chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; headache; injection site pain; tiredness; feeling unwell; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 16:00 (Lot number: FJ8762) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Cats" (unspecified if ongoing), notes: known allergies: Cats and mold; "known allergies: mold" (unspecified if ongoing), notes: known allergies: Cats and mold. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Vaccine Administration Time: 11:00 AM), administration date: 16Apr2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208, Vaccine Administration Time: 01:30 PM), administration date: 15Mar2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 16:00, outcome "unknown", described as "Dose number: 3"; CHILLS (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "feeling unwell". Therapeutic measures were not taken as a result of chills, headache, vaccination site pain, fatigue, malaise.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Immunisation
Clinical narrative: Dose number=3; injection-site soreness; radiating pain up neck; migraine; fatigue; chills; sweats; arthralgia (esp in knees); leg and foot cramping; tingling in injection arm for 1 day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 15:00 (Lot number: F51620) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemiplegic migraines" (unspecified if ongoing), notes: Known verbatim: Hemiplegic migraines. Concomitant medication(s) included: PROBIOTICS; PRILOSEC [OMEPRAZOLE]. Past drug history included: Demerol, reaction(s): "Known allergy: Demerol", notes: Known allergy: Demerol. Vaccination history included: Bnt162b2 (Previous dose details:, Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot number: ER8730, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 10Apr2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "injection-site soreness", "radiating pain up neck", "lymph node swelling", "migraine", "Fatigue"; Bnt162b2 (Previous dose details:, Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot number:EW0185,, Prev dose dose number: 2, Prev dose vaccine location: Right arm), administration date: 08May2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "injection-site soreness", "radiating pain up neck", "lymph node swelling", "migraine", "Fatigue". The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 15:00, outcome "unknown", described as "Dose number=3"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "injection-site soreness"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "radiating pain up neck"; MIGRAINE (non-serious) with onset Dec2021, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset Dec2021, outcome "not recovered", described as "fatigue"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Dec2021, outcome "not recovered", described as "sweats"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "not recovered", described as "arthralgia (esp in knees)"; MUSCLE SPASMS (non-serious) with onset Dec2021, outcome "not recovered", described as "leg and foot cramping"; VACCINATION SITE PARAESTHESIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "tingling in injection arm for 1 day". Therapeutic measures were not taken as a result of vaccination site pain, pain, migraine, fatigue, chills, hyperhidrosis, arthralgia, muscle spasms, vaccination site paraesthesia.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Pfizer booster; I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "brain aneurysm" (unspecified if ongoing), notes: patient had brain aneurysm just last year; "quadruple heart bypass" (unspecified if ongoing), notes: patient had quadruple heart bypass. The patient's concomitant medications were not reported. Past drug history included: Oxycodone, notes: even after my heart surgery patient had oxycodone and only took two of those. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "arm hurting"; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "arm hurting". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: arm pain; tiredness; headache; muscle aches; chills; fever; nausea; Booster Dose; 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 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 10:45 (Lot number: FH8027) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 04Feb2021, when the patient was 23 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Booster Dose"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "arm pain"; FATIGUE (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "tiredness"; HEADACHE (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "headache"; MYALGIA (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "muscle aches"; CHILLS (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "chills"; PYREXIA (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "fever"; NAUSEA (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "nausea". Therapeutic measures were taken as a result of pain in extremity, fatigue, headache, myalgia, chills, pyrexia, nausea.  Additional information: The patient had no known allergies. The patient received treatment with Tylenol. The patient had not received other vaccine in four weeks. The patient had no COVID prior vaccination and had not been tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: arm pain; tiredness; headache; muscle aches; chills; fever; nausea; Booster Dose; 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 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 10:45 (Lot number: FH8027) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 04Feb2021, when the patient was 23 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Booster Dose"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "arm pain"; FATIGUE (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "tiredness"; HEADACHE (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "headache"; MYALGIA (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "muscle aches"; CHILLS (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "chills"; PYREXIA (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "fever"; NAUSEA (non-serious) with onset 13Dec2021 15:00, outcome "recovered" (Dec2021), described as "nausea". Therapeutic measures were taken as a result of pain in extremity, fatigue, headache, myalgia, chills, pyrexia, nausea.  Additional information: The patient had no known allergies. The patient received treatment with Tylenol. The patient had not received other vaccine in four weeks. The patient had no COVID prior vaccination and had not been tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Vertigo
Clinical narrative: I have severe dizziness; vertigo; dose received: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), solution for injection, administered in arm left, administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), administration date: May2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: Mar2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "dose received: 3"; DIZZINESS (non-serious) with onset 15Dec2021, outcome "recovering", described as "I have severe dizziness"; VERTIGO (non-serious) with onset 15Dec2021, outcome "recovering", described as "vertigo". Therapeutic measures were not taken as a result of dizziness, vertigo. 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 medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient reported that four days after the injections she had severe dizziness/ vertigo, lasting 2 days. (The patient never experienced this before in her life). It was reported that lot number details was misplaced/discarded .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation
Clinical narrative: Extreme fatigue; Dose 3 (Booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 14:30 (Lot number: FE3594) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 14Apr2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 15Dec2021 07:00, outcome "recovering", described as "Extreme fatigue"; IMMUNISATION (non-serious) with onset 14Dec2021 14:30, outcome "unknown", described as "Dose 3 (Booster)". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Advil. Reported event was extreme fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain in extremity
Clinical narrative: hair loss; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 13Sep2021 (Lot number: FC3183) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional info- The patient reported that she has still hair loss and is going to be bald because clumps come out  No Follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Inappropriate schedule of product administration
Clinical narrative: Alopecia Areata-significant hair loss in the month following the vaccine; Alopecia Areata-significant hair loss in the month following the vaccine; prev dose administration date 06Oct2021, prev dose dose number 1, Most recent dose: administration date 20Oct2021,dose number 2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Pennicilin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 06Oct2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), ALOPECIA (non-serious) all with onset 17Nov2021, outcome "not recovered" and all described as "Alopecia Areata-significant hair loss in the month following the vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Oct2021, outcome "unknown", described as "prev dose administration date 06Oct2021, prev dose dose number 1, Most recent dose: administration date 20Oct2021,dose number 2". The event "alopecia areata-significant hair loss in the month following the vaccine" and "alopecia areata-significant hair loss in the month following the vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: the patient received treatment for the adverse event which included Steroid injections into scalp. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Immunisation, Nasal congestion, Rhinorrhoea
Clinical narrative: Booster; had a stuffy, running nose; had a stuffy, running nose; cough; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunisation; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious), RHINORRHOEA (non-serious), outcome "recovered" and all described as "had a stuffy, running nose"; COUGH (non-serious), outcome "recovered", described as "cough"; FATIGUE (non-serious), outcome "recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, rhinorrhoea, cough, fatigue.  Additional information: The person received a booster dose and noted the following day was tired and had a stuffy, running nose and a cough. Recovered in 2 days and took a COVID-19 test. Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Booster; had a stuffy, running nose; had a stuffy, running nose; cough; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunisation; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious), RHINORRHOEA (non-serious), outcome "recovered" and all described as "had a stuffy, running nose"; COUGH (non-serious), outcome "recovered", described as "cough"; FATIGUE (non-serious), outcome "recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, rhinorrhoea, cough, fatigue.  Additional information: The person received a booster dose and noted the following day was tired and had a stuffy, running nose and a cough. Recovered in 2 days and took a COVID-19 test. Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Caller states she is calling about the Pfizer Covid 19 vaccine, Booster; Headache; Left arm hurt; Arm swollen, upper left arm; Lump, in upper part of left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Batch/Lot number: unknown) at the age of 66 years as booster dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, NDC/Expiration: Unknown, Lot:EN6205, Site: Unknown), administration date: 04Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, NDC/Expiration: Unknown, Lot: ER8733, Site: Unknown), administration date: 31Mar2021, when the patient was 66 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Caller states she is calling about the Pfizer Covid 19 vaccine, Booster"; HEADACHE (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Left arm hurt"; PERIPHERAL SWELLING (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Arm swollen, upper left arm"; LIMB MASS (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Lump, in upper part of left arm".  Additional information: it was reported that patient was not received any other vaccine, but stated that she gets a B12 shot once a month but was unsure what the date was.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Rash
Clinical narrative: Severe Joint Pain; Rash; Achy Muscles; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 63 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 09Dec2021 16:45 (Lot number: FG3527) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Stage 3A Kidney Disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Pfizer COVID 19, Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Right), administration date: 21Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Pfizer COVID 19, Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Dec2021, outcome "recovering", described as "Severe Joint Pain"; RASH (non-serious) with onset 13Dec2021, outcome "recovering", described as "Rash"; MYALGIA (non-serious) with onset 13Dec2021, outcome "recovering", described as "Achy Muscles"; FATIGUE (non-serious) with onset 13Dec2021, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of arthralgia, rash, myalgia, fatigue. Additional information The patient did not receive any other vaccine within 4 weeks prior to the vaccine. 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 had no known allergies.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Chronic hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ENO117) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 04Mar2021, for COVID-19 Immunization. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: URTICARIA (medically significant) with onset 08Apr2021, outcome "not recovered", described as "Chronic hives". The event "chronic hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria and include antihistamines and cream.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: swollen lymph nodes underneath his arm; booster; 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 male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 13Dec2021, outcome "unknown", described as "swollen lymph nodes underneath his arm".  Additional information: After 24 hours, patient had swollen lymph nodes underneath his arm. They were as big as half of a tennis ball. Caller wanted to know if it was a common side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye pain, Ocular hyperaemia, Peripheral swelling, Pyrexia
Clinical narrative: red eyes; feels them sore; red eyes, the patient felt them sore and there was yellow stuff coming out; swollen left arm; slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 13Dec2021 (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: PERIPHERAL SWELLING (non-serious) with onset 13Dec2021, outcome "unknown", described as "swollen left arm"; PYREXIA (non-serious) with onset 13Dec2021, outcome "unknown", described as "slight fever"; OCULAR HYPERAEMIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "red eyes"; EYE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "feels them sore"; EYE DISCHARGE (non-serious) with onset 16Dec2021, outcome "unknown", described as "red eyes, the patient felt them sore and there was yellow stuff coming out".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Lymphadenopathy, Malaise, Myocarditis
Clinical narrative: myocarditis; tiredness for 2 months; fever; night sweats; feeling unwell; swollen lymph glands; lost 15 pounds; dose 1 on 26Feb2021, dose 2 in Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: EN6202) as dose 2, single for covid-19 immunisation in Clinic. The patient was not pregnant when administration. Known allergies: dairy & preservatives. Other medical history: some digestive. The patient took some vitamins & Blood pressure, & coloresterol pre in 2 weeks. The patient didn't receive other vaccines in 4 weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3242, Location of injection: Arm Left), administration date: 26Feb2021 01:30 PM, when the patient was 81 years old, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The following information was reported: MYOCARDITIS (medically significant) with onset 01Mar2021 14:00, outcome "recovered", described as "myocarditis"; FATIGUE (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "tiredness for 2 months"; PYREXIA (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "fever"; NIGHT SWEATS (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "night sweats"; MALAISE (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "swollen lymph glands"; WEIGHT DECREASED (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "lost 15 pounds". The events "myocarditis", "fever", "night sweats", "feeling unwell", "swollen lymph glands" and "lost 15 pounds" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of myocarditis, fatigue, pyrexia, night sweats, malaise, lymphadenopathy, weight decreased.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Weight decreased
Clinical narrative: myocarditis; tiredness for 2 months; fever; night sweats; feeling unwell; swollen lymph glands; lost 15 pounds; dose 1 on 26Feb2021, dose 2 in Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: EN6202) as dose 2, single for covid-19 immunisation in Clinic. The patient was not pregnant when administration. Known allergies: dairy & preservatives. Other medical history: some digestive. The patient took some vitamins & Blood pressure, & coloresterol pre in 2 weeks. The patient didn't receive other vaccines in 4 weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3242, Location of injection: Arm Left), administration date: 26Feb2021 01:30 PM, when the patient was 81 years old, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The following information was reported: MYOCARDITIS (medically significant) with onset 01Mar2021 14:00, outcome "recovered", described as "myocarditis"; FATIGUE (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "tiredness for 2 months"; PYREXIA (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "fever"; NIGHT SWEATS (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "night sweats"; MALAISE (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "swollen lymph glands"; WEIGHT DECREASED (non-serious) with onset 01Mar2021 14:00, outcome "recovered", described as "lost 15 pounds". The events "myocarditis", "fever", "night sweats", "feeling unwell", "swollen lymph glands" and "lost 15 pounds" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of myocarditis, fatigue, pyrexia, night sweats, malaise, lymphadenopathy, weight decreased.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: breakthrough COVID infection; breakthrough COVID infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "parkinson's" (unspecified if ongoing). The patient's concomitant medications were not reported.Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "recovering" and all described as "breakthrough COVID infection". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (15Dec2021) positive, notes: Nasal Swab. Clinical course: It was unknown, if patient had any known allergies.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Atrial fibrillation, Dizziness, Echocardiogram, Magnetic resonance imaging
Clinical narrative: Syncopy; Afib attack; Dizziness; palpitations; awaiting diagnosis for Postural Orthostatic Tachycardia Syndrome (POTS); 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), administered in arm left, administration date 05Apr2021 (Lot number: 6206) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Former Afib" (unspecified if ongoing); "Sleeve Gastorectomy" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing); "Appendix removed" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications (no other medications in two weeks ). Past drug history included: Trazodone, reaction(s): "Allergy"; Abilify, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number:8733, Anatomical Location:Left arm), administration date: 14Mar2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: SYNCOPE (hospitalization, disability, medically significant) with onset 24Apr2021, outcome "not recovered", described as "Syncopy"; ATRIAL FIBRILLATION (hospitalization, disability, medically significant) with onset 24Apr2021, outcome "not recovered", described as "Afib attack"; DIZZINESS (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "Dizziness"; PALPITATIONS (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "palpitations"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "awaiting diagnosis for Postural Orthostatic Tachycardia Syndrome (POTS)". The patient was hospitalized for dizziness, palpitations (hospitalization duration: 3 day(s)); the patient was hospitalized for syncope, atrial fibrillation, postural orthostatic tachycardia syndrome (hospitalization duration: 3 day(s)). The events "syncopy", "afib attack", "dizziness", "palpitations" and "awaiting diagnosis for postural orthostatic tachycardia syndrome (pots)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: unknown results; echocardiogram: unknown results; magnetic resonance imaging: unknown results; sars-cov-2 test: negative. There was no covid prior vaccination and covid tested post vaccination. Therapeutic measures were taken as a result of syncope, atrial fibrillation, dizziness, palpitations, postural orthostatic tachycardia syndrome.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test, Syncope
Clinical narrative: Syncopy; Afib attack; Dizziness; palpitations; awaiting diagnosis for Postural Orthostatic Tachycardia Syndrome (POTS); 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), administered in arm left, administration date 05Apr2021 (Lot number: 6206) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Former Afib" (unspecified if ongoing); "Sleeve Gastorectomy" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing); "Appendix removed" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications (no other medications in two weeks ). Past drug history included: Trazodone, reaction(s): "Allergy"; Abilify, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number:8733, Anatomical Location:Left arm), administration date: 14Mar2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: SYNCOPE (hospitalization, disability, medically significant) with onset 24Apr2021, outcome "not recovered", described as "Syncopy"; ATRIAL FIBRILLATION (hospitalization, disability, medically significant) with onset 24Apr2021, outcome "not recovered", described as "Afib attack"; DIZZINESS (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "Dizziness"; PALPITATIONS (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "palpitations"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "awaiting diagnosis for Postural Orthostatic Tachycardia Syndrome (POTS)". The patient was hospitalized for dizziness, palpitations (hospitalization duration: 3 day(s)); the patient was hospitalized for syncope, atrial fibrillation, postural orthostatic tachycardia syndrome (hospitalization duration: 3 day(s)). The events "syncopy", "afib attack", "dizziness", "palpitations" and "awaiting diagnosis for postural orthostatic tachycardia syndrome (pots)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: unknown results; echocardiogram: unknown results; magnetic resonance imaging: unknown results; sars-cov-2 test: negative. There was no covid prior vaccination and covid tested post vaccination. Therapeutic measures were taken as a result of syncope, atrial fibrillation, dizziness, palpitations, postural orthostatic tachycardia syndrome.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Inappropriate schedule of product administration, Memory impairment
Clinical narrative: Left Bell's Palsy; Facial distortion; Memory issues, forgetting names/events/dates.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 76-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11May2021 16:00 (Lot number: EN6205) at the age of 76-years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Depression" (unspecified if ongoing); and "Sleep Apnea" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; LEVOTHYROXINE; ATORVASTATIN; TAMSULOSIN; CLONAZEPAM; ALLOPURINOL; METFORMIN. Vaccination history included: Bnt162b2 (Lot number=EN6200, dose administrator route: Intramuscular, dose administration date: 19Feb2021, dose administration time: 4:00PM, dose number: 1, vaccine location: Left Arm), when the patient was 75-years-old, for Covid-19 Immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: BELL'S PALSY (disability) with onset 01Aug2021, outcome "not recovered", described as "Left Bell's Palsy"; FACIAL DISCOMFORT (disability) with onset 01Aug2021, outcome "not recovered", described as "Facial distortion"; MEMORY IMPAIRMENT (disability) with onset 01Aug2021, outcome "not recovered", described as "Memory issues, forgetting names/events/dates."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11May2021 16:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "left bell's palsy", "facial distortion" and "memory issues, forgetting names/events/dates" were evaluated at the physician office visit. Therapeutic measures taken as a result of bell's palsy, facial discomfort, memory impairment included "IFC 8MV". It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on temporal association , a causal association between BNT162B2 and the reported events Bells Palsy, facial Paralysis, Memory impairment  cannot be completely 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Throat tightness
Clinical narrative: thickening and discomfort in throat within 5 minutes; thickening and discomfort in throat within 5 minutes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid 19", start date: Nov2020 (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing), notes: was diagnosed after she had Covid in Nov2020; "allergy to corn" (unspecified if ongoing), notes: experienced thickening or discomfort in her throat/ she gets that when she eats corn or bi products. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, LOT- EL3246), administration date: 16Jan2021, for Covid-19 immunization. The following information was reported: The patient had both Pfizer COVID vaccines, had second one in "Jan2021 or Feb of last year" and stated she had a reaction to the second one. She experienced THROAT TIGHTNESS (medically significant), OROPHARYNGEAL DISCOMFORT (medically significant) all with onset 06Feb2021, outcome "unknown" and all described as "thickening and discomfort in throat within 5 minutes". The event "thickening and discomfort in throat within 5 minutes" and "thickening and discomfort in throat within 5 minutes" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of throat tightness, oropharyngeal discomfort.in the emergency room and included PEPCID, BENADRYL, and prednisone for treatment. There was no additional investigation. When she was treated they gave her some solumedrol pack to take at home, finished that dose pack at home. She wanted to know if there is corn in the Pfizer vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, and a close temporal association, a causal association between the reported events of oropharyngeal discomfort and throat tightness cannot be totally 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.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Immunisation
Clinical narrative: Booster; back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (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) with onset 11Dec2021, outcome "unknown", described as "Booster"; BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "back pain".  Additional information: Caller named took the booster shot last Saturday. He was having a back pain and he was asking if once he took the medication Medrol will the Pfizer covid-19 vaccine be less effective and would like to know if he would encounter some adverse reaction. He needed to take Medrol for his back and he wanted to know if it would have issues with the effectiveness of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.