chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Vaccination site pain
Clinical narrative: pain is excruciating, it has been terrible, the pain in left arm; she can hardly move her arm, she cannot dress, states she cannot do anything; she can hardly move her arm, she cannot dress, states she cannot do anything; This is a spontaneous report from a contactable consumer reporting for herself.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular on 19Jan2021 at 13:30 (at the age of 86 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Concomitant medication included tramadol 50mg tablet by mouth every 8 hours as needed for pain from 19Jan2021, and she stated it does not do any good. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced excruciating pain in left arm, it has been terrible, the pain in left arm. The pain is between her elbow and shoulder, she can hardly move her arm, she cannot dress, states she cannot do anything. woke her up in the middle night hurting. The patient received treatment of excruciating pain in the left arm. The clinical outcome of excruciating pain in left arm was not recovered, and for she can hardly move her arm, she cannot dress, states she cannot do anything was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, Chills, Headache, Fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Injection site inflammation, Injection site rash
Clinical narrative: A large, red, inflamed rash began to develop near the injection site approximately 7.5 days after the injection. The rash burned more so than it itched. It remained very red and inflamed for approximately 36 hours and then began to subside. I did not treat the rash with anything, as it began to improve on its own fairly quickly.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Welts; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of bnt162b2 (lot: EX9231), via an unspecified route of administration in left arm on 23Dec2020 08:30 at single dose for covid-19 immunization. Medical history included allergic to Sulfate, diabetes, blood pressure, cholesterol, "helps regulate heart", thyroid, stomach. Concomitant medication included ongoing atorvastatin for Cholesterol, acetylsalicylic acid (BAYER ASPIRIN) as blood thinner, cyanocobalamin for Vitamin Supplementation, dofetilide to help regulate heart, glipizide for Diabetes, iron as Supplementation Therapy, ongoing insulin glargine (LANTUS) for Diabetes, ongoing levothyroxine for thyroid, lisinopril for Blood pressure, magnesium for Supplementation therapy, metformin for Diabetes, metoprolol for Blood pressure, insulin aspart (NOVOLOG) for Diabetes, ongoing omeprazole for stomach, dabigatran etexilate mesilate (PRADAXA) as blood thinner, colecalciferol (VITAMIN D3) for Vitamin Supplementation. The patient previously took amiodarone, carafate, nexium [esomeprazole magnesium] and all experienced allergic. After the first vaccine, 9 days later (01Jan2021) he broke out in a rash. He states a lot of them are pretty good size welts. He did call the health department and they said it was just a rash, they didn't act like they were really concerned about it. Patient confirmed he noticed the rash 9 days after the first vaccine. He received his shot on a Wednesday (23Dec2020) and the Friday of the next week (01Jan2021), he noticed the rash. Patient confirmed the rash is still ongoing. He stated it seems like the rash is getting better but then he breaks back out in welts, the welts are the size of a quarter or so. The events did not require a visit to Emergency Room/Physician Office. The patient received the second dose of bnt162b2 (lot: EL8982), via an unspecified route of administration in left arm on 13Jan2021 11:00 at single dose for covid-19 immunization. The outcome of the event rash was recovering, the event welts was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: she heard 2 other people tested positive after receiving the vaccine; she heard 2 other people tested positive after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is second of two reports.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the reporter stated that she heard 2 other people tested positive after receiving the vaccine. The clinical outcome of the event was unknown.    Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082649 same reporter/drug/event, different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's father. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), intramuscular at left arm on 20Jan2021 14:30 at single dose for COVID-19 immunization at a Nursing Home. The patient's medical history included hypertension and increased blood cholesterol. For concomitant medications, there was no other vaccine in four weeks. The father experienced sore arm and headache on 20Jan2021 after his first dose vaccination. He was scheduled for 2nd dose on 10Feb2021. Overall, the father was fine with the vaccine. Treatment was received for the events included Tylenol. The outcome of the events was recovered (in Jan2021). The father had no COVID-19 prior to the vaccination. The father had tested post vaccination, included COVID-19 virus test (Nasal Swab) on an unspecified date: Negative.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: Fever body pain freezing even when room temp 80 & dressed & heating blanket. 99.9 when just in pjs.  Did layers after temp.  Nauseous none
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-years-old female patient received  bnt162b2 (BNT162B2, lot number: EL3302, Expiry Date: 31May2021) via an unspecified route of administration in Left arm on 21Jan2021 10:45 at SINGLE DOSE to gain immunity against Covid-19. Medical history included asthma well controlled Diagnosed 6 years ago. No Prior Vaccinations within 4 weeks. There were no concomitant medications. The patient experienced mildly sore arm on 21Jan2021, tired on an unspecified date. The AEs did not require a visit to emergency room or physician office. The outcome of the event mildly sore arm was recovering.  No follow-up attempts possible. No further information expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Knee swelling/has swelling in his right knee as if like water is in there almost; This is a spontaneous report from a contactable Consumer. This 87-year-old male consumer received the first dose of BNT162B2 (COVID Vaccine, lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration on 21Jan2021 at 11AM at single dose on right arm for COVID-19 immunisation. Medical history included cardiac pacemaker placed about 12 years before. There were no concomitant medications. The consumer previously received the shingles shot in Nov2020 at the age of 87-year-old for immunization and at that time the in Nov2020 fingers were so sore but after a couple days it went away in Nov2020. The patient experienced knee swelling on 22Jan2021. He got up this morning and noticed that he had swelling in his right knee as if like water is in there almost. He had not had a problem with the knee before and all the sudden this morning he saw his knee. The knee swelling looks like its getting better, he did put a gel on it and he doesn't know if that did it or if its getting better on its own. The outcome of the event was recovering.  Pfizer is a marketing authorization holder of COVID Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID Vaccine has submitted the same report to the regulatory authorities.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Visual impairment
Clinical narrative: Waves of weakness; dizziness and lightheadedness; Feels like I am about to pass out while sitting/resting.; Fading vision approx 24hr post admin of second vaccine; This is a spontaneous report from a contactable other hcp, the patient. This 30-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 13:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included prehypertension from an unknown date and unknown if ongoing and attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. The patient had no history of syncopal events. The patient did not have any known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and lisinopril (LISINOPRIL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: Unknown), dose #1, via an unspecified route of administration on an unspecified date in the left arm as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 15:30, the patient experienced lightheadedness, dizziness and waves of weakness and fading vision approximately 24 hours post administration of the second dose of the vaccine. He stated it felt like he was about to pass out while sitting/resting. No therapeutic measures were taken as a result of the events. The clinical outcomes of the lightheadedness, dizziness, waves of weakness, fading vision and felt like he was about to pass out while sitting/resting were unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Type 2 diabetes mellitus
Clinical narrative: type 2 diabetes mellitus; herpes pain has disappeared; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the first dose on 28Dec2020 (lot number: EJ1686, Expiry Date: Mar2021) at single dose in Left arm, via an unspecified route of administration at the second dose on  19Jan2021 (Lot Number: EL3249, Expiry Date: Mar2021) at single dose for prevent infection from Coronavirus. Medical history included ongoing essential hypertension and allergy, patient had genital herpes virus since age 26 and ongoing. Ongoing concomitant medications included chlortalidone from Oct2020 at 25mg daily for essential hypertension, montelukast sodium (SINGULAIR) from Oct2020 at 10mg at bedtime for Allergy and took vitamins, immunity booster and natural remedies. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient experienced herpes pain has disappeared in Jan2021 and was reported to serious due to Medically significant. The reporter considered the event herpes pain has disappeared was related to BNT162B2. Caller was reporting a positive effect with Covid-19 vaccine. She had had genital herpes virus since age 26. She had always had pain and flares. 4-5 days after receiving the first dose the pain has disappeared. She received the second dose on Tuesday 19Jan2021. She had no pain. She felt normal. She didn't get medical attention for this. She used an immunity booster and natural remedies. Caller was working at a clinic administering the vaccine to residents to a long term care facility. After the residents were vaccinated she was offered the vaccine since she is also a nurse. She went to a drive thru clinic for the second dose. The patient reported she had type 2 diabetes mellitus from 19Jan2021 (also reported it was medical history from 19Jan2021). The patient had no relevant tests. The outcome of the event herpes pain has disappeared was not recovered, the outcome of the type 2 diabetes mellitus was unknown.; Sender's Comments: The event type 2 diabetes mellitus was most likely an underlying condition and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: I had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose; This is a spontaneous report from a contactable Other HCP (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 1284), via an unspecified route of administration in left arm on 12Jan2021 15:15 at second single dose for COVID-19 immunization. The patient medical history was not reported. No COVID prior vaccination. No known allergies. Concomitant medication included sertraline. No other vaccine received in four weeks. The patient previously tool first dose BNT162B2 (Lot number: EL 1284) on 22Dec2020 03:30PM in left arm for COVID-19 immunization. The patient had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose. Adverse event start date/time: 12Jan2021 10:15 PM. No treatment received for AE. No COVID tested post vaccination. Outcome of the event was recovered in Jan2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: chest tightness; This is a spontaneous report from a contactable physician reported for herself. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on left deltoid on 17Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma well controlled.  There were no concomitant medications. The patient experienced chest tightness on 17Jan2021 with outcome of recovered on 17Jan2021.  Event reported as serious with medically significant. It is reported that the patient wanted to report a side effect she had when she and her husband got their first Covid vaccine from Pfizer on 17Jan2021. She had chest tightness 15 minutes later. She asked for her husband's albuterol inhaler and was back within baseline within minutes. Stated that she used her husband's albuterol inhaler once and recovered completely. Clarified the name as Albuterol HFA 90mcg Inhaler (90mcg; one box has 200 puffs). Sender's Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Hyperhidrosis, Hypotension
Clinical narrative: low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation.  Medical history included panic attack.  There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Pallor, Vaccination site pain
Clinical narrative: low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation.  Medical history included panic attack.  There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: felt dizzy and sick; felt dizzy and sick; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of bnt162b2 (Lot Number: EL9261), via an unspecified route of administration in left arm on 21Jan2021 14:30 at single dose for covid-19 immunization. Medical history included Thyroid issues, whole body hurts, car accident in 2006 (lost her arm and husband, she only has part of her right arm), A-Fib, cardioversion (about a little over a month ago), heart disorder. Concomitant medication included apixaban (ELIQUIS) for heart, thyroid medication. The patient previously received the Shingle shots for immunization and experienced tired the next day. The patient experienced increased heart rate, felt dizzy and sick on 21Jan2021. She got the shot on 21Jan2021. She was ok at first but then about 4pm when got home she felt dizzy and sick. She took her heart rate and it was 156. She had A-Fib but just had a cardioversion about a little over a month ago so this really scared her. She felt really sick and didn't want to go into the hospital. She was ok overnight other than her heart was beating too fast. She took her heartrate this morning (22Jan2021) and it was back to 67-70. Today she is just taking it easy. The events did not require a visit to Emergency Room/Physician Office. The second dose is due on 13Feb2021. She is leery of getting it but is going to talk her heart doctor about it and will also see her primary care doctor on Monday. She had a Thyroid issues, things like that. Basically her whole body hurts, this is something that was going on prior to the shot. The only issue with the shot is the increase in her heart rate. There was no treatment, she had nothing to take for this, she doesn't think Tylenol would have helped but she doesn't know. The patient's mom had cancer. The outcome of the events was recovered on 22Jan2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Blood pressure, ongoing Cholesterol.  Concomitant medication included nifedipine (ADALAT) for Blood pressure and ongoing, atorvastatin (ATORVASTATIN) had been on this medication 6-7 year and ongoing for Cholesterol. Historical Vaccine included flu and had Soreness in her arm. The patient experienced soreness in arm on 20Jan2021; chills, cool, fever, night sweats on 21Jan2021. She woke up drenched. She imagined the fever was breaking. She woke up, and did not have a fever, and was fine other than that; She just couldn't warm up. She was cool, and the chill wouldn't go away with clothes or blankets or the fire place. The event outcome of soreness in arm was recovering, outcome of other events was recovered on 21Jan2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness after injection;was sore from inoculation; This is a spontaneous report from a contactable consumer reporting for himself. This 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982, expiry date 31May2021) on 21Jan2021 around 13:00 at 0.3mL single dose intramuscularly in the left arm for COVID-19 vaccination. The patient had asthma which was diagnosed about 6 years ago, as reported on 22Jan2021. He started coughing late 1980s, then got the diagnosis that it was definitely asthma. Concomitant drugs were none, as th patient stated he did not receive any new medications nor had any other recent vaccinations. The patient received the first dose on 21Jan2021 and all he got was soreness in his arm afterwards that went away. He said he was okay, he was sore from inoculation. The event was resolved on an unspecified date in Jan2021 (21Jan2021 or 22Jan2021).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache after the first dose of COVID-19 Vaccine; Fatigue and tiredness after the first dose of COVID-19 Vaccine; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL942 or EL0142 hard to read writing on patient card provided) at left arm, via an unspecified route of administration on 29Dec2020 16:30 at single dose for covid-19 immunisation. Medical history was none. Concomitant medication included ongoing biotin, ongoing fish oil, ongoing vitamin D3, ongoing cyanocobalamin (VITAMIN B12) and Multivitamin. The patient experienced headache after the first dose of covid-19 vaccine on 29Dec2020, fatigue and tiredness after the first dose of covid-19 vaccine in Dec2020. Patient stated she had the first dose of the vaccine on 29Dec2020 and had the normal side effects headache, fatigue, and general tiredness. The headache lingered for two days or so and that was longer than anyone else she knows who experience a headache after getting the COVID-19 Vaccine. On the night of 29Dec2020 she started to get a headache and it lasted all day the following day. She took Ibuprofen and it helped the headache subside. However, after the Ibuprofen wore off the headache would come back. The following day she had a low grade headache. After two days the headache was gone. By that point she was just left with fatigue and tiredness. She noticed the fatigue and tiredness the following two days after getting the first dose of the vaccine. She was fine by that weekend. The outcome of events was recovered.   Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021087124 same reporter/patient, different vaccine dose and event.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Vomiting
Clinical narrative: Stomach uncomfortable; Vomiting; Had cough that would not quit; This is a spontaneous report from a contactable consumer (patient). This 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL3246), via an unspecified route of administration on 21Jan2021 at single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. Patient took COVID 19 vaccine was because of her age group and risks. The patient experienced stomach uncomfortable, vomiting and had cough that would not quit, all on 21Jan2021. Clinical course reported as follow: patient stated she had yesterday that got first COVID vaccine. Stated that she had it at 9:00PM. Stated that she was fine until 3:30. Stated that her stomach was uncomfortable. Stated that at 7:00 she started vomiting for 4-5 hours. Had a cough that would not quit that started at 7PM. Patient stated that her stomach and cough resolved at midnight. Stated that she recovered completely from both. No treatment received. Outcome of the events was recovered on 21Jan2021. No investigation assessment.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: resulted in her arm looking like cartoon character but she felt like this was related to the size of the needle instead of the vaccine itself; resulted in her arm looking like cartoon character but she felt like this was related to the size of the needle instead of the vaccine itself; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (Solution for injection in pre-filled syringe, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, at single dose for Immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she had a bad reaction to a pneumonia vaccine which resulted in her arm looking like cartoon character but she felt like this was related to the size of the needle instead of the vaccine itself. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Valent Conjugated Vaccine (Diphtheria CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Valent Conjugated Vaccine (Diphtheria CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: FLUX, FLUX, PPV
Symptoms: Chills, Feeding disorder, Impaired work ability, Malaise
Clinical narrative: got sick; chills; couldn't eat; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (reported as pneumonia shot, unspecified trade name) at a single dose, influenza vaccine (reported as "regular flu vaccine", unspecified trade name) at an unspecified dose and influenza vaccine (reported as "flu vaccine for senior citizen", unspecified trade name) at an unspecified dose all via an unspecified route of administration on an unspecified date in 2019 immunization. The patient's medical history and concomitant medications were not reported. In 2019 she got 2 flu vaccines at the same time, the regular flu and the one for senior citizens, and also the pneumonia shot. So she got 3 vaccines at once. She has no product names, NDC, Lot, or Expiry for those products. Afterward she got sick and was in bed with chills and everything, she couldn't eat and was sick for the day. It was explained that she was at work but left for the day. This only lasted for the one day and she was fine and back to work the next day. Outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Fall, Hemiplegia, Impaired work ability, Intensive care
Clinical narrative: fell down the stairs; unable to speak; unable to  move her left side; Patient received COVID 19 and was not feeling well afterwards.; This is a spontaneous report from a non-contactable nurse.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular on 13Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.   On 13Jan2021, after the vaccine, the patient was not felling well and the patient called out of work on 14Jan2021.  On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side. She was taken by ambulance to the emergency room and admitted to neuro intensive care unit. She was treated with unspecified medications. She was in the hospital for 12 days from 16Jan2021 to 28Jan2021. From 28Jan2021, she was in rehabilitation. The clinical outcomes of the feeling unwell, fall, unable to speak, and unable to mover her left side was not recovered. The events were reported as serious for hospitalization and being life-threatening.     No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: On 13Jan2021, after the vaccine, the patient was not felling well.  On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side.  A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events feeling unwell, fall, unable to speak, and unable to mover left side cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder
Clinical narrative: fell down the stairs; unable to speak; unable to  move her left side; Patient received COVID 19 and was not feeling well afterwards.; This is a spontaneous report from a non-contactable nurse.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular on 13Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.   On 13Jan2021, after the vaccine, the patient was not felling well and the patient called out of work on 14Jan2021.  On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side. She was taken by ambulance to the emergency room and admitted to neuro intensive care unit. She was treated with unspecified medications. She was in the hospital for 12 days from 16Jan2021 to 28Jan2021. From 28Jan2021, she was in rehabilitation. The clinical outcomes of the feeling unwell, fall, unable to speak, and unable to mover her left side was not recovered. The events were reported as serious for hospitalization and being life-threatening.     No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: On 13Jan2021, after the vaccine, the patient was not felling well.  On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side.  A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events feeling unwell, fall, unable to speak, and unable to mover left side cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Endotracheal intubation, Sedative therapy, Staring
Clinical narrative: found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Coronavirus test negative, Heart rate increased
Clinical narrative: her heart went into atrial fibrillation (AFib) and heart rate was up to 155; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation.  Medical history included blood cholesterol abnormal, atrial fibrillation and ongoing high blood pressure.Concomitant medication included losartan for high blood pressure, atorvastatin for cholesterol, gabapentin, hydrochlorothiazide (HYDROCHLORZIDE). The patient experienced her heart went into atrial fibrillation (AFib) and heart rate was up to 155 on 20Jan2021 with outcome of unknown. The patient went to the hospital last night on 20Jan2021 and corona virus test that was negative last night.The patient stated she was still in the hospital, until 21Jan2021. (Dates of hospitalization was not available over the call, hence hospitalization was checked as seriousness criteria). The patient received a medicine that they put in the drip, IV, to lower her heart rate.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Swelling in her forehead/her 'eyebrows' were swollen; some tingling in her forehead; her 'eyebrows' were swollen; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 21Jan2021 at 4pm for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had the vaccine administered at hospital on 21Jan2021 and she had some swelling in her forehead and some tingling in her forehead and her 'eyebrows' were swollen and they send her home. The consumer reported she still has swelling and this is going bad. The consumer inquired about treating the fact that she was swollen after the injection, she asked if she could take Benadryl. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Headache; Chills; Body ache; This is a spontaneous report from a contactable consumer (Patient's wife). This male patient of unspecified age received the second dose of BNT162B2 on 20Jan2021 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The consumer reported that he got his second shot yesterday, the Covid 19. He started fever, the chills and body ache and he could not get warm and then we checked his temperature this morning it's a 100.1 and he has got headache this morning. The clinical outcome of the events fever, chills, body ache, and headache unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Confusional state, Erythema, Hypertension
Clinical narrative: My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization.  The patient medical history included food allergy from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: I have been really nauseous and dizzy most of the day; I have been really nauseous and dizzy most of the day; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELT284), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included being diabetic, glaucoma. Concomitant medications were not reported. Patient stated that she had the vaccine on Tuesday (19Jan2021) she was reading over the 'notary' the side effects to be expected and that list one here it say, it could be an allergic reaction but it says that would happen after few hours after the injection but she got it on Tuesday, yesterday (20Jan2021) she was fine. On 21Jan2021, she had been really nauseous and dizzy most of the day, patient wondered whether that was something that she should expect you know would happen because the list here says dizziness and weakness is one of the side effects so is that just something that last for a while and then go away or she should be concerned about.  09Feb2021 is the date that would be for her second shot.  Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Vaccine actually drip down arm/ vaccinator had to wipe it off; not sure if she got the vaccine; sore arm; This is a spontaneous report from a contactable pharmacist. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unknown route of administration on 15Jan2021 as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021 the patient experienced " Vaccine actually dripped down arm and the vaccinator had to wipe it off; they are not sure if she actually got the vaccine or not" and experienced had a sore arm for a few day from an unknown date. The clinical outcome of the events incorrect dose administered and pain in extremity was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeling cold, Illness
Clinical narrative: Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; I was not feeling good; I couldn't eat and I was just so cold; Fever / temperature was about 100; I have got chills right now and my body is shaking; Nauseous; couldn't eat; body is shaking; sick; This is a spontaneous report from a contactable consumer. This consumer received the first dose of BNT162B2 (COVID Vaccine, lot number: EL3249), via an unspecified route of administration on an unspecified date in right arm at single dose for COVID-19 immunisation. Medical history included Covid from first week of Mar2020. The concomitant medications were not reported. The consumer previously got flu shots and shingles shot for immunization. The consumer got injected and then sometime in the middle of the night 2 or 3 clock, the consumer had terrible pain and swelling in the injection site so the consumer didn't pay attention to it, so the consumer went out and around 3 o'clock, the consumer was not feeling good, the consumer was feeling low but the consumer was like he/she will go out for and do things and all, so the consumer went to the lunch with a friend and he/she couldn't eat and was just so cold and then came home and the consumer take temperature. Normally my is 97 its never 98 and temperature was about 100, the consumer have got a fever and have got chills and body is shaking. The consumer had Covid in first week of Mar2020 until got the Covid test by the time Apr2020. The consumer already gone through but this is how the symptoms started, the consumer don't want to get it again. The consumer have got flu shots and shingles shot and stuff but nothing like this so sick, the consumer was nauseous, have a fever, have chills, arm pains, arm at the injection site is so sore and it's swollen, whole body is shaking. The consumer need to go to bed, whole body is just shaking terribly. The consumer will wait through the morning if not, he/she will go to the ER, was not going to get sick like he/she get in March, the consumer won't survive if I get sick again. The outcome of the events was unknown.