chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: I contracted Covid-19 confirmed with a PCR test the week of 27Oct; I contracted Covid-19 confirmed with a PCR test the week of 27Oct; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 15:00 (Lot number: FC3184) at the age of 53 years as dose 3 (booster), single, administered in arm left (Lot number: EN6199) as dose 2 , single and administered in arm left (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing), notes: Other medical history: Inflammatory arthritis. Concomitant medication(s) included: METHOTREXATE; HYDROXYCHLOROQUINE; LEVOXYL; LEUCOVORI. Vaccination history included: Flu (vaccination date: 10Aug2021, lot number: UJ586AA, dose number: 1, vaccine location: left arm), administration date: 10Aug2021. The following information was reported: IMMUNISATION (medically significant) with onset 30Aug2021 15:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Oct2021 12:00, outcome "unknown" and all described as "I contracted Covid-19 confirmed with a PCR test the week of 27Oct". The event "i contracted covid-19 confirmed with a pcr test the week of 27oct" and "i contracted covid-19 confirmed with a pcr test the week of 27oct" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Oct2021) positive, notes: COVID Test type post vaccination: Nasal swab COVID test name: SAR-COV-2, RT-PCR COVID test date: 28Oct2021 test result: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: AE treatment: Regen-COV, OTC cold meds and benzonatate. Adverse event: Patient contracted Covid-19 confirmed with a PCR test the week of October 27th. First symptoms that week.   No follow up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Immunisation
Clinical narrative: Fatigue; Headache; Dizziness; Dose number:3; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in right arm, administration date 28Nov2021 at 10:00 (Lot number: FH8027) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 2, SINGLE, Lot Number: EL3247, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 09Feb2021, when the patient was 31 years old, and Comirnaty (DOSE 1, SINGLE, Lot Number: EL3247, Anatomical location: Right arm, Route of administration: Intramuscular), administration date: 19Jan2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 at 10:00, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 29Nov2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovering", described as "Dizziness". Therapeutic measures were not taken as a result of fatigue, headache and dizziness.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient did not get booster and tested positive for COVID on 11/26/21; Patient did not get booster and tested positive for COVID on 11/26/21; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EP6955) as dose 1, single and administration date Apr2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 26Nov2021, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 26Nov2021, outcome "unknown" and all described as "Patient did not get booster and tested positive for COVID on 11/26/21". It was unknown if patient was diagnosed with COVID 19 prior to vaccination. It was unknown if patient receive any other medications within 2 weeks and any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood pressure measurement, Chest pain, Headache, Hypertension
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 17:00 (Lot number: 33030BD) at the age of 70 years as dose 3 (booster), single for covid-19 immunization. Patients' medical history included rheumatoid arthritis, fibromyalgia, shrogen's syndrome, hypertension, heart murmur, ulcer, known allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included: lisinopril; multivitamins, Nyquil, Tylenol, magnesium. past drug history included: morphine, reaction(s) include known allergies: morphine, Demerol, reaction(s): known allergies: Demerol, tramadol, reaction(s): known allergies: tramadol, stadol, reaction(s): known allergies: stadol. Patient previously received Bnt162b2 (COVID 19, Pfizer, lot number=EW0167, location=Left arm), on 21Mar2021, at 12:00 am, when the patient was 74 years old, as DOSE 1 SINGLE, for COVID-19 immunization and Bnt162b2 (COVID 19 immunization, Pfizer, lot number=EW0167, location=Left arm) as DOSE 2, SINGLE, on 29Apr2021 at 12:00 am, when the patient was 70 years old, for Covid-19 immunization. On 20Nov2021patient experienced dose number: 3, On 20Nov2021 12:00 Persistent hypertension even with Lisinopril. Was taking 15mg OD (had weaned down over past year from 30mg BID) Had to go back to 30mg BID. Still ranging from 180/110 to 140/90, PVC's chest pain, left arm numbness with tinnitus, left arm numbness with tinnitus, headache, Aggravated ulcer with abdominal pain, vomiting, Multiple joints and muscles painful, Aggravated ulcer with abdominal pain. Patient underwent lab tests and procedures which include blood pressure measurement 180/110 to 140/90 on an unspecified date. Therapeutic measures were not taken as a result of hypertension, chest pain, hypoesthesia, tinnitus, headache, abdominal pain, vomiting, pain. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Pain, Tinnitus, Ulcer
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 17:00 (Lot number: 33030BD) at the age of 70 years as dose 3 (booster), single for covid-19 immunization. Patients' medical history included rheumatoid arthritis, fibromyalgia, shrogen's syndrome, hypertension, heart murmur, ulcer, known allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included: lisinopril; multivitamins, Nyquil, Tylenol, magnesium. past drug history included: morphine, reaction(s) include known allergies: morphine, Demerol, reaction(s): known allergies: Demerol, tramadol, reaction(s): known allergies: tramadol, stadol, reaction(s): known allergies: stadol. Patient previously received Bnt162b2 (COVID 19, Pfizer, lot number=EW0167, location=Left arm), on 21Mar2021, at 12:00 am, when the patient was 74 years old, as DOSE 1 SINGLE, for COVID-19 immunization and Bnt162b2 (COVID 19 immunization, Pfizer, lot number=EW0167, location=Left arm) as DOSE 2, SINGLE, on 29Apr2021 at 12:00 am, when the patient was 70 years old, for Covid-19 immunization. On 20Nov2021patient experienced dose number: 3, On 20Nov2021 12:00 Persistent hypertension even with Lisinopril. Was taking 15mg OD (had weaned down over past year from 30mg BID) Had to go back to 30mg BID. Still ranging from 180/110 to 140/90, PVC's chest pain, left arm numbness with tinnitus, left arm numbness with tinnitus, headache, Aggravated ulcer with abdominal pain, vomiting, Multiple joints and muscles painful, Aggravated ulcer with abdominal pain. Patient underwent lab tests and procedures which include blood pressure measurement 180/110 to 140/90 on an unspecified date. Therapeutic measures were not taken as a result of hypertension, chest pain, hypoesthesia, tinnitus, headache, abdominal pain, vomiting, pain. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 17:00 (Lot number: 33030BD) at the age of 70 years as dose 3 (booster), single for covid-19 immunization. Patients' medical history included rheumatoid arthritis, fibromyalgia, shrogen's syndrome, hypertension, heart murmur, ulcer, known allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included: lisinopril; multivitamins, Nyquil, Tylenol, magnesium. past drug history included: morphine, reaction(s) include known allergies: morphine, Demerol, reaction(s): known allergies: Demerol, tramadol, reaction(s): known allergies: tramadol, stadol, reaction(s): known allergies: stadol. Patient previously received Bnt162b2 (COVID 19, Pfizer, lot number=EW0167, location=Left arm), on 21Mar2021, at 12:00 am, when the patient was 74 years old, as DOSE 1 SINGLE, for COVID-19 immunization and Bnt162b2 (COVID 19 immunization, Pfizer, lot number=EW0167, location=Left arm) as DOSE 2, SINGLE, on 29Apr2021 at 12:00 am, when the patient was 70 years old, for Covid-19 immunization. On 20Nov2021patient experienced dose number: 3, On 20Nov2021 12:00 Persistent hypertension even with Lisinopril. Was taking 15mg OD (had weaned down over past year from 30mg BID) Had to go back to 30mg BID. Still ranging from 180/110 to 140/90, PVC's chest pain, left arm numbness with tinnitus, left arm numbness with tinnitus, headache, Aggravated ulcer with abdominal pain, vomiting, Multiple joints and muscles painful, Aggravated ulcer with abdominal pain. Patient underwent lab tests and procedures which include blood pressure measurement 180/110 to 140/90 on an unspecified date. Therapeutic measures were not taken as a result of hypertension, chest pain, hypoesthesia, tinnitus, headache, abdominal pain, vomiting, pain. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: soreness of the arm; a "lump" on the armpit of the arm; a swelling of her lymph node under the left arm pit; 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 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of the arm"; SWELLING (non-serious) with onset 28Nov2021, outcome "not recovered", described as "a "lump" on the armpit of the arm"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "not recovered", described as "a swelling of her lymph node under the left arm pit". Therapeutic measures were taken as a result of pain in extremity, swelling, lymphadenopathy.  Additional information: One week later on 28Nov2021 the patient experienced a "lump" on the armpit of the arm, she received the vaccine in along with soreness of the arm.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Frequent bowel movements, Headache, Immunisation
Clinical narrative: I felt very tired and dizzy; I felt very tired and dizzy; The pain in the head (mainly on top and ears) is aggravating; pain at injection site; severe headache; feverish feeling; I received my booster dose (3rd dose); pass my stools 2 times at night; hand pain reappeared; could not sleep well as the headache and hand pain reappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Dec2021 10:00 (Lot number: FF8841, Expiration Date: Mar2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot# EL3247), administration date: 24Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, Lot# EL3248), administration date: 06Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 10:00, outcome "unknown", described as "I received my booster dose (3rd dose)"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 01Dec2021, outcome "unknown", described as "pass my stools 2 times at night"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "not recovered", described as "hand pain reappeared"; DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "I felt very tired and dizzy"; INSOMNIA (non-serious) with onset 01Dec2021, outcome "unknown", described as "could not sleep well as the headache and hand pain reappeared"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "pain at injection site"; HEADACHE (non-serious) with onset 01Dec2021 22:00, outcome "not recovered", described as "severe headache"; PYREXIA (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "feverish feeling"; HEADACHE (non-serious) with onset 02Dec2021, outcome "unknown", described as "The pain in the head (mainly on top and ears) is aggravating". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, headache, pyrexia, headache.  Additional information: The patient took acetaminophen 575 mg before sleeping for pain at injection site, severe headache and feverish feeling. The pain in the head (mainly on top and ears) is aggravating that need pain reducer again.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: I felt very tired and dizzy; I felt very tired and dizzy; The pain in the head (mainly on top and ears) is aggravating; pain at injection site; severe headache; feverish feeling; I received my booster dose (3rd dose); pass my stools 2 times at night; hand pain reappeared; could not sleep well as the headache and hand pain reappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Dec2021 10:00 (Lot number: FF8841, Expiration Date: Mar2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot# EL3247), administration date: 24Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, Lot# EL3248), administration date: 06Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 10:00, outcome "unknown", described as "I received my booster dose (3rd dose)"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 01Dec2021, outcome "unknown", described as "pass my stools 2 times at night"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "not recovered", described as "hand pain reappeared"; DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "I felt very tired and dizzy"; INSOMNIA (non-serious) with onset 01Dec2021, outcome "unknown", described as "could not sleep well as the headache and hand pain reappeared"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "pain at injection site"; HEADACHE (non-serious) with onset 01Dec2021 22:00, outcome "not recovered", described as "severe headache"; PYREXIA (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "feverish feeling"; HEADACHE (non-serious) with onset 02Dec2021, outcome "unknown", described as "The pain in the head (mainly on top and ears) is aggravating". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, headache, pyrexia, headache.  Additional information: The patient took acetaminophen 575 mg before sleeping for pain at injection site, severe headache and feverish feeling. The pain in the head (mainly on top and ears) is aggravating that need pain reducer again.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Drug ineffective, Dysstasia, Musculoskeletal stiffness
Clinical narrative: COVID-19 virus test: He acquired Covid/felt very ill; COVID-19 virus test: He acquired Covid/felt very ill; extreme joint pain; his hands were swollen; could not get up; had stiffness; pain; This is a spontaneous report received from a contactable reporter (Consumer) for a sponsored program (marketing program name not available).  A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (ongoing). Concomitant medications included: ENBREL taken for rheumatoid arthritis (ongoing); ENBREL (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2021, outcome "not recovered" and all described as "COVID-19 virus test: He acquired Covid/felt very ill"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "extreme joint pain"; PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "his hands were swollen"; DYSSTASIA (non-serious) with onset Mar2021, outcome "unknown", described as "could not get up"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "had stiffness"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain". Clinical details: On 09Nov2021, the patient had COVID-19 acquired and felt very ill. He reported he still had some side effects from it and he was unable to work. On an unknown date in Mar2021, the patient had extreme joint pain, could not get up and his hands were swollen after COVID-19 vaccination in Mar2021. The patient stated that he did not stop taking Enbrel while he had COVID-19 or when he was vaccinated. From last two months, on an unknown date in 2021, the patient was having pain and stiffness because of not receiving Enbrel. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (09Nov2021) he acquired covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test: He acquired Covid/felt very ill; COVID-19 virus test: He acquired Covid/felt very ill; extreme joint pain; his hands were swollen; could not get up; had stiffness; pain; This is a spontaneous report received from a contactable reporter (Consumer) for a sponsored program (marketing program name not available).  A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (ongoing). Concomitant medications included: ENBREL taken for rheumatoid arthritis (ongoing); ENBREL (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2021, outcome "not recovered" and all described as "COVID-19 virus test: He acquired Covid/felt very ill"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "extreme joint pain"; PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "his hands were swollen"; DYSSTASIA (non-serious) with onset Mar2021, outcome "unknown", described as "could not get up"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "had stiffness"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain". Clinical details: On 09Nov2021, the patient had COVID-19 acquired and felt very ill. He reported he still had some side effects from it and he was unable to work. On an unknown date in Mar2021, the patient had extreme joint pain, could not get up and his hands were swollen after COVID-19 vaccination in Mar2021. The patient stated that he did not stop taking Enbrel while he had COVID-19 or when he was vaccinated. From last two months, on an unknown date in 2021, the patient was having pain and stiffness because of not receiving Enbrel. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (09Nov2021) he acquired covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Productive cough, Respiratory tract congestion
Clinical narrative: Difficulty sleeping; I am having major chest congestion; Coughing up lots of mucus; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 13:00 (Lot number: Fr3182) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 25Aug2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Difficulty sleeping"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 26Nov2021, outcome "not recovered", described as "I am having major chest congestion"; PRODUCTIVE COUGH (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Coughing up lots of mucus"; DYSPNOEA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Shortness of breath". Therapeutic measures were taken as a result of insomnia, respiratory tract congestion, productive cough, dyspnoea.  Additional information: Patient received treatment OTC medicine. Prior to vaccination, was the patient does not diagnose with COVID-19. Since the vaccination, has the patient does not test for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash on front legs and arm lasted 24 hours; Itchy skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 14:30 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Red rash on front legs and arm lasted 24 hours"; PRURITUS (non-serious) with onset Dec2021, outcome "unknown", described as "Itchy skin".  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Immunisation, Interchange of vaccine products
Clinical narrative: Headache that has lasted six days, evolving into ocular migraine then regular migraine; Headache that has lasted six days, evolving into ocular migraine then regular migraine; Headache that has lasted six days, evolving into ocular migraine then regular migraine; Chills; Nausea; Diarrhea persisting the same length oftime.; Dose received: 3 / dose number = 3; Off label use; Interchange of vaccine product; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 at 14:00 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot Number: 019821A, Route of Administration: Unknown, Anatomical Location: Right arm), administration date: 24Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot Number: 045b21A, Route of Administration: Unknown, Anatomical Location: Left arm), administration date: 21Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Dose received: 3 / dose number = 3"; OFF LABEL USE (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Interchange of vaccine product"; HEADACHE (non-serious), OPHTHALMIC MIGRAINE (non-serious), MIGRAINE (non-serious), CHILLS (non-serious), NAUSEA (non-serious), DIARRHOEA (non-serious) all with onset 29Nov2021 at 15:00, outcome "not recovered", and all described as "Headache that has lasted six days, evolving into ocular migraine then regular migraine". Therapeutic measures were not taken as a result of headache, ophthalmic migraine, migraine, chills, nausea and diarrhoea.  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 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Off label use, Ophthalmic migraine
Clinical narrative: Headache that has lasted six days, evolving into ocular migraine then regular migraine; Headache that has lasted six days, evolving into ocular migraine then regular migraine; Headache that has lasted six days, evolving into ocular migraine then regular migraine; Chills; Nausea; Diarrhea persisting the same length oftime.; Dose received: 3 / dose number = 3; Off label use; Interchange of vaccine product; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 at 14:00 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot Number: 019821A, Route of Administration: Unknown, Anatomical Location: Right arm), administration date: 24Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot Number: 045b21A, Route of Administration: Unknown, Anatomical Location: Left arm), administration date: 21Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Dose received: 3 / dose number = 3"; OFF LABEL USE (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Interchange of vaccine product"; HEADACHE (non-serious), OPHTHALMIC MIGRAINE (non-serious), MIGRAINE (non-serious), CHILLS (non-serious), NAUSEA (non-serious), DIARRHOEA (non-serious) all with onset 29Nov2021 at 15:00, outcome "not recovered", and all described as "Headache that has lasted six days, evolving into ocular migraine then regular migraine". Therapeutic measures were not taken as a result of headache, ophthalmic migraine, migraine, chills, nausea and diarrhoea.  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 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Tinnitus, Urticaria
Clinical narrative: Tinnitus; Hives; raised red rash left chest, sporadic over body; raised red rash left chest, sporadic over body; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.    A 66-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Nov2021 at 10:15 (Lot number: 33030BD) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypertension (HTN)" (unspecified if ongoing); "Asthma" (unspecified if ongoing) and "COVID-19" (unspecified if ongoing). Concomitant medications included: VALSARTAN; ATENOLOL; NORVASC; PROTONIX; ASPIRIN and HTZ. Past drug history included: Naproxen, reaction: "Drug allergy", notes: known allergies: Naproxen and Codeine, reaction: "Drug allergy", notes: known allergies: codeine.  The following information was reported: TINNITUS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Tinnitus"; URTICARIA (non-serious) with onset 03Dec2021, outcome "recovering", described as "Hives"; RASH ERYTHEMATOUS (non-serious), RASH PAPULAR (non-serious) both with onset 03Dec2021, outcome "recovering", and both described as "raised red rash left chest, sporadic over body". Therapeutic measures were not taken as a result of tinnitus, urticaria, rash erythematous and rash papular.  Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Pain in extremity
Clinical narrative: Severe pain in left armpit lasting for more than one day (still painful at time of reporting); Pain down entire left arm for about 12 hours after shot but this has subsided; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 at 14:45 (Lot number: FF2589) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included None. Concomitant medication(s) included INFLUENZA VACCINE taken for Immunization, start date: 01Dec2021, stop date: 01Dec2021; MUCINEX and AZITHROMYCIN. Vaccination history included Bnt162b2 (DOSE 1, SINGLE; Lot number: EN5318; Anatomical site: left arm; Route of administration: intramuscular; Administration time: 15:00), administration date: 28Jan2021, when the patient was 38 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EN5318; Anatomical site: left arm; Route of administration: intramuscular; Administration time: 15:00), administration date: 18Feb2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported IMMUNISATION (non-serious) with onset 03Dec2021 at 14:45, outcome unknown; AXILLARY PAIN (non-serious) with onset 03Dec2021 at 16:00, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021 at 16:00, outcome recovering. Therapeutic measures were not taken as a result of axillary pain and pain in extremity.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pain woke her up in the middle of the night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Left side lymph nodes under armpit swollen one day after vaccination; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient (Pfizer colleague).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Dec2021 at 11:00 (Lot number: unknown) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Iodine contrast media allergy" , notes: Known allergy: iodine contrast dye. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Route of administration: Unspecified), administration date: 01Mar2021, when the patient was 43 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Route of administration: Unspecified), administration date: 22Mar2021, when the patient was 43 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 11:00, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 03Dec2021 at 21:00, outcome "not recovered", described as "Left side lymph nodes under armpit swollen one day after vaccination". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Prior to 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. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Headache 48 hours after shot; Fever for 36 hours; Body aches for 24 hours; Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there; Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there; Thirsty; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 at 12:00 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: other medical history: no; known allergies: no. Concomitant medication(s) included: BOVINE COLOSTRUM; BRYONIA and ZEEL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; Anatomical site: left arm: Administration time: 11:00), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8733; Anatomical site: left arm; Administration time: 11:00), administration date: 30Mar2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 01Dec2021 at 20:00, outcome "recovered" (03Dec2021 at 08:00), described as "Fever for 36 hours"; PAIN (non-serious) with onset 01Dec2021 at 20:00, outcome "recovered" (02Dec2021 at 20:00), described as "Body aches for 24 hours"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), all with onset 01Dec2021 at 20:00, outcome "recovering", all described as "Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there"; THIRST (non-serious) with onset 01Dec2021 at 20:00, outcome "recovering", described as "Thirsty"; HEADACHE (non-serious) with onset 03Dec2021 at 12:00, outcome "recovering", described as "Headache 48 hours after shot". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy, lymph node pain, thirst and headache.  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 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Headache 48 hours after shot; Fever for 36 hours; Body aches for 24 hours; Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there; Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there; Thirsty; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 at 12:00 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: other medical history: no; known allergies: no. Concomitant medication(s) included: BOVINE COLOSTRUM; BRYONIA and ZEEL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; Anatomical site: left arm: Administration time: 11:00), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8733; Anatomical site: left arm; Administration time: 11:00), administration date: 30Mar2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 01Dec2021 at 20:00, outcome "recovered" (03Dec2021 at 08:00), described as "Fever for 36 hours"; PAIN (non-serious) with onset 01Dec2021 at 20:00, outcome "recovered" (02Dec2021 at 20:00), described as "Body aches for 24 hours"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), all with onset 01Dec2021 at 20:00, outcome "recovering", all described as "Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there"; THIRST (non-serious) with onset 01Dec2021 at 20:00, outcome "recovering", described as "Thirsty"; HEADACHE (non-serious) with onset 03Dec2021 at 12:00, outcome "recovering", described as "Headache 48 hours after shot". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy, lymph node pain, thirst and headache.  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 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Nasal congestion, Pain
Clinical narrative: 24 hours after the shot my daughter became extremely weak and sore; 24 hours after the shot my daughter became extremely weak and sore; High fever of 103.4; Lots of congestion; Cough; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Dec2021 at 16:00 (Lot number: FL0007) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There was no concomitant medication. The following information was reported: ASTHENIA (non-serious) with onset 04Dec2021 at 17:00, outcome "not recovered", described as "24 hours after the shot my daughter became extremely weak and sore"; PAIN (non-serious) with onset 04Dec2021 at 17:00, outcome "not recovered", described as "24 hours after the shot my daughter became extremely weak and sore"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "High fever of 103.4"; NASAL CONGESTION (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Lots of congestion"; COUGH (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Cough". The events "Extremely weak", "Sore", "High fever of 103.4", "Lots of congestion" and "Cough" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether therapeutic measures were taken as a result of the events asthenia, pain, pyrexia, nasal congestion and cough.  Additional Information: It was reported that around midnight she developed a high fever and they had been battling it all night. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 24 hours after the shot my daughter became extremely weak and sore; 24 hours after the shot my daughter became extremely weak and sore; High fever of 103.4; Lots of congestion; Cough; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Dec2021 at 16:00 (Lot number: FL0007) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There was no concomitant medication. The following information was reported: ASTHENIA (non-serious) with onset 04Dec2021 at 17:00, outcome "not recovered", described as "24 hours after the shot my daughter became extremely weak and sore"; PAIN (non-serious) with onset 04Dec2021 at 17:00, outcome "not recovered", described as "24 hours after the shot my daughter became extremely weak and sore"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "High fever of 103.4"; NASAL CONGESTION (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Lots of congestion"; COUGH (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Cough". The events "Extremely weak", "Sore", "High fever of 103.4", "Lots of congestion" and "Cough" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether therapeutic measures were taken as a result of the events asthenia, pain, pyrexia, nasal congestion and cough.  Additional Information: It was reported that around midnight she developed a high fever and they had been battling it all night. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.