chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cough, Fear, Feeling hot, Insomnia
Clinical narrative: She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Skin burning sensation, Weight decreased
Clinical narrative: She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Swelling at the injection site, red rash area about 2 inches wide below injection site that nearly encircled the arm, itchy -- all lasting about a week; had no reaction to the first shot
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain in extremity
Clinical narrative: join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints; Within first hour of injection slight nausea that lasted a few hours; pain in hands; This is a spontaneous report from a contactable healthcare professional.  A 41-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 28Dec2020 10:15 at a single dose for covid-19 immunisation. Medical history included food allergies to dairy and nuts. Concomitant medication was not reported. On 28Dec2020 11:00, the patient experienced slight nausea that lasted for few hours, along with join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints. By end of day the patient could not type on phone due to pain in hands. Ongoing joint pain for almost three weeks now. The patient did not receive treatment for the events. The outcome of event nausea was recovered in Dec2020; all other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Eye swelling, Headache
Clinical narrative: eye pain; eye pain and swelling/eye is swollen; chills; headache; This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program Pfizer. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given COVID vaccine today and was experiencing a side effect that caller believed has not seen documented, the patient was experiencing eye pain and swelling on 13Jan2021. The eye pain started 6 hours after receiving the vaccine. The patient got a headache, chills, and eye pain on 13Jan2021. On 14Jan2021, the chills subsided, the headache was minor, eye pain was the same, and today on unspecified date, the patient has no more chills and no more headache, but still has eye pain and now her eye is swollen. The eye swelling is now hurts to blink. The first dose was 21 days from Wednesday on unspecified date. The patient was not given vaccination cards, the only thing she was given was information. The caller has hasn't seen vaccines cause eye problems. The causality for chills and headache was unknown. The outcome of the events chills and headache was recovered on unspecified date. The outcome of the remaining events was not recovered.  Information requested on Lot/ Batch number of suspect product.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Cardiac flutter, Electrocardiogram
Clinical narrative: Reports temp of 101 at 9:30pm. States around 10am began feeling heart flutters and used pulse oximetery at home. Reports heart rate up to 160.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Lymphadenopathy, Pain in extremity
Clinical narrative: pt states she has sore left arm around the injection site and looks like she had two injection marks.  Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: pt states she has sore left arm around the injection site and looks like she had two injection marks.  Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital  twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events.  No follow-up attempts are possible; information about batch number has been obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Laboratory test, Malaise, Paraesthesia
Clinical narrative: Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital  twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events.  No follow-up attempts are possible; information about batch number has been obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Loss of consciousness, Seizure, Vision blurred, Visual impairment
Clinical narrative: About 5 minutes after the vaccine, I felt my vision going dark and blurry. I then lost consciousness and was told my eyes rolled back and slightly convulsed. I regained consciousness after a short time frame.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dysstasia, Headache, Pyrexia
Clinical narrative: I had vomit/I'm still vomiting; I had fever; pain in the bones; shivers; severe headache; I cannot stand up. If I stand up, I feel like I'm going to fall to the ground; This is a spontaneous report from a contactable consumer. A 45 (unit: unknown) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 13Jan2021 at 12:00, at a single dose, for COVID-19 immunization. Medical history included exposure to COVID-19 (reported as "My wife came up being COVID positive this morning. She is getting steroid shot to help the lungs. I will get tested today".). Concomitant medications were not reported. The patient received the Pfizer COVID shot on 13Jan2021 at 12 pm. Last night (on 14Jan2021) he had vomit, fever, pain in the bones, shivers, and severe headache. Patient was still vomiting. He cannot stand up. If he stands up, he feels like he is going to fall to the ground. He called his doctor and a nurse answered, and they have not given him any advice yet. His wife came up being COVID positive this morning and she was getting steroid shot to help the lungs. Patient stated further, "I will get tested today and if I come out positive today with the virus, and if my doctor prescribes any medications for me, will that interfere with the Pfizer Covid vaccine?" Outcome of the event vomiting was not recovered, while for the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I had vomit/I'm still vomiting; I had fever; pain in the bones; shivers; severe headache; I cannot stand up. If I stand up, I feel like I'm going to fall to the ground; This is a spontaneous report from a contactable consumer. A 45 (unit: unknown) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 13Jan2021 at 12:00, at a single dose, for COVID-19 immunization. Medical history included exposure to COVID-19 (reported as "My wife came up being COVID positive this morning. She is getting steroid shot to help the lungs. I will get tested today".). Concomitant medications were not reported. The patient received the Pfizer COVID shot on 13Jan2021 at 12 pm. Last night (on 14Jan2021) he had vomit, fever, pain in the bones, shivers, and severe headache. Patient was still vomiting. He cannot stand up. If he stands up, he feels like he is going to fall to the ground. He called his doctor and a nurse answered, and they have not given him any advice yet. His wife came up being COVID positive this morning and she was getting steroid shot to help the lungs. Patient stated further, "I will get tested today and if I come out positive today with the virus, and if my doctor prescribes any medications for me, will that interfere with the Pfizer Covid vaccine?" Outcome of the event vomiting was not recovered, while for the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Obstructive airways disorder
Clinical narrative: His reaction was swollen lymph nodes nearly blocking his airway; His reaction was swollen lymph nodes nearly blocking his airway; This is a spontaneous report from a contactable consumer (pharmacy intern) reported a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reaction was swollen lymph nodes nearly blocking his airway. He did not seek treatment and it did subside.  It was reported that a patient received the first dose of the Pfizer Covid vaccine and it seems like there was swelling of the lymph nodes in the neck to the point where it started to block the airway. Patient had no swelling of the tongue or shortness of breath, but there was swelling that was starting to block the airway due to that. Patient had no anaphylaxis reaction. They are wondering if he should get the second vaccine. Knows there is extensive guidance on the CDC and on Pfizer website about not to get the second dose if anaphylaxis occurs, but they don't consider this anaphylaxis reaction in this case. Should patient get it or not or if he can get it to go to a facility where he can be monitored and have Epipen on stand by if needed. They know normally it would be treated with steroids, but they tend to counter interact with the vaccine which can affect the immune system. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Paraesthesia
Clinical narrative: Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) intramuscularly at right arm on 14Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. The patient's concomitant medications were not reported. The patient experienced elevated heart rate at 7pm on evening of vaccine (administered at noon), tingling sensation all over. Laid down and issue resolved within 2 hours. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on 14Jan2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking  through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking  through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Body aches; Low grade fever; Headache; This is a spontaneous report from a contactable nurse (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK5730), via an unspecified route of administration in right arm, on 06Jan2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It has already been a week since he had the first dose of COVID-19 vaccine and he is still experiencing or having symptoms such as chills, body aches, low grade fever, and headache from 06Jan2021. The patient had been taking paracetamol (TYLENOL) for the symptoms, but they still reappear after the medication has worn off. Symptoms will go away with the paracetamol but come back when it wears off. The patient did not feel this is serious, just a little concerning. The patient wanted to know if this is a normal response. The patient had not recovered from the events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: One week after I got my 1st shot my left arm started to itch and feel swollen. The next day it was swollen the size of a baseball, red, sticking out an inch, itching and bumpy skin.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Right sided trigeminal neuralgia; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the right arm, on 09Jan2021 13:30 at a single dose for COVID-19 immunization. at a clinic Patient was generally healthy, though has history of migraines, symptoms were not typical of migraine and dairy allergy that has resolved, no current allergies. Patient is not pregnant. Concomitant medication included colecalciferol (VITAMIN D), calcium, sumatriptan, cetirizine hydrochloride (ZYRTEC), and fish oil, vitamin e nos (OMEGA 3). Patient previously took  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9899), intramuscular at the left arm, on 19Dec2020, 09:15. The patient experienced right sided trigeminal neuralgia  on 10Jan2021 06:00, began 17 hours post 2nd dose vaccine and lasted 24 hours in duration. No history of this condition. Self resolved. Most likely diagnosis confirmed by neurology colleague, though definitive testing was not able to be done due to short duration of symptoms.  No treatment was given for the events. The 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 and was not tested for it since the vaccination. The patient recovered from the event.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Sleep disorder
Clinical narrative: heart attack; chest pressure; hardly slept; This is a spontaneous report from a contactable consumer (patient's wife).  An 80-year-old male patient (reported also as 81-years-old, to be clarified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 13Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 80-years-old. Medical history included ongoing emphysema and ongoing diabetes (caller has been diagnosed for 35 years for both conditions), heart was damaged because of the diabetes, and a history of bypass 4 years ago however he hasn't had any issues with chest pressure since before the bypass. Concomitant medications were none. On 15Jan2021 at 1:am he developed pressure in the chest which ultimately resolved. This trouble last night, lasted over 1 hour. He couldn't get back to bed. He had to sleep sitting up on the sofa. That was the only way he was comfortable. Her husband has hardly slept. She was seeing how he was doing. He said he was okay sitting. The pressure on his chest would go away while he was sitting, but laying down it would come back. This morning (15Jan2021) she made him check when he woke up at 8 o'clock. She made him lay down, and he said it was gone after sitting the whole night. He is well now. He is feeling fine. He didn't even ask for help getting on his clothes. He got the vaccine because of his age and because of underlying conditions. Her husband has done very well this year. He even has underlying conditions. He has had Emphysema for 35 years, but it hasn't been bothering him. He has also had diabetes for 35 years. The reporter spoke to her husband's hcp (nurse) who said it could have a heart attack and for him to go to hospital if it reoccurs. She did speak with a nurse with his primary doctor, and she said the pressure in his chest for 1 hour could have been a heart attack. That if it occurs again to give him the nitroglycerin. She told the nurse it wasn't pain. The reporter stated chest pressure could have been a heart attack. He is scheduled to get the 2nd dose on 21Jan2021. The reporter was wondering if her husband can have the second dose given it has potassium in it (given he has bypass history). The reporter is afraid the vaccine is not safe, and they may not go for the second vaccine. She wants more information if it is safe.  The events recovered on 15Jan2021.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever - taking acetaminophen every 6 hours
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Pain
Clinical narrative: tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention.  Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago).  Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine.  The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention.  Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago).  Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine.  The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. 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: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Loss of consciousness
Clinical narrative: trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician.  A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician.  A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Mobility decreased, Rash, Swelling, Vaccination site pain
Clinical narrative: Initial severe pain at site of vaccination.  Arm became heavy after two hours and pt felt she could not move it. On the 27th developed increasing swelling and a bull's eye rash extending 8.5 cm in diameter at time of this exam
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to faint; Nausea; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; Headache; Severe pain at injection site; Fatigue; Muscle weakness; For about 12 hours or so I had on and off fever and chills; For about 12 hours or so I had on and off fever and chills; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 13Jan2021 19:00 at single dose in Left arm for COVID-19 immunization.  Medical history included allergies to Sulfa drugs, attention deficit hyperactivity disorder (ADHD), seasonal allergic rhinitis. Concomitant medication included ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluticasone propionate (FLONASE), clarithromycin (CLARITIN). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 23Dec2020 18:00 at single dose which was administered at Left Arm for COVID-19 immunization. There were no other vaccines received in four weeks. The patient did not have covid-19 prior to vaccination and covid-19 not tested post vaccination. The patient started with dizziness and nausea on 14Jan2021 12:30. Then felt like she was going to faint on 14Jan2021 12:30. The patient became pale, diaphoretic, and tachycardia (100s) on 14Jan2021 12:30. Also had a headache and severe pain at injection site as well as fatigue and muscle weakness on 14Jan2021 12:30. For about 12 hours or so the patient had on and off fever and chills as well the rest of the symptoms listed above which started from 14Jan2021 12:30. Today (40+ hours later) on 15Jan2021, the patient developed swelling at injection site and swollen lymph nodes at under arm. No treatment received for the reported events. The outcome of the events was recovered in Jan2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscular weakness, Nausea, Pallor, Pyrexia
Clinical narrative: swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to faint; Nausea; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; Headache; Severe pain at injection site; Fatigue; Muscle weakness; For about 12 hours or so I had on and off fever and chills; For about 12 hours or so I had on and off fever and chills; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 13Jan2021 19:00 at single dose in Left arm for COVID-19 immunization.  Medical history included allergies to Sulfa drugs, attention deficit hyperactivity disorder (ADHD), seasonal allergic rhinitis. Concomitant medication included ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluticasone propionate (FLONASE), clarithromycin (CLARITIN). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 23Dec2020 18:00 at single dose which was administered at Left Arm for COVID-19 immunization. There were no other vaccines received in four weeks. The patient did not have covid-19 prior to vaccination and covid-19 not tested post vaccination. The patient started with dizziness and nausea on 14Jan2021 12:30. Then felt like she was going to faint on 14Jan2021 12:30. The patient became pale, diaphoretic, and tachycardia (100s) on 14Jan2021 12:30. Also had a headache and severe pain at injection site as well as fatigue and muscle weakness on 14Jan2021 12:30. For about 12 hours or so the patient had on and off fever and chills as well the rest of the symptoms listed above which started from 14Jan2021 12:30. Today (40+ hours later) on 15Jan2021, the patient developed swelling at injection site and swollen lymph nodes at under arm. No treatment received for the reported events. The outcome of the events was recovered in Jan2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to faint; Nausea; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; Headache; Severe pain at injection site; Fatigue; Muscle weakness; For about 12 hours or so I had on and off fever and chills; For about 12 hours or so I had on and off fever and chills; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 13Jan2021 19:00 at single dose in Left arm for COVID-19 immunization.  Medical history included allergies to Sulfa drugs, attention deficit hyperactivity disorder (ADHD), seasonal allergic rhinitis. Concomitant medication included ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluticasone propionate (FLONASE), clarithromycin (CLARITIN). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 23Dec2020 18:00 at single dose which was administered at Left Arm for COVID-19 immunization. There were no other vaccines received in four weeks. The patient did not have covid-19 prior to vaccination and covid-19 not tested post vaccination. The patient started with dizziness and nausea on 14Jan2021 12:30. Then felt like she was going to faint on 14Jan2021 12:30. The patient became pale, diaphoretic, and tachycardia (100s) on 14Jan2021 12:30. Also had a headache and severe pain at injection site as well as fatigue and muscle weakness on 14Jan2021 12:30. For about 12 hours or so the patient had on and off fever and chills as well the rest of the symptoms listed above which started from 14Jan2021 12:30. Today (40+ hours later) on 15Jan2021, the patient developed swelling at injection site and swollen lymph nodes at under arm. No treatment received for the reported events. The outcome of the events was recovered in Jan2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Injection site erythema, Injection site pain
Clinical narrative: Initial normal redness and tenderness of injection site (about size of silver dollar) cleared after several days, but on evening of day 9 (1/25/21),  large round redness, with hardness and heat suddenly reappeared and expanded.  Given history of cellulitis, I consulted primary care physicians office and was seen 1/26/21.  Agreed to treat with antibiotic cephalexin if perimeter still expanding by morning of 1/17/21, which it was.  After 48 hours on antibiotic, looking much better, but itchy. Advised today to stop antibiotic as medical clinic has become aware of "Covid Arm" rash in USA Today article, and I was advised to report this event to VAERS.  Now suspecting this is delayed rash not cellulitis.  Will prep right arm for #2 vaccine on 2/13/21 with ChloraPrep and monitor.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Initial normal redness and tenderness of injection site (about size of silver dollar) cleared after several days, but on evening of day 9 (1/25/21),  large round redness, with hardness and heat suddenly reappeared and expanded.  Given history of cellulitis, I consulted primary care physicians office and was seen 1/26/21.  Agreed to treat with antibiotic cephalexin if perimeter still expanding by morning of 1/17/21, which it was.  After 48 hours on antibiotic, looking much better, but itchy. Advised today to stop antibiotic as medical clinic has become aware of "Covid Arm" rash in USA Today article, and I was advised to report this event to VAERS.  Now suspecting this is delayed rash not cellulitis.  Will prep right arm for #2 vaccine on 2/13/21 with ChloraPrep and monitor.