiration Date: 20Apr2022) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D2. The following information was reported: RASH (non-serious) with onset 12Feb2022, outcome "recovered" (Feb2022), described as "full body rash". The event "full body rash" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of rash.  Additional information: The report was related to a study or programme. She stated a female patient that received the 1st dose of the Comirnaty vaccine on 11Feb2022 developed a full body rash 30 hours after receiving the dose and went to the ER. Reporter mentioned that 3 days after the event, the rash was completely gone with no residual effects. Reporter asked if there was any information on whether she could receive or not the second dose and if there were any studies about it. The patient also mentioned to them the time when she got it, that would be 2 PM and after 24 hours the patient got body rashes and the health care provider also mentioned the covid 19 vaccine that they provide that would be grey cap. Pharmacist stated, "20Apr2022, that was the best use date, pharmacist thought instead of expiration date." (Further clarification unknown). Pharmacist mentioned that the patient had marked no for prior to vaccination within 4 weeks. Pharmacist wanted to know if Pfizer had any data on whether or not she should take the second shot as she had body rash."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: a large blotchy red rash has broken out on the left side of my face and neck; a large blotchy red rash has broken out on the left side of my face and neck; 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.  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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "not recovered" and all described as "a large blotchy red rash has broken out on the left side of my face and neck".  Additional information: After receiving covid booster a large blotchy red rash has broken out on the left side of face and neck. It has lingered now for three weeks since patient had the shot. Patient was little concerned and unsure what can be done to get it to go away. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%)."For any specific questions regarding the risks of the vaccine based on your medical condition or treatment recommendations, please speak with your healthcare provider.  The lot number for bnt162b2 was not provided and will be requested during follow up.