chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Rash, Urticaria
Clinical narrative: allergic to the Pfizer covid vaccine; swollen lip; rash; few hives; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unknown date, patient stated she was allergic to the Pfizer covid vaccine, from the first dose. She had swollen lip and a few hives. Her doctor prescribed her steroids and the hives/rash comes back once she finishes the steroids treatment. She wanted to know what she can do about her symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach spasms; loose stools; This is a spontaneous report from contactable consumer (patient) via medical information team. A 73-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 at 10:50 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/Lot Number: EN6206) on 20Mar2021 (at the age of 73-years-old) for COVID-19 immunization. The patient received vaccine within 4 weeks prior to the next dose of vaccine. On 10Apr2021 at 23:30 the next night, she started to have "stomach spasms" that lasted all night and into the morning. She also reports some loose stools, but did not classify them as diarrhea. She reports that she is "still having terrible spasms". After she came home, she was ok, but then she was up all night going to the bathroom with severe stomach spasms. Patient reported severe stomach spasms and diarrhea and took Bentyl, Diarrhea medicine, Gaviscon, nothing seems to be working. A visit to emergency room and physician office not required for events. She should have went somewhere but she did not. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity
Clinical narrative: I got tested because of my job and I tested positive; I got tested because of my job and I tested positive; allergies; stuffy nose; This is a spontaneous report from a contactable consumer (Patient herself). A 43-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. Medical history and Concomitant medication were not reported. The patient experienced allergies, stuffy nose on Apr2021 and on 14Apr2021 patient tested positive. The patient stated she had allergies and had them for three weeks and was around someone that tested positive and so got tested because of her job and tested positive. She had a stuffy nose but that was her only symptom and her 10 days of quarantine would be complete. Scheduled second dose on 23Apr2021. The outcome of the event allergies was recovered. and the outcome of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced arm pain on an unspecified date with outcome of unknown. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Vasovagal; This is a spontaneous report from a contactable physician reported on behalf of the daughter(patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced vasovagal after injection on an unspecified date with outcome of unknown. Physician asked if Pfizer had any information on syncope in terms with Covid vaccines? He said his daughter had a vasovagal after injection.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eosinophilic oesophagitis
Clinical narrative: eosinophilia esophagitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced eosinophilia esophagitis on an unspecified date with outcome of unknown after full course of COVID vaccine and nothing else in her life changed.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: fever; chills; sweaty; This is a spontaneous report received from a contactable physician via a Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration Date not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient experienced fever, chills and sweaty on an unspecified date. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted Covid 19; contracted Covid 19; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient contracted Covid19 in between doses. They are asking if the patient can get the second dose, now that he shows no symptoms and has completed quarantine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced slight headache for 5 minutes on unspecified date. The outcome of the event was resolved on unspecified date.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: chills overnight; FEVER; SWEATY; This is a spontaneous report from a received from Pfizer program. A contactable nurse reported that patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills overnight, fever, sweaty. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is an Initial spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable nurse reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain in injection arm. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore; This is a spontaneous report from a received from Pfizer colleagues Immediate Family and household Vaccination program. A contactable nurse reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore on unknown date. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches; This is a spontaneous report from a received from Pfizer colleagues Immediate Family and household Vaccination program. A contactable nurse reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced muscle aches on an unspecified date. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: loss of appetite; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support from a contactable other hcp.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced loss of appite 24 hours on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report received from a Pfizer sponsored program. The contactable nurse reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced body aches on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nasopharyngitis
Clinical narrative: brain fog grassy; Feeling off; cold; This is a spontaneous report from a Pfizer-sponsored program, . A contactable nurse reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had cold for 1 week (brain fog grassy feeling off) on unspecified date. He stated he felt the same way after a flu shot. The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he was in hospital at the intensive care for 3 weeks and he is still ill; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wants to cancel his 2nd dose appointment because was hospitalized and stayed 3 weeks in intensive care. Cannot take the 2nd shot because still ill. The patient was hospitalized for the event for 21 days. The outcome of the event was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021421729 similar report from same reporter
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site rash, Vaccination site urticaria
Clinical narrative: allergic reaction; hives on the arm, described as rash down the arm where she received the injection; hives on the arm, described as rash down the arm where she received the injection; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) on 18Mar2021 as single dose in deltoid right for covid-19 immunisation at the age of 39-year-old. The patient medical history and concomitant medications were not reported. The patient experienced hives on the arm, described as rash down the arm where she received the injection 5 days after receiving the vaccine, the pharmacist considered it as an allergic reaction. The second dose of vaccine was scheduled 28 days after the first vaccine, the patient was at risk for not getting the second dose of vaccine, due to previous reaction. The reporter considered the events were contraindicated and wanted to check with Pfizer to see if it is alright to get the second vaccine. Outcome of the events was unknown. The events were assessed as non-serious by pharmacist.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: I had a headache for 10 days; 5 days were migraine-like'; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 56-year-old female (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration on 23-MAR-2021 as single dose for covid-19 immunization. The patient medical history and concomitant medication were not reported.Caller reported that  'When I recieved the 1st vaccine, I had a headache for 10 days, 5 days were migraine-like'. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: low fever; diarrea; headache; fatigue; This a spontaneous report received from consumer (patient) via a Pfizer Sponsored program. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiration date was not reported) via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. Medical history included acid reflux, other gastrointestinal issues, patient was allergic to bee stings, delayed allergic reaction to codeine medication, allergic to IV contrast, lactose intolerant and can't tolerate dairy products. Concomitant medications were not reported. Patient previously took probiotics, zinc, vitamins and minerals (prior to getting her first dose but would like to know if they interfere with the vaccine). On 23Mar2021, after first dose of vaccine patient experienced low fever, diarrhea, headache, and fatigue. Patient inquired about possible drug interactions between the vaccine and probiotics and vitamins they take for acid reflux and other gastrointestinal issues. Outcome for the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received their first doses/Tested positive for covid illness; Received their first doses/Tested positive for covid illness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (patient herself and husband). This is the first of two reports.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history included COVID-19 exposure.  Concomitant medications were not reported. The patient and her husband received their first doses of COVID-19 vaccine in Apr2021, and both tested positive for COVID illness in Apr2021. They believe their exposure was the day they received their vaccination, as her husband came in contact with COVID-19 the same day. The patient had two negative tests for COVID-19 in Apr2021. Their second dose is scheduled on 23Apr2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421935 Same reporter, product, event; different patient
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Myalgia
Clinical narrative: Right in the center of chest is tender; feel like it's muscle pain when I push on it; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got his second shot Tuesday (Apr2021), woke up this morning (15Apr2021) and right in the center of chest is tender. He wanted to know this is because of the shot. It does feel like it's muscle pain when he pushed on it. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Hypokinesia
Clinical narrative: moderate nausea; severe headache; moderate joint pain; Muscle pain; So bad she cannot get up from the bed; pain at injection site; small redness at injection point; chills; fever 102 F; She couldn't sleep well due to fever and chills.; This is a spontaneous report from a contactable consumer and Follow-up (15Apr2021) received from same reporter processed together with initial information. A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727) via an unspecified route of administration on 14Apr2021 at 10:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021, 3-4 hours after the patient experienced pain at injection site, small redness at injection point, At night chills, fever 102 f, patient couldn't sleep well due to fever and chills and On 15Apr2021, moderate nausea, severe headache, moderate joint pain, muscle pain, so bad she cannot get up from the bed. The patient underwent lab tests and procedures which included body temperature increased: 102 Fahrenheit on   fever 102 F. Outcome of the event's moderate nausea, severe headache, moderate joint pain and muscle pain was not recovered, and remaining events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Poor quality sleep, Pyrexia, Vaccination site erythema
Clinical narrative: moderate nausea; severe headache; moderate joint pain; Muscle pain; So bad she cannot get up from the bed; pain at injection site; small redness at injection point; chills; fever 102 F; She couldn't sleep well due to fever and chills.; This is a spontaneous report from a contactable consumer and Follow-up (15Apr2021) received from same reporter processed together with initial information. A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727) via an unspecified route of administration on 14Apr2021 at 10:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021, 3-4 hours after the patient experienced pain at injection site, small redness at injection point, At night chills, fever 102 f, patient couldn't sleep well due to fever and chills and On 15Apr2021, moderate nausea, severe headache, moderate joint pain, muscle pain, so bad she cannot get up from the bed. The patient underwent lab tests and procedures which included body temperature increased: 102 Fahrenheit on   fever 102 F. Outcome of the event's moderate nausea, severe headache, moderate joint pain and muscle pain was not recovered, and remaining events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: moderate nausea; severe headache; moderate joint pain; Muscle pain; So bad she cannot get up from the bed; pain at injection site; small redness at injection point; chills; fever 102 F; She couldn't sleep well due to fever and chills.; This is a spontaneous report from a contactable consumer and Follow-up (15Apr2021) received from same reporter processed together with initial information. A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727) via an unspecified route of administration on 14Apr2021 at 10:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021, 3-4 hours after the patient experienced pain at injection site, small redness at injection point, At night chills, fever 102 f, patient couldn't sleep well due to fever and chills and On 15Apr2021, moderate nausea, severe headache, moderate joint pain, muscle pain, so bad she cannot get up from the bed. The patient underwent lab tests and procedures which included body temperature increased: 102 Fahrenheit on   fever 102 F. Outcome of the event's moderate nausea, severe headache, moderate joint pain and muscle pain was not recovered, and remaining events was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure, Vomiting
Clinical narrative: unconscious; seizure; throwing up while unconscious; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ew0169), dose 1 intramuscular, administered in Arm Right on 13Apr2021 14:45 (at the age of 23years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 14Apr2021 (10:15 PM), the patient was unconscious for about 15 seconds, having a seizure for 5 seconds, and throwing up while unconscious. The adverse events resulted in Emergency room/department or urgent care. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events loss of consciousness, seizure, vomiting and the suspect vaccine BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: Lymphadenopathy
Clinical narrative: experienced a lymph node under his arm on the same side he got the shot/swollen lymph  node; This is a spontaneous report from a contactable consumer or other non hcp.  A 43-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a lymph node under his arm on the same side he got the shot/swollen lymph node (lymphadenopathy). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she was tested positive for covid; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 18Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Jan2021, 10 days later after she received her first dose, the patient was tested positive for covid. She stated she had not received her second dose of the vaccine and was asking when can she get it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. Outcome of event was unknown.  Information on lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose (dose 1) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer BioNTech Covid 19 vaccine on 23Mar2021 and then 3-4 days later tested positive for COVID and had it for 8 days (as reported, pending clarification). He was scheduled to receive second vaccine on 20Apr2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive in Mar2021.  The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: the platelet level was 101,000; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of bnt162b2, via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Recently physician ordered screening labs prior to a medication initiation and the platelet level was 101,000. The platelets were noticed to be clumped in the lab tube, this is being repeated. Her physician is performing follow-up testing in 2 weeks. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain
Clinical narrative: body aches and chills; body aches and chills; dizziness and nausea; dizziness and nausea; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced body aches, chills, dizziness and nausea on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Swelling
Clinical narrative: swelling; lack of sleep following the second vaccine dose; This is a spontaneous report from a daily monitoring. A non-contactable consumer (patient) reported a patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient has been taking a lot of prednisone due to swelling following her second Pfizer COVID-19 vaccine. She also cited a lack of sleep following the second vaccine dose. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (age at vaccination 56 years old), via an unspecified route of administration on 28Jan2021 (batch/lot number: EJ1685) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife tested positive for COVID-19 on 25Mar2021. The patient's first symptoms were on 27Mar2021 and tested positive on 28Mar2021. Re-tested 2 weeks later (Apr2021) and tested positive again. It was unknown if the patient had Covid prior to vaccination and was Covid tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: pain in leg/muscle; pain in leg/muscle; headaches; numbness on the left side of her face mostly around her mouth; This is a spontaneous report from a Pfizer Sponsored  from two contactable consumers (patient and patient's mother). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 13Apr2021 patient experienced pain in leg/muscle and lips were numb and on unknown date in Apr2021 she experienced headaches, numbness on the left side of her face mostly around her mouth. Patient stated that she received first dose on 03Apr2021 and on 13Apr2021 (reported as today) she had pain in leg/muscle and lips were lumb. She was asking if this was a side effect. Patient's mother also stated that patient received the first dose of the Pfizer COVID-19 vaccine on 03Apr2021 and she was experiencing muscle pain, headaches and numbness on the left side of her face mostly around her mouth. Patient's mother wanted to know if the numbness that her daughter was experiencing could be Bell's Palsy from the Pfizer COVID-19 vaccine. Patient's mother stated that her daughter had no issues with moving any part of her face, no loss of control, no difficulty eating, drinking or smiling. Outcome of the events was unknown, at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Dizziness
Clinical narrative: pain at injection site; chills; fatigue; nausea; dizziness; sore throat; bad cough; lymphadenopathy; lost her taste; lost smell; Feeling bad; unable to go to work; This is a spontaneous report from a contactable consumer received from Pfizer Sponsored. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Started to feel bad on 07Apr2021 now she was unable to go to work symptoms include coughing, chills, pain at injection site, nausea the first 2 days, dizziness, sore throat, bad cough and lymphadenopathy. She also lost her taste and smell. She was scheduled for her second dose on 24Apr2021 and it was wondering if she should still get the second dose or if she should wait. She and her son took the vaccine the same day and he was not showing any adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Lymphadenopathy, Nausea
Clinical narrative: pain at injection site; chills; fatigue; nausea; dizziness; sore throat; bad cough; lymphadenopathy; lost her taste; lost smell; Feeling bad; unable to go to work; This is a spontaneous report from a contactable consumer received from Pfizer Sponsored. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Started to feel bad on 07Apr2021 now she was unable to go to work symptoms include coughing, chills, pain at injection site, nausea the first 2 days, dizziness, sore throat, bad cough and lymphadenopathy. She also lost her taste and smell. She was scheduled for her second dose on 24Apr2021 and it was wondering if she should still get the second dose or if she should wait. She and her son took the vaccine the same day and he was not showing any adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: pain at injection site; chills; fatigue; nausea; dizziness; sore throat; bad cough; lymphadenopathy; lost her taste; lost smell; Feeling bad; unable to go to work; This is a spontaneous report from a contactable consumer received from Pfizer Sponsored. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Started to feel bad on 07Apr2021 now she was unable to go to work symptoms include coughing, chills, pain at injection site, nausea the first 2 days, dizziness, sore throat, bad cough and lymphadenopathy. She also lost her taste and smell. She was scheduled for her second dose on 24Apr2021 and it was wondering if she should still get the second dose or if she should wait. She and her son took the vaccine the same day and he was not showing any adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever chills nausea.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Pt fell out of chair 5 minutes after vaccine. Showed symptoms of seizure. Briefly unconscious. recovered quickly and was coherent. Pt stated she had had this reaction previously when being fitted for contact lenses
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: Fist sized Rash, warm to the touch, but no itching, no other adverse effects.  feel fine otherwise.  According to this should go away in 5 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Nausea, Sensory disturbance, Vomiting
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient experienced difficulty breathing through the nose and odd sensation on upper palette of the mouth. Patient was given water and two 25mg tablets of Benadryl. Patient felt anxious and nauseated which lead to one instance vomiting. Patient felt significantly better after 10 minutes and requested to go home. Patient was informed to speak to her physician about the event and was advised that a second dose may not be beneficial due to potential for allergy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling and rash at injection site. Itchy as well. About 4 inches x 3 inches of redness. Have not sought medical attention as of  5/1 due to reading about ?COVID arm? related to COVID injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever 101.7 all day and night April 22 and fatigue Tylenol  and slept all day and night
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Sore at injection site.  Fever and entire body aches began 12 hours after injection and lasted approximately 12 hours.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient developed a flat, red rash on her arm in the area of the injection site 8 days after the shot. It doubled in size from 1 quarter to approximately 2 quarters in size overnight. Patient advised to contact us with any further reaction.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Fatigue, Headache, Magnetic resonance imaging
Clinical narrative: tieredness and headache and nights sweats a few hours later lasted for days than on Wednesday it was similar to a mini stroke leaving no signs on any tests at hospitals tests and still ill with tiredness and headache.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Night sweats
Clinical narrative: tieredness and headache and nights sweats a few hours later lasted for days than on Wednesday it was similar to a mini stroke leaving no signs on any tests at hospitals tests and still ill with tiredness and headache.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash ,swelling,burning,itchy at injection site-Mild, Additional Details: patient believes she may have been allergic to the band aids
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash ,swelling,burning,itchy at injection site-Mild, Additional Details: patient believes she may have been allergic to the band aids
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever of 103.5, vomiting, diarrhea recovered within 48 hours
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood pressure increased, Tinnitus
Clinical narrative: Tinnitus noted three days post immunization. High pitched constant tone, both ears. First thought related to BP elevation 150/90, however no change in tinnitus with BP treatment.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Muscle tightness, Neck pain
Clinical narrative: Low grade fever Chills Body aches  Neck pain  Muscle tension  Fatigue  General flu-like symptoms
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever Chills Body aches  Neck pain  Muscle tension  Fatigue  General flu-like symptoms
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, stomach cramping, fever, chills, body aches
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, nausea, stomach cramping, fever, chills, body aches
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Sore shoulder at injection site after 12 hours, aching joints.  Aching joints lasted until I took a couple of Advil and went away within 30 minutes.  Soreness and symptoms showed no evidence in the first 12 hours.  Sore shoulder lasted 3 days, was not debilitating.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Pain
Clinical narrative: Body aches, headache, cold sweats, fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Borrelia test, Ear swelling, Erythema
Clinical narrative: Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tissue)  swollen areas started to appear on face, ears, mouth and hands followed by significant swelling, pain and stiffness in a number of joints including knees, elbows, hands, fingers and feet. Biopsy pathology came back as vasculitis. Severe symptoms last 2 weeks and lesser symptoms continue following prescribed course of anti-inflammatories. Doctor suggested symptoms may persist until vaccine dissipates in symptoms (approx. 30 days from injection date).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Joint swelling, Mouth swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tissue)  swollen areas started to appear on face, ears, mouth and hands followed by significant swelling, pain and stiffness in a number of joints including knees, elbows, hands, fingers and feet. Biopsy pathology came back as vasculitis. Severe symptoms last 2 weeks and lesser symptoms continue following prescribed course of anti-inflammatories. Doctor suggested symptoms may persist until vaccine dissipates in symptoms (approx. 30 days from injection date).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face, Vasculitis
Clinical narrative: Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tissue)  swollen areas started to appear on face, ears, mouth and hands followed by significant swelling, pain and stiffness in a number of joints including knees, elbows, hands, fingers and feet. Biopsy pathology came back as vasculitis. Severe symptoms last 2 weeks and lesser symptoms continue following prescribed course of anti-inflammatories. Doctor suggested symptoms may persist until vaccine dissipates in symptoms (approx. 30 days from injection date).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Noticeable swelling at injection site accompanied by increased surface temperature beginning one week after initial injection - "Covid arm"
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus, still ringing just as loud 2 weeks after second shot
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Pain in injection area, headaches and tiredness
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Eye swelling, Feeling hot, Flushing
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: she felt numb in her left side of face, face was hot red itchy felt some swelling in lips, itching on face and body dizzy and nauseaous-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Mild
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Lip swelling, Mouth swelling, Nausea
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: she felt numb in her left side of face, face was hot red itchy felt some swelling in lips, itching on face and body dizzy and nauseaous-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Mild