chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). This 36-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 30Mar2021 10:00 (Batch/Lot number was not reported) as single dose at age of 35 years old for COVID-19 immunization. There was no concomitant medication. The patient did not receive other vaccine in four weeks, no other medications in two weeks. Medical history included asthma and migraine, from an unknown date and unknown if ongoing. The patient had known allergies but unspecified. The patient's concomitant medications were not reported. The patient experienced irregular menstrual cycle (12 days late), extremely heavy flow and blood clots on 01Jun2021. No treatment received for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, SARS-CoV-2 test
Clinical narrative: post menopausal vaginal bleeding; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 21Apr2021 16:45 (Lot Number: EW0161) at the age of 56-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included hypertension, anxiety, depression, COVID-19 (Prior to vaccination, the patient was the patient diagnosed with COVID-19). The patient had no known allergies.The patient previously received first dose of bnt162b2(lot number: ER8732) at arm left on 31Mar2021 04:30PM at the age of 56-year-old for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hcl; metoprolol tartrate; multivitamin; hydrochlorothiazide (HCTZ); all taken for an unspecified indication, start and stop date were not reported. One week after the second dose (28Apr2021), the patient began to have post menopausal vaginal bleeding. It lasted for 8 days and ended on 08May2021. The bleeding was similar to a menstrual cycle. Her last menstrual cycle was in Sep2017. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test post vaccination covid test type post vaccination(Nasal Swab) on 03May2021 was negative. No treatment received for the event. The event was recovered on 08May2021.; Sender's Comments: Based on the information currently available, the reported event post menopausal vaginal bleeding one week after the second dose more likely represented intercurrent illness, but not related to bnt162b2.  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 Committees, and investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: Fatigue, Incorrect dose administered, Pain, Product use issue, Wrong product administered
Clinical narrative: Received third dose of Covid 19 vaccine; the patient had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID-19 vaccine to the patient; also get the Hepatitis B vaccine afterward(administered on Same Date of the Pfizer Suspect); body aches, pains; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported for a 23-year-old female patient (Reporter's Niece). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) at the age of 23-year-old as single dose at arm for covid-19 immunisation; hepatitis b vaccine via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported), at single dose for immunization. The patient's other medical history reported as none. The patient's dad was diabetic, but the reporter did not know for sure. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 23-year-old(Maybe 3 weeks before second dose) for covid-19 immunisation. Prior vaccinations (within 4 weeks) also reported as no. The patient previously received second dose of bnt162b2 on May2021 (22May2021 or 23May2021) at the age of 23-year-old for covid-19 immunisation and experienced body aches, pains, tiredness. The patient had the second dose of the Pfizer COVID-19 vaccine 10 days before. The day before yesterday, the patient had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID-19 vaccine to the patient and at the time of the report, from Jun2021, the patient was experiencing minor adverse events that were similar to the adverse events she had experienced during her Pfizer COVID-19 vaccine second dose. She did also get the Hepatitis B vaccine afterward(administered on Same Date of the Pfizer Suspect). She felt nervous because she had both. Report reported as non-serious. Events did not resulted in emergency room and physician office. Treatment reported as none. Relevant tests was none. The outcome of the events body aches, pains, tiredness was recovering. Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: suffered a PE; This is a spontaneous report from a non-contactable consumer via a sales representative. A 23-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 23-years-old, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hereditary gene disorder with lupus. The patient's concomitant medications were not reported. The patient experienced suffered a PE (pulmonary embolism) on an unspecified date with outcome of unknown. Her team of physicians treating her acutely, did not feel it was attributed to the vaccine and rather due to a hereditary gene disorder with lupus. Event took place after use of product.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Laboratory test, X-ray
Clinical narrative: Moderate to severe inflammation; This is a spontaneous report from a contactable other HCP (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Jan2021 (Batch/Lot Number: EC3247) as 1st dose, single for covid-19 immunisation. Medical history included Auto immune disease, depression, Hypercholemia, Anemia. No Covid prior vaccination. Concomitant medication(s) included secukinumab (COSENTYX); celecoxib (CELEXA); ergocalciferol (VIT D); vitamin b complex (B COMPLEX (B50)); rosuvastatin calcium (CRESTOR). The patient was allergy to Sulfur. The patient experienced moderate to severe inflammation on 29Jan2021 17:00. Patient received: Prednisone tabs, Streoid injection, lab work, x rays. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Inflammation. 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 Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24May2021 at single dose (lot: EW0191) for COVID-19 immunization. Medical history included blood pressure abnormal, she had blood pressure medicine (medical condition was not clarified further). Concomitant medications included carvedilol and hydrochlorothiazide for blood pressure.  Patient stated she had an allergic reaction on 27May2021 and she thought she was still having reaction, she was at the hospital, ER for two days really. She was in the emergency room. Treatment included paracetamol (TYLENOL), 500 mg tablet. The outcome of event was not recovered.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Hyperpyrexia, Pain
Clinical narrative: run a fever of 107F; He also had aches all over; He just feels horrible; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 17:30 (at the age of 13 years old) (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included had gotten Covid twice this year; He had allergies to food, dog dander, and fish; Asthma. He had them for years. He had an asthma medication, Qvar. He was an allergy kid and had an epi pen. Concomitant medications included epinephrine (EPIPEN 2-PAK); beclometasone dipropionate (QVAR) ongoing for asthma (They just changed his medication about a year ago. She (mother) didn't know where it was to give a dosage). No vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AE(s). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 02Jun2021. Today (03Jun2021) he started to run a fever of 107F and was given Tylenol and went down to 100.3F. He also had aches all over. Caller was asking how high was the normal fever, what can she give to her son and how long would the AE last. He was running a fever and had aches all over. This was his first dose of the Covid vaccine. She asked if that was normal and how high his temperature should go. Aches all over was reported as worsened. The mother called and said he was running a fever. Her daughter just gave him Tylenol and he still had a fever of 100.3. It was a little bit higher. It was like 100.7 and came down to 100.3 (03Jun2021). He just feels horrible. It was Extra Strength Tylenol, lot: SMC200, expiration date: Jun2022. The aches started this morning. The events did not require a visit to Emergency Room and Physician Office. The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) at 71-year-old as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated she received a call from a community member who received her first dose of the Pfizer COVID-19 vaccine in Feb2021 and had an anaphylactic reaction to the vaccine, she reported this already to the CDC and to her HCP who has reported it as well. Caller was looking for information to give to the member about the possibility of being vaccinated with the Jansen 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: Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) via unspecified route of administration in left arm on 02Feb2021 01:00 PM as 2nd dose, single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at hospital (facility type). The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within two weeks of vaccination included simvastatin and telmisartan both from unspecified date. The patient previously took levofloxacin (LEVAQUIN) and it was reported as known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via unspecified route of administration in left arm on 12Jan2021 12:00 PM (at the age of 73-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On unspecified date in Mar2021 the patient experienced pericarditis treated with unspecified medication and resulted in doctor or other healthcare professional office/clinic visit. The had patient been tested for COVID-19 on unspecified date in May2021 with nasal swab test and a negative result was reported. The outcome of the event was not resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Bleeding in the middle of the cycle; This is a spontaneous report from a contactable consumer(patient). This 40-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0167)on 13May2021 16:30 via an unknown route in left arm at 40-year-old for Covid-19 immunization. Medical history and past drug history were not reported.  Patient had no known allergies.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. Patient experienced adverse event of bleeding in the middle of the cycle on 26May2021. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the event was unknown.  Since the vaccination, the patient had not been tested for COVID-19. The reported was assessed as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat started to close down it was very hard to breathe; I could barely talk; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0161) on 08Apr2021 at 13:00 (at the age of 41 years), as first single dose, in left arm, for COVID-19 immunization. Medical history included penicillin allergy, latex allergy and peach, papaya allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levocetirizine dihydrochloride (XYZAL) pro air inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09May2021 at 14:00 the patient experience difficulty breathing, joint pain, headache, chills, nausea, diarrhea, body ache, hives, her throat started to close down, it was very hard to breathe and she could barely talk. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included allergy medication, another inhaler and epinephrine (EPIPEN). The events were resolving. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Speech disorder, Throat tightness, Urticaria
Clinical narrative: Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat started to close down it was very hard to breathe; I could barely talk; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0161) on 08Apr2021 at 13:00 (at the age of 41 years), as first single dose, in left arm, for COVID-19 immunization. Medical history included penicillin allergy, latex allergy and peach, papaya allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levocetirizine dihydrochloride (XYZAL) pro air inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09May2021 at 14:00 the patient experience difficulty breathing, joint pain, headache, chills, nausea, diarrhea, body ache, hives, her throat started to close down, it was very hard to breathe and she could barely talk. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included allergy medication, another inhaler and epinephrine (EPIPEN). The events were resolving. Since the vaccination, the patient had not been tested for COVID-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Weight fluctuation
Clinical narrative: His weight is fluctuating; This is a spontaneous report from a Pfizer-sponsored program. A contactable 62 years old male consumer (patient) received 1st dose of Pfizer-BioNTech Covid-19 Vaccine BNT162B2 (Lot Number: EN6203), at the age of 62 years old, on 11Mar2021 in the Left arm for covid-19 immunization. Patient History was Blood clot in both legs. No Family Medical History Relevant. Concomitant Products clopidogrel bisulfate (PLAVIX) Ongoing for Blood thinner, he began taking Plavix 2 years ago after he had blood clots in both legs. Caller reported that he was supposed to get his second dose on 01Apr2021 but was hospitalized for a bypass that he had on 26Mar2021. Patient experienced Vascular graft on 26Mar2021. His weight is fluctuating. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Pain, Pain in extremity
Clinical narrative: pain in the left arm; Loss of grip strength; pain in the left arm, her whole left side/ right side had pain; This is a spontaneous report from a contactable consumer(patient). This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 05Apr2021 (lot number EW0150), 2nd dose on 26Apr2021 (lot number EW0164), both at 53-year-old via an unknown route for Covid-19 immunization. Patient stated she had no medical conditions, was a healthy individual. Concomitant drug was not provided.   Patient experienced pain in the left arm, her whole left side, and pain was continuing. It was severe. She went to the emergency room on 23May2021. When she got the second vaccine she was still having pain and it had not gone away. She went to the hospital they gave her a muscle relaxer and an injection. She had taken Diclofenac Sodium and then changed to take Diclofenac Potassium. The right side had pain but the left was much worse. She had also lost her grip strength. She could not carry anything, could not open a bottle. She has a doctor appointment upcoming this month (as of 03Jun2021) related to these symptoms. Patient also stated that pain was getting worse.  Her pain was extreme. She was worried and hopes she does not die. Outcome of the events was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Aplasia pure red cell, Investigation
Clinical narrative: Had to postpone the second dose because of a medical issue, anemia; Red blood cell aplasia; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), first dose intramuscularly, administered in arm left at 23Mar2021 07:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 64-year-old. Medical history included Addison's disease from 1980 and ongoing, slightly hypothyroid from 1980 and ongoing, ongoing Good syndrome, cholesterol increased from 2018 and ongoing, adrenal insufficiency and IGG deficiency (diagnosed with it five to six years prior to this report). No family medical history relevant to event. Concomitant medications included hydrocortisone taken for Addison's disease from 1980 and ongoing; fludrocortisone taken for Addison's disease from 1980 and ongoing; atorvastatin (LIPITOR) taken for lowering cholesterol from 2018 and ongoing; levothyroxine taken for slightly hypothyroid from 1980 and ongoing; immunoglobulin human normal (HIZENTRA) taken for Good syndrome. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient got his first dose on 23Mar2021. He knew it is supposed to be within 42 days for the second dose, but his was scheduled about 60 days. He would like to get his second dose. His second dose was scheduled pretty far apart, about 60-70 days since his first dose. The patient had anemia and still had it. The patient had to postpone the second dose because of a medical issue, anemia. They decided to postpone. He was diagnosed with a red blood cell aplasia. He got blood transfusions. He was hospitalized three weeks after getting the first dose. The same day he was supposed to have the second vaccine they discovered the problem and he had to be hospitalized. He had blood transfusions. They are still trying to figure out why he had it. The treatment included blood transfusions, he got concentrated red blood cells. Four times, once in the hospital. Confirmed as he received four units. The third one he just had outpatient. He had one two weeks after, since the beginning of April. He just had one yesterday. He had them about every two weeks. He was about to start treatment for this anemia. The both events require a visit to emergency room and physician office. The patient had relevant tests and was diagnosed with red blood cell aplasia and then hospitalized, but unable to provide exact details. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: had a side effect (nearly passed out); This is a spontaneous report from a Pfizer sponsored program from a non-contactable male consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a side effect (nearly passed out) and would like to know if he should take the second covid vaccine. 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: Chest pain, Coronary artery occlusion, Electrocardiogram, Lethargy, Myocardial infarction
Clinical narrative: heart attack; he ended up having a triple bypass to clear the blockage found.; extremely lethargic; chest pains; This is a spontaneous report received from a Non-contactable consumer(patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 20May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for covid-19 immunisation and tested COVID positive a few weeks after receiving his first vaccine. Once all virus symptoms were gone, he was advised by the clinic to go ahead and get his second shot (approximately 1 week after virus symptoms cleared). The vaccine was given on 20May2021 and within several days, he was extremely lethargic and experiencing chest pains. During a visit to local urgent care he was told he had had a heart attack. Following an echocardiogram, he ended up having a triple bypass to clear the blockage found. He did have some family history of heart disease but was unaware of any issues with his own health and had not experienced any symptoms prior to this incident. Date of start of reaction/event was 23May2021. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported no hospitalization prolonged. The outcome of event extremely lethargic was unknown, of the other events was recovering.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: heart attack; he ended up having a triple bypass to clear the blockage found.; extremely lethargic; chest pains; This is a spontaneous report received from a Non-contactable consumer(patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 20May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for covid-19 immunisation and tested COVID positive a few weeks after receiving his first vaccine. Once all virus symptoms were gone, he was advised by the clinic to go ahead and get his second shot (approximately 1 week after virus symptoms cleared). The vaccine was given on 20May2021 and within several days, he was extremely lethargic and experiencing chest pains. During a visit to local urgent care he was told he had had a heart attack. Following an echocardiogram, he ended up having a triple bypass to clear the blockage found. He did have some family history of heart disease but was unaware of any issues with his own health and had not experienced any symptoms prior to this incident. Date of start of reaction/event was 23May2021. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported no hospitalization prolonged. The outcome of event extremely lethargic was unknown, of the other events was recovering.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Gallbladder disorder, Hepatic enzyme increased, Liver function test, SARS-CoV-2 test
Clinical narrative: three severe gallbladder attacks; elevated liver enzymes and bloodwork; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 29Apr2021 (lot no: EW0151) (at age 18 years old) as single dose for covid-19 immunisation. Medical history included neoplasm tumor in leg when young and food allergies in childhood. No COVID prior to vaccination. The patient's concomitant medications included antibiotics. The patient previously received the first dose of BNT162B2 in left arm on 08Apr2021 (lot no: EW0171) (at age 18 years old) for COVID-19 immunization and experienced severe eye pain, difficulty seeing after the first vaccination. On an unspecified date, within a few weeks after the second vaccination, the patient experienced three severe gallbladder attacks, two emergency room (ER) visits. The second ER visit resulted in admission in hospital for 4 days and removal of the gallbladder and cleaning of the bile ducts; elevated liver enzymes and bloodwork. The events were reported as serious (hospitalization). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Antibiotic for the eye/surgery for gallbladder att. The patient underwent COVID test (nasal swab) with negative result on 24May2021. The patient was recovering from the events.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Gastric ulcer
Clinical narrative: Stomach ulcer; Heart burn; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stomach ulcer and heart burn on an unspecified date. It was reported that the patient got the finally shot couple of days ago and the patient's doctor is closed. The patient had a heartburn and inquired if Gaviscon is gonna interact with the vaccine that the patient took the first dose. The patient paraphrased and reported that "for stomach ulcer, for heart burn." The outcome of the events was unknown.  Information about lot/batch has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal swelling, Urticaria
Clinical narrative: broke out into hives; throat began to swell; breathing became difficult; anaphylaxis; patient age: 15; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 03Jun2021 14:30 (at 15-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included low growth hormone production, and known allergies: many foods. Concomitant medications included somatropin (NORDITROPIN); anastrozole (ANASTRAZOLE DENK); olopatadine; levocetirizine dihydrochloride (XYZAL); diclofenac sodium, heparin sodium (ALLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), via an unspecified route of administration, administered in left arm on 13May2021 17:30 (at 15-year-old) as 1st dose, single dose for COVID-19 immunization. On 03Jun2021 at 17:30, the patient experienced 3-4 hours after dose, broke out into hives. He took benadryl. Throat began to swell and breathing became difficult. He used epi-pen to stop anaphylaxis. The seriousness criteria of the events was reported as life threatening. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events hives, throat began to swell, breathing became difficult, anaphylaxis was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out after receiving first vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 reported. The patient passed out after receiving first vaccine on an unspecified date. The outcome of the event was unknown. The event was considered as serious (medically signficant).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Circulatory collapse, Infection, Loss of consciousness, Pyrexia, Seizure
Clinical narrative: familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 14-year-old female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications were not reported. On an unspecified date, after getting the second dose of the Covid Vaccine immediately started experiencing fever, shaking; her eyes were back as she seemed unconscious and collapsed; it was familiar to a seizure; was taken to the hospital, they told possible sign of infection and she was advised to go ahead and just to report what had happened. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 14-year-old female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications were not reported. On an unspecified date, after getting the second dose of the Covid Vaccine immediately started experiencing fever, shaking; her eyes were back as she seemed unconscious and collapsed; it was familiar to a seizure; was taken to the hospital, they told possible sign of infection and she was advised to go ahead and just to report what had happened. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Eye pain, Facial paralysis, Feeding disorder, Headache
Clinical narrative: She had no taste now, and she lost her sense of taste 2 days ago; She was not able to eat because of her twisted mouth; She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only/On the night of 24May2021, she couldn't close her left eye/mouth was getting "twisted; She had a terrible pain in the left-side of her head that started on the afternoon of 24May2021; On the night of 24May2021, her left eye began hurting a lot; On the night of 24May2021, her left eye had a lot of tears coming out of it.; She said she was not able to work; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 10:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that on 24May2021, covid-19 vaccine left her partially paralyzed in the left side of her face only, she had a terrible pain in the left-side of her head that started in the afternoon. On the night of 24May2021, her left eye began hurting a lot, her left eye had a lot of tears coming out of it and she couldn't close her left eye. On the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted". She was not able to eat because of her twisted mouth. She said she was not able to work. She had no taste now, and she lost her sense of taste 2 days ago. The events She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only was reported as serious, medically significant. The outcome of the events she said the COVID-19 vaccine left her partially paralyzed in the left side of her face only, on the night of 24May2021, her left eye began hurting a lot, on the night of 24May2021, her left eye had a lot of tears coming out of it, on the night of 24May2021, she couldn't close her left eye, on the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted", she had no taste now, and she lost her sense of taste 2 days ago and she said she was not able to work was not recovered while the outcome of the event she had a terrible pain in the left-side of her head that started on the afternoon of 24May2021 was resolved on unspecified date of 2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Lacrimation increased
Clinical narrative: She had no taste now, and she lost her sense of taste 2 days ago; She was not able to eat because of her twisted mouth; She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only/On the night of 24May2021, she couldn't close her left eye/mouth was getting "twisted; She had a terrible pain in the left-side of her head that started on the afternoon of 24May2021; On the night of 24May2021, her left eye began hurting a lot; On the night of 24May2021, her left eye had a lot of tears coming out of it.; She said she was not able to work; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 10:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that on 24May2021, covid-19 vaccine left her partially paralyzed in the left side of her face only, she had a terrible pain in the left-side of her head that started in the afternoon. On the night of 24May2021, her left eye began hurting a lot, her left eye had a lot of tears coming out of it and she couldn't close her left eye. On the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted". She was not able to eat because of her twisted mouth. She said she was not able to work. She had no taste now, and she lost her sense of taste 2 days ago. The events She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only was reported as serious, medically significant. The outcome of the events she said the COVID-19 vaccine left her partially paralyzed in the left side of her face only, on the night of 24May2021, her left eye began hurting a lot, on the night of 24May2021, her left eye had a lot of tears coming out of it, on the night of 24May2021, she couldn't close her left eye, on the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted", she had no taste now, and she lost her sense of taste 2 days ago and she said she was not able to work was not recovered while the outcome of the event she had a terrible pain in the left-side of her head that started on the afternoon of 24May2021 was resolved on unspecified date of 2021.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Presyncope
Clinical narrative: Nearly passed out; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm at the age of 42-year-old on 03Jun2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunisation. Medical history included None. There were no concomitant medications.  The patient experienced nearly passed out on 03Jun2021.  As reported as follows: Transferring agent stated, "I have the caller on the line. The reason for this transfer is because he nearly passed out after receiving the first Covid vaccine about 2 hours ago and he wants to know if he should take the second vaccination and if this vaccination card that he received from his first vaccination will be valid for him to get the second one." When paraphrased the concern, consumer stated, "Yes that was half of my question. I wanted to consult with my physician but it is a little late in the day today, so I couldn't get a hold of him after I received it. But I am pretty sure that the second dose probably will not necessarily have this circumstances now, am I correct?" The patient underwent lab tests and procedures which included laboratory test: unknown results in May2021 (3 weeks ago). Not received treatment for the event. The outcome of event was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's palsy over one month later. Right side facial paralysis.; Bell's palsy over one month later. Right side facial paralysis.; This is a spontaneous report from a contactable consumer.  A 55-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in right arm on 08Apr2021 at 11:00 (at the age 54-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included hypothyroidism and patient had known allergies gluten, bee or wasp venom. Patient took 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207) administered in right arm on 11Mar2021; administration time at 11:00 AM. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient's concomitant medications were not reported. The patient experienced bell's palsy over one month later and right side facial paralysis on 25May2021 at 12:00. The treatment medications include prednisone and Valtrex. The outcome of the event was not resolved.  Follow-up attempts are needed. Further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Diarrhoea, Faeces discoloured, Inflammation
Clinical narrative: Chron's disease flare up; Discolored stools; Inflammation; diarrhea; This is a spontaneous report received from a contactable physician. A 63-year old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 07Apr2021 (at the age of 63-year old) at single dose for COVID-19 immunization and adalimumab (HUMIRA) solution for injection in pre-filled pen, subcutaneous on an unknown date at an unspecified dosage for Moderate to severe adult Crohn's disease and moderate to severe ulcerative colitis. relevant medical history and concomitant medications were not reported. On an unknown date the patient experienced dark stools, inflammation, diarrhea and Crohn's disease flare up. The action taken with adalimumab was unknown. The outcome of the events diarrhea and Crohn's disease aggravated was recovered while the outcome of the other events was unknown. The causality assessment with adalimumab was No reasonable possibility for events diarrhea and Crohn's disease aggravated and not reported for the other events. The causality assessment with BNT162B2 was not reported for all events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Computerised tomogram, Lumbar puncture, Magnetic resonance imaging, Optic nerve injury
Clinical narrative: Losing vision in her right eye; The eye, sight issues or anything to do with the optic nerve; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Unknown), via an unspecified route of administration in Mar2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration for COVID-19 immunization. Caller stated she had the second dose of the Pfizer covid 19 vaccine the end of March. Caller was wondering if there were any side effects linked to the vaccine that were related to the eye, sight issues or anything to do with the optic nerve. Caller stated she was losing vision in her right eye. Caller stated they were having trouble diagnosing the cause. she just got out of the hospital. she had no history of any eye issues or optic nerve issues. she was calling about the Covid Vaccine. she was just wondering if Pfizer has seen any side effects linked to the vaccine relating to the optic nerve, eye or sight issues. Caller states that she does not know if she needs to report it. She does not know if it was from the vaccine. She just knows that before she had no eye issues. States she had the second shot at the end of March. She was recently at the hospital because she was losing sight in her right eye. Caller states they were having a hard time diagnosing what was going on. States her CAT scan, MRI, and spinal tap didn't show anything. Says she was told her optic nerve was having trouble sending messages to her brain. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: I got Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 17May2021 at 15:45 (at the age of 16-years-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included I used to have Bell's Palsy and shellfish allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. About 2 weeks later (may be on 02Jun2021 or 03Jun2021), the patient got bell's palsy. On 03Jun2021, the patient underwent nasal swab sars-cov-2 test and tested negative. Therapeutic measures were taken as a result of bell's palsy and patient received 21 Prednisone 20 mg and 10 Valacyclovir HCL 500 mg. The clinical outcome of event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.