chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes on the armpit; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had some reactions like rashes on the armpit after the 1st dose of the vaccine on an unknown date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable consumer (patient) through a -sponsored program, SUPPORT. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 28Feb2021, the patient had loss of taste. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Joint swelling, Pyrexia
Clinical narrative: swollen shoulder part; Pretty high fever of 101; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 27Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Saturday night of 27Feb2021, the patient started feeling bad. On Sunday morning of 28Feb2021, the patient woke up with a pretty high fever of 101. She felt bad all day. The patient woke up the morning of 01Mar2021, and the fever was gone. The patient's shoulder part below the neck and closer to the base, between her neck and arm was now swollen (on the same side where she received the COVID vaccine). The patient wanted to make sure this was normal. The patient underwent lab tests and procedures on 28Feb2021, which included fever: pretty high fever of 101. The patient recovered from pretty high fever of 101 on 01Mar2021. The outcome for the rest of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: Coughing up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 25Feb2021 (Batch/lot number not reported), as dose number unknown, single, for COVID-19 immunisation. Relevant medical history was not reported. There were no concomitant medications (the reporter was refraining from giving the patient some of the patient's medications). On 25Feb2021 (Thursday), the patient received Pfizer COVID-19 Vaccine and did not have any problems. On 28Feb2021, the patient was coughing up blood. This only happened twice. The reporter was wondering if there was something the patient should do. The reporter looked up the fact sheet and didn't see coughing up blood as one of the side effects. The reporter was a little confused. The reporter was not looking for a treatment plan. The reporter was refraining from giving the patient some of the patient's medications because the reporter does not know how it will interact or if it was related to the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Epistaxis, Platelet count
Clinical narrative: Nasal drainage; coughing; tight chest; nose bleed from left side of nose; chest pain; This is a spontaneous report from a contactable Consumer (patient). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administrated in Left arm on 04Mar2021 10:45 (age at the time of vaccination 61-years-old), as a single dose for COVID-19 immunization. The patient's medical history included blood platelets tend to be low, when last tested 26Jun2020 it was 143 (x10E3/uL); and on 11Feb2021, patient took Hepatitis A, and hepatitis B vaccine, dose number 3, on Left arm. The patient's concomitant medications were not reported. Patient had no known allergies. On 05Mar2021 10:15, the patient experienced Nasal drainage, coughing, tight chest, nose bleed from left side of nose, and chest pain. On 26Jun2020, the patient underwent lab tests and procedures which included Platelet count: 143, low. No treatment was received. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Nasal drainage; coughing; tight chest; nose bleed from left side of nose; chest pain; This is a spontaneous report from a contactable Consumer (patient). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administrated in Left arm on 04Mar2021 10:45 (age at the time of vaccination 61-years-old), as a single dose for COVID-19 immunization. The patient's medical history included blood platelets tend to be low, when last tested 26Jun2020 it was 143 (x10E3/uL); and on 11Feb2021, patient took Hepatitis A, and hepatitis B vaccine, dose number 3, on Left arm. The patient's concomitant medications were not reported. Patient had no known allergies. On 05Mar2021 10:15, the patient experienced Nasal drainage, coughing, tight chest, nose bleed from left side of nose, and chest pain. On 26Jun2020, the patient underwent lab tests and procedures which included Platelet count: 143, low. No treatment was received. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 01Mar2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient needs to take Tylenol for knee pain on 01Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swelling
Clinical narrative: Sore throat; Swelling; This is a spontaneous report from a contactable consumer patient via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 27Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the patient experienced sore throat and swelling. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: extreme skin rashes; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 05Feb2021 (lot number and expiry date not reported), then second dose on an unspecified date (lot number and expiry date not reported), both via unspecified routes of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she already had the first and second dose. She developed extreme skin rashes after the first dose on an unspecified date and until the time of reporting. She said the rashes started on her arm even now on her back and thigh. Patient was asking what medication will be able to recommend to her. Outcome of extreme skin rashes was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: severe pain in her upper stomach/stomach cramp and was puking; stomach cramp and was puking; diarrhea every 15 minutes; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date patient received 1st shot of the vaccine and 2nd shot is due on Saturday. She experienced a stomach cramp and was puking. She added that she had severe pain in her upper stomach. She is also experiencing diarrhea every 15 minutes. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe pain on her right side of her shoulder; This is a spontaneous report received from the Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (Pfizer COVID-19 Vaccine, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced severe pain on her right side of her shoulder on an unspecified date in 2021. The outcome of the event was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face is swollen; This is a spontaneous report from a Pfizer-sponsored program,Support from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the shot on 23Feb2021, then her face was swollen on an unspecified date. Her 2nd dose is on 15Mar2021 and wanted to know how to make her swollen face go down. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; runny nose; sore throat; This is a spontaneous report from a Contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 12:15 (Batch/Lot number was not reported) (at the age of 36 years) as dose 1, single for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccines in 4 weeks. No other medications in two weeks. No COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced sneezing, runny nose, sore throat, all on 28Feb2021 with outcome of not recovered, without treatments.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 antibody test
Clinical narrative: I do have arthritis. But since the injections I am experiencing it in my shoulders and very severely in my elbows.; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:00 (at the age of 78-years-old) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 08:45 (Batch/Lot Number: EL9266) as dose 2, single for covid-19 immunisation.  Medical history included hypertension, ongoing arthritis. Patient had no Known allergies. Patient received no other vaccine in four weeks. Concomitant medication included valsartan; spironolactone. The patient experienced "i do have arthritis. but since the injections i am experiencing it in my shoulders and very severely in my elbows" on 29Jan2021.  The patient thought shoulder pain was injection site pain but lingering. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative. Treatment was given for the event. Patient received Tylenol for arthritis. Prior to vaccination, the patient was not diagnosed with COVID. Patient tested for COVID post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable other healthcare professional (patient).   A 39-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 01Mar2021 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient did not have COVID-19 prior the vaccination. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.  On 01Mar2021 21:00, the patient experienced chills and fever. The outcome of the events was not recovered.  No treatment was received for the events. The patient was not tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 26Feb2021 at 15:15 (Lot Number: PAA165969) as dose 1, single for COVID-19 immunization.  Medical history included ongoing high blood pressure. The patient did not have COVID prior to vaccination. Concomitant medications include unspecified blood pressure medication and cholesterol medication. The patient did not receive other vaccines in four weeks from the COVID vaccine. On 27Feb2021 at 02:00, the patient experienced nose bleed. The patient did not receive treatment for the event. The outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Periorbital swelling, Swelling face
Clinical narrative: Tender around his nose area on one side; Swelling around nose and eyes; Swelling around nose and eyes; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 01Mar2021 (at the age of 59 years), as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took his first COVID-19 shot yesterday (01Mar2021) and had swelling around nose and eyes. The patient was reading the pamphlet and it said that it could be swelling. It was tender around his nose area this morning (02Mar2021). The patient wanted to know if it should be tender around his nose area on one side like that. The patient was just trying to be cautious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Rash erythematous
Clinical narrative: Rash; still red; it has increased in size slightly and it's progressing down the shoulder, down towards the elbow; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported) via an unspecified route of administration, administered in right arm on 22Feb2021 (at the age of 74 years old) as dose 2, single for covid-19 immunisation (for prevention of Covid-19 as reported). Medical history included thyroid (disorder) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (THYROXINE) taken for thyroid (disorder) at 25 ug, start and stop date were not reported; and tiotropium bromide (SPIRIVA) via respiratory inhalation at 2.5 ug, twice a day taken for an unspecified indication, start and stop date were not reported.  The patient had the first dose of bnt162b2 as covid-19 immunization (lot EL9269) on 01Feb2021 and had zero reaction, "no pain, no swelling, nothing". On 26Feb2021, patient had rash; still red; it has increased in size slightly and it's progressing down the shoulder, down towards the elbow. This was further reported as approximately four days later, patient did not know the exact time because patient did not noticed it, patient developed a rash, not around the injection site itself but below it, it started sort of a regular, squarish, rectangular, pattern. It was the still red and spread somewhat; does not itch, has no blisters, no pain for med site. Patient could not really tell if patient have any other symptoms at all. Patient was seeing family physician at the time of the report as he wanted to have a look at that. The rash, it was on the arm, but it has spread slightly since patient first discovered it and the rash was a small area about the size of 3 fingers wide and about 4 inches long and it has increased in size slightly and its progressing down the shoulder, down towards the elbow. Patient had laboratory tests for respiratory relief, chest, and lungs on an unknown date with unknown results. Patient stated that it was spreading, persisting and patient was going to see family doctor. At the time of the report, patient was not taking any medication for it. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on inside of left elbow.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm at the age of 51 years old on 02Feb2021 12:00 (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported. On an unspecified date, the patient experienced rash on inside of left elbow. No treatment was received. The outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: just some bruise; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date in Dec2020 as dose 1, single; second dose (Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported to experience just some bruise. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches and pains; fever; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer Sponsored Program, Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced aches and pains and fever on an unspecified date (reported as a week ago, last Thursday). The patient's doctor told him that he would be fine in 72 hours and he was. The patient wanted to know how to schedule his second shot. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: she is having dental surgery a week after that and she will be on antibiotics; This is a spontaneous report from a contactable consumer (patient herself). A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: F.L.9266), via an unspecified route of administration on 17Feb2021 (age at vaccination: 87 years) as DOSE 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was having dental surgery a week after that and she will be on antibiotics (amoxicillin). She did not have a sore arm. The second dose was scheduled on 10Mar2021 (reported as this month). The outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: feel chest tightness/pressure/pain intermittently, worse on evening of 4th day post vaccine; feel chest tightness/pressure/pain intermittently, worse on evening of 4th day post vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 17:30 (at the age of 58-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Other vaccine received in four weeks was none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient reported that, 2 days post vaccine started to feel chest tightness/pressure/pain intermittently, worse on evening of 4th day post vaccine on 05Mar2021 at 19:00 (as reported). Patient did not receive any treatment for the event. Outcome of all the events were recovering.  No follow-up attempts are possible no further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: experienced itching on her upper torso after 2nd dose; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date as single dose for COVID-19 immunization. The patient experienced itching on her upper torso after 2nd dose on an unspecified date and wanted to know if she can take Benadryl. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: muscle ache; pain; low-grade fever (99.9 °F); This is a spontaneous report from a contactable consumer (patient) Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose last February 10th and scheduled for her second dose tomorrow (March 3rd). She tested negative for the Rapid COVID-10 test and no symptoms anymore. On unspecified date, last week, she had muscle ache, pain and low-grade fever (99.9 °F). She was still waiting for the result of her second COVID-19 test. She wanted to know if she can get the second dose tomorrow. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoglycaemia, Hypotension, Rash
Clinical narrative: the patient began to experience lightheadedness; hypoglycemia; hypotension; generalized rash; This is a spontaneous report from a non-contactable other hcp. An elderly male (Age: 97, Unit: unknown) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history included his electric wheelchair from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced the patient began to experience lightheadedness, hypoglycemia, hypotension, generalized rash on an unspecified date. Adverse event: During his 15-minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. Great response to eating and drinking. Symptoms resolved. Patient monitored for total of 30 minutes. He feels well to go home. Wife with him. He was able to operate his electric wheelchair out accompanied by his wife. Treatment included: water and snacks. The outcome for all events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in shoulder; This is a spontaneous report from a contactable consumer (patient) from a Pfizer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced pain in shoulder. The patient also wanted to know if she can take ibuprofen after receiving the first dose. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: sore muscles; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore muscles and fever on an unspecified date. The patient called to cancel and reschedule his second dose of Covid-19 vaccine scheduled on 05Mar2021, his first dose was given on 12Feb2021. Patient wants to reschedule to a date starting 15Mar2021 onwards after he comes back from his travel since he doesn't want to feel any of the reactions caused by the vaccine while he travels. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Loss of personal independence in daily activities
Clinical narrative: administration date: 05Feb2021/administration date:12Feb2021; administration date: 05Feb2021/administration date:12Feb2021; Severe headache; nausea; dizziness; Debilitating; I'm unable to work or care for my family; vestibular migraine; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 12Feb2021 at 14:15 at the age of 41-year-old as single dose for COVID-19 immunization. Medical history included known allergy to sulfa medications. The patient didn't received other vaccine in four weeks. No known history of migraine or vestibular issues. The patient was not COVID prior vaccination. The patient was not test post vaccination. Concomitant medication included citalopram. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 05Feb2021 at 02:15 PM at the age of 41-year-old as single dose for COVID-19 immunization. On 27Feb2021 at 12:00, the patient experienced severe headache accompanied by nausea and dizziness, debilitating, Ent said it's vestibular migraine. It's been ongoing for 10 days. Debilitating and patient was unable to work or care for my family. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone and eye exercises. The outcome of inappropriate schedule of vaccine administered and off label use was unknown. The outcome of other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Vestibular migraine
Clinical narrative: administration date: 05Feb2021/administration date:12Feb2021; administration date: 05Feb2021/administration date:12Feb2021; Severe headache; nausea; dizziness; Debilitating; I'm unable to work or care for my family; vestibular migraine; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 12Feb2021 at 14:15 at the age of 41-year-old as single dose for COVID-19 immunization. Medical history included known allergy to sulfa medications. The patient didn't received other vaccine in four weeks. No known history of migraine or vestibular issues. The patient was not COVID prior vaccination. The patient was not test post vaccination. Concomitant medication included citalopram. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 05Feb2021 at 02:15 PM at the age of 41-year-old as single dose for COVID-19 immunization. On 27Feb2021 at 12:00, the patient experienced severe headache accompanied by nausea and dizziness, debilitating, Ent said it's vestibular migraine. It's been ongoing for 10 days. Debilitating and patient was unable to work or care for my family. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone and eye exercises. The outcome of inappropriate schedule of vaccine administered and off label use was unknown. The outcome of other events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her arm; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program regulatory authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on her arm on an unspecified date after the second dose. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EL9264), via an unspecified route of administration, administered in left arm on 05Feb2021 10:15 (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. Medical history included back fusion in Jul2020 and Aug2020. Concomitant medications included estradiol, triamterene, vitamin D, and melatonin, all taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (lot number: EL 8982), administered in left arm on 15Jan2021 10:15 and experienced muscle and joint very sore, fever, and arm shoulder swollen. The patient experienced only a sore arm with the second shot on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient's oxygen came out of her mouth and she experienced difficulty breathing. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer via Pfizer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose1 of BNT162B2 received on 24Feb2021. The patient experienced rash on 03Mar2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Nodule, Pain in extremity
Clinical narrative: Area of red inflammation on left arm; Area of red inflammation on left arm; Little knot below the injection site on her arm; Left arm was sore; This is a spontaneous report from the contactable consumers (patient's husband and patient herself). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9264), via an unspecified route of administration in left arm, on 26Feb2021 (at the age of 81 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included serious diarrhea and chronic obstructive pulmonary disease (COPD) from probably 25 years ago (1996); both were ongoing. The patient's serious diarrhea was ongoing for a long time. The patient started with antibiotics about 1.5 years ago. The patient has fought serious diarrhea off and on and was getting medicine for it, but it has been a while since she had taken. The patient had like 3 antibiotics before being hospitalized where she had intravenous (IV) for 15 days in the hospital. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EN6202) on 05Feb2021 (at the age of 81 years) for COVID-19 immunization (left arm). The patient got her second Pfizer COVID-19 vaccine injection on Friday the 26th and things seemed to be going well. On Saturday (27Feb2021) at unknown time in the morning, the patient got a red inflammation down from the injection site on her arm. There also seemed to be a little knot below the injection site on her arm which was still there. When the patient changed clothes, she noticed that her left arm was sore and had an area of red inflammation on left arm and a little knot not at the actual injection site, but around 1 inch or so below the injection site on the same arm that she was administered the vaccine injection. The red inflammation down from the injection site on her arm has decreased. They put some cortisone cream on it, and it seems like the area is not a rash. They looked at the thing they gave them, and that rash was supposed to go over the whole body which did not happen to her. The red inflammation down from the injection site on her arm is maybe a 4-inch area of red inflammation. It looked like it could have been an infection, but the patient's husband knew it is not an infection. The arm that she got the injection in is also fairly sore too to the touch. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Left side of nose bleeding; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9267; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 01Mar2021 at 14:00 (at the age of 64-years-old) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included high blood pressure (taking high blood pressure medication for a long time) from an unknown date. There were no concomitant medications. The patient experienced left side of nose bleeding on 02Mar2021. The reporter and her husband went and got COVID-19 Shot on Monday at 2PM. Her husband's nose started bleeding off and on. Is this a side effect? The reporter must go and get the second COVID-19 Shot. Nose bleeding started yesterday morning (02Mar2021) and it was off and on. The reporter found a paper towel with blood on it. She then saw her husband with a piece of paper towel up his nose in case it starts bleeding again. Nose is just bleeding from one side and thinks it is the left side. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; temperature of 101; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, EN6202), via an unspecified route of administration on 02Mar2021 14:00 (at the age of 73-year-old) as single dose for covid-19 immunisation. Medical history included high blood pressure, gout, heart attack, heart problems; all via unspecified date and unknown if ongoing. On 03Mar2021 at around 3:00 in the morning, the patient started getting chills and temperature of 101. The patient did not receive any treatment in response to the event. Outcome of chills was not recovered, while outcome of temperature of 101 was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Throat swelling after COVID vaccine; Tongue swelling after COVID vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced throat swelling and tongue swelling after Covid vaccine on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: feels like a bruise at the injection site; This is a spontaneous report from a contactable consumer.   A 35-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 02Mar2021 14:15, at the age of 35-years-old, (Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. The patient is not pregnant at the time of vaccination. The patient did not have COIVD-19 prior vaccination. Concomitant medication includes multivitamin daily. The patient experienced feels like a bruise at the injection site on 03Mar2021 with outcome of recovering. The patient was not tested for COVID-19 post vaccination.  No treatment was received for the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: pain on her arm; itching; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Mar2021 as dose number unknown, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On Mar2021, the patient experienced pain on her arm, and itching. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: LAD of the L axillary area; fever; chills; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 22Dec2020 18:50 at the age of 37-year-old (Lot Number: EJ1685; Expiration Date: Mar2021) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient provided information to the physician regarding the reported adverse events with the use of BNT162B2. The physician considered the BNT162B2 had a causal effect to the events. The patient experienced LAD of L axillary area, fever and chills on 26Dec2020 23:00. The patient was not admitted to hospital. No emergency  or physician office done, no treatment for the events given. It was reported that there was a reasonable possibility that the event is related to BNT162B2. The events recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia
Clinical narrative: face is bright red with prickly feeling; face is bright red with prickly feeling; This is a spontaneous report from Pfizer-sponsored Program from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he got his first dose an hour ago (unspecified date), then his face was bright red with prickly feeling on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Pain in extremity
Clinical narrative: Very low body temperature; little ache on his arm; This is a spontaneous report from a contactable consumer (patient) received from Pfizer-sponsored program Support. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on an unknown date, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced very low body temperature and little ache on his arm. The patient underwent lab tests and procedures which included body temperature: low. It was reported that, the patient wanted to confirm what he needs to do before taking the second dose vaccine tomorrow (on 06Mar2021). The outcome of events was unknown.  Information on the lot/batch number has been requested.