chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site mass
Clinical narrative: a tender lump under my left arm in my armpit; Chills; headache; tiredness; This is a spontaneous report from a contactable consumer for himself. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 10:30 (Lot number: EL3247) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization at workplace clinic. The patient had no medical history and not had allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 14:30 (Lot number: EL3247) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has not taken any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient experienced chills, headache, tiredness the second morning after the second dose administered on 23Feb2021 the patient noticed a tender lump under his left arm in armpit on 25Feb2021 06:45. The reporter assessed the events as non-serious. The patient has not received treatment. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for COVID-19. Wanted to know if it is okay to get the second dose tomorrow, as scheduled or do they have to wait. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Epistaxis, Neck pain, Nervousness
Clinical narrative: Joint pain in her hands next day; patient felt shaky same day of vaccine and described it "like when you do very heavy exercising, but you didn't fuel/eat enough so you feel a bit shaky; patient felt pain behind her ear/neck area like fluid pressure; patient felt pain behind her ear/neck area like fluid pressure; a few days later had a nose bleed. After the nose bleed neck pressure was gone; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 04Feb2021, as single dose for COVID-19 immunization, at workplace clinic. Patient had allergies to Soy, nuts and seasonal and history of Cancer. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Patient felt shaky same day of vaccine and described it "like when you do very heavy exercising, but you didn't fuel/eat enough so you feel a bit shaky". Joint pain in her hands next day (05Feb2021). Few days post (3-4 days) boost, patient felt pain behind her ear/neck area like fluid pressure and then a few days later had a nose bleed. After, the nose bleed neck pressure was gone. Patient was not received treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Headache, SARS-CoV-2 test
Clinical narrative: increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous report from a contactable nurse (patient).  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration at arm left on 28Jan2021 at 11:00 (at the age of 54-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant.  Medical history included atrial fibrillation (AFib), depression, aortic stenosis and allergy to sulfa, all from an unknown date and unknown if ongoing.  Concomitant medication included losartan, HCTZ, sertraline hydrochloride (ZOLOFT), vitamin D3, magnesium and cyanocobalamin (VITAMIN B12).  The patient previously took LEVOQUIN and prednisone and experienced allergies. On 02Feb2021 at 08:00, the patient experienced increased AFib episodes, joint ache esp. to left knee with pain and headache.  The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 22Feb2021. Therapeutic measures were taken as a result of the events and included acupuncture and the events required physician office visit. The patient outcome of the event was not recovered.; Sender's Comments: There is not a reasonable possibility that event atrial fibrillation is related to BNT162B2.  The event only occurred 4 days after vaccination.  And the patient had underlying atrial fibrillation, which is considered the most likely cause of the reported event.   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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This is a spontaneous report from a contactable consumer reported for herself that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years via an unspecified route of administration in left arm on 24Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure; fibromyalgia; kidney stones. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL ARTHRITIS); enalapril; amlodipine; hydrochl (as reported). The patient historically received first single dose of BNT162B2 at the age of 51-years via an unspecified route of administration in left arm on 03Feb2021 03:00 PM for COVID-19 immunization. On 26Feb2021 06:00 AM, the patient experienced swollen lymph node under left arm causing pain. It was unknown if treatment was received for the adverse events. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Haematoma, Haemorrhage subcutaneous, Rash, Skin discolouration
Clinical narrative: its bluish in color and it looks like there is bleeding under the skin; noticed his reaction/an area on the inside of his right thigh that looks like a hematoma; he has like a hematoma almost like a discoloration of the skin on the inside of his thigh/purplish color, like a bluish reddish but it is not red.; rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN6198), via an unspecified route of administration on the left arm, first dose at age 83 years, on 25Feb2021 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Patient stated that he got the Pfizer COVID 19 Vaccine yesterday (25Feb2021) at noon and this morning (26Feb2021), he has a rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma, almost like discoloration of the skin, it doesn't hurt but he wants to see if this is something that normally occurs. He showered last night and didn't notice it until this morning. He only noticed it about a half hour ago so he is not sure if there is any difference. He clarifies the area on the inside of his thigh is a purplish color, like a bluish reddish but it is not red. It looks like a hematoma, like bleeding under the skin. There is no swelling, it is not raised and it doesn't hurt to touch, just there. He didn't call his primary about this. He got this information so his doctor does not know anything about it. If it is something to be concerned about he will run down to the emergency room but he will see if he can find the office contact info. Outcome of the events was not recovered. Case was reported as non-serious.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cardiac discomfort, Chills, Dyspnoea, Fatigue
Clinical narrative: headache; Chills; Jaw pain; Tiredness; Nausea; Vomiting; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; stress on my heart; have no energy and I cannot breath and it is just that I have not energy now; I cannot breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246; expiration date: unknown) at 79-year-old vaccination age via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported getting both the shots of the vaccine (COVID Vaccine) and the patient was still having a lot of symptoms that the patient should not be having like headache, chills, jaw pain, tiredness, nausea and vomiting which the patient had both of them in both shots and the patient also have been in the hospital with this. The patient had bad, bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then, and then the patient got the second shot on 26Jan2021 and it got worse. The patient reported having several doctors which includes a cardiologist and stomach doctor. They did several tests (2021), the patient was bleeding, stool was black from blood, and the patient was vomiting blood. The patient reported that "I had stress on my heart and I did not have a heart attack but I had stress on my heart." The patient mentioned having no energy and the patient cannot breath and it is just that the patient having not energy now. When the patient was in the hospital, they gave the patient some medications and the patient don't have it in front of the patient. The outcome of the events was unknown.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Haematemesis, Haemorrhage, Headache, Laboratory test, Melaena
Clinical narrative: headache; Chills; Jaw pain; Tiredness; Nausea; Vomiting; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; stress on my heart; have no energy and I cannot breath and it is just that I have not energy now; I cannot breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246; expiration date: unknown) at 79-year-old vaccination age via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported getting both the shots of the vaccine (COVID Vaccine) and the patient was still having a lot of symptoms that the patient should not be having like headache, chills, jaw pain, tiredness, nausea and vomiting which the patient had both of them in both shots and the patient also have been in the hospital with this. The patient had bad, bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then, and then the patient got the second shot on 26Jan2021 and it got worse. The patient reported having several doctors which includes a cardiologist and stomach doctor. They did several tests (2021), the patient was bleeding, stool was black from blood, and the patient was vomiting blood. The patient reported that "I had stress on my heart and I did not have a heart attack but I had stress on my heart." The patient mentioned having no energy and the patient cannot breath and it is just that the patient having not energy now. When the patient was in the hospital, they gave the patient some medications and the patient don't have it in front of the patient. The outcome of the events was unknown.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in jaw, Vomiting
Clinical narrative: headache; Chills; Jaw pain; Tiredness; Nausea; Vomiting; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; stress on my heart; have no energy and I cannot breath and it is just that I have not energy now; I cannot breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246; expiration date: unknown) at 79-year-old vaccination age via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported getting both the shots of the vaccine (COVID Vaccine) and the patient was still having a lot of symptoms that the patient should not be having like headache, chills, jaw pain, tiredness, nausea and vomiting which the patient had both of them in both shots and the patient also have been in the hospital with this. The patient had bad, bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then, and then the patient got the second shot on 26Jan2021 and it got worse. The patient reported having several doctors which includes a cardiologist and stomach doctor. They did several tests (2021), the patient was bleeding, stool was black from blood, and the patient was vomiting blood. The patient reported that "I had stress on my heart and I did not have a heart attack but I had stress on my heart." The patient mentioned having no energy and the patient cannot breath and it is just that the patient having not energy now. When the patient was in the hospital, they gave the patient some medications and the patient don't have it in front of the patient. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Hernia
Clinical narrative: hernia; anemia; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his first dose but then was diagnosed with a hernia and had to have emergency surgery with a blood transfusion for anemia.  Therapeutic measures were taken as a result of hernia which included surgery and anemia which included blood transfusion. The patient's second dose was due today and the reporter asks if he should get it or if should be delayed due to getting transfusion. The outcome of the events was unknown.  Information on Lot/Batch has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the 2nd Pfizer-BioNTech COVID-19 vaccine was administered on 17Feb2021, she tested positive for COVID-19 on 22Feb2021/chills, fever, fatigue, headache/exposed to COVID between her 1st and 2nd vaccine; the 2nd Pfizer-BioNTech COVID-19 vaccine was administered on 17Feb2021, she tested positive for COVID-19 on 22Feb2021/chills, fever, fatigue, headache/exposed to COVID between her 1st and 2nd vaccine; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 31-year-old female patient started received her first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and EN6200), via an unspecified route of administration on 27Jan2021 and on 17Feb2021 both at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. A patient completed her vaccination schedule, the 2nd Pfizer-BioNTech COVID-19 vaccine was administered on 17Feb2021, she tested positive for COVID-19 on 22Feb2021, asks if a COVID infection may have a negative impact on the vaccine efficacy. Patient had (COVID-like) symptoms for 48 hours after her 2nd vaccination, her husband was exposed to COVID-19 on 14Feb2021 and tested positive on 20Feb2022. She received a positive test result on 22Feb2021, considers she was exposed to COVID between her 1st and 2nd vaccine doses. The patient clarified that her symptoms were fever, chills, headache, and fatigue on the eighteenth through the nineteenth. The patient underwent lab tests and procedures which included covid-19: positive and RTPCRt: positive on 22Feb2021. Outcome of the events was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: hearing loss; This is a spontaneous report from a contactable consumer reporting for self. A 77-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration in right arm on 08Feb2021 (Age at Vaccination was 77 years old) 13:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient stated overall in good health. Concomitant medication included finasteride, gabapentine. From 11Feb2021 12:00, patient almost a total hearing loss right ear. He wore hearing aids and they were checked to be working properly. He was concerned about this hearing loss and went to urgent care today. He was given a prescription for PredniSone and also a prescription for Neomycin- Polymyxin-hc (ear drops). 2- For the first time in 77 years, he had been given a prescription for glasses this week. Outcome of event was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team. A 78-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration on the right arm on 04Feb2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital; the vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient tested positive for the COVID-19 virus on 22Feb2021. The patient requested guidance on when to receive his second dose. The patient stated he was scheduled to get his second COVID-19 vaccine shot on 02Mar2021 and asked if he should get the second COVID-19 vaccine shot, since he tested positive for the COVID-19 virus. He had a COVID-19 virus nasal swab test administered on 22Feb2021 that provided almost an immediate positive result. He clarified he had gone to an emergency care clinic for his COVID-19 virus test. He was prescribed some medication after he was diagnosed with the COVID-19 virus. He said he did not have all the medications with him as he was on his way to the emergency clinic to be retested for the COVID-19 virus. He stated he was prescribed a liquid cough medicine, promethazine 6.25-15mg/4/5ml. He said he did take promethazine liquid cough syrup. He said he was also prescribed prednisone 20 mg tablets, and that he was taking the prednisone 20 mg tablets twice a day. He was also prescribed an albuterol sulfate inhaler (NDC Number: 0093-3174-31; lot number: DAF07A, and expiration date: Aug2022) to use every 4 hours, as needed. He said the albuterol sulfate inhaler seemed to help. He also reported that his girlfriend had an extra (new and unopened) azithromycin (Z-PAK) that he took when he first started feeling bad. He said he took his girlfriend's Z-Pak at 2 tablets the first day, and 1 tablet a day for 4 days from an unspecified date in Feb2021 and completed that. The adverse event did not require a visit to a physician office. The patient underwent lab tests and procedures, which included COVID-19 virus test: positive on 22Feb2021. Therapeutic measures were taken as a result of the event "tested positive for the COVID-19 virus." The outcome of the event was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team. A 78-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration on the right arm on 04Feb2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital; the vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient tested positive for the COVID-19 virus on 22Feb2021. The patient requested guidance on when to receive his second dose. The patient stated he was scheduled to get his second COVID-19 vaccine shot on 02Mar2021 and asked if he should get the second COVID-19 vaccine shot, since he tested positive for the COVID-19 virus. He had a COVID-19 virus nasal swab test administered on 22Feb2021 that provided almost an immediate positive result. He clarified he had gone to an emergency care clinic for his COVID-19 virus test. He was prescribed some medication after he was diagnosed with the COVID-19 virus. He said he did not have all the medications with him as he was on his way to the emergency clinic to be retested for the COVID-19 virus. He stated he was prescribed a liquid cough medicine, promethazine 6.25-15mg/4/5ml. He said he did take promethazine liquid cough syrup. He said he was also prescribed prednisone 20 mg tablets, and that he was taking the prednisone 20 mg tablets twice a day. He was also prescribed an albuterol sulfate inhaler (NDC Number: 0093-3174-31; lot number: DAF07A, and expiration date: Aug2022) to use every 4 hours, as needed. He said the albuterol sulfate inhaler seemed to help. He also reported that his girlfriend had an extra (new and unopened) azithromycin (Z-PAK) that he took when he first started feeling bad. He said he took his girlfriend's Z-Pak at 2 tablets the first day, and 1 tablet a day for 4 days from an unspecified date in Feb2021 and completed that. The adverse event did not require a visit to a physician office. The patient underwent lab tests and procedures, which included COVID-19 virus test: positive on 22Feb2021. Therapeutic measures were taken as a result of the event "tested positive for the COVID-19 virus." The outcome of the event was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bell's palsy, Hypoaesthesia oral, Insomnia, Lacrimation increased
Clinical narrative: symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient).  A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose.  The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain
Clinical narrative: symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient).  A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose.  The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Gait disturbance, Hypertension, Oxygen saturation
Clinical narrative: started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization.  The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could "pull down his pants", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown.  Information on the lot/batch number has been requested.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Unresponsive to stimuli
Clinical narrative: started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization.  The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could "pull down his pants", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gallbladder disorder, Headache, Pain in extremity
Clinical narrative: fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at the age of 60-year-old at left arm on 23Feb2021 08:15 at single dose for COVID-19 immunization. Medical history included heart failure, sarcoidosis and psoriatic arthritis. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced sore arm and slight headache in first day on 23Feb2021 09:00, joint pain in 2nd day on 24Feb2021, headache and fatigue and problems with his gall bladder in 3rd day on 25Feb2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There wasn't treatment received for the adverse event. The outcome of events was recovered in Feb2021. This report was reported as non-serious report. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Peripheral swelling
Clinical narrative: Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: whole body muscle aches; fever; chills; Headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 25Feb2021 10:15 (at 39-year-old) at single dose (Left arm) for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took avelox and experienced allergy, patient also previously took first dose of bnt162b2 (Lot number: EL3247) on 05Feb2021 10:15 at 39-year-old Left arm for COVID-19 immunization. Patient was not pregnant at the time of vaccination.  Facility where the most recent COVID-19 vaccine was administered was at the  clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The patient experienced Fever, chills, headache, whole body muscle aches, and fatigue on 26Feb2021 02:30. No treatment was given for events. The outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Patient noted they had 'every symptom expected including nausea'; This is a spontaneous report from a non-contactable consumer (patient reporting for herself). An adult female patient of unspecified age received a dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Not available/provided to reporter at the time of report completion), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. It was unknown if the patient is pregnant at the time of vaccination. The patient was vaccinated at School/ Student Health Clinic. It was also unknown if the patient was diagnosed with COVID-19 with prior to vaccination; if been tested for COVID-19 since the vaccination; if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient noted they had 'every symptom expected including nausea' on Feb2021. It was unknown if treatment was received for the adverse event. The outcome of the event was unknown. The case was considered as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; mild headache; This is a spontaneous report from a contactable consumer (patient) that a 65-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) via an unspecified route of administration on 25Feb2021 at 13:30 (65-year-old at vaccination), at single dose at left arm, for covid-19 immunization. The patient's medical history included blood pressure. The patient did not have allergies to medication, food, or other products. Concomitant medications included unspecified medication for blood pressure. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at upper left arm at single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness and mild headache on 26Feb2021 at 04:00. Seriousness was reported as no, there was no result in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapability, no abnomaly/birth defect. Therapeutic measures were taken as a result of the events and included naproxen sodium (ALEVE). The outcome of the events was recovered in Feb2021.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Injection site soreness; fever; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient self). A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201, expiration date: unknown), via an unspecified route of administration (location: Left arm) on 26Feb2021 13:00 at age of 21-year-old at single dose for COVID-19 immunization. Medical history included depression, anxiety, obesity, liver disease, avoidant/ restrictive food intake disorder (ARFID). The patient was in the hospital with COVID in April2020. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Facility where the most recent COVID-19 vaccine was administered was doctor's office/ urgent care. Concomitant medication included fluoxetine hydrochloride (PROZAC), metformin and melatonin. The patient experienced injection site soreness, fever, chills, headache and weakness, all on 27Feb2021 04:00 AM. The patient received acetaminophen (TYLENOL) as treatment. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: AFib; major side effects at the injection site, her left arm swelled up it got hard and red; major side effects at the injection site, her left arm swelled up it got hard and red; left arm still itchy; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An 84-year-old female patient (mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 22Feb2021 at a single dose for COVID-19 immunisation.  Medical history included hives or redness to unspecified medicines in the past.  The patient's concomitant medications were not reported.  The reporter stated that her mother received the first dose of COVID-19 vaccine this Monday (on 22Feb2021) she is 84 years old and she has AFib (unspecified date). The patient has major side effects at the injection site, her left arm swelled up it got hard and red on unspecified date. The reporter asked if it is common/normal that the patient's left arm still itchy after six days. The patient previously experienced hives or redness to unspecified medicines in the past. The reporter wanted to know if the patient should get the second dose as scheduled. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Movement disorder, Seizure, Speech disorder
Clinical narrative: Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 10:00, at single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing food allergy (to cantaloupe). Patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin b complex (B COMPLEX) and calcium carbonate, colecalciferol (CALCIUM + D3). Patient did not receive other vaccine in four weeks. The patient experienced seizure (medically significant) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, chills (non-serious) on 27Feb2021 with outcome of recovered in 2021. No therapeutic measures were administered as a result of the events. Clinical course: the patient reported that she had been having chills for several hours. During the night while sleeping, she believe she had a seizure. She was awakened with her body quivering from head to toe. She had no pain. She was aware of what was happening. She could not move nor speak. The event did not last very long and, when the quivering ceased, she no longer had chills. Patient did not test for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Malaise, Myocardial infarction, Nausea
Clinical narrative: heart attack; became ill; I became nauseous; vomiting; dry heaves; dizzy; tingling in my face and right hand; right hand didn't feel like I could get up on my own; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 10:15 at SINGLE DOSE in left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with lot number: EL3249 on 20Jan2021 in right arm. After receiving the 2nd dose on 10Feb2021, the patient became ill on 11Feb2021, while sitting on the toilet, she became nauseous and vomiting repeatedly even dry heaves also then became dizzy and felt a tingling in my face and right hand didn't feel like the patient could get up on her own so the patient's son and daughter assisted her to her bed. She didn't know what was wrong and her daughter thought it was a side effect of the vaccine and called the nurse on call. After arriving at the emergency and was examined the patient was told she was being kept for observation since she had just had the vaccine. The patient was later told she also had a mild heart attack and to her knowledge I never had any heart issues. She could then no longer use her walker to walk because she couldn't bear weight on her right hand. She was hospitalized for 8 days and transferred to rehab and I'm still in rehab. The events were assessed as serious (hospitalized and disability). The outcome of the events was not recovered. The patient received treatment for the events.