chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 51-years-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Product: Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nose is bleeding. Caller, inquiring on behalf of her husband, would like to know whether their side effect; bloody nose, was related to the COVID-19 vaccine. She stated they already reported AE to previous agent. Caller reports that her husband received the Pfizer covid vaccine yesterday at about 1:00. At 10:00, last night, his nose started bleeding and has not stopped. He received the vaccine on his left side and only the left side of his nose is bleeding. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Rhinorrhoea, Seasonal allergy, Sneezing
Clinical narrative: allergies due to the wind blowing outside; started having runny nose; sneezing; itchy eyes; This is a spontaneous report from Pfizer sponsored program and medical information team. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, caller (name) reported that she received the 1st dose of the vaccine last 13Mar2021 and she was scheduled on Saturday for her second dose which was 03Apr2021. She was having allergies due to the wind blowing outside and started having runny nose, sneezing and itchy eyes on an unspecified date in Mar2021. She was consulting if she could take the second dose or if she needs to wait for a while. Also, wanted to know if a person would be hurt if they take a vaccine without knowing that they got the COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive covid test the second week of March; positive covid test the second week of March; This is a spontaneous report received from a  contactable physician reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had a positive covid test the second week of March and has been hospitalized and on a ventilator for 3 weeks. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Feeling abnormal, Pain
Clinical narrative: received the first covax 2 weeks ago and is still feeling bad; Fatigue; fever; body aches; dry cough; runny nose; diarrhea; vomiting; This is a spontaneous report received from a contactable female consumer (patient) via Pfizer sponsored program . A female patient of unspecified age received BNT162B2 (BNT162B2, formulation: solution for injection, lot no: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the patient had received covax 2 weeks ago and was still feeling bad. she had Fatigue, fever, body aches and dry cough with runny nose and diarrhea and vomiting. She was scheduled for the second covax on 06 Apr 2021 and was asking whether to take second dose if she is still feeling this bad. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: received the first covax 2 weeks ago and is still feeling bad; Fatigue; fever; body aches; dry cough; runny nose; diarrhea; vomiting; This is a spontaneous report received from a contactable female consumer (patient) via Pfizer sponsored program . A female patient of unspecified age received BNT162B2 (BNT162B2, formulation: solution for injection, lot no: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the patient had received covax 2 weeks ago and was still feeling bad. she had Fatigue, fever, body aches and dry cough with runny nose and diarrhea and vomiting. She was scheduled for the second covax on 06 Apr 2021 and was asking whether to take second dose if she is still feeling this bad. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: sore tongue; This is spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248, Expiry date: Unknown), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient's medical history included she had a lot of wax and dry skin and her ear was compacted. Concomitant medications of patient were not reported. On an unspecified date patient experienced sore tongue. She states after her 1st dose 15Jan2021 she got a sore tongue, her tongue got sore and she thought it may have been something that she ate, it was nothing drastic it stayed sore. Outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Glomerulonephritis minimal lesion, Nephropathy, Nephrotic syndrome, Renal tubular disorder
Clinical narrative: minimal change disease; Nephrotic syndrome; kidney disease; tubular damage to her kidneys; This is a spontaneous report received from a contactable consumer and from a Pfizer-sponsored program. A 70-year-old female consumer received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced minimal change disease, nephrotic syndrome, kidney disease/"tubular damage" to her kidneys in 2021.  The patient received her 2nd Pfizer vaccine dose on 28Jan21. She was then hospitalized for 12 days. Her diagnosis was minimal change disease/ Nephrotic syndrome/ kidney disease. She has had tubular damage to her kidneys. Reporter is asking if there is any information/data on this particular side effect, how often has this happened to other people. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Swollen tongue
Clinical narrative: tongue was swelling; mouth felt like it was stretching/she sounded funny; This is a spontaneous report. A contactable female consumer (Pa-tient herself) of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not re-ported.The patient stated that last Saturday she had taken first dose of covid vaccine. After vac-cine she sat in her car for about 15 minutes. She Said her mouth felt like it was stretching, and tongue was swelling. Had called fiance said she sounded funny. she stated that she came across an article which stated that if one is allergic to vaccine then one should not get the second dose of the vaccine.The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Had Feeling Similar To Covid Effects; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) at SINGLE DOSE (Took Her 2 Covid Shots) for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. Patient reported caught Covid in Nov2020. Then she took her 2 Covid Shots By Mar2021. On 12Mar2021, she was feeling similar to covid effects and resolved on 29Mar2021.    No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Hypoaesthesia, Muscular weakness, SARS-CoV-2 test
Clinical narrative: numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a spontaneous report from a contactable consumer (reporting for himself). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Leg Left on 11Mar2021 at 05:30 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included transverse myelitis. The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and terbinafine, both for unspecified indication and experienced allergies. On 11Mar2021 at 10:30, the patient experienced numbness and weakness in his legs and some difficulty urinating. The patient was hospitalized. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The outcome of the events was recovering.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient got the vaccine 18 days before and the contracted COVID; the patient got the vaccine 18 days before and the contracted COVID; This is a spontaneous report received from a contactable consumer. This consumer reported for a friend (patient) that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient got the vaccine 18 days before and the contracted COVID. The friend wanted to know should he proceed with the second dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She received her first dose on 09Mar2021 and tested positive for Covid on 29Mar2021.; She received her first dose on 09Mar2021 and tested positive for Covid on 29Mar2021.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EJ1686), at same age, intramuscular administered in arm left on 09Mar2021 as single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced she received her first dose on 09Mar2021 and tested positive (sars-cov-2 test positive) for covid on 29Mar2021 (drug ineffective) (medically significant) on 29Mar2021. Patient stated that she had symptoms starting Saturday, Saturday the 27Mar2021. And she tested positive Monday 29Mar2021. Patient did not receive the treatment for COVID. The outcome of the event was unknown.  Follow-up (02Apr2021): New information reported via a contactable consumer (patient) includes: patient details, medical history details, suspect medicine details, and event details.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Headache
Clinical narrative: Sevier Low Back Pain; Sevier low back pain; Slite Headacke; This is a spontaneous report received from a contactable consumer. A 72-year-old consumer(patient) reported in response to Non-HCP letter sent to consumer which included that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:15 (Batch/Lot Number: EN6201; Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Medical history included knee operation from Jun2020 and ongoing Osteoarthritis Knee surgery Pertinent details: 06-2020 , ongoing osteoarthritis Back, Hips and Neck In stop date : she mention osteoarthritis , cerebrovascular accident from Jun2017 to an unknown date Family medical history: Mother- Stroke & COPD Father- Lung Cancer & COPD; Mezolthezmalona Grandmother- Stroke , arthralgia, hormone replacement therapy ocular discomfort , hypotonia Concomitant medications included paracetamol (TYLENOL) taken for arthritis, arthralgia oestrogens conjugated (PREMARIN) taken for hormone replacement therapy orphenadrine taken for hypotonia . The patient experienced severe low back pain on 08Feb2021 slite headache on 06Feb2021 18:00 severe low back pain on 01Mar2021The patient underwent lab tests and procedures which included covid-19: negative   on Mar2020 Comments:  Respiratory Infection, covid-19: negative   on Dec2020 Comments:  Sinus Infection. and outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination site pain
Clinical narrative: mild upper arm soreness/Only hurt if you touched, bumped or slept on injection area; This is a spontaneous report from a contactable consumer. A 67-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Jan2021 13:00 (Batch/Lot Number: EL9262) at single dose for covid-19 immunisation administered at Pharmacy or drug store. Medical history included breast cancer female from 20May2018 to 2018 (Pertinent details: Lumpectomy, Radiation summer 2018; irritable bowel syndrome from 2000 and ongoing; breast conserving surgery from 2018 to an unknown date (Lumpectomy for breast cancer); radiotherapy from 2018 to an unknown date (Radiation for breast cancer). Historical vaccine included PNEUMOCOCCAL CONJUGATE VACCINE (PCV13-Pneumonia vaccine) (After 2 hours of the vaccine: fever, nausea, vomiting, diarrhea, nosebleed and dehydration). Concomitant medication(s) included anastrozole (ANASTRAZOLE DENK), oral from Sep2018 and ongoing for breast cancer female; amitriptyline, oral from Sep2019 and ongoing for irritable bowel syndrome; colecalciferol (VITAMIN D [COLECALCIFEROL]), oral; cyanocobalamin (B12 [CYANOCOBALAMIN]), oral; calcium, oral; melatonin, oral; famotidine (PEPCID [FAMOTIDINE]), oral. The patient reported, mild upper soreness for 2 days. Did not hurt to move arm. Only hurt if you touched, bumped or slept on injection area. The patient underwent lab tests and procedures which included influenza negative on an unspecified date. The outcome of event was unknown.  Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor, Vital signs measurement
Clinical narrative: Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving.   Information on lot/batch number obtained. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he tested positive for Covid-19; This is a spontaneous report received from a Pfizer sponsored program.  An unspecified age of male patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on 18Mar2021 at single dose for covid-19 immunization. It was reported that caller (Patient Name) got his 1st dose last 18Mar2021 and he tested positive for Covid-19 last 26Mar2021 he is calling in today to know if he can take his 2nd dose on 8Apr2021. No unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was "unknown".  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Pollakiuria, Pyrexia
Clinical narrative: Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent urination and jittery feeling; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:00 (Lot Number: ER8737) at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. Medical history was none, no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported; biotin taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (lot number: EN6206) on 08Mar2021 04:00 PM for covid-19 immunization and experienced sore arm. The patient experienced second vaccine fever and frequent urination and jittery feeling on 31Mar2021 12:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. Seriousness criteria was no.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: she has no taste or smell right now; she has no taste or smell right now; This is a spontaneous report from a contactable consumer (patient reported for herself) Pfizer Sponsored Program. A female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 24Mar2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date at single dose for Covid-19 immunization. It was reported that, "caller, received her second dose last Wednesday (24Mar2021). She only had few and minor side effects from the vaccine. However, she had no taste or smell right now and wanted to know if she had Covid or if it was an effect from the vaccine. Tried to transfer her to different department but the call got disconnected. Interaction number was requested to document". Outcome of the events was unknown.  Follow-up attempts are completed. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got the first dose of COVID-19 vaccine last 12Mar2021 and he will be getting the second dose tomorrow (30Mar2021) and experiencing dizziness and some stomach problems. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: My second shot resulted in some chills; Fever; This is a spontaneous case received from a consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced some chills and fever after getting second shot. It was reported that patient guess that just proves that the first shot was working. The side effects only lasted a day. The outcome of the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: patient did not feel well after first dose; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient's concomitant medications were not reported. It was reported that caller inquiring if a diabetic patient recieved second dose of vaccine if it could possily affect the preexisting condition, as patient did not feel well after first dose. Also wondering how to register to recieve first dose of vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: positive for her COVID test; positive for her COVID test; she came in contact with somebody who was COVID positive; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient mentioned that she received the first dose of the vaccine on 15Mar2021. On 26Mar2021, she came in contact with somebody who was COVID positive. On 31Mar2021 she came in positive for her COVID test, but on 01Apr2021 her PCR test came back negative. Patient was scheduled to receive her second dose on 05Apr2021 and would like to find out whether she will need to reschedule. It was reported that people who have a Negative COVID Diagnosis would reasonably receive their vaccine as scheduled, but patient would need to confirm her status with her doctor. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19after the 1st dose.; tested positive for covid-19after the 1st dose.; This is a spontaneous report from a contactable Pharmacist reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that the pharmacist asked if she can administer the covid-19 vaccine to her patient who tested positive for covid-19 after the 1st dose on an unknown date in Mar2021. The patient got the 1st dose last 02Mar2021 and is scheduled for 2nd dose on 30Mar2021. The outcome of the events were unknown.; Sender's Comments: The contribution of the suspect drug to the onset of event 'drug ineffective' cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced pain at the injection site (non-serious) on an unspecified date. The clinical outcome of the event was recovered on an unspecified date; two days after first dose.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on neck and face; This is a spontaneous report from Pfizer sponsored program COVAX US Support. A contactable female patient of an unspecified age received first dose of BNT162b2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient developed rash on neck and face after receiving first dose of COVID-19 vaccine. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Relative has a bladder infection; This is a spontaneous report received from a contactable consumer for her relative via Pfizer sponsored program.   A  female patient of unspecified age  received BNT162B2 (BNT162B2, formulation: solution for injection, lot no: unknown ), via an unspecified route of administration on 21-MAR-2021 as SINGLE DOSE for covid-19 immunisation. Medical history and Concomitant medication were not reported. on unspecified date, the patient experienced bladder infection and she was prescribed Cipro. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Investigation, Pain, Pain assessment, Peripheral swelling
Clinical narrative: rheumatoid arthritis; Both of his hands were swollen; face is swollen; pain was 3 to 4 from a scale of 1-10; This is a spontaneous report from a contactable consumer reported for her husband that a male patient of an unspecified age (reported as 71, no unit) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Patient received both doses of the vaccine with the last one on 12Feb2021, he was 70 (no unit) when he had the shot. His wife stated his doctors were a bit flabbergasted at his symptoms and the test had not given any indication of where he should go next. He is having some issues that look like rheumatoid arthritis and he has had several tests from emergency and a primary care provider. At first, they said there was not an indication of rheumatoid arthritis and then it said it was questionable as to "ANA." Both of his hands were swollen. Initially it was little and it got to be huge. His pain was 3 to 4 from a scale of 1-10. They gave prednisone and his hands went down and then several days later they were swollen again. He had prednisone again and then it went up again. He woke up and his face was swollen. The doctors were saying cold compresses. They looked at rheumatoid arthritis positive tests online and found that one way to be positive is due to a vaccine. She wanted to know if there is any help they can be referred to or any information on this. The wife stated she has already spoke with 3 people and reported this to all 3 agents. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor, Swelling face
Clinical narrative: rheumatoid arthritis; Both of his hands were swollen; face is swollen; pain was 3 to 4 from a scale of 1-10; This is a spontaneous report from a contactable consumer reported for her husband that a male patient of an unspecified age (reported as 71, no unit) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Patient received both doses of the vaccine with the last one on 12Feb2021, he was 70 (no unit) when he had the shot. His wife stated his doctors were a bit flabbergasted at his symptoms and the test had not given any indication of where he should go next. He is having some issues that look like rheumatoid arthritis and he has had several tests from emergency and a primary care provider. At first, they said there was not an indication of rheumatoid arthritis and then it said it was questionable as to "ANA." Both of his hands were swollen. Initially it was little and it got to be huge. His pain was 3 to 4 from a scale of 1-10. They gave prednisone and his hands went down and then several days later they were swollen again. He had prednisone again and then it went up again. He woke up and his face was swollen. The doctors were saying cold compresses. They looked at rheumatoid arthritis positive tests online and found that one way to be positive is due to a vaccine. She wanted to know if there is any help they can be referred to or any information on this. The wife stated she has already spoke with 3 people and reported this to all 3 agents. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza A virus test, Influenza B virus test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2nd via an unspecified route of administration on 02Mar2021 (Lot Number: EN6198) as single dose, dose 1st via an unspecified route of administration on 09Feb2021 (Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included afib, heart disease, hypothyroidism, hyperlipedemia, aortic valve disorders. Concomitant medication(s) included levothyroxine, omeprazole, rivaroxaban (XARELTO), rosuvastatin and flecainide. On 26Mar2021, the patient experienced flu like symptoms, fever, body aches, loss of smell and taste and weakness. On 31Mar2021, nasal swab test was done which showed SARS COV2 RNA as positive and for INFLUENZA A & INFLUENZA B as negative. There was no treatment given for the reported events. There was no covid prior to vaccination. The patient was tested for covid post vaccination. The outcome of the events was not recovered.; Sender's Comments: As it is reported that the patient had received both the doses of the vaccine within the required time interval yet the efficacy of the vaccine varies from patient to patient and can be affected by various factors. However, a contributory role of the usage of the vaccine BNT162B2 to the reported events vaccination failure and COVID-19 cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the Pfizer Covid vaccine and tested positive for the virus; received the Pfizer Covid vaccine and tested positive for the virus; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received the Pfizer Covid vaccine and tested positive for the virus. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Vision blurred
Clinical narrative: His entire left arm was completely numb; His mouth went completely numb; His tongue is having a tingling sensation; He has headache; His vision was blurred seeing very weird things; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient).  A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration on 26Mar2021 in the left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It reported that, patient received the 1st dose of vaccine on 26Mar2021 and due to take his 2nd shot on 16Apr2021. The patient stated on an unspecified date in Mar2021 last night his entire left arm was completely numb to touch down to his fingers and he couldn't feel the things that he is touching, his mouth went completely numb and his tongue was having a tingling sensation, headache and his vision was blurred seeing very weird things. The patient wanted to know if there was a report regarding this side effects after taking the vaccine. The outcome of the patient's events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Cough, Fatigue, Headache
Clinical narrative: arm was very heavy; dry cough; vomit; headache; chills; bones hurt; fever; right arm was swollen; feels tired; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (yesterday at 1:00 p.m) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced felt her arm was very heavy, at night had a lot of dry cough and about 2-3 times during the day, after which she was vomit, headache, chills, bones hurt, fever, right arm was swollen and when she does something and feels tired on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: arm was very heavy; dry cough; vomit; headache; chills; bones hurt; fever; right arm was swollen; feels tired; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (yesterday at 1:00 p.m) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced felt her arm was very heavy, at night had a lot of dry cough and about 2-3 times during the day, after which she was vomit, headache, chills, bones hurt, fever, right arm was swollen and when she does something and feels tired on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Transient ischaemic attack
Clinical narrative: Possible TIA; He woke up with black clouds in both eyes surrounded by red; This is a spontaneous report from a contactable consumer (patient's son/daughter). A 75-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EN6202, expiration date unknown) via unspecified route of administration at arm left on 04Mar2021 at 11:30 AM at age of 74-year-old at single dose for COVID-19 immunisation. Medical history included traumatic brain injury (TBI) 1.5 years ago due to a horse accident. There was no known allergies. Concomitant medication was reported as none. There was no other vaccine in four weeks and no other medications in two weeks. Patient woke up with black clouds in both eyes surrounded by red. He went to an eye doctor the next day that told him not to get the next dose and to go see a doctor immediately. He did, he has still not received any real answers. The eye doctor was afraid it was a possible transient ischaemic attack (TIA). Onset date of events was 24Mar2021 at 03:30 AM. Outcome of events was not recovered. No treatment received for the events. Events resulted in doctor or other healthcare professional office/clinic visit. There was no Covid prior vaccination. Covid was not tested post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Skin lesion, Syncope
Clinical narrative: fainted; generally feeling fatigued; little dizzy; headache; cuts on her face and a bump on her head; This is a spontaneous report from a contactable consumer (reporting for herself). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included marijuana taken for an unspecified indication, start and stop date were not reported. On 01Apr2021, the patient fainted. The patient also been generally feeling fatigued and a little dizzy. The patient fainted after going to the restroom, stood up after finishing her business and blacked out and woke up on the floor with cuts on her face and a bump on her head. The patient is fine now just a little tired, dizzy and headache. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Herpes zoster, SARS-CoV-2 test
Clinical narrative: Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; This is a spontaneous report received from a contactable consumer (Patient). A 79-Year-old female patient (Pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The relevant medical history included pre-diabetic, high Cholesterol, shingles (many years had gone by) and allergies: Penicillin, Statins, Hazelnuts, all from unspecified date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL3247, right arm) on 15Feb2021 at the age of 79 years old for Covid-19 immunization. On 20Mar2021, within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab on 09Mar2021 and 10Mar2021, both showed negative. The outcome of the event was recovering.  No follow up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; This is a spontaneous report received from a contactable consumer (Patient). A 79-Year-old female patient (Pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The relevant medical history included pre-diabetic, high Cholesterol, shingles (many years had gone by) and allergies: Penicillin, Statins, Hazelnuts, all from unspecified date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL3247, right arm) on 15Feb2021 at the age of 79 years old for Covid-19 immunization. On 20Mar2021, within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab on 09Mar2021 and 10Mar2021, both showed negative. The outcome of the event was recovering.  No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with Covid; tested positive with Covid; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer Sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 12Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced tested positive with COVID. The consumer would like to cancel her and the patient's second dose schedule that was due the next day because her husband tested positive with COVID. The patient underwent lab tests and procedures which included SARS-COV-2 test: Positive on unspecified date in Mar2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.