chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Person Contracted COVID; Person Contracted COVID; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Jan2021 (Batch/Lot Number: EL3249) as dose 1, single (age at vaccination: 24 years old) for covid-19 immunisation. Medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient contracted covid on Jul2021. The event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included COVID-19 test: positive   on Jul2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID19 disease; I tested positive for COVID19 disease; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 17Mar2021 11:30 (lot number: EL3247; expiry date: unknown) at the age of 55-years-old, as dose 2, single; and intramuscular, administered in Arm Left on 24Feb2021 11:30 (lot number: EL3247; expiry date: unknown) at the age of 55-years-old as dose 1, single for COVID-19 immunization. Medical history included asthma and high blood pressure. Concomitant medications included amlodipine, quinapril, and budesonide, formoterol fumarate (SYMBICORT) taken for unspecified indications, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in other facility. On 25Jul2021, the patient tested positive for COVID-19 disease. The event was considered serious, medically significant. The patient underwent lab tests and procedures which included nasal swab: positive on 25Jul2021. The patient has not been tested for COVID-19 since vaccination. Therapeutic measures were taken as a result of event which included ibuprofen, VItamin C, Vitamin D, Vitamin B12, Allegra and Advil sinus. The patient recovered from the event on unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer . A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The reporter stated not to know which vaccine the patient received, just knew that the patient was fully immunized with an unspecified COVID-19 vaccine. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID-19 (medically significant) on 21Jul2021 with outcome of unknown. The patient started to feel symptomatic on 21Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jul2021.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: experienced a neurological event after receiving the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (advocate). A 4-decade-old (reported as in his 30's) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, caller was called on behalf of a family whose family member experienced a neurological event after receiving the Pfizer COVID vaccine and currently in the hospital and doctors have not been to determine what the diagnosis was, and they don't have a treatment plan for him. Caller stated that, the doctors were just sending the patient for physical therapy without having a diagnosis for the patient. Caller wanted to know if Pfizer could provide treatment recommendations for the patient. The response included Pfizer cannot provide treatment recommendations for patients. The outcome of the event was unknown.  Information on batch/lot number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Feeling abnormal, Heart rate, Heart rate irregular
Clinical narrative: he had an erratic heartbeat/irregular heartbeat; a burning sensation in his chest, stomach, throat; dizziness; can't calm down; He was believed to be having an allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp.   A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 11:00 (at the age of 34-years-old) as DOSE 1, SINGLE for covid 19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken for hypertension from 2014 and ongoing; buspirone (BUSPIRONE) taken for an unspecified indication from Oct2020 and ongoing. On 09Feb2021, the patient experienced he was believed to be having an allergic reaction.  On 10Feb2021, the patient experienced he had an erratic heartbeat/irregular heartbeat, a burning sensation in his chest, stomach, throat, dizziness, can't calm down.  The patient underwent lab tests and procedures which included heart rate: erratic heartbeat on 09Feb2021 At 11:00, he had an erratic heartbeat all the way up to 100 while sitting, heart rate: irregular   on 10Feb2021 today 10Feb2021, he started to have an irregular heart beat.  The outcome of the event he was believed to be having an allergic reaction was unknown. The outcome of the events had an erratic heartbeat/irregular heartbeat, can't calm down was recovering. The outcome of the event burning sensation in his chest, stomach, throat, dizziness was not recovered.  Follow-up (11May2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: he had an erratic heartbeat/irregular heartbeat; a burning sensation in his chest, stomach, throat; dizziness; can't calm down; He was believed to be having an allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp.   A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 11:00 (at the age of 34-years-old) as DOSE 1, SINGLE for covid 19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken for hypertension from 2014 and ongoing; buspirone (BUSPIRONE) taken for an unspecified indication from Oct2020 and ongoing. On 09Feb2021, the patient experienced he was believed to be having an allergic reaction.  On 10Feb2021, the patient experienced he had an erratic heartbeat/irregular heartbeat, a burning sensation in his chest, stomach, throat, dizziness, can't calm down.  The patient underwent lab tests and procedures which included heart rate: erratic heartbeat on 09Feb2021 At 11:00, he had an erratic heartbeat all the way up to 100 while sitting, heart rate: irregular   on 10Feb2021 today 10Feb2021, he started to have an irregular heart beat.  The outcome of the event he was believed to be having an allergic reaction was unknown. The outcome of the events had an erratic heartbeat/irregular heartbeat, can't calm down was recovering. The outcome of the event burning sensation in his chest, stomach, throat, dizziness was not recovered.  Follow-up (11May2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea; sore arms; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN). The patient experienced nausea and sore arms on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue
Clinical narrative: fatigue; general ickyness off; This is a spontaneous report from a non-contactable physician (patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date (December or January) for covid-19 immunization. On an unspecified date, the patient experienced fatigue and general ickyness off. She indicated that it was a good sign her immune system was working. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and pain at the injection site; Swelling and pain at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 08Feb2021 at 14:15 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and pain at the injection site on 08Feb2021. Treatment was not received for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Paraesthesia
Clinical narrative: Immediately after shot, fast heartrate; Feel tingling in arm and hand of injection; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: EN6201, expiration date: 30Jun2021) via an unspecified route of administration, administered in Arm Right on 17Feb2021 at 14:00(age at vaccination 37-year-old) as dose 1 single for COVID-19 immunization. Medical history included ankylosing spondylitis, Thalassaemia (Verbatim reported as Thamlesemia). Concomitant medication(s) included meloxicam 15mg (MOBIC), ascorbic acid, borago officinalis oil, fish oil, magnesium, nicotinamide, pyridoxine, zinc 1280mg (OMEGA- 3), vitamin d3 1,000 i.u (MANUFACTURE UNKNOWN) received within 2 weeks of vaccination. The Patient did not receive any other vaccines within 4 weeks Prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Consumer stated that When his first got COVID-19 Vaccine on 17Feb2021. Immediately after shot he had a fast heartrate, and it was up in the 90 for heartrate for about 5 or so hours. Then that went away, and his heartrate began to become normal on 17Feb2021 and he also has tingling in arm and hand and his wondering if you can tell me if it was something that was being reported and if there was anything, he can do about it. The patient stated that he wants Should his take the second shot. The patient just need to know if it is going to be systemic if it is temporary and if anyone has been reporting this before or if it is common. The patient did not receive any treatment for the events. The outcome of the events Immediately after shot, fast heartrate was recovered on 17Feb2021 and Feel tingling in arm and hand of injection was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Paraesthesia
Clinical narrative: his heartbeat went up to 100; tingling down to his arms and hands; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patients mother) reported. A male patient unspecified age received BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number, Expiry date: Unknown), via an unspecified route of administration on 17Feb2021 as dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. On Feb2021, Reporter stated that my son had the first shot (Covid Vaccine) on 17th just Wednesday, after the shot he was having rapid heartbeat for about 5 hours and now he still has tingling down his arm, the arm that got the shot down to his hands, palm, fingers and everything else. The outcome of the event was unknown.   No follow up attempts are needed. information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site ached a little bit for about 12 hours after the injection administered; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EL3247) via an unspecified route of administration on 13Feb2021 as dose 1, single for covid-19 immunization (at the age of 83-years-old). The patient medical history and concomitant medications were not reported. The previously took flu shot (brand name/lot/NDC/Expiry: Not provided) on an unspecified date and stated that it hurts a little bit. The patient stated that after receiving the dose of vaccine he had no symptoms, no side effects at all. The only thing he experienced with the Pfizer COVID-19 Vaccine was injection site ached a little bit for about 12 hours after the injection administered on an unspecified date in Feb2021. The patient further mentioned as the people at the administering site treated him great, he could not be happier. He would recommend the Pfizer COVID-19 Vaccine to anyone. The main reason he called was to ask how many days after the second dose of Pfizer COVID-19 Vaccine is administered does the immunity kick in. One person said it would kick in in 7 days, another lady said 21 days, someone else said 14 days. The outcome of the event was recovered.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, SARS-CoV-2 test
Clinical narrative: "feeling like coming down" for a short period of time; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 31Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient experienced "feeling like coming down" for a short period of time. It was reported that patient wanted to know if there was any safety information or recommendation for her situation. she is not sure if the vaccine is working, she was in contact with her daughter for 5 days. Wants to know how to participate as part of the clinical trials of the vaccine. The patient underwent lab tests and procedures which included covid antigen test which resulted as negative. The outcome of event was unknown.  Information about lot Batch requested  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: itching on her upper body; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient).A 49-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Feb2021 16:00 (at the age of 49-years-old female) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took copaxone for multiple sclerosis and experienced anaphylactic reaction. On 24Feb2021 15:00, the patient experienced itching on her upper body and allergic reaction to the vaccine.The clinical course as follows caller is calling about the covid 19 vaccine. The caller had the first vaccine 2 days ago then yesterday, 24 hours after the vaccine, she became itchy on her upper body, mostly on her back and head. The caller took Benadryl. The caller thinks it may have been an allergic reaction to the vaccine. The caller is concerned because she had anaphylactic reaction in the past not to a vaccine, but to a medication, clarified as an injection, she received for her Multiple Sclerosis. The caller wants to know should she have the second vaccine or not,what should she do in advance of the vaccine, and what should she do after it, what precautions and what aftercare. Therapeutic measures were taken as a result of itching on her upper body and allergic reaction to the vaccine. The outcome of events was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat within one minute; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6206, expiry date was not reported) dose 1 via an unspecified route of administration at arm left on 04Mar2021 12:00 (at the age of 62-years-old) as a single dose, for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and blood pressure meds (both as other medications in two weeks). No other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 12:00 the patient experienced rapid heartbeat within one minute. The patient resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included heart rate: rapid on 04Mar2021. No treatment was given for adverse event. Outcome of the events was recovering.  No follow-up attempts are possible. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased
Clinical narrative: rapid heartbeat; flushing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced rapid heartbeat and flushing, 1.5 to 2 hours after the first dose on an unspecified date. And reported that events did not last for long, was fine the next morning. Patient stated that she read that rapid heartbeat was listed in fact sheet and she wanted to know that how to make an educated decision on getting the 2nd dose if experienced adverse reactions. Doctor told her as long if it did not last few days then it was ok. The events were assessed to be non-serious as per reporter. The clinical outcome for the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibromyalgia, Vaccination site pain
Clinical narrative: Soreness at injection site; Deep fatigue; fibromyalgia; This is a spontaneous report from a contactable consumer (reported herself).A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 08Mar2021 14:15 (age at vaccination 67-year-old) as dose 1, single for covid-19 immunization.Medical history included fibromyalgia, cervical arthritis, hypertension and ventricular bigeminy. The patient had known allergies to codeine, erythromycin. The patient was not diagnosed with COVID prior vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included valsartan, acetylsalicylic acid (ASPIRIN 81), pravastatin, ubidecarenone (COQ10 [UBIDECARENONE]). There was no other vaccine in four weeks.On 08Mar2021 at 18:00, the patient experienced soreness at injection site, deep fatigue (bear in mind, she had fibromyalgia, pain and fatigue were a large part of the syndrome. but it was pronounced a few hours after the vaccination). The events were not treated. The patient did not had Covid prior vaccination and not tested for Covid post vaccination. The patient had not yet recovered from events.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate abnormal
Clinical narrative: fast heart beat that fluctuate from 57 to over 116; Weakness in chest; This is a spontaneous report from a contactable consumer (patient).A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported) via an unspecified route of administration, administered in Arm Left on 11Feb2021 at 04:00 as dose 1, single and patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: EN6199) via an unspecified route of administration, administered in Arm Right on 10Mar2021 at 03:30 as dose 2, single for covid-19 immunization.Medical history included high blood pressure. Concomitant medication included lisinopril. The patient was allergies for iodine. Prior to vaccination, the patient did not had covid-19. Post vaccination, the patient has not tested for covid-19. There was no other vaccine in four weeks. On 12Feb2021 at 01:00 the patient experienced weakness in chest and fast heartbeat that fluctuate from 57 to over 116. It was reported that on 12Feb2021 the patient experienced really fast heartbeat that fluctuate from 57 to over 116. It goes up and down included with all of the other non-threatening side effects. Weakness in chest. she had it checked out, but she was still having the problems. She had the same problems the first time, but this time it was worst. The adverse event resulted in doctor or other healthcare Professional office/clinic visit, emergency room/department or urgent care. On an unspecified date the patient underwent lab tests which included heart rate: fluctuate from 57 to over 116 and results included that really fast /It goes up and down. The patient had not yet recovered from the events.    No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Fast heart beat; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:45 (at the age of 42 years) as dose 1, single for COVID-19 immunization. The patient medical history included hypertension. Concomitant medication included nature made VITAMIN D [VITAMIN D NOS] and multi vitamin taken for an unspecified indication. Patient had no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Facility type vaccine: Hospital. The patient experienced fast heartbeat on 10Mar2021. The patient underwent lab tests and procedures which included heart rate: fast on 10Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: after my second vaccine my chronic tinnitus is much louder; fatigue; chills; muscle aches (arms, shoulders); chest pressure on left side; tachycardia; Left outer elbow felt numb; tingling sensation; This is a spontaneous report from a contactable other hcp (patient). A 62-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9246, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 16Feb2021 10:30 (at the age of 62-years-old) as dose 2, single for covid-19 immunisation in school or student health clinic. The patient did not receive any recent vaccines for any other conditions within 4 weeks prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-Biotech COVID-19 vaccine vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included, osteoporosis, osteoarthritis, erythromelalgia, trigeminal neuralgia. Concomitant medication(s) included nortriptyline taken for trigeminal neuralgia, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3246, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 14:30 (at the age of 62-years-old) as dose 1, single for covid-19 immunisation in school or student health clinic and experienced itching and swelling on left side of tongue 2.5 hrs after first vaccine. The patient previously took, nortriptyline for trigeminal neuralgia, levaquin and experienced drug hypersensitivity. On an unspecified date, after her second vaccine her chronic tinnitus was much louder. On 16Feb2021, the patient experienced left outer elbow felt numb and tingling sensation. On 17Feb2021, the patient experienced fatigue, chills, muscle aches (arms, shoulders), chest pressure on left side, tachycardia. The reported events were considered as non-serious by reporter. The outcome of the event after her second vaccine her chronic tinnitus was much louder was not recovered and all other events was recovered on 17Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tachycardia, Tinnitus
Clinical narrative: after my second vaccine my chronic tinnitus is much louder; fatigue; chills; muscle aches (arms, shoulders); chest pressure on left side; tachycardia; Left outer elbow felt numb; tingling sensation; This is a spontaneous report from a contactable other hcp (patient). A 62-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9246, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 16Feb2021 10:30 (at the age of 62-years-old) as dose 2, single for covid-19 immunisation in school or student health clinic. The patient did not receive any recent vaccines for any other conditions within 4 weeks prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-Biotech COVID-19 vaccine vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included, osteoporosis, osteoarthritis, erythromelalgia, trigeminal neuralgia. Concomitant medication(s) included nortriptyline taken for trigeminal neuralgia, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3246, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 14:30 (at the age of 62-years-old) as dose 1, single for covid-19 immunisation in school or student health clinic and experienced itching and swelling on left side of tongue 2.5 hrs after first vaccine. The patient previously took, nortriptyline for trigeminal neuralgia, levaquin and experienced drug hypersensitivity. On an unspecified date, after her second vaccine her chronic tinnitus was much louder. On 16Feb2021, the patient experienced left outer elbow felt numb and tingling sensation. On 17Feb2021, the patient experienced fatigue, chills, muscle aches (arms, shoulders), chest pressure on left side, tachycardia. The reported events were considered as non-serious by reporter. The outcome of the event after her second vaccine her chronic tinnitus was much louder was not recovered and all other events was recovered on 17Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate irregular
Clinical narrative: felt tired; Irregular Heart Beat; This is a spontaneous report from a contactable consumer (the patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 14:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation at Doctor's office/urgent care. Medical history included triple bypass in 2018 and enlarged prostate from an unknown date, COVID-19 from an unknown date (prior to vaccination). Concomitant medications included tamsulosin taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; ezetimibe taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient did not receive any other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 10Mar2021, the patient experienced irregular heart beat. On 11Mar2021, he felt tired. It was reported that "Irregular Heart Beat on the day of the shot and the following day. Also felt tired the day following." The patient underwent lab tests and procedures which included heart beat: irregular on 10Mar2021 and heart beat: irregular on 11Mar2021. The patient did not receive any treatment for adverse events. The outcome of events was recovered on unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Crying, Depressed mood, Mood altered
Clinical narrative: Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:00 (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included omeprazole and thrive lifestyle supplements taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient experienced extreme moodiness. 12 hrs after shot anger (10Mar2021 23:00) and 2 days later (12Mar2021) sadness and crying out of nowhere. Patient was not received any treatment for adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Head discomfort, Rhinorrhoea
Clinical narrative: sinus headache; loss of energy. (Just felt very tired very fast); loss of energy. (Just felt very tired very fast); I felt like I was getting a sinus infection with pressure in my head; I felt like I was getting a sinus infection with pressure in my head; My nose was runny; just started feeling bad; Not sure if the headache woke me up or I just woke up; This is a spontaneous report from a contactable consumer. This 50-year-old male consumer (patient) reported.   A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:45 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunization. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No known allergies were reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: 9581), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:30 as dose 1, single for COVID-19 immunization and left arm was sore about 2.5 hours the shot. It had felt like a had a Techna shot. The soreness went away 5-6 hours after the shot. It was reported that after the second shot, three hours later the patient was working outside in the yard and had a noticeable loss of energy on 10Mar2021 23:30. (Just felt very tired very fast).The patient felt like he was getting a sinus infection with pressure in his head and his nose was runny and just started feeling bad on 10Mar2021. As the evening progressed at about 7:30 pm- 8 pm he went to bed and feel asleep very fast. He woke up at 11:30 pm with a what felt like a sinus headache on 10Mar2021. He was able to fall asleep again and awoke at 04:30 am with a pounding headache not sure if the headache woke him up or he just woke up on an unspecified date in Mar2021. Treatment medication included Naproxen 250 mg for the event sinus headache and event not sure if the headache woke me up or I just woke up. Outcome of all the events was reported as recovering at this time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache, Sinusitis, Sleep disorder
Clinical narrative: sinus headache; loss of energy. (Just felt very tired very fast); loss of energy. (Just felt very tired very fast); I felt like I was getting a sinus infection with pressure in my head; I felt like I was getting a sinus infection with pressure in my head; My nose was runny; just started feeling bad; Not sure if the headache woke me up or I just woke up; This is a spontaneous report from a contactable consumer. This 50-year-old male consumer (patient) reported.   A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:45 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunization. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No known allergies were reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: 9581), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:30 as dose 1, single for COVID-19 immunization and left arm was sore about 2.5 hours the shot. It had felt like a had a Techna shot. The soreness went away 5-6 hours after the shot. It was reported that after the second shot, three hours later the patient was working outside in the yard and had a noticeable loss of energy on 10Mar2021 23:30. (Just felt very tired very fast).The patient felt like he was getting a sinus infection with pressure in his head and his nose was runny and just started feeling bad on 10Mar2021. As the evening progressed at about 7:30 pm- 8 pm he went to bed and feel asleep very fast. He woke up at 11:30 pm with a what felt like a sinus headache on 10Mar2021. He was able to fall asleep again and awoke at 04:30 am with a pounding headache not sure if the headache woke him up or he just woke up on an unspecified date in Mar2021. Treatment medication included Naproxen 250 mg for the event sinus headache and event not sure if the headache woke me up or I just woke up. Outcome of all the events was reported as recovering at this time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Limb discomfort
Clinical narrative: extreme shortness of breath; chest pressure; fatigue; sensation of heaviness in my legs; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 71-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration in Arm Left on 27Feb2021 10:00 (age at the time of vaccination 71-years-old), as a single dose for COVID-19 immunization. The patient's medical history included allergy with narcotics. The patient's concomitant medications included Ropinerole 1mg, and Olmesartin 10mg. The patient previously took first dose of BNT162B2 vaccine, on 06Feb2021 11:30 (age at the time of vaccination 71-years-old), as a single dose for COVID-19 immunization and experienced shortness of breath. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Mar2021 11:30, the patient experienced extreme shortness of breath, chest pressure, fatigue, and sensation of heaviness in my legs. The adverse event result in emergency room/department or urgent care. No treatment was received for the adverse event. The outcome for all the events was recovering.  No follow-up attempts are needed. No further information is expected.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) :  Same reporter, patient/ similar events/ different dose;US-PFIZER INC-2021304348 Same reporter, patient/ similar events/ different dose
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Dizziness
Clinical narrative: dizzy; She is very upset; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunization. The patient wanted to know does the second dose have the same amount of ingredients as the first. Do people get dizzy from the vaccine. She was very upset; she has been transferred 3 times now and has been on the phone for 2 hours on an unspecified date. Outcome of events was unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast pain, Chills, Lymphadenopathy, Maternal exposure during pregnancy
Clinical narrative: exposure during pregnancy; had breast pain; painful swollen lymph node in my left armpit / breast area.; Flu like chills; fever fluctuated from 99-101.5 F; my body felt like it was hit by a truck; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 32-years-old) as single dose for COVID-19 immunisation. Medical history included thalassemia minor. The patient did not have any allergies to medications, food, or other products. The patient's last menstrual date was on 18Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pyridoxine hydrochloride; doxylamine succinate (DICLEGIS) and glucomannan (GARDEN OF LIFE PRENATAL), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0202), via an unspecified route of administration in the left arm on 28Feb2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was pregnant during vaccination with gestational period of 13 weeks. On 22Mar2021 at 02:30, 12 hours after the second dose she had flu like chills, her body felt like it was hit by a truck and she had a fever that fluctuated from 99-101.5 F. These symptoms lasted from 02:30 on 22Mar2021 until 10:00 on 24Mar2021, when she woke up and the fever broke. On 24Mar2021, in the morning, she had breast pain and noticed a painful swollen lymph node in her left armpit/breast area. The expected delivery date was on 24Sep2021. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events chills, general body pain, breast pain, fluctuating fever and painful lymphadenopathy. The clinical outcome of the events chills and general body pain were recovered on 24Mar2021 at 10:00 while that of breast pain, fluctuating fever, painful lymphadenopathy and maternal exposure during pregnancy, first trimester was unknown.