chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Adult female had COVID after Pfizer vaccine; Adult female had COVID after Pfizer vaccine; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.On an unknown date, patient had COVID after Pfizer vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Drug ineffective, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 (Age time of vaccination; 77 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On an unspecified date in Jul2021, the patient experienced fatigue, diarrhoea, nasal congestion, and labored cough. The patient underwent lab tests and procedures which included Covid test/nasal swab: positive on 02Aug2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 (Age time of vaccination; 77 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On an unspecified date in Jul2021, the patient experienced fatigue, diarrhoea, nasal congestion, and labored cough. The patient underwent lab tests and procedures which included Covid test/nasal swab: positive on 02Aug2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Infection, Pyrexia
Clinical narrative: Diagnosed with Covid 19; Diagnosed with Covid 19; Ran a fever and miserable for three days; Infections; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 1, single both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the Pfizer two shots in April of 2021. On 29Jul2021, the patient experienced diagnosed with Covid 19. Ran a fever and miserable for three days in 2021. Patient thought breakthrough infections was higher than being reported in 2021. Should be tracked. The patient underwent lab tests and procedures which included body temperature: fever in 2021 and sars-cov-2 test: diagnosed with covid 19 on 29Jul2021. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid 19; Diagnosed with Covid 19; Ran a fever and miserable for three days; Infections; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 1, single both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the Pfizer two shots in April of 2021. On 29Jul2021, the patient experienced diagnosed with Covid 19. Ran a fever and miserable for three days in 2021. Patient thought breakthrough infections was higher than being reported in 2021. Should be tracked. The patient underwent lab tests and procedures which included body temperature: fever in 2021 and sars-cov-2 test: diagnosed with covid 19 on 29Jul2021. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure via breast milk, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A male baby of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via trans mammary route on 04Jun2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0217) on 25Jun2021 as single dose for COVID-19 immunization. Patient had no medical history or known allergies. Patient concomitantly received prenatal multivitamins via trans mammary route within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. On 04Jun2021, patient received first dose of vaccine via trans mammary route (Vaccine exposure via breast milk) and later received second dose on 25Jun2021. On 02Aug2021, patient underwent lab test of Abbott BinaxNOW (Nasal Swab) and was tested positive, diagnosed with COVID-19. As per reporter (patient's mother), since her child got COVID-19, so the antibodies transferred through her breastmilk wasn't enough to protect him. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100998441 Mother case
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal, Vertigo
Clinical narrative: Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; vertigo; This is a spontaneous report from a contactable nurse (psychiatric nurse at a mental institute; reporting for the second family member, who also had the same symptoms, as reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient, who was described as another family member of the reporting nurse and had the reporting nurse's DNA, further described as another sibling, experienced "brain fog, usually when you kind of feel retarded, like you had a concussion or stroke or high altitude sickness, like less oxygen in the brain, you just felt kind of gazed or confused or you felt extremely tired." The reporting nurse didn't know if there was a bad batch, but they got like a horrible batches of Pfizer; had no clue and did not know if it got mixed with something else. The reporting nurse also mentioned that they (all) had tiredness; they went to sleep for 8 hours, woke up for 2 or 3 hours, and got some coffee, then were really tired, then had to lay in bed and deal with vertigo on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: There is a reasonable possibility that the event fatigue was related to BNT162b2 based on known drug safety profile. The association between the events feeling abnormal and confusion can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Herpes zoster
Clinical narrative: Shingles; pain in eye; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28May2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included appendectomy in 2011, chickenpox as a child, and also have sulfonamide (sulfa) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included levonorgestrel (MANUFACTURER UNKNOWN) for birth control on unknown date, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021, within 28 days of second dose of vaccine, the patient was diagnosed with Shingles within 28days of second dose of vaccine. This was first experience with shingles. Previously, the patient had chickenpox as a child. The patient was in good general health. Diagnosed with shingles within 2 days of symptoms and took prescription Valtrex. The patient visited to emergency room at eye hospital due to pain in eye. Therapeutic measures were taken as a result of adverse event shingles and included treatment with prescription drug Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The events singles resulted in doctor or other healthcare professional office/clinic visit. The event pain in eye resulted in emergency room/department visit or urgent care. The clinical outcome of the event pain in eye and shingles was recovering at the time of this report.    The batch numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebellar infarction, SARS-CoV-2 test
Clinical narrative: Cerebellum stroke, flocculus modular area; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 14May2021 09:00 (Batch/Lot Number: EW0172) (at age 53-year-old) as dose 2, single for covid-19 immunisation. The first dose was received on 23Apr2021 13:00 on the left arm. There were no medical history. Concomitant medication included CBD for sleep and occasional calcium supplement. The patient experienced cerebellum stroke, flocculus modular area on 04Jun2021 05:30. The patient was hospitalized for cerebellum stroke, flocculus modular area (cerebellar infarction) for 3 days. Event resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jul2021. Medication, testing/monitoring, physical therapy was given as treatment. Outcome of the event was recovered with sequel.  Patient was not diagnosed with COVID-19 prior to vaccination and has been tested on 11Jul2021 (nasal swab: negative).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid and he had the Pfizer vaccine; Tested positive for Covid and he had the Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: unknown; expiration date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history was not provided. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA). On an unspecified date patient tested positive for covid and patient has not had any issues other than loss of smell. Patient had the Pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: I rush to the hospital with abdominal pain; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient was a bariatric patient and had gastric sleeve done. Concomitant medication was not reported. On an unspecified date, the patient rushed to the hospital with abdominal pain. The event caused hospitalization. The patient said that he just wanted to know was there any connection between the COVID-19 vaccine in bariatric patient that get bariatric sleeve. he outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dyskinesia, Eye movement disorder, Feeling abnormal
Clinical narrative: Not feeling right; No idea where I was; Struggling to stay on the chair; blacked out; had a wave of heat hit my body/heat rushed back into my body; sweat/ skin was dripping; Head felt like it was being squeezed; Eyes rolled into the back of my head; my whole body was convulsing; I was ice cold; my body jerked; This is a spontaneous report from a contactable consumer via COVAES. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 02Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that within 2 minutes the patient started not feeling right; he woke up with his head against the shelf and had no idea where he was. The person who gave the shot was nowhere to be found and his wife and son were talking a few feet away. The patient's wife quickly noted he was struggling to stay on the chair and ran over to help. The patient told her he was not okay and then blacked out. Within about a minute the patient had a wave of heat hit his body; it felt like he was in an oven. The patient  sweat right through his shirt and his skin was dripping in sweat; his head felt like it was being squeezed and he blacked out again. The patient's wife told him that his eyes rolled into the back of his head, his whole body was convulsing, and he was ice cold. After 1 minute of convulsing, he woke up again; a few minutes passed until the heat rushed back into his body. He lost consciousness for another minute while his body jerked, and his eyes were in the back of his head. He woke up to the paramedics helping him onto the stretcher. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was received. The events required an emergency room visit. The clinical outcomes of the events were recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Not feeling right; No idea where I was; Struggling to stay on the chair; blacked out; had a wave of heat hit my body/heat rushed back into my body; sweat/ skin was dripping; Head felt like it was being squeezed; Eyes rolled into the back of my head; my whole body was convulsing; I was ice cold; my body jerked; This is a spontaneous report from a contactable consumer via COVAES. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 02Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that within 2 minutes the patient started not feeling right; he woke up with his head against the shelf and had no idea where he was. The person who gave the shot was nowhere to be found and his wife and son were talking a few feet away. The patient's wife quickly noted he was struggling to stay on the chair and ran over to help. The patient told her he was not okay and then blacked out. Within about a minute the patient had a wave of heat hit his body; it felt like he was in an oven. The patient  sweat right through his shirt and his skin was dripping in sweat; his head felt like it was being squeezed and he blacked out again. The patient's wife told him that his eyes rolled into the back of his head, his whole body was convulsing, and he was ice cold. After 1 minute of convulsing, he woke up again; a few minutes passed until the heat rushed back into his body. He lost consciousness for another minute while his body jerked, and his eyes were in the back of his head. He woke up to the paramedics helping him onto the stretcher. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was received. The events required an emergency room visit. The clinical outcomes of the events were recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Not feeling right; No idea where I was; Struggling to stay on the chair; blacked out; had a wave of heat hit my body/heat rushed back into my body; sweat/ skin was dripping; Head felt like it was being squeezed; Eyes rolled into the back of my head; my whole body was convulsing; I was ice cold; my body jerked; This is a spontaneous report from a contactable consumer via COVAES. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 02Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that within 2 minutes the patient started not feeling right; he woke up with his head against the shelf and had no idea where he was. The person who gave the shot was nowhere to be found and his wife and son were talking a few feet away. The patient's wife quickly noted he was struggling to stay on the chair and ran over to help. The patient told her he was not okay and then blacked out. Within about a minute the patient had a wave of heat hit his body; it felt like he was in an oven. The patient  sweat right through his shirt and his skin was dripping in sweat; his head felt like it was being squeezed and he blacked out again. The patient's wife told him that his eyes rolled into the back of his head, his whole body was convulsing, and he was ice cold. After 1 minute of convulsing, he woke up again; a few minutes passed until the heat rushed back into his body. He lost consciousness for another minute while his body jerked, and his eyes were in the back of his head. He woke up to the paramedics helping him onto the stretcher. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was received. The events required an emergency room visit. The clinical outcomes of the events were recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: Kind of achy all over; Feel achy; Feel of weak; Weak; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old (also the age at the time of vaccination) patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in arm Left on 02Aug2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. There were no medical history concomitant medications.  On 03Aug2021, the patient felt weak and like kind of achy all over.  No treatment was provided but the nurse who gave the patient the shot instructed that if the patient had any pain or anything, just to take Tylenol. Outcome of the events were unknown.   Information regarding the batch/lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pruritus, Rash, Vaccination site pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via COVID-19 VaccineReporting System. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Aug2021 10:00 (Lot Number: EW0170; at the age of 55-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, allergy to sesame seeds and penicillin. The patient's concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 03Aug2021 17:00, The patient experienced rash, itching at the injection site, and across the chest and up towards the neck, nausea, and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as the result of the events which included Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via COVID-19 VaccineReporting System. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Aug2021 10:00 (Lot Number: EW0170; at the age of 55-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, allergy to sesame seeds and penicillin. The patient's concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 03Aug2021 17:00, The patient experienced rash, itching at the injection site, and across the chest and up towards the neck, nausea, and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as the result of the events which included Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Burning sensation, Hot flush, Muscle tightness
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This 44-year-old female consumer (patient) reported for herself that: A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection and Batch/Lot Number: EW0187), dose 1 via an unspecified route of administration, administered in Arm Right on Jun2021 at 02:00 PM as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included Thyroidectomy, Food Sensitivities, Allergies to cashew, Allergies to peanuts, Allergies to gluten, Allergies to wheat, Penicillin allergy, Hair dye sensitivity from unknown date and unknown if ongoing. Concomitant medication(s) included SYNTHROID 100 Mg taken for an unspecified indication, start and stop date were not reported. Patient did not suffer from COVID prior vaccination and patient did not COVID tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Anaphylaxis on 05Jun2021, within 2 minutes my arm began to burn, Hot flash, and My neck began to tighten by 3 minutes on 05Jun2021. Benadryl was received as treatment for all the events. There was no other vaccine in four weeks. On unspecified date in 2021, the events were resolved with sequelae. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a non-contactable consumer (patient). This 61-year-old male patient received dose 1 of BNT162B2 on 24Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included secondary progressive multiple sclerosis, nerve pain, anxiety, hypertension, itchy, skin red, sore, immune system compromised, broke fingers, flare ups, and painful. Concomitant medications included ocrelizumab (OCREVUS), hydrochlorothiazide, amlodipine, metoprolol, alprazolam (XANAX), naltrexone, baclofen, methylprednisolone (SOLUMEDROL), diphenhydramine (BENADRYL), and paracetamol (TYLENOL) from unknown dates for unknown indications. On 25Mar2021 the patient experienced nausea. The outcome of nausea was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : LRN4301673 Genentech
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, COVID-19, Chest X-ray
Clinical narrative: COVID test, which yielded a positive result (03Aug2021 10AM); COVID test, which yielded a positive result (03Aug2021 10AM); Fainted; Unresponsive for 20 minutes; Hit his head while falling; Hit his head/ received 7 staples in head; This is a spontaneous report from a contactable consumer.A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 13Mar2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization.Medical history included heart bypass (5 years ago), prostate removed (2-3 years ago), lower lumbar surgery (10 years ago) and cholesterol.Concomitant medications within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) QD, blood thinner QD taken for an unspecified indication and cholesterol medication QD taken for cholesterol. There was no known allergies.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, had the patient been tested for COVID-19 was mentioned as no.It was reported that the patient attended a conference from 26Jul2021 to 30Jul2021 and returned home on 30Jul2021 where he presented with fever and dizziness. Fever self-reported at 101 degrees, symptoms persisted through 02Aug2021. On the morning of 02Aug2021, while preparing coffee at home he fainted and hit his head while falling resulting in being unresponsive for 20 minutes. Ambulance called and withheld taken to hospital. Woke up on his own after 20 min. Received 7 staples in head and hospital performed EKG, BP, chest X-ray, CAT scan, bloodwork and urinalysis. All tests were clean except for the COVID test, which yielded a positive result (03Aug2021, 10AM). Sample sent for variant confirmation. The patient was placed on fluids, antibiotics, steroids and was quarantined at the hospital. Also stated between 6 and 9 other conference attendees tested positive for COVID. As of 04Aug2021 (10AM), withheld reports fever has broken, no longer dizzy, feels better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for 3 days. The patient received treatment with regard to events. On 02Aug2021, patient recovered from loss of consciousness whereas patient was recovering  from events syncope, fall, head injury and covid-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Fall, Head injury, Loss of consciousness
Clinical narrative: COVID test, which yielded a positive result (03Aug2021 10AM); COVID test, which yielded a positive result (03Aug2021 10AM); Fainted; Unresponsive for 20 minutes; Hit his head while falling; Hit his head/ received 7 staples in head; This is a spontaneous report from a contactable consumer.A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 13Mar2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization.Medical history included heart bypass (5 years ago), prostate removed (2-3 years ago), lower lumbar surgery (10 years ago) and cholesterol.Concomitant medications within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) QD, blood thinner QD taken for an unspecified indication and cholesterol medication QD taken for cholesterol. There was no known allergies.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, had the patient been tested for COVID-19 was mentioned as no.It was reported that the patient attended a conference from 26Jul2021 to 30Jul2021 and returned home on 30Jul2021 where he presented with fever and dizziness. Fever self-reported at 101 degrees, symptoms persisted through 02Aug2021. On the morning of 02Aug2021, while preparing coffee at home he fainted and hit his head while falling resulting in being unresponsive for 20 minutes. Ambulance called and withheld taken to hospital. Woke up on his own after 20 min. Received 7 staples in head and hospital performed EKG, BP, chest X-ray, CAT scan, bloodwork and urinalysis. All tests were clean except for the COVID test, which yielded a positive result (03Aug2021, 10AM). Sample sent for variant confirmation. The patient was placed on fluids, antibiotics, steroids and was quarantined at the hospital. Also stated between 6 and 9 other conference attendees tested positive for COVID. As of 04Aug2021 (10AM), withheld reports fever has broken, no longer dizzy, feels better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for 3 days. The patient received treatment with regard to events. On 02Aug2021, patient recovered from loss of consciousness whereas patient was recovering  from events syncope, fall, head injury and covid-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope, Urine analysis, Vaccination failure
Clinical narrative: COVID test, which yielded a positive result (03Aug2021 10AM); COVID test, which yielded a positive result (03Aug2021 10AM); Fainted; Unresponsive for 20 minutes; Hit his head while falling; Hit his head/ received 7 staples in head; This is a spontaneous report from a contactable consumer.A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 13Mar2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization.Medical history included heart bypass (5 years ago), prostate removed (2-3 years ago), lower lumbar surgery (10 years ago) and cholesterol.Concomitant medications within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) QD, blood thinner QD taken for an unspecified indication and cholesterol medication QD taken for cholesterol. There was no known allergies.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, had the patient been tested for COVID-19 was mentioned as no.It was reported that the patient attended a conference from 26Jul2021 to 30Jul2021 and returned home on 30Jul2021 where he presented with fever and dizziness. Fever self-reported at 101 degrees, symptoms persisted through 02Aug2021. On the morning of 02Aug2021, while preparing coffee at home he fainted and hit his head while falling resulting in being unresponsive for 20 minutes. Ambulance called and withheld taken to hospital. Woke up on his own after 20 min. Received 7 staples in head and hospital performed EKG, BP, chest X-ray, CAT scan, bloodwork and urinalysis. All tests were clean except for the COVID test, which yielded a positive result (03Aug2021, 10AM). Sample sent for variant confirmation. The patient was placed on fluids, antibiotics, steroids and was quarantined at the hospital. Also stated between 6 and 9 other conference attendees tested positive for COVID. As of 04Aug2021 (10AM), withheld reports fever has broken, no longer dizzy, feels better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for 3 days. The patient received treatment with regard to events. On 02Aug2021, patient recovered from loss of consciousness whereas patient was recovering  from events syncope, fall, head injury and covid-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Haemoptysis, Peripheral swelling
Clinical narrative: dry eyes; dry mouth; Mucous with a little blood; arm swelled up associated it with vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 43 units not provided) received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced dry eyes, dry mouth, mucous with a little blood and arm swelled up so associated it with vaccine. Patient asked what happened if he did not take the second dose. He doesn't think he wanted to take the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 with symptoms; Tested positive for COVID-19 with symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose number unknown, single (Age at vaccination was 75 Years) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient underwent Nasal Swab test on 27Jul2021 which result was positive. Symptoms include diarrhea, nasal congestion, labored cough and fatigue. AE results in Emergency room/department or urgent care. The patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: she is immunocompromised; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE and  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was inquiring as to if she would be an appropriate candidate for a clinical trial we have. The patient has gotten both doses of the Pfizer vaccine. The patient stated that she was immunocompromised, and her doctor has written a letter that she was a candidate for a 3rd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis and was rushed to the hospital where she had to undergo emergency surgery; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ewo186), via an unspecified route of administration on 11Jun2021 (at the age of 23-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated exactly one week after receiving her first dose of the vaccine on 19Jun2021, she had appendicitis and was rushed to the hospital where she had to undergo emergency surgery. The event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient considered the event as serious as it was life-threatening, caused/prolonged hospitalization (hospitalized for 2 days) and Disabling/Incapacitating. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of appendicitis was surgery. The event outcome was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 29-year-old non-pregnant female patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on an unknown date in Apr2021 (Batch/Lot number was not reported, age at vaccination: 28-year-old) as dose 2, single and dose 1 via an unspecified route of administration, administered in Arm Left on an unknown date in Mar2021 (Batch/Lot number was not reported, age at vaccination: 28-year-old) as dose 1, single for covid-19 immunisation administered in clinic. The patient was not pregnant at the time of vaccination. No medical history was reported. The patient had no known allergies. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has been tested for covid-19 since the vaccination. On 16Jul2021, the patient contracted covid-19 and tested positive for at least 10 days. No treatment was received for the event. The patient underwent lab tests and procedures which included nasal swab test on 15Jul2021 and result was positive, on 19Jul2021 and result was positive, on 23Jul2021 and result was negative. The outcome of event contracted covid-19 and tested positive for at least 10 days (covid-19) was recovered on an unknown date in Jul2021. No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Headache, Occupational exposure to SARS-CoV-2
Clinical narrative: This is a spontaneous report from a contactable other hcp (nurse). A 4-decade-old (at late 30s) male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's wife reported she tested positive for COVID-19 after receiving both doses of the Moderna COVID-19 vaccine. She reports she was indirectly exposed to a patient who had not been vaccinated on Friday and swabbed the same day. The PCR test results came back positive for COVID-19 yesterday, 01Aug2021. Patient who was also fully vaccinated with the Pfizer vaccine, was directly exposed to an unvaccinated patient and also tested positive for COVID-19 via PCR testing (medically significant). The reporting HCP states she tested positive after exposure, but was completely asymptomatic, while the patient experienced a dry cough and a little headache for one day, the patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Jul2021. Declined to provide any identifiers other than initials, age, and gender. No additional information obtained. Safety team follow-up consent provided for reporter. The clinical outcome of event headache and dry cough was recovered on 31Jul2021 and for all other events outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other hcp (nurse). A 4-decade-old (at late 30s) male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's wife reported she tested positive for COVID-19 after receiving both doses of the Moderna COVID-19 vaccine. She reports she was indirectly exposed to a patient who had not been vaccinated on Friday and swabbed the same day. The PCR test results came back positive for COVID-19 yesterday, 01Aug2021. Patient who was also fully vaccinated with the Pfizer vaccine, was directly exposed to an unvaccinated patient and also tested positive for COVID-19 via PCR testing (medically significant). The reporting HCP states she tested positive after exposure, but was completely asymptomatic, while the patient experienced a dry cough and a little headache for one day, the patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Jul2021. Declined to provide any identifiers other than initials, age, and gender. No additional information obtained. Safety team follow-up consent provided for reporter. The clinical outcome of event headache and dry cough was recovered on 31Jul2021 and for all other events outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash/Hives all over torso; Rash/Hives all over torso; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA1484) via an unspecified route of administration in the left arm on 03Aug2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and allergies to latex, adhesive and multiple foods. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. 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. The patient did not receive any concomitant medications within two weeks of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Aug2021 at 13:30, the patient experienced rash/hives all over torso. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events rash/hives all over torso was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.