chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received only a partial dose; A Spontaneous report was received from a healthcare professional concerning a female healthcare worker in her '50s' who was participating in the mRNA-1273 Emergency Use Program and the patient received only a partial dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 028L20A) for prophylaxis of COVID-19 infection. The patient received only a partial dose and does not have any special condition. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The event, patient received only a partial dose was considered resolved on 27 JAN 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Pain, Pyrexia
Clinical narrative: Chills. Fever. Body aches. Ear hurts. Fatigue.
Sex: U
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: vaccine removed from freezer and only thawed for 20 minutes before being administered to patient; A spontaneous report was received from a healthcare professional concerning a patient, of unknown age/gender, who received Moderna's COVID-19 vaccine that was removed from the freezer and then allowed to only thaw for 20 minutes before being administered to the patient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient received Moderna's COVID-19 vaccine that was removed from the freezer and then allowed to only thaw for 20 minutes before being administered. Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the event, vaccine removed from freezer and only thawed for 20 minutes before being administered to patient, was resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender, who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Product preparation error.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Vaccination site pain
Clinical narrative: some of the vaccine to drip out on my arm; my arm was painful and kind of sore where the injection site was; some of the vaccine to drip out on my arm; A spontaneous report  was received from a consumer, who is 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate dose of vaccine administered and some drops went out, pain and soreness at injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 27 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient received the vaccine resulting in the event of inappropriate dose of vaccine administered and some of liquid went down from shoulder to her wrist. The patient experienced pain and soreness at injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, inappropriate dose of vaccine administered, was considered as resolved on 27-Janp-2021 and the event, pain and soreness at injection site, was not reported.; Reporter's Comments: This case concerns a 62 old female patient who received  her first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection and resulting in the event of inappropriate dose of vaccine administered and some drops went out, and non-serious listed event of pain and soreness at injection site. Based on the current available information, the event of pain and soreness at the injection site is an expected event.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2 patients were inadvertently injected with 1.0 mL, instead of 0.5 mL, of Moderna COVID vaccine; A spontaneous report  was received from a health care professional (Physician) concerning two patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental overdose.  The patients' medical history was not provided. Concomitant products were not provided.  On an unknown date, the patients received their doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection (route of administration and injection site unknown).   The HCP stated that, the patients were inadvertently injected with 1.0mL, instead of 0.5mL of the vaccine.   Treatments for these events were not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, accidental overdose was considered resolved.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Computerised tomogram, Diarrhoea, Dizziness
Clinical narrative: Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Heart rate increased, Laboratory test
Clinical narrative: Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site.  This lasted for 3 days
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site.  This lasted for 3 days
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: shortness of breath, chest tightness
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: SWOLLEN ARM , REDNESS, ITCHY AND WARM TO TOUCH, RASH
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: While receiving  second dose the vaccinator inserted what appeared to be an empty syringe. The vaccinstor stated "oops" and withdrew the needle. The vaccinator then filled a second syringe and and re-injected patient.  The issue is the person being vaccinated is concerned that he may have had air injected into the deltoid muscle and/or may have been over vaccinated. He reported to the Pod Commander and his supervisor at work.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: "didn't feel well"
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Muscular weakness
Clinical narrative: Whole body moderate muscular weakness and fatigue beginning 18 hours after injection, increasing in severity to 36 hours after injection. Moderate to severe migraine beginning 24 hours increasing to 36 hours after injection.  Full recovery 42 hours after administration.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Injection site pain radiating down into the elbow, up the shoulder and into the neck. L arm was sore first week but worsened the 2nd week and is not having  mobility issues with terrible constant pan.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The night of the vaccine I got a mild headache during the night and it lasted about 24 hours.  A WEEK AFTER THE VACCINE I AM EXPERIENCING VERY ITCHY AREA WHERE THE VACCINE WAS INJECTED. IT IS RED AND HOT BUT THERE IS NO PAIN.  I ALSO EXPERIENCED FATIGUE ON THURSDAY, FEB. 4TH.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: COVID 19 Vaccine  Swollen arm at injection site.  Itchy but not painful
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Oxygen saturation decreased
Clinical narrative: Increased heart rate to the point where he could hear it; Oxygen level dropped to mid-eighties; Blood pressure 161/91; This is a spontaneous report from a contactable consumer (patient himself). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib), cryotherapy (cryoablation), blood pressure abnormal, and anticoagulant therapy (blood thinner). The patient was vaccinated at a clinic. Concomitant medications included metoprolol succinate, quinapril for blood pressure, dabigatran etexilate mesilate (PRADAXA), hydrochlorothiazide, zinc, colecalciferol (VITAMIN D [COLECALCIFEROL]), and krill oil. The patient previously took flu shot (INFLUENZA) in Nov2020 two months ago, and shingles shot (SHINGRIX) years ago and experienced sore arm. The patient reported having no problem until 18:30 when he felt an "increased heart rate to the point where he could hear it". He pursued saying he read his "oxygen level at 95" and "pulse at 121" with a pulse oximeter, and took his blood pressure, which was at 161/91 wilt a pulse between 128-130. He mentioned therefore going to bed and laid down, and his "oxygen level was at 85" and "pulse at 136" still using his pulse oximeter. He specified that his wife verified the pulse oximeter and after a delayed that felt like 5 minutes, she took his "oxygen level and pulse" which were at 95 and 72 respectively. He stated that "all lasted 30 minutes". As per source, "Received first COVID-19 Vaccine. Sat for 15 minutes and didn't have any problems. Last night around 6:30PM noticed a heart rate increase rapidly to the point where he could almost hear or feel it. Pulse oximeter showed pulse was 121 and an oxygen level of 94. Talked to his wife and sat down. Took blood pressure and it was 161/91. Put on pulse oximeter. Oxygen level was dropping to mid-eighties and pulse was between 135- 136. Laid down for 10-15minutes. Tried again and his oxygen level was back to 95 and pulse was 72. Whole episode lasted about 30 minutes. Was reading paperwork and talked about rapid heart rate. Had Afib, takes medication for it and had a cryoablation about eight years ago. Feels fine today. Has not had any more episodes like that and wanted to report it. Wants to know if he should contact his doctor. Wondering will he expect this again with the second dose. Could it happen again and is there anything he can do as a safety guard? Stated he could almost hear his heart beating and was checking his pulse on his neck. His heart rate returned to 71, which is low for him. Usually his heart rate is high seventies or low eighties." Clinical outcome of the events was recovered on 20Jan2021.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Taste disorder
Clinical narrative: Headache, body aches, bad taste in mouth
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peroneal nerve palsy, Spinal X-ray
Clinical narrative: Guillain Barre syndrome; he had severe right foot drop and was taken to the ER; This is a spontaneous report from a contactable consumer and nurse. A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 08Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Jan2021, he had severe right foot drop and was taken to the ER, was seen by an internist and evaluated with an MRI and Xray of the spine and was scheduled for EMG and MRI of the brain at a later date. A stroke was ruled out and now wants to know if he has Guillain Barre syndrome (18Jan2021). Outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature intolerance
Clinical narrative: increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes; This is a spontaneous report from a contactable consumer (patient sister). A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration, on 30Dec2020 13:00 at single dose in right arm for covid-19 immunization. The patient medical history reported as none. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. It was reported that the patient had reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine. Lastly, she had reported that other coworkers have reported the same increase in temperature sensitivity in their extremities. No treatment was received.  The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: Received 1st injection 01/19/2021.  Has red warm rash approximately 5-6 cm to left deltoid.  She reported it had been present for 1 week and it was worsening.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: she has two lung disorders, bronchiectasis and mycobacterium; she has two lung disorders, bronchiectasis and mycobacterium; a tender arm; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Consumer stated she has two lung disorders, bronchiectasis and mycobacterium. She then elaborated the circumstances leading to a prescription of erythromycin and a steroid, on Monday. She said she received the first dose of the COVID-19 vaccine yesterday, while being on these medications. She mentioned feeling great this morning (Jan2021), "only a tender arm, but nothing".  She explained reading about a potential effect of steroid on the vaccine's effectiveness. She specified discussing with her HCP about it, who will follow-up with her. She asked if steroid reduces the effectiveness of the vaccine. The outcome of the events was unknown.  Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain in extremity, Pyrexia
Clinical narrative: She could not breath; Headache; Pain in the arm; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller mentioned that yesterday on an unspecified date she got the first dose of the vaccine and in the night, she had side effects to it: headache, pain in the arm, fever and she could not breath. Caller wanted to know how long the side effects of the vaccine will last. The outcome of the events was unknown.  Information about Lot/batch no has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Electrocardiogram abnormal, Fatigue, Injection site discomfort, Tachycardia
Clinical narrative: Tachycardia/ possible supra ventricular tachycardia/heart rate 209; Temp 99.9 (orally); Mild local discomfort at injection site; General fatigue; This is a spontaneous report from a contactable physician reported for himself. A 74-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 18Jan2021 13:15 at single dose for COVID-19 immunisation. There was no medical history. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Morning following the injection noted mild local discomfort at injection site on 19Jan2021, no other signs or symptoms. General fatigue later that day. Awakened 11:30 pm (19Jan2021) with temp 99.9 (orally). Noted tachycardia. Did limited ECG with Kardia: heart rate 209, possible supra ventricular tachycardia. Otherwise asymptomatic. Slept until 5am on 20Jan2021. Awoke asymptomatic. Afebrile, sinus rhythm, pulse 102. At 5pm 20Jan2021, afebrile, sinus rhythm, pulse 92, asymptomatic. On 21 and 22 January, asymptomatic. Sinus rhythm, pulse <100.  Limited ECG 9 am on 22Jan2021 showed RSR, rate 87. Note that the patient has had NO previous history of cardiac problems, take no medications or supplements, all ECG's previously normal. No treatment received for the adverse event. Events outcome was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Tachycardia/ possible supra ventricular tachycardia/heart rate 209" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling  surrounding injection site elbow to shoulder at peak on 2/3/2021.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Blood in stool; 36 hours after receiving his first dose of the COVID-19 Vaccine (at 4:00PM), he had massive diarrhea; This is a spontaneous report from a contactable consumer (patient). An 80-year old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 07:00AM (vaccine location: Arm, Left Upper) at single dose for COVID-19 immunisation. The patient's medical history included ongoing parkinson's disease (probably had Parkinson's disease for 8 years, but was formally diagnosed 6 years ago) and peripheral neuropathy. The concomitant medications was reported as sinemet for parkinson's disease and gabapentin for peripheral neuropathy, about 6 years. Patient said 36 hours after having his first COVID-19 Vaccine dose, he had massive diarrhea on 14Jan2021 at 04:00PM. He said the diarrhea only happened one time. He said he went on a BRAT diet for a few days and then back to a regular diet. He clarified the diarrhea was brown. He said he had 1 incident of blood in his stool after that on 15Jan2021. He said he couldn't get an appointment with his doctor, so he went to emergency room. He said he was at the emergency room from 8:00AM-4:00 PM. He said the emergency room doctor told him he probably didn't have any recurrence of blood in his stool, because the blood was caused by his episode of diarrhea the day before. He said the emergency room doctor postulated that his diarrhea was caused by the COVID-19 Vaccine because there was a 36-hour delay between receiving the COVID-19 Vaccine and having diarrhea. The outcome of diarrhea was recovered on 14Jan2021. The outcome of blood in stool was recovered on 15Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 06:45 at single dose (vaccine location=right arm) for covid-19 immunisation.  The patient medical history was not reported. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO).  The patient previously received first dose of BNT162B2 on unspecified date at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient experienced severe fatigue, chills, fever, rigors, myalgia, global weakness, sweating and nausea on 21Jan2021 07:00 PM. It was unknown if treatment received for events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events  cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.  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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 06:45 at single dose (vaccine location=right arm) for covid-19 immunisation.  The patient medical history was not reported. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO).  The patient previously received first dose of BNT162B2 on unspecified date at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient experienced severe fatigue, chills, fever, rigors, myalgia, global weakness, sweating and nausea on 21Jan2021 07:00 PM. It was unknown if treatment received for events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events  cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.  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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: achy muscles, tired 2 days
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Magnetic resonance imaging, Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient's wife). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899, expiry: 31Mar2021), via an unspecified route of administration on 16Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included diabetes, cholesterol (abnormal), kidney (disorder), heart (disorder) and thyroid (disorder).  Concomitant medications included insulin aspart (NOVOLOG) for diabetes, insulin glargine (LANTUS) for diabetes, atorvastatin for cholesterol, tamsulosin, valsartan (DIOVAN) for the kidneys, levothyroxine for thyroid, diltiazem for heart, metformin hcl, macrogol 3350 (MIRALAX) from 01Feb2013, aspirin [acetylsalicylic acid], vitamin D3 and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). It was reported that the patient had seizures between his first and second dose of the COVID vaccine on an unspecified date. He has never had a seizure in his life, and he had the Covid shot last Saturday a week ago, not yesterday but the week before (16Jan2021). The patient's wife was asking if they are suggesting that a seizure could have been an allergic reaction and if there has been any other call with someone having a seizure after having the COVID 19 vaccine. The patient was admitted in a hospital from 22Jan2021 to 23Jan2021. Friday of this week (Jan2021), they did a CT scan, blood work, and an MRI. The doctor gave him a pill, anti-seizure pill to start taking. It is Keppra low dose, one in the morning and one in the evening. The patient's wife was not stating that the seizure is caused by Pfizer, but her husband has no history or family history of seizures and is wondering if her husband should take his second shot on 06Feb2021. The outcome of the event was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Good syndrome
Clinical narrative: Good; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021, at 10:00 as first single dose for covid-19 immunization.  Medical history included penicillin allergy.  The patient's concomitant medications were not reported.  The patient experienced Good on 22Jan2021, at 10:00. The event was reported as non-serious.  No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination, nor has he been tested for COVID-19 following vaccination.  The outcome of Good was recovered in Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash on left arm at site of shot
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: resurgence of Covid-19 symptoms experienced the month prior; I still feel sick; congestion; sore throat; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231) on 08Jan2021 17:00 at single dose in left arm for Covid 19.  The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sleep, had Covid back in Dec, early Dec. Concomitant medication within 2 weeks of vaccination included zolpidem tartrate (AMBIEN) to sleep. The patient experienced resurgence of Covid-19 symptoms experienced the month prior on 11Jan2021 12:00 AM. She had her first dose on 08Jan2021 and all of her Covid symptoms return except this time little bit worse than the first. It says 13 days since her dose and she still feel sick on 11Jan2021 12:00 AM, congestion on 9Jan2021, sore throat on 9Jan2021. No treatment received for all the events. All the events result in Doctor or other healthcare professional office/clinic visit. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. The outcome was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated, "Advil, probably 400 mg maybe like two times a day at most but it wasn't every day. I did not take it every day, I take it for couple of days."; Sender's Comments: The 41-year-old female patient had Covid in early Dec2020. On 08Jan2021, she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and experienced resurgence of Covid-19 symptoms on 11Jan2021.  The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the resurgence of Covid-19 symptoms most likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: woke up with a subconjunctival hemorrhage in right eye; This is a spontaneous report from a contactable consumer reporting for himself   A  67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 23Jan2021 at 01:00 a.m.  at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included diabetes. Concomitant medications included empagliflozin (JARDIANCE), lisinopril, rosuvastatin, tamsulosin hydrochloride (TAMULOSIN). On 24Jan2021 the patient woke up with a subconjunctival hemorrhage in right eye. No Treatment was given for the event.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pain in extremity, Pruritus, Skin induration
Clinical narrative: 48 hours after vaccine,  area became red, hard, painful, warm and swollen.  Area was mapped at that time, measured 7x7 cm. Reddened area became bigger next day and more painful, measured 9x9 cm. Employee health called  72 hrs after vaccine who directed me to call  PCP. On call provider directed me to take antihistamine, apply ice and OTC steroid cream. I took loratadine and diphenhydramine and used ice. Next days swelling and pain better. One week later, there is some remaining itchiness but no redness, pain or swelling.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: 48 hours after vaccine,  area became red, hard, painful, warm and swollen.  Area was mapped at that time, measured 7x7 cm. Reddened area became bigger next day and more painful, measured 9x9 cm. Employee health called  72 hrs after vaccine who directed me to call  PCP. On call provider directed me to take antihistamine, apply ice and OTC steroid cream. I took loratadine and diphenhydramine and used ice. Next days swelling and pain better. One week later, there is some remaining itchiness but no redness, pain or swelling.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abstains from alcohol, Imaging procedure abnormal, Liver disorder, Non-tobacco user
Clinical narrative: swelling of spleen and liver; swelling of spleen and liver; Fever followed by unremitting abdominal pain; Fever followed by unremitting abdominal pain; This is a spontaneous report from a contactable Other HCP. A 33-year-old male Other HCP reported that he receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), intramuscular at single dose into the left arm on 18Jan2021 at 10:45 am for COVID-19 immunization. The patient had received the first dose of vaccine (Lot number ElC9231) on 28Dec2020 at 11:30 am intramuscular into the left arm. Medical history was none. Concomitant drugs were none. On 20Jan2021 the patient experienced fever followed by unremitting abdominal pain that led to hospital admission for pain management and diagnostic imaging that revealed swelling of spleen and liver. Proton pump inhibitor via IV. Opioid IV in ER. the patient was hospitalized for 3 days. Unremarkable patient history prior to this even for GI and cardio. Non smoker non alcohol user. First ever hospitalization as an adult. On 21Jan2021 the patient had a negative Nasal Swab test for covid. The outcome of the event was recovering.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events fever, abdominal pain and swelling of spleen and liver.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Spleen disorder
Clinical narrative: swelling of spleen and liver; swelling of spleen and liver; Fever followed by unremitting abdominal pain; Fever followed by unremitting abdominal pain; This is a spontaneous report from a contactable Other HCP. A 33-year-old male Other HCP reported that he receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), intramuscular at single dose into the left arm on 18Jan2021 at 10:45 am for COVID-19 immunization. The patient had received the first dose of vaccine (Lot number ElC9231) on 28Dec2020 at 11:30 am intramuscular into the left arm. Medical history was none. Concomitant drugs were none. On 20Jan2021 the patient experienced fever followed by unremitting abdominal pain that led to hospital admission for pain management and diagnostic imaging that revealed swelling of spleen and liver. Proton pump inhibitor via IV. Opioid IV in ER. the patient was hospitalized for 3 days. Unremarkable patient history prior to this even for GI and cardio. Non smoker non alcohol user. First ever hospitalization as an adult. On 21Jan2021 the patient had a negative Nasal Swab test for covid. The outcome of the event was recovering.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events fever, abdominal pain and swelling of spleen and liver.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Headache, Nausea, Pain
Clinical narrative: meningioencephalitis; Severe headache; severe nausea; migraine; small subarachnoid hemorrhage postulated; This is a spontaneous report from a contactable Physician (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 07Jan2021 at 02:30 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included hypertension, hypercholesterolemia, hypothyroidism and dust allergy. Concomitant medications in two weeks prior to the vaccination included levothyroxine sodium (SYNTHROID), chlorthalidone and rosuvastatin calcium (CRESTOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 PM patient experienced severe headache with severe nausea requiring emergency room (E R) visit and intravenous (I. V) morphine, toradol and ondansetron. Computed tomography angiography (C T A) of head performed on unknown date was normal. Pain unbearable. Lumbar puncture (L P) not done. Pain persisted four days later, though diminished. Diagnosis (Dx) uncertain but possible migraine with right (r) eye preference or small subarachnoid hemorrhage postulated. Another troublesome possibility could be vaccine reaction (meningioencephalitis). Events resulted in Emergency room/department or urgent care. Treatments received included IV morphine, zophran (as reported), ketorolac tromethamine (TORADOL) and metoclopramide hydrochloride (REGLAN). Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient recovered with sequel from the reported events.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events meningoencephalitis, headache, nausea, migraine and subarachnoid hemorrhage. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Swollen tongue, Urticaria
Clinical narrative: About 5 minutes after vaccination, patient reported tongue swelling and lightheadedness.  Patient was closely monitored and tongue swelling resolved quickly.  Patient also developed hives on face and was given 25mg Benadryl orally.  Tachycardia was monitored and patient remained in clinic for 1 hour until symptoms resolved and she could demonstrate a steady gait to walk back to her car.  No additional treatment provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Loss of consciousness
Clinical narrative: headache; had chills; freezing; body aches; got really hot; passed out; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at 13:15 at single dose for COVID-19 immunization. The patient medical history included COVID-19 from Mar2020 to an unknown date.  The patient's concomitant medications were not reported. On 24Jan2021, the patient experienced at 4:00 she was freezing and had chills and body aches. At 7:15, she felt body aches and a bad headache. Things started spinning and she passed out. After that, she got really hot and she went back to bed and stayed in bed until 14:00. It seemed very severe. She didn't have a fever, but her body hurt like she did. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vertigo
Clinical narrative: headache; had chills; freezing; body aches; got really hot; passed out; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at 13:15 at single dose for COVID-19 immunization. The patient medical history included COVID-19 from Mar2020 to an unknown date.  The patient's concomitant medications were not reported. On 24Jan2021, the patient experienced at 4:00 she was freezing and had chills and body aches. At 7:15, she felt body aches and a bad headache. Things started spinning and she passed out. After that, she got really hot and she went back to bed and stayed in bed until 14:00. It seemed very severe. She didn't have a fever, but her body hurt like she did. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery bypass, Dyspnoea, Hyperlipidaemia, Hypothyroidism, Type 1 diabetes mellitus
Clinical narrative: Hypothyroidism; Diabetes mellitus Type 1; Shortness of breath; Hyperlipidemia; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 22Jan2021 01:00 at single dose for COVID-19 immunization. Medical history included known allergies to latex. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been testes for COVID-19 post vaccination. The patient experienced hypothyroidism, diabetes mellitus type 1, shortness of breath, hyperlipidemia, and had a heart surgery (triple bypass) on an unspecified date. The events resulted in visit to doctor's office or another health professional and hospitalization for 11 days. The patient received treatment for the events. The outcome of the events was recovered with sequels.  Information on the Lot/Batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on inside elbows both arms
Age: 1.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines were exposed to 0.7 C for 25 hours and 24 minutes/ NO AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center.  This case involve a INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiry date not reported) which was exposed to 0.7 Celsius for 25 hours and 24 minutes (product storage error) excursion occurred in December-2020. Also one year patient administered post exposed 0.5 mL FLUZONE (batch number: UJ477AA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site on 06-Jan-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to product storage error temperature too low.  It was reported that 11 doses of Fluzone quadrivalent were administered post excursion.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available for DAPTACEL, ADACEL, IPOL, MENACTRA and PENTACEL on the batch number for this case.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Swelling face
Clinical narrative: PATIENT STATED THAT AFTER 3 HOURS OF RECEIVING THE FIRST DOSE OF THE COVID-19 VACCINE, HER LEFT EYE BECAME RED AND PART OF HER CHEECK BECAME SWOLLEN, PT STATED THAT SHE TOOK BENADRYL AND IBUPROFEN. DIDN'T SEEK MEDICAL ATTENTION.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: temp of 100.2
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Feeling cold, Nausea, Sinus operation
Clinical narrative: female with dizziness after Moderna, 2nd shot on 1/29. Cramping in stomach, nausea, and continued dizziness. Temp 99, minor chills, minor nasal sinus symptoms. "
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Peripheral swelling, Rash
Clinical narrative: Rash all over body, light headedness, then the next day swollen hands and feet.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Nasal discomfort, Red blood cell abnormality, Swelling face
Clinical narrative: Tickle high up in nose- right eye swelled- and face got puffy and bright red- occurred about 20 minutes after vaccine.  Took Benadryl  and puffiness remained or about two hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain
Clinical narrative: Joint pain to right elbow and wrist area.  "Bone" pain to  right upper arm and right shoulder/shoulder blade and neck. Dull ache pain.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pain, Skin discolouration, Skin warm
Clinical narrative: The day after the injection I was sore and the arm was bruised, purplish color, and hot to the touch. And this morning I got very itchy around the vaccine site and its still red and hard to the touch, like there was a lump under the skin.  The bruise has faded a little but its not getting much better. Medical provider called to recommend benadryl and tylenol, and keep a warm pack on it, and also to seek help if it has not improved over the weekend.