chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 64 year old Female was administered 18minutes beyond the 6hours labelled time; 64 year old Female was administered 18minutes beyond the 6hours labelled time; 64 year old Female was administered 18minutes beyond the 6hours labelled time; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (COMIRNATY) (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 X; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "64 year old Female was administered 18minutes beyond the 6hours labelled time".  Additional information: Nurse who is seeking information regarding re-vaccination of booster shot. she states that two patients were administered with Pfizer BioNtech covid vaccines that were diluted beyond the 6hours storage.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101676401 same reporter/different patients/same event
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Rash, Rash pruritic
Clinical narrative: a very itchy rash on my neck lasted all day; woke up the next morning the rash was over my; diagnosed it with shingles; dose number=3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 02:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Total mastectomy due to breast cancer" (unspecified if ongoing), notes: Total mastectomy due to breast cancer; "Shingles" (unspecified if ongoing), notes: I had shingles before that was mild like this about seven years prior; "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; CONCERTA. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number= ER8729, Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 10Apr2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number= ER8727, Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 20Mar2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 02:00, outcome "unknown", described as "dose number=3"; RASH PRURITIC (non-serious) with onset 24Nov2021, outcome "recovering", described as "a very itchy rash on my neck lasted all day"; RASH (non-serious) with onset 24Nov2021, outcome "recovering", described as "woke up the next morning the rash was over my"; HERPES ZOSTER (non-serious) with onset 24Nov2021, outcome "recovering", described as "diagnosed it with shingles". The events "a very itchy rash on my neck lasted all day", "woke up the next morning the rash was over my" and "diagnosed it with shingles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash pruritic, rash, herpes zoster.  Additional information: There were no other vaccine taken in four weeks. The patient took the antiviral Valtrex as the treatment. There were no allergies.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Vaccination site pain
Clinical narrative: Mild pain and tenderness near injection site; Mild pain and tenderness near injection site; mild chills; mild fatigue; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 10:00 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 033B21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 20May2021, when the patient was 53 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 007C21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Apr2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 10:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Nov2021, outcome "recovered" (2021) and all described as "Mild pain and tenderness near injection site"; CHILLS (non-serious) with onset 28Nov2021, outcome "recovered" (2021), described as "mild chills"; FATIGUE (non-serious) with onset 28Nov2021, outcome "recovered" (2021), described as "mild fatigue". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pain, chills, fatigue. The lot number for bnt162b2 was not provided and will be requested during follow up.  Adverse event treatment: OTC Advil. No covid prior vaccination. No covid tested post vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Malaise
Clinical narrative: she had symptom worsening in her hands and ankle; she had symptom worsening in her hands and ankle; booster vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, manufacturer-unknown), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, manufacturer-unknown), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Sep2021, outcome "unknown", described as "booster vaccine"; MALAISE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 15Sep2021, outcome "recovered" (29Sep2021) and all described as "she had symptom worsening in her hands and ankle". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation
Clinical narrative: Booster; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 11:45 (Lot number: FH8030) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 11:45, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 27Nov2021, outcome "recovered" (Nov2021), described as "Chills". Therapeutic measures were not taken as a result of chills.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Headache, Immunisation
Clinical narrative: diarrhea; Fever (100-101 C throughout the day; start approx. 9:00 am); Body ache; Nausea; Vomiting; dizziness; Migraine (pm); Head ache (am); Receiving the 3rd injection of Pfizer's COVID-19 vaccine (booster shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:10 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: MHx of Migraines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Time of Injection: 2:34 pm, Anatomical location: Left upper biceps, Lot number: ER8733), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "Chills", "Body ache", "Headache", "Low grade fever", "Severe lower back pain (hard to get up or sit)", "Severe wrist and thumb joint pain", "Tiredness", "Migraine"; Bnt162b2 (Dose 2, Time of Injection: 2:34 pm, Anatomical location: Left upper biceps, Lot number: ER8733), administration date: 31Mar2021, for COVID-19 Immunization, reaction(s): "Severe lower back pain (hard to get up or sit)"; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 13:10, outcome "unknown", described as "Receiving the 3rd injection of Pfizer's COVID-19 vaccine (booster shot)"; MIGRAINE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Migraine (pm)"; HEADACHE (non-serious) with onset 27Nov2021, outcome "recovered" (27Nov2021), described as "Head ache (am)"; PYREXIA (non-serious) with onset 27Nov2021 09:00, outcome "not recovered", described as "Fever (100-101 C throughout the day; start approx. 9:00 am)"; PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Body ache"; NAUSEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Vomiting"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "unknown", described as "dizziness"; DIARRHOEA (non-serious) with onset 28Nov2021, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Lot # ??3527 (lot number letter not clear on vaccination card).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: diarrhea; Fever (100-101 C throughout the day; start approx. 9:00 am); Body ache; Nausea; Vomiting; dizziness; Migraine (pm); Head ache (am); Receiving the 3rd injection of Pfizer's COVID-19 vaccine (booster shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:10 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: MHx of Migraines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Time of Injection: 2:34 pm, Anatomical location: Left upper biceps, Lot number: ER8733), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "Chills", "Body ache", "Headache", "Low grade fever", "Severe lower back pain (hard to get up or sit)", "Severe wrist and thumb joint pain", "Tiredness", "Migraine"; Bnt162b2 (Dose 2, Time of Injection: 2:34 pm, Anatomical location: Left upper biceps, Lot number: ER8733), administration date: 31Mar2021, for COVID-19 Immunization, reaction(s): "Severe lower back pain (hard to get up or sit)"; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 13:10, outcome "unknown", described as "Receiving the 3rd injection of Pfizer's COVID-19 vaccine (booster shot)"; MIGRAINE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Migraine (pm)"; HEADACHE (non-serious) with onset 27Nov2021, outcome "recovered" (27Nov2021), described as "Head ache (am)"; PYREXIA (non-serious) with onset 27Nov2021 09:00, outcome "not recovered", described as "Fever (100-101 C throughout the day; start approx. 9:00 am)"; PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Body ache"; NAUSEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Vomiting"; DIZZINESS (non-serious) with onset 27Nov2021, outcome "unknown", described as "dizziness"; DIARRHOEA (non-serious) with onset 28Nov2021, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Lot # ??3527 (lot number letter not clear on vaccination card).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Myalgia, Pyrexia
Clinical narrative: booster; severe fever; chills; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FF8839) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 01Apr2021, when the patient was 30 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 10Mar2021, when the patient was 30 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "severe fever"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "chills"; MYALGIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "muscle pain". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia.  Additional information: The most recent COVID-19 vaccine was administered at workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination the patient was not tested for COVID-19 or diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Therapeutic response unexpected
Clinical narrative: She has cancer and her readings are better; booster dose; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Oct2021 (Lot number: FE3592) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "colon cancer" (unspecified if ongoing); "kidney cancer" (unspecified if ongoing); "four heart ablations" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "ectopic pregnancy" (unspecified if ongoing); "hemorrhoids" (unspecified if ongoing); "surgery for ganglion in her wrist." (unspecified if ongoing); "basal cell taken off her nose" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: given on 29Jan2021. Pfizer lot number is EL9264. , Expiry: unknown , location site: Left arm), administration date: 29Jan2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Second dose: given on 04Mar2021. Lot number: EN6198. , Expiry: unknown , location site: Left arm), administration date: 04Mar2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Oct2021, outcome "unknown", described as "booster dose"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She has cancer and her readings are better".  Follow up (29Nov2021) This is a follow up spontaneous report from a contactable Physician. This Physician reported for a 78 year old female consumer (patient) that:  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Malaise
Clinical narrative: Mild fatigue; mild joint aches; mild feeling of unwellness; 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 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 13:15 (Batch/Lot number: unknown) at the age of 57 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, Location of injection: Arm Right, Vaccine Administration Time: 02:00PM), administration date: 19Feb2021, when the patient was 57 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Vaccine Administration Time: 02:00PM), administration date: 27Jan2021, when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 13:15, outcome "unknown", described as "Dose Number 3"; FATIGUE (non-serious) with onset 25Nov2021 17:00, outcome "recovering", described as "Mild fatigue"; ARTHRALGIA (non-serious) with onset 25Nov2021 17:00, outcome "recovering", described as "mild joint aches"; MALAISE (non-serious) with onset 25Nov2021 17:00, outcome "recovering", described as "mild feeling of unwellness". Therapeutic measures were not taken as a result of fatigue, arthralgia, malaise.  Additional information: Patient did not receive any other vaccine in 4 weeks. Patient did not have covid prior to vaccination. Post vaccination, not tested for covid. It was unknown if patient had any allergies. IT was reported that Seriousness was no.Seriousness criteria-Results in death was no.Seriousness criteria-Life threatening was No.Seriousness criteria-Caused/prolonged hospitalization was No.Seriousness criteria-Disabling/Incapacitating was No.Seriousness criteria-Congenital anomaly/birth defect was No patient can confirm that the event start date was 25Nov2021, 24 hours after COVID booster shot. The delay was due to the holiday, the report was submitted on  first day of returning to work.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Flu like symptoms; fever; body aches; headache; Arm pain to the point when it hurt to move my arm at all for 36 hours; Dose Number 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:00 (Lot number: EW0196) at the age of 30years 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: 1, Batch/Lot No: EL3247, Location of injection: Left Arm, Vaccine Administration Time: 10:00), administration date: 23Feb2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 16Mar2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "Flu like symptoms", "Fever", "body aches", "headache", "Arm pain". The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:00, outcome "unknown", described as "Dose Number 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "body aches"; HEADACHE (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "Arm pain to the point when it hurt to move my arm at all for 36 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness, pyrexia, pain, headache, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; fever; body aches; headache; Arm pain to the point when it hurt to move my arm at all for 36 hours; Dose Number 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:00 (Lot number: EW0196) at the age of 30years 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: 1, Batch/Lot No: EL3247, Location of injection: Left Arm, Vaccine Administration Time: 10:00), administration date: 23Feb2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 16Mar2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "Flu like symptoms", "Fever", "body aches", "headache", "Arm pain". The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:00, outcome "unknown", described as "Dose Number 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "body aches"; HEADACHE (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "Arm pain to the point when it hurt to move my arm at all for 36 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness, pyrexia, pain, headache, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Starting about 6 hours after injection: Soreness at injection site;; Stiffness when raising arm; Chills starting about 8 hours after injection, lasting about 28 hour; Dose: 3; 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 26Nov2021 11:15 (Lot number: 30155BA) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MAGNESIUM CITRATE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Lot #EN6200), administration date: 20Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Lot #EN6199), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 11:15, outcome "unknown", described as "Dose: 3"; VACCINATION SITE PAIN (non-serious) with onset 26Nov2021 17:15, outcome "recovered" (2021), described as "Starting about 6 hours after injection: Soreness at injection site;"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Nov2021 17:15, outcome "recovered" (2021), described as "Stiffness when raising arm"; CHILLS (non-serious) with onset 26Nov2021 17:15, outcome "recovered" (Nov2021), described as "Chills starting about 8 hours after injection, lasting about 28 hour". Therapeutic measures were not taken as a result of vaccination site pain, musculoskeletal stiffness, chills.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Caller states she received her Pfizer BTC vaccine Booster dose; The person jabbing me did it really hard and I had large area of redness on my upper right arm, the size of my palm if not bigger; itchiness started; injection site swelling; arm pain; 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 68-year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (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. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Caller states she received her Pfizer BTC vaccine Booster dose"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "unknown", described as "The person jabbing me did it really hard and I had large area of redness on my upper right arm, the size of my palm if not bigger"; PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "itchiness started"; VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "injection site swelling"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm pain".  Additional information: After several days, the patient had then and now it was still big, but black and blue and still itchy but not as bad. The patient wanted to know if other people had this itchiness. Side effects that have been reported with the vaccine included: non-severe allergic reactions such as itching, injection site redness, injection site swelling and arm pain.   Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Skin discolouration, Vaccination site erythema, Vaccination site pruritus, Wrong technique in product usage process
Clinical narrative: Caller states she received her Pfizer BTC vaccine Booster dose; The person jabbing me did it really hard and I had large area of redness on my upper right arm, the size of my palm if not bigger; itchiness started; injection site swelling; arm pain; 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 68-year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (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. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Caller states she received her Pfizer BTC vaccine Booster dose"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "unknown", described as "The person jabbing me did it really hard and I had large area of redness on my upper right arm, the size of my palm if not bigger"; PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "itchiness started"; VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "injection site swelling"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm pain".  Additional information: After several days, the patient had then and now it was still big, but black and blue and still itchy but not as bad. The patient wanted to know if other people had this itchiness. Side effects that have been reported with the vaccine included: non-severe allergic reactions such as itching, injection site redness, injection site swelling and arm pain.   Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Booster; the person who administered did it very hard; large red itchy spot at injection site; large red itchy spot at injection site; States today is the 7th day since the vaccine and it is starting to subside, it is now turning black and blue.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 17:30 (Batch/Lot number: unknown) at the age of 68 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 1, single), for Covid-19 Immunization, reaction(s): "he had no issues with the first ones"; Bnt162b2 (Dose 2, single), for Covid-19 Immunization, reaction(s): "he had no issues with the first ones". The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 17:30, outcome "unknown", described as "Booster"; VACCINATION SITE PRURITUS (non-serious) with onset Nov2021, outcome "recovering", SKIN DISCOLOURATION (non-serious) with onset Nov2021, outcome "unknown" and all described as "States today is the 7th day since the vaccine and it is starting to subside, it is now turning black and blue."; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Nov2021, outcome "recovering", described as "large red itchy spot at injection site"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 23Nov2021 17:30, outcome "unknown", described as "the person who administered did it very hard".  Additional information: Caller stated that she had no issues with the first ones, has had Pfizer all the way. Caller stated that she received the booster vaccine Tuesday, 23Nov2021, stated she got it at 5:30 PM, the spot started the same day, states the next day after she showered it was the size of her palm, stated that she was surprised. After the second or third day the itching started, on and off throughout the day. Caller stated that the person who administered did it very hard. Caller wanted to know if this was a sign of an allergic reaction, should she avoid Pfizer vaccines in the future. NDC Lot and Expiration date unknown, did not have vaccination record card on hand at this time.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Skin discolouration, Vaccination site erythema, Vaccination site pruritus, Wrong technique in product usage process
Clinical narrative: Booster; the person who administered did it very hard; large red itchy spot at injection site; large red itchy spot at injection site; States today is the 7th day since the vaccine and it is starting to subside, it is now turning black and blue.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 17:30 (Batch/Lot number: unknown) at the age of 68 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 1, single), for Covid-19 Immunization, reaction(s): "he had no issues with the first ones"; Bnt162b2 (Dose 2, single), for Covid-19 Immunization, reaction(s): "he had no issues with the first ones". The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 17:30, outcome "unknown", described as "Booster"; VACCINATION SITE PRURITUS (non-serious) with onset Nov2021, outcome "recovering", SKIN DISCOLOURATION (non-serious) with onset Nov2021, outcome "unknown" and all described as "States today is the 7th day since the vaccine and it is starting to subside, it is now turning black and blue."; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Nov2021, outcome "recovering", described as "large red itchy spot at injection site"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 23Nov2021 17:30, outcome "unknown", described as "the person who administered did it very hard".  Additional information: Caller stated that she had no issues with the first ones, has had Pfizer all the way. Caller stated that she received the booster vaccine Tuesday, 23Nov2021, stated she got it at 5:30 PM, the spot started the same day, states the next day after she showered it was the size of her palm, stated that she was surprised. After the second or third day the itching started, on and off throughout the day. Caller stated that the person who administered did it very hard. Caller wanted to know if this was a sign of an allergic reaction, should she avoid Pfizer vaccines in the future. NDC Lot and Expiration date unknown, did not have vaccination record card on hand at this time.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Urticaria
Clinical narrative: Left lymph nods swollen; Breaking out in hives on stomach and back; 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 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 27Nov2021 14:45 (Lot number: 33030BD) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Other medical history: Thyroid; "Hoshimoto" (unspecified if ongoing), notes: Other medical history: hoshimoto. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EW973, Administration time: 01:15 PM, Vaccine location: Left arm, Dose number: 2), administration date: 05May2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Lot number: EW0153, Administration time: 03:00 PM, Vaccine location: Left arm, Dose number: 1), administration date: 07Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 14:45, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 29Nov2021 05:45, outcome "not recovered", described as "Left lymph nods swollen"; URTICARIA (non-serious) with onset 29Nov2021 05:45, outcome "not recovered", described as "Breaking out in hives on stomach and back". Therapeutic measures were not taken as a result of lymphadenopathy, urticaria.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Immunisation, Nausea, Tinnitus
Clinical narrative: booster; numbness in his pinky; dizziness; nausea; ringing in his ears; could not see well; 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 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Nov2021 (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 (Initial dose, Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster"; HYPOAESTHESIA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "numbness in his pinky"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "dizziness"; NAUSEA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "nausea"; TINNITUS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "ringing in his ears"; VISION BLURRED (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "could not see well".   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further infor-mation is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: booster; numbness in his pinky; dizziness; nausea; ringing in his ears; could not see well; 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 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Nov2021 (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 (Initial dose, Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster"; HYPOAESTHESIA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "numbness in his pinky"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "dizziness"; NAUSEA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "nausea"; TINNITUS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "ringing in his ears"; VISION BLURRED (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "could not see well".   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further infor-mation is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Dyspnoea, Headache, Immunisation
Clinical narrative: High temp 102 degrees; Shortness of breath; Severe headache; sweats chills; nausea; Body ache; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:45 (Lot number: Fh8027) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: er2613, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 19Mar2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en2603, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Feb2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "High temp 102 degrees"; DYSPNOEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Shortness of breath"; HEADACHE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Severe headache"; COLD SWEAT (non-serious) with onset 27Nov2021, outcome "not recovered", described as "sweats chills"; NAUSEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Body ache"; IMMUNISATION (non-serious) with onset 26Nov2021 13:45, outcome "unknown", described as "Dose Number: 3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, dyspnoea, headache, cold sweat, nausea, pain.  Additional information: 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. Since the vaccination, the patient had not been tested for COVID-19. At the time of report, no known allergies were reported. The patient was administered vaccine in a pharmacy.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: High temp 102 degrees; Shortness of breath; Severe headache; sweats chills; nausea; Body ache; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:45 (Lot number: Fh8027) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: er2613, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 19Mar2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en2603, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Feb2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "High temp 102 degrees"; DYSPNOEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Shortness of breath"; HEADACHE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Severe headache"; COLD SWEAT (non-serious) with onset 27Nov2021, outcome "not recovered", described as "sweats chills"; NAUSEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Body ache"; IMMUNISATION (non-serious) with onset 26Nov2021 13:45, outcome "unknown", described as "Dose Number: 3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, dyspnoea, headache, cold sweat, nausea, pain.  Additional information: 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. Since the vaccination, the patient had not been tested for COVID-19. At the time of report, no known allergies were reported. The patient was administered vaccine in a pharmacy.  No follow-up attempts are possible. No further information is expected.