chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: I have popped up with a rash that looks a lot like shingles/it broke out into rash around my stomach and my back below the waist no actually above the waist.; I have popped up with a rash that looks a lot like shingles; It is painful; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included broke some bones and not ongoing; and fell. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS).  There was no investigation assessment. Patient stated that she had the Pfizer shot on 12Jan2021. Yesterday or maybe the day before she had popped up with a rash that looked a lot like shingles. She saw on the website it can produce rashes. She was going to go to her dermatologist. It was painful in Jan2021. Last night and maybe yesterday it broke out into rash around her stomach and her back below the waist no actually above the waist. She was just trying to figure out if it is from the vaccination or if she should go to dermatologist. Patient stated she did see where it can cause rashes. In fact, it did not cause all over your body but since this is one specific area. She thought maybe it was something known and they could tell her what she need to do. Possibly the 15th or 16th.  She knew she had it on 16th but she may got a little bit of. It started on 15Jan2021.  Patient stated she had not done anything for the rashes. She didn't know what to do. She was going to physical therapist because she fell in August and broke some bones. But she was fine now. She was not taking any medication other than vitamins. Outcome of events were unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Onset of body aches, chills, headache, and sore throat.  Started about 18 hours post injection and lasted about 48 hours after injection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness at injection site which then became swollen/looks like a huge mosquito bite, large horizontal oval shape; Itchiness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-year-old, intramuscular in the right arm on 08Jan2021 at 14:00 at a single dose in the hospital for covid-19 immunization. Medical history included sulfa allergies. The patient is not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) and celecoxib (CELEBREX). 8 days after vaccine (16Jan2021 at 13:00), patient developed itchiness at injection site which then became swollen by 9th day after vaccine (17Jan2021). Itchy and looks like a huge mosquito bite, large horizontal oval shape. The patient did not receive treatment for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Vision blurred
Clinical narrative: Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate.  pharmacist gave 1 dose of IM EPI in the L thigh
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dizziness, Emotional disorder, Nausea
Clinical narrative: Nauseous; Lightheadedness; very Emotional; Crying; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:00 at single dose (Lot number= EL3246, Vaccine location=Left arm) for covid-19 immunisation. Medical history included low thyroid, high blood pressure, reflux disease, anxiety, depression, Allergies: sulfa "caflex". Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included calcium citrate, venlafaxine hcl, pantoprazole, nortriptyline, levothyroxine sodium (SYNTHROID), amlodipine, estrogens conjugated (PREMARIN), paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nauseous, lightheadedness, very emotional, crying on 16Jan2021 09:00. No treatment received for the events. Events result in clinic visit. Outcome of events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Peripheral swelling
Clinical narrative: severe swollen lymph nodes to left arm pit ( injection arm); severe swollen lymph nodes to left arm pit ( injection arm); developed very mild headache; severe chills; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 13Jan2021 07:45 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included loratadine, progesterone, docosahexaenoic acid, eicosapentaenoic acid (OMEGA 3 FISH OIL), colecalciferol (D3), cyanocobalamin (B12). The patient previous received the first dose of bnt162b2 (lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 06:00 AM for COVID-19 immunization. The patient experienced developed very mild headache on 13Jan2021 11:00, severe chills on 13Jan2021, muscle aches on 13Jan2021, severe swollen lymph nodes to left arm pit on 14Jan2021. The treatment paracetamol (TYLENOL) and ibuprofen (ADVIL) was used. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Approximate 4 hours post second vaccine dose, developed very mild headache, followed by, approximate 15 hours post second dose, severe chills, muscle aches, lasting about 8 hours, followed by, approximate 24 hours post second dose, severe swollen lymph nodes to left arm pit (injection arm), lasting approximate 24 hours. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Not Known allergies.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pain in injection site, fatigue
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Short-term memory loss; This is a spontaneous report from a contactable nurse (the patient). A 54-year-old male patient receive his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: 31May2021), via an unspecified route of administration on 16Jan2021 06:40 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received his first dose of COVID-19 vaccine with lot #: EJ1685. It was reported that the patient received his second dose of vaccine and he wanted to report a strange side effect of short-term memory loss on 16Jan2021. He does not think that he has it now at the time of report but it never happened before. He mentioned he was walking down the hospital and he had a momentary memory loss. He did not know where he was going. He lost complete direction. He has worked in that hospital for 20 years. The outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache, Migraine, SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included spinal stenosis and allergies to cephalosporin. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included gabapentin. On 30Dec2020 19:00, the patient experienced severe headache/migraine which lasted for over 2 weeks, required prescription medication to make them bearable but even then, they didn't go away and were very bad. The patient spent the good part of two weeks in bed or at least not doing her regular level of activity. She went to Urgent Care twice and to the Emergency Room once. The patient was given prescription medication and IV pain medication as treatment for the events. The patient underwent lab tests and procedures which included nasal swab test (COVID-19 virus test) on 11Jan2021: negative result; and the same test on 14Jan2021 with negative result. The patient was recovering from the events.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site swelling, Pain
Clinical narrative: Day after vaccine I had pain in injection site, joint pain, body aches, fatigue. Left early from work. The day after that I was completely normal. Fast forward to today (9 days after vaccine) and my arm is swollen at injection site and painful. I have body aches and fatigue. No fever. The vaccination site is also red and itching.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Day after vaccine I had pain in injection site, joint pain, body aches, fatigue. Left early from work. The day after that I was completely normal. Fast forward to today (9 days after vaccine) and my arm is swollen at injection site and painful. I have body aches and fatigue. No fever. The vaccination site is also red and itching.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable nurse (reported for herself). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) intramuscular on 10Jan2021 10:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The first dose of BNT162B2 (Pfizer brand) for COVID-19 immunization was administered on 23Dec2020 08:00 AM intramuscularly in the left arm (at the age of 49 years old). On 15Jan2021, patient was unable to smell or taste at 6 day post injection. No treatments received in response to the events reported. Patient had Covid test post vaccination as Nasal Swab, Pcr on 15Jan2021 with negative result. The outcome of the events unable to smell or taste at 6 day post injection was not recovered.   Information about lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Pain
Clinical narrative: Soreness in left shoulder; Shoulder blade flare up of arthritics.History of arthritis in left shoulder. However, pain intensified and was completely gone within 48 hours.; pain intensified; This is a spontaneous report from a contactable consumer, the patient.  A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 15Jan2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunization.  Medical history included diabetes mellitus, high blood pressure, heart valve replacement, and history of arthritis in left shoulder.  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 unspecified medications taken within 2 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took warfarin (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy.  On 15Jan2021 at 18:00, the patient experienced soreness in left shoulder and shoulder blade flare up of arthritis in left shoulder. The pain intensified in Jan2021. The patient went to the urgent care (physician's office) for the events. The patient took gabapentin (MANUFACTURER UNKNOWN) 300 mg for treatment and to get some sleep. The clinical outcome of the soreness in left shoulder, shoulder blade flare up of arthritis in left shoulder, and pain intensified were recovered on 17Jan2021 after approximately 48 hours.     No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: I just noticed redness and swelling around injection site 8 days after vaccination.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Acute Unilateral Sensorineural Hearing Loss; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular in left arm on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously received the first dose of bnt162b2 on an unknown date for COVID-19 immunization. The patient experienced acute unilateral sensorineural hearing loss on 17Jan2021 07:00 with outcome of not recovered. The event caused physician office visit.  Therapeutic measures were taken as a result of acute unilateral sensorineural hearing loss that included prednisone. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there is a reasonable possibility that the event acute unilateral sensorineural hearing loss is related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Lymphadenopathy, Muscle swelling, SARS-CoV-2 test
Clinical narrative: Muscle or lymph nodes in right arm pit is swollen; Muscle or lymph nodes in right arm pit is swollen; painful from elbow to breast a week out; painful from elbow to breast a week out; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), intramuscular in the right arm on 07Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included epilepsy. The patient's concomitant medications were not reported. The patient did not have vaccine in four weeks. The patient had no COVID prior vaccination. The patient is not pregnant. The patient experienced muscle or lymph nodes in right arm pit is swollen and painful from elbow to breast a week out on 08Jan2021 06:00. No treatment received for the reported events. The patient underwent lab tests and procedures which included nasal swab (COVID) on an unspecified date: negative. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: An expired dose of Pediarix was given to six month old patient by a medical assistant working at our clinic who does not usually work at our facility, the medical assistant who gave the expired vaccine usually works at our sister office. The expired Pediarix had been left next to the unexpired vaccines by mistake and not isolated and marked like it should have been. The MA who gave the expired vaccine did not check the expiration date closely enough before giving the vaccine. I do the VFC reconciliations for our clinic, so I discovered this error while completing my January 2021 reconciliation. The patient who received the expired vaccine may need to repeat the vaccine if the patient is not immune. I will do a better job at identifying and isolating expired vaccines. The medical staff has been notified that they need to remember to check expiration dates on vaccines three times before administration, once when the vaccine is pulled from the fridge, second check while preparing the vaccine, and third check right before administration.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (COVID-19, brand: Pfizer) via an unspecified route of administration in left arm on 17Jan2021 15:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. The patient had no COVID prior to vaccination and was not COVID tested post vaccionation. There were no concomitant medications. No other vaccine in four weeks. The patient previously took trazodone and tramazole and experienced allergies to both. On 17Jan2021 16:00, the patient experienced severe headache and nausea. Treatment was not given to events. The patient had not recovered from the events. Information on the Lot/Batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 14:30, at left arm, at single dose for covid-19 immunization. Medical history included migraines from an unknown date, Allergies to medications, food, or other products: penicillin, sulfa. Concomitant medication included propranolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) via an unspecified route of administration on 23Dec2020 15:00 at left arm, at single dose for covid-19 immunization. The patient experienced Severe rash, red skin and hives across my abdomen and legs. Hot to the touch, all on 16Jan2021 16:00. Treatment was reported unknown. The outcome of the event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: round rash with itchiness at site of vaccination
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Oedema peripheral, Swelling
Clinical narrative: the right side swelling, swelling underneath armpit, swelling of collarbone and neck; This is a spontaneous report from a contactable Nurse reporting for herself.    A 39-years-old female patient  received the second dose of bnt162b2 (BNT162B2; Lot # EL0142) vaccine, intramuscular on 12Jan2021 15:30 at single dose for Covid-19 immunisation.  Medical history included deep vein thrombosis, provoked DVT, and moderate asthma .  There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 23Dec2020. The patient experienced right side swelling on 12Jan2021 some hours after injection. On 13Jan2021 swelling underneath armpit was significant, swelling of collarbone and neck was also present. The reported event was considered Important Medical event. The outcome of the event was  recovering.  The event was treated with  Round the clock Ice pack. Antihistamine and NSAIDs.  Followup information has been requested. Lot number already provided.; Sender's Comments: Based on the compatible temporal association, a contributory role of suspect vaccine BNT162B2 in the development of "the right side swelling, swelling underneath armpit, swelling of collarbone and neck" cannot be excluded. The impacts of this report on the benefit/risk profile of the 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site rash, Pain, Pain in extremity
Clinical narrative: Pain in arm around injection site for 36 hours post-injection; joint pain for 36 hours post-injection.  Rash below injection site developed 8 days post injection.  Rash was red, blotchy, itchy and painful, gradually resolved over 4 days.  Also pain in latissimus dorsi on the left side.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Pain in arm around injection site for 36 hours post-injection; joint pain for 36 hours post-injection.  Rash below injection site developed 8 days post injection.  Rash was red, blotchy, itchy and painful, gradually resolved over 4 days.  Also pain in latissimus dorsi on the left side.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Allergic respiratory symptom, Anosmia, Back pain, COVID-19
Clinical narrative: she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in extremity, Respiratory tract congestion, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Vertigo
Clinical narrative: syncope; Dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received both 1st and 2nd doses of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had received two of the COVID vaccine and would like to report about a possible side effect. Three days after each shot the patient had an episode of dizziness with vertigo and syncope. The patient was not sure if this was related to the vaccine but since the patient had not had this before and wanted to report.  Information on the Lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient presented and advised clinic staff that she has had two previous anaphylatic reactions to medications (calcipotriene and lidocaine) including swelling of the tongue, angioedema and SOB).  Patient received COVID 19 vaccine and was being monitored for 30 min duration.  Ten minutes into the monitoring period the patient developed pruritus starting with her hands and then developed to a generalized pruritus.  Patient was checked into the ED, given Benadryl IM and was monitored.  Released after about 3 hrs of observation.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Facial paralysis, Periorbital swelling, Swelling of eyelid
Clinical narrative: Raspy voice in the morning; The right side of his mouth is droopy. The droopiness is not excessive, but it is odd.; Right eyelid puffiness/ on the right side of patient's face, the eyelid was puffy; Right eye full of fluid/Under that eyelid is full of fluid; Can't hardly see out of right eye due to swelling; This is a spontaneous report from a contactable consumer. A 71-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3299) via an unspecified route of administration on the left arm on 13Jan2021 14:00 at a single dose for COVID-19 immunization at a clinic/ used empty offices. Medical history included being diabetic, had heart attacks and blood clots on unspecified dates. It was confirmed that all of this occurred years ago prior to COVID-19 vaccination. The patient had no relevant family medical history and no relevant tests. The patient takes a number of medications (unspecified). The patient previously received Flu shot at least six weeks ago in Nov2020 and had no adverse events. The patient had no additional vaccines administered on the same date as BNT162B2. The reporter and her husband (patient) got their shots on Wednesday afternoon. That morning, on 15Jan2021 at 08:00, on the right side of patient's face, the eyelid was puffy/ right eyelid puffiness. He can hardly see out of it. He can see. Under that eyelid was full of fluid/ right eye full of fluid. The right side of his mouth was droopy. The droopiness was not excessive, but it was odd. The reporter also stated that the "patient had a raspy voice in the morning anyways." The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinusitis
Clinical narrative: he has a sinus infection and took an antibiotic (Augmentin); tested positive; tested positive; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable other healthcare professional (patient).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of COVID-19 vaccine last 09Jan2021 and was going to receive the second dose on 30Jan2021. He was being tested in their facility twice a week for COVID-19. He mentioned that for those two consecutive tests, he said he was positive last Tuesday and was negative on Thursday. However, this Friday 15Jan2021, the patient was tested positive and had no symptoms. He asked if he can have the second dose of the vaccine as a booster shot since he was tested positive. He mentioned that he also had a sinus infection and took an antibiotic (Augmentin). Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 09Jan2021, and COVID-19 test positive on 15Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  The reported a sinus infection was more likely an intercurrent disease, and less likely causally related to the first dose of BNT162B2. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eye disorder
Clinical narrative: eye problem before, did get worse after 1st shot; eye problem before, did get worse after 1st shot; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included eye problem, and cataract surgery. The patient's concomitant medications were not reported. It was reported that on 01Feb2021, a small eye surgery was scheduled to remove an eye film, from a post cataract surgery result. Patient had first vaccine. It was reported that the patient had eye problem before, and it did get worse after the first shot on an unspecified date, and so surgery scheduled. The second dose of vaccine was scheduled prior to surgery. The clinic wants to have him get Covid test prior to surgery and wants to know if Covid test will provide a positive result just because of the vaccine. The patient does not think the eye problem was result of vaccine but will fax as possible worsening of condition after shot. Outcome of event was unknown.  Information on the batch/lot number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no side effects  2nd dose given too soon
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphonia, Erythema, Headache, Lip swelling
Clinical narrative: raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocardial infarction
Clinical narrative: gastritis; heart burn; Chest pain; The EKG said she had a heart attack; This is spontaneous report from a contactable nurse (patient). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 13:00 at single dose at right arm for covid-19 immunization. Medical history included heart attack from Apr2019 to an unknown date, covid-19 from Jul2020 to an unknown date (really sick with it). The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first COVID19 vaccine and a few days after started having chest pain on 02Jan2021 at 1:00AM, event was serious per medically significant. She went to the doctor and they did an EKG on 08Jan2021. The EKG said she had a heart attack. The heart attack was about the time she had chest pain after the first injection. Patient called her doctor on Monday, 04Jan2021. She had a televideo appointment on 06Jan2021. She went to the doctor's office and had EKG on 08Jan2021 and was sent to the hospital. She didn't get admitted because there were no beds. Outcome of the event chest pain, she would say she had recovered on 02Jan2021 with lasting effects because she was in the hospital again for the same thing. She went to the hospital the second time for chest pain that woke her up on 11Jan2021. It started at like 3AM. She thought it was heart burn. She tried to go back to sleep. It continued while she was at work. She told her supervisor who sent her to the hospital. They did not admit her. They did do an EKG on 11Jan2021 and it was abnormal, but not indicative of heart attack. Thought it was gastritis. Her doctor thought the heart attack was on the 02Jan2021. The same thing happened with her heart and she had a heart attack in Apr2019. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer suspect. Patient stated she didn't go to the ER, but called doctor's office on the following Monday. There was no adverse event following prior vaccinations. Outcome of event chest pain was recovered with sequel, and outcome of other events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of the suspect BNT162B2 in the development of the events chest pain and heart attack cannot be excluded. The events are confounded by the patient's underlying cardiovascular conditions. The impacts of this report on the benefit/risk profile of the 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Injection site rash, Nausea
Clinical narrative: Rash below injection site, tender to palpation and slightly itchy.  2 inches wide, 4 inches long in a semi circle pattern.  Rash started day after injection and is still present 5 days later.  Also,  during the 24 hours following injection, I experienced fever, chills, nausea, aches and fatigue.  These symptoms have subsided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pruritus, Pyrexia
Clinical narrative: Rash below injection site, tender to palpation and slightly itchy.  2 inches wide, 4 inches long in a semi circle pattern.  Rash started day after injection and is still present 5 days later.  Also,  during the 24 hours following injection, I experienced fever, chills, nausea, aches and fatigue.  These symptoms have subsided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Feeling abnormal, Feeling hot, Headache
Clinical narrative: 8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Muscle tightness, Osteoarthritis, Pain
Clinical narrative: 8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. 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.