chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: redness on arm and cheek. Evaluated by EMS-Cleared
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with Covid-19
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hard red bump in arm near vaccine area. Painful , itchy
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After going to sleep on my legs started hurting really bad and better next morning.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, a slight cough, and brain fog. I have mucus buildup as well.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, a slight cough, and brain fog. I have mucus buildup as well.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who never received Twinrix third dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th October 2019) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by pharmacist technician. The age at vaccination was not applicable for this report. The reporter asked safety information about the patient. The patient never received Twinrix third dose from standard dosing schedule, which led to incomplete course of vaccination. No information was reported about lot numbers from 1st and 2nd dose. The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red, itchy, tender, swollen giant hives around a few inches from injection site; red, itchy, tender, swollen giant hives around a few inches from injection site; red, itchy, tender, swollen giant hives around a few inches from injection site; red, itchy, tender, swollen giant hives around a few inches from injection site; A spontaneous report was received from a consumer concerning a 41-year-old female patientwho received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red, itchy, tender, swollen giant hives around a few inches from injection site.  The patient's medical history not provided. The concomitant medications were not reported.  On 10-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 20-JAN-2021, the patient noticed red, itchy, tender, swollen giant hives around a few inches from injection site. The event swollen giant hives around a few inches from injection site was assessed as serious as per IME list. Labs were not reported. Consumer took Benadryl at 10:30am to treat symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events red, itchy, tender, swollen giant hives around a few inches from injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperglycaemia, Ketoacidosis
Clinical narrative: blood sugar was high (758 mg/dL); Ketoacidosis; A spontaneous report was received from consumer concerning a 73 Year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced High blood sugar(758mg/Dl) and Ketoacidosis.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The report stated that the patient was physically and mentally healthy before vaccination.   On 4 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown)  via intramuscular route on her upper Arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, Patient experienced high blood sugar (758 mg/DL) and she was admitted to hospital because of her high blood sugar and ketoacidosis. The patient was hospitalized on 11 Feb 2021 and released on 20Feb 2021.  High blood sugar and Ketoacidosis were deemed as life threatening for seriousness criteria. Consent was received to save the caller information within our database and for safety to follow up.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events experienced High blood sugar (758mg/Dl) and Ketoacidosis  was considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vomiting
Clinical narrative: Began throwing up; Face swelled up; A spontaneous report  was received from a consumer concerning her sister, a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face swelled up/swelling face and began throwing up/ vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, immediately after the second dose, the patient experienced face swelled up. A few hours later, patient began throwing up and had to go to the hospital and was hospitalized for 3 days.   Treatment details not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of events, face swelled up and began throwing up was resolved (ok now) on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted in the shower; A spontaneous report was received from a consumer concerning a friend who is a patient of unknown age and race that received Moderna's COVID-19 Vaccine (mRNA-1273) and fainted in the shower (Syncope).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient fainted in the shower. No treatment information was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, fainted in the shower was considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD-2021-031707:patient's case
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Drug ineffective, Feeling hot, Malaise, Nausea
Clinical narrative: Diarrhea; Felt hot, but no temperature; Nausea; Vomiting; Appears the Botox did not work; Shaking from the Parkinson's is aggravated; He was not feeling well; A spontaneous report was received from a consumer concerning a 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work.   The patient's medical history, as provided by the reporter included parkinson's. Concomitant medications reported included botox injection.  On 08 Mar 2021 at 01:00 pm, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 003A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.   On the 09 Mar 2021, after receiving mRNA-1273, the patient experienced he was not feeling well, shaking from the parkinson's is aggravated and appears the botox did not work. On 10 Mar 2021, the patient experienced, diarrhea, nausea, vomiting, felt hot, but no temperature.   Lab details was not provided by the reporter.  Treatment for the events was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinsonism, Vomiting
Clinical narrative: Diarrhea; Felt hot, but no temperature; Nausea; Vomiting; Appears the Botox did not work; Shaking from the Parkinson's is aggravated; He was not feeling well; A spontaneous report was received from a consumer concerning a 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work.   The patient's medical history, as provided by the reporter included parkinson's. Concomitant medications reported included botox injection.  On 08 Mar 2021 at 01:00 pm, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 003A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.   On the 09 Mar 2021, after receiving mRNA-1273, the patient experienced he was not feeling well, shaking from the parkinson's is aggravated and appears the botox did not work. On 10 Mar 2021, the patient experienced, diarrhea, nausea, vomiting, felt hot, but no temperature.   Lab details was not provided by the reporter.  Treatment for the events was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diverticulitis, Loss of consciousness, Pyrexia
Clinical narrative: passed out on way to bathroom; Maybe it was a seizure; Feeling weak; Fever of 103,Lowest the fever could get is 101; Diverticulitis attack; A spontaneous report was received from a consumer concerning a female patient of 68 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Diverticulitis attack, felt weak, passed out, seizure and Fever of 103.  The patients medical history included sensitivity to medicines. No relevant Concomitant medications were reported.  On 08 Mar 2021,prior to the onset of events, the patient received the first of two planned doses of mRNA-1273(Lot number: 011A21A) vaccine through unknown route for prophylaxis of COVID-19 infection.  On 10 Mar 2021, at 1am, she woke up with a fever of 103. The highest was 103 and the lowest she could get it down to was 101. The patient passing out on way to bathroom at one point also and does not know how long she was out for. She believes she could have had a seizure. She also had a diverticulitis attack in this time period which she states being the worse attack and she felt pretty weak .  Treatment for the event included Tylenol and used icepacks and was on a liquid diet.  Action taken with the mRNA-1273 in response to the event was not provided.  The fever resolved on 12 Mar 2021 while the diverticulitis attack and weakness resolved on 16 Mar 2021. The outcome were unknown for other events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: passed out on way to bathroom; Maybe it was a seizure; Feeling weak; Fever of 103,Lowest the fever could get is 101; Diverticulitis attack; A spontaneous report was received from a consumer concerning a female patient of 68 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Diverticulitis attack, felt weak, passed out, seizure and Fever of 103.  The patients medical history included sensitivity to medicines. No relevant Concomitant medications were reported.  On 08 Mar 2021,prior to the onset of events, the patient received the first of two planned doses of mRNA-1273(Lot number: 011A21A) vaccine through unknown route for prophylaxis of COVID-19 infection.  On 10 Mar 2021, at 1am, she woke up with a fever of 103. The highest was 103 and the lowest she could get it down to was 101. The patient passing out on way to bathroom at one point also and does not know how long she was out for. She believes she could have had a seizure. She also had a diverticulitis attack in this time period which she states being the worse attack and she felt pretty weak .  Treatment for the event included Tylenol and used icepacks and was on a liquid diet.  Action taken with the mRNA-1273 in response to the event was not provided.  The fever resolved on 12 Mar 2021 while the diverticulitis attack and weakness resolved on 16 Mar 2021. The outcome were unknown for other events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Parkinson's disease, Postmenopausal haemorrhage, Premenstrual syndrome, Rash pruritic
Clinical narrative: had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: She has recently fallen and broken her hip which caused her to have surgical repair; She has recently fallen and broken her hip which caused her to have surgical repair; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on Monday, 15Mar2021. She has recently fallen and broken her hip which caused her to have surgical repair on 03Mar2021 and now she was in a nursing home recovering. She wanted to know what she should do about postponing her second dose. The reporter considered the events as non-serious. Therapeutic measures were taken as a broken hip which included surgical repair. The patient was recovering from the events.  Information on lot number/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dizziness postural, Oropharyngeal pain, Syncope
Clinical narrative: fainted when I sat down; stood up and started to feel dizzy; I felt throat pain like strep throat pain; started feeling very intensive cramps in my lower abdomen like very intense period cramps for about 10 minutes.; felt very weak with no energy to get out of bed; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302) via an unspecified route of administration, administered on the right arm on 11Mar2021 16:00 at a single dose for COVID-19 immunisation. Medical history included low thyroid. There were no concomitant medications. After receiving the shot of the vaccine on 11Mar2021 16:00, the patient stood up and started to feel dizzy. She was able to find a nearby chair and fainted when she sat down. When she woke up seconds later of fainting, she felt throat pain like strep throat pain and then she started feeling very intensive cramps in her lower abdomen like very intense period cramps for about 10 minutes. The patient stated that nobody in the (Pharmacy name) was prepared to react to these symptoms and the rescue took too long to come in, when they came in she was feeling better and did not see the need of going to the hospital. But it was an immediate reaction that affected 3 different parts of her body that was very painful. During the day and the day after she felt very weak with no energy to get out of bed. "I am wondering if I can still receive the second dose after this reaction to the first dose?" No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a pharmacy drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Speech disorder
Clinical narrative: stroke; Left side stroke which affected his speech, and right side; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number En6199 and expiration date unknown), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 at a single dose for COVID-19 immunization. Medical history included myasthenia gravis, rheumatoid arthritis, and high blood pressure. Concomitant medications included pyridostigmine (PYRIDOSTIGMINE), metoprolol (METOPROLOL), tamsulosin (TAMSULOSIN) and amlodipine (AMLODIPINE). The patient had known allergies with aspirin [acetylsalicylic acid]. The patient had no other vaccine in four weeks. The patient had a left side stroke which affected his speech and right side, on Tuesday morning 48 hours after taking the vaccine (on 09Mar2021 at 05:00). The event resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. It was also reported that treatment was administered for the events and the patient was still in the hospital. The patient had no COVID-19 prior vaccination and has tested post vaccination (09Mar2021), with a pending result. The patient was recovering from the events at the time of the report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Illness, Tinnitus
Clinical narrative: my ears started ringing; some amount of loss due to the ringing i wasn't able to hear high frequency at low volumes; I called in sick; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: En6200), via an unspecified route of administration in left arm on 17Feb2021 12:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The vaccine facility type was a school or student health clinic. Medical history included heart attack in Oct2020. The patient had no known allergies. The patient did not have covid prior vaccination and was not covid tested post vaccination. The patient did not have other vaccine in four weeks. Concomitant medications included atorvastatin; clopidogrel and metoprolol. It was reported that on 18Feb2021 (the day after the patient got the covid shot) at approximately 17:00 his ears started ringing, he called in sick and got a doctor's appointment asap. The patient said that there was no blockage or infection, so he got a referral to an audiologist to get hearing test. The test only revealed some amount of loss due to the ringing he wasn't able to hear high frequency at low volumes. The patient was concerned about getting second shot. Not sure what to do. The events resulted in doctor or other healthcare professional office/clinic visit and was considered disability or permanent damage. There was no treatment for the events. The outcome of the events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Muscular weakness
Clinical narrative: Weakness in hands, feet and legs; Facial numbness and drooping 30 mins after injection; Facial numbness and drooping 30 mins after injection; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization at age 26 years old. The patient was not pregnant at the time of vaccination. The patient had covid prior to vaccination. No known allergies. Patient was not tested post vaccination. There were no concomitant medications. No other vaccines in four weeks and no other medication in two weeks. On 12Mar2021 14:30, 30 mins after injection, the patient experienced facial numbness and drooping 30 mins after injection. On 13Mar2021 02:00, weakness in hands, feet and legs starting 12 hours after injection. Treatment was not given for events. The patient had not recovered from the events.    Information about lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable consumer (reporting for himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204, expiration date: unknown), via an unspecified route of administration in left arm on 11Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included gout. The patient's concomitant medications were not reported. On 12Mar2021 at 01:00, the patient experienced atrial fibrillation. The patient stated that it was his first time to have ever had any heart issues. The patient did not received treatment for the event. The outcome of the event was not recovered. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: experience his legs and arms shaking/quivering (went to ER for treatment) which resolved but came back the morning of 12Mar2021; This is a spontaneous report received from a contactable pharmacist (patient) via Medical information team. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection dose, Lot number and expiration date was not reported) via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. Historical vaccine included BNT162b2 first Pfizer COVID vaccine dose on 13Feb2021 for COVID-19 immunization, after which he experienced neck tightness and denies any issues with breathing. On 10Mar2021 the patient experienced his legs and arms shaking/quivering went to ER for treatment which resolved but came back the morning of 12Mar2021. As per the reporter seriousness criteria reported as hospitalization. Therapeutic measures were taken as a result of experience his legs and arms shaking/quivering went to ER for treatment which resolved but came back the morning of 12mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event tremor limb and the suspect drug. 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: M
Vaccine: COVID19
Symptoms: Gastritis, Gastrointestinal pain, SARS-CoV-2 test, Ulcer
Clinical narrative: Severe GI pain; gastritis; ulcers; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 35 years age), dose 1 via an unspecified route of administration, administered in arm left on 29Jan2021 14:00 (Batch/Lot Number: EL9262) as a single dose for COVID-19 immunisation. Medical history included allergy from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy, start and stop date were not reported. The patient had no COVID prior vaccination. The patient experienced severe GI pain, gastritis and ulcers, all  on 05Feb2021 with outcome of recovering. The patient was hospitalized for the events on the 6th day (Feb2021) after initial COVID vaccine dose (as reported). The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events; patient was given ulcer medicine. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) with negative result on 16Feb2021. The patient took dose 2 of vaccine on 19Feb2021.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Ear infection, Hypoacusis, Sinusitis, Tinnitus
Clinical narrative: lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hearing like a buzzing sound, hollow sound; she couldn't hear very well; This is a spontaneous report from a contactable consumer. This consumer reported for a 51-year-old female patient (Reporter's sister-in-law) that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247;solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient's age was 52 years old at the time of vaccination with weight 76.644 kg, height; 154.94 cm. Patient's medical history included diabetes. Patient's concomitant medications included Metformin at 1000 mg for diabetes, Lisinopril at 10 mg for blood pressure, Insulin at 100 units, Atorvastatin at 40 mg (therapy dates unspecified). Reporter stated, "This is regarding my sister-in-law, it's in regards to, I had called few weeks ago and they had told me to call back I need to know who do I speak to as I need to send some paper work. She had a reaction to the Covid injection and I have all the paper work here. They told me that we needed to send also that they are going to try and see how she can get compensated back because she had to go to the hospital, she had to go to the  clinic twice, she had to see specialist and things like that." Reporter stated, "On 29Jan2021 (Later corrected), she got it done at work and couple of hours later she started hearing like a buzzing sound, she end up she couldn't hear very well and then the next day she (word incomprehensible) out of her right ear. It's been like the longest time. Pfizer EL3247." Treatment: Reporter stated, "Well she went to the clinic twice although she had, one doctor said she had sinus infection the other doctor said she had ear infection. So, she went to a specialist ENT and he said she had none of those infections. He did put her on Prednisone because she lost hearing of the right ear so, he gave her 10 mg of Prednisone, gave 6 tablets 5, 4, 3 like that." She did not take the 2nd vaccine. She had loss of hearing, a buzzing sound, hollow sound, still has loss of hearing in right ear. Reporter was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 am to 8 pm Monday to Sunday as per (EST). Investigation assessment; no. The outcome of events was not recovered for lost hearing of the right ear and for other events were unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hearing like a buzzing sound, hollow sound; she couldn't hear very well; This is a spontaneous report from a contactable consumer. This consumer reported for a 51-year-old female patient (Reporter's sister-in-law) that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247;solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient's age was 52 years old at the time of vaccination with weight 76.644 kg, height; 154.94 cm. Patient's medical history included diabetes. Patient's concomitant medications included Metformin at 1000 mg for diabetes, Lisinopril at 10 mg for blood pressure, Insulin at 100 units, Atorvastatin at 40 mg (therapy dates unspecified). Reporter stated, "This is regarding my sister-in-law, it's in regards to, I had called few weeks ago and they had told me to call back I need to know who do I speak to as I need to send some paper work. She had a reaction to the Covid injection and I have all the paper work here. They told me that we needed to send also that they are going to try and see how she can get compensated back because she had to go to the hospital, she had to go to the  clinic twice, she had to see specialist and things like that." Reporter stated, "On 29Jan2021 (Later corrected), she got it done at work and couple of hours later she started hearing like a buzzing sound, she end up she couldn't hear very well and then the next day she (word incomprehensible) out of her right ear. It's been like the longest time. Pfizer EL3247." Treatment: Reporter stated, "Well she went to the clinic twice although she had, one doctor said she had sinus infection the other doctor said she had ear infection. So, she went to a specialist ENT and he said she had none of those infections. He did put her on Prednisone because she lost hearing of the right ear so, he gave her 10 mg of Prednisone, gave 6 tablets 5, 4, 3 like that." She did not take the 2nd vaccine. She had loss of hearing, a buzzing sound, hollow sound, still has loss of hearing in right ear. Reporter was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 am to 8 pm Monday to Sunday as per (EST). Investigation assessment; no. The outcome of events was not recovered for lost hearing of the right ear and for other events were unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Fatigue, Headache, Pneumonia, SARS-CoV-2 test
Clinical narrative: shortness of breath; headache; fatigue; pneumonia; This is a spontaneous report from a contactable other health professional. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as a single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR, Batch/Lot number was not reported), oral from Jan2021 and ongoing, at 11 mg, 1x/day for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. Patient reported receiving samples from medical doctor (MD) office to start in January. Patient reported having COVID vaccine at the end of February, 9 days later started having COVID symptoms including shortness of breath, headache, and fatigue; called primary MD and was instructed by MD to go to urgent care 10Mar2021 where she was treated with steroids and given prescription for antibiotic and sent home. COVID test negative, treating as rule out pneumonia on Feb2021 as they are unsure if it is related to vaccination as a delayed reaction or separate infection. Prescribing MD not aware. Patient has not stopped XELJANZ therapy as she has not been able to speak with prescribing physician. She has appointment for second shingles vaccine. Encouraged patient to inform MD of illness/infection and being on XELJANZ prior to receiving vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date. The action taken in response to the event for tofacitinib citrate was dose not changed. Therapeutic measures were taken as a result of shortness of breath, headache and fatigue. The outcome of the events was unknown.; Sender's Comments: Reported event pneumonia is probably associated to tofacitinib based on its drug safety profile but is unlikely related to BNT162B2.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: getting the shot lost vision of half of patient right eye.; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for 02 patients. This is the 2nd of 02 reports. An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date a friend of patient was reported as after 20 minutes after getting the shot lost vision of half of patient right eye. That lasted a few minutes. Have a friend who has a friend who suffered the same effect. Outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274179 same reporter/drug/AE, different patients.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Chills, Palpitations
Clinical narrative: Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Night sweats, Palpitations
Clinical narrative: Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A female patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included celiac disease. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 27Jan2021 for Covid-19 immunisation. It was reported symptoms of Bell's Palsy appeared 5 days later on Monday following second dose on 22Feb2021. Patient believes that her neurologist did report the adverse event but has met with resistance in reporting the adverse event. Patient is currently still experiencing symptoms and is taking Gabapentin for the nerve pain. She is willing to talk with someone from Pfizer if you would like additional information and was very pleased that we were reporting her adverse reaction immediately. The outcome of the event was not recovered.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.