chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Hypertension
Clinical narrative: experiencing Fluctuating blood pressure; blood pressure high; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 11Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, but it is pretty well controlled with medication, product dose omission issue from an unknown date and unknown if ongoing. Reportedly, patient does have history of elevated blood pressure and missed his morning medication. The patient's concomitant medications were not reported. Vaccine history for dose 1 was not provided. He had no reaction to the 1st dose and really no reaction to the 2nd dose. It was reported that patient took second dose on Thursday, on 14Feb2021 (third day) after second dose indicated high and varying blood pressure. Patient received Second dose of Covid vaccine on Thursday- Last night patient was experiencing Fluctuating blood pressure back and forth between somewhat high and very high- wants to know if that s from the vaccine. The patient said that he took his blood pressure a couple of times and noticed that the numbers kept changing, which was abnormal. He stated that normally if he takes his blood pressure multiple times, it stayed pretty close in the same range, but that time when he retook it the first number was down and the second number was up, then he was able to get the second number down, but the first number was up again. He said that he even tried a second machine, but each time he took it, it was different and this all occurred over a number of hours. He said that on 15Feb2021 morning, it was little high, but not that bad. He had not called his doctor yet and was debating where to start but thought he would see if it was from the vaccine before he called the doctor. The patient underwent lab tests and procedures which included blood pressure measurement: high on 14Feb2021. The outcome for the events was unknown. Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I was pretty much covered in hives; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunization. The patient was 49-years-old at the time of vaccination. The past medical history and concomitant medications were not reported. On 05Feb2021 the patient experienced i was pretty much covered in hives, therapeutic measures (took Benadryl) were taken as a result of i was pretty much covered in hives. The patient wondering, she got the vaccine on Tuesday night and she was doing fine and last night at 2 o' clock or 2:30 in the morning, she woke up and she was pretty much covered in hives, when she looked on her paperwork, said that, that could happen but like usually within an hour of vaccine. So, she was wondering if that could still be the side effect of the vaccine." When paraphrased the concern, consumer stated, "No, not two nights later, it was last night." (clarified as 5Feb2021). The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Haematochezia, Heart rate
Clinical narrative: blood in stool; The initial case was missing the following minimum criteria: of No Adverse Event Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 04Feb2021 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included open heart surgery in 2019 (two years ago), brain stroke, ongoing dizziness from 2018 (3 years ago), ongoing blood pressure from 2018 (3 years ago), heart beat high, ongoing anxiety from 2018 (3 years ago), urine frequency. Concomitant medications include metoprolol fumarate for blood pressure, mirabegron (MYRBETRIQ) for urine frequency, sertraline hydrochloride, nifedipine, atorvastatin, acetylsalicylic acid (ASPIRIN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 13Jan2021 (at the age of 71-years-old) for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first administration date of the vaccine. On an unspecified date, the patient experienced a lot of blood in the stool. In Feb2021 (two months ago), the patient had a colonoscopy with unknown results. The patient still had blood in the stool but not as much as before. The clinical outcome of blood in the stool was resolving.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears that started about 2-3 days after 2nd vaccine dose, 2 weeks at this point, seems worse in L ear.; This is a spontaneous report from a contactable physician (patient). A 44-years-old non-pregnant female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318, expiration date unknown) via unspecified route of administration on arm left at a single dose on 31Jan2021 09:45 (age at the time of vaccination 44-year-old) for COVID-19 immunization. The facility type for vaccine was fire station. The patient had medical history of asthma. Patient had no known allergies. The patient received other medications within 2 weeks of vaccination reported as Beclometasone Dipropionate (QVAR), MVI, Ascorbic Acid (Vit C), Colecalciferol (D3), Melatonin, Diphenhydramine Hydrochloride (Benadryl). The historical vaccination patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246, expiration date unknown) via unspecified route of administration on arm left at a single dose on 10Jan2021 10:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 02Feb2021 (started about 2-3 days after second dose) patient experienced ringing in ears after second dose. After 2 weeks at this point seems worse in left ear. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcome of the event as not recovered. Information on the lot/batch number is captured.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; This is a spontaneous report from a contactable consumer (reported for himself). A 55-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 16Feb2021 at 07:45 as SINGLE DOSE (at the age of 55-years) in left arm for covid-19 immunization. Medical history included high cholesterol. The patient had no known allergies. Historical vaccine included: the patient received first dose of bnt162b2 via an unspecified route of administration on 26Jan2021 at 07:30 as SINGLE DOSE (at the age of 55-years) for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Concomitant medications included: atorvastatin (Lipitor), diphenhydramine hydrochloride (Benadryl), Ibuprofen and unspecified multivitamins. Prior to the vaccination the patient was not diagnosed with COVID-19. On 16Feb2021 at 20:00, about 12 hours after vaccination, the patient experienced headache, chills, body aches and low fewer which lasted until next day. It was reported that there was no treatment for events. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Neck pain
Clinical narrative: lot of discomfort; pain in the back of her head down to the neck area near the left ear and hairline; pain in the back of her head down to the neck area near the left ear and hairline; This is a spontaneous report from contactable consumer via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date: Not reported) dose 2 via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunizations. The patient medical history was not reported. The patient historical vaccine includes 1st COVID-19 VACCINE. The patient medical history and concomitant medications were not reported. The patient had been waiting for an hour and half to talk to someone. She had her second Pfizer COVID19 Vaccine on Friday, 12Feb2021. She didn't have any effects after that and was alright. On Tuesday 16Feb2021, she started having a lot of discomfort and pain in the back of her head down in the neck area near the left ear and hair line. That was yesterday morning around 9AM. She has been using hot and cold packs. She was on Hydrocodone anyway. She had been adding Aleve and Aspirin. She has held her hand there and pressing it while she had been on hold. By using the hot and cold and the Aleve it was not getting rid of it. It might not be anything to do with the vaccine. She wanted to check with Pfizer to know if it was a side effect. While she was on hold, she was pressing hard and rubbing it. When she puts the hot and cold on, she changes it back and forth and it gives some relief. The outcome of the events was reported as not recovered.   Information about lot/batch has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; extreme exhaustion; Felt like she was freezing and had the chills; arm is still sore; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9264)intramuscularly into the left arm on 05Feb2021 17:00 (at the age of 73-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said that she had some adverse events after receiving the vaccine. On 05Feb2021, the patient stated that her arm was still sore. The hcp that gave her the injection was not gentle. She said that she noticed the soreness in her arm on Friday night. Laying in bed if she laid on that side, she noticed that it was sore and not up to par. She said that she did not expect it to last this long. On 06Feb2021, the patient reported of extreme exhaustion after receiving the injection which was like having Covid all over again and felt like she was freezing and had chills both of which resolved on 07Feb2021 after a good nights sleep at about 10:00 to 12:00. She had 3 weeks of it with Covid though. She said that it started about 18 hours after she had the shot. She stated that she felt fine when she woke up, but after she started doing some stuff, she just could not function. On 07Feb2021, she had a bit of a headache which recovered on the same day. She said that she took a couple of Tylenol and it seemed to resolve. She had Covid over the holidays and that her brain does not always match her tongue when she was trying to explain her symptoms. She stated that she was not looking forward to the second vaccine because everyone she spoke with said that the side effects are worse with the second vaccine than they are with the first. No further details provided. No prior vaccinations within four weeks nor any relevant tests done. Outcome for exhaustion, headache and chills was recovered/resolved whereas it was recovering/resolving for pain in arm.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hangover, Nasal congestion, Pain in extremity, Sneezing
Clinical narrative: Her arm was sore; hangover; sneezing; nose was stuffy; This is a spontaneous report from a contactable consumer (patient). A 79-Year- old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications were not reported. On 30Jan2021, patient nose was stuffy and she was sneezing. On 03Feb2021, patient experienced hangover. She has recovered completely she says the next morning she woke up and felt rejuvenated. She said the stuffiness and sneezing happened before the hangover feeling it was probably Saturday after the vaccine that she had the stuffy nose and sneezing, she says 30Jan2021 sounds right. She says she has recovered completely since then everything is going good. Patient asked who she was talking to she got the number off the paper she got after the Pfizer COVID 19 vaccine. She wanted to people applaud her people for being so orderly and efficient it only took, she only had to wait half an hour all together it was about 45 minutes but the efficiency was great that they gave them at the Hospital. She said she wanted to tell Pfizer how much she appreciated and just check to see how long after the vaccine could she have any kind of reaction. She said she was asking because she thinks she may have had a reaction but she does not know so she wanted to try to see if it was one. She said this happened a week later didn't have any thing when she got the vaccine except her arm was sore but that was it. Then, she is 80 years old and she doesn't drink but she felt like a she had a hangover and her nose was stuffy and she sneezing. Patient declined to provide email address. She hardly ever uses it. It was reported that decline to provide because she was fine. She feels like a million bucks. She had to get her glasses to read the vaccine record card. She does not see and expiration date or NDC number just the date she got it. It was reported that she did not want to get the dangerous flu at her age that would be a horrible death. She was only on high blood pressure medication. The outcome of the event her arm was sore was unknown and outcome of the other events was recovered.  No further information provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Malaise, Myalgia
Clinical narrative: painful muscle; joint aching; temperature of 99.4; injection site pain; dizziness; general feeling of malaise; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 18Feb2021 at 10:15 (at the age of 79 years old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergic to penicillin. Concomitant medications included Levothyroxine .075MG, Losartan 25MG and Eye vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) in left arm on unspecified date for covid-19 immunisation. On 19Feb2021 at 12:30 the patient experienced 15 hours after the second dose COVID 19 vaccine I had painful muscle and joint aching, temperature of 99.4, injection site pain, dizziness and general feeling of malaise. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 99.4 on 12Feb2021. The outcome of the events was recovering.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: painful muscle; joint aching; temperature of 99.4; injection site pain; dizziness; general feeling of malaise; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 18Feb2021 at 10:15 (at the age of 79 years old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergic to penicillin. Concomitant medications included Levothyroxine .075MG, Losartan 25MG and Eye vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) in left arm on unspecified date for covid-19 immunisation. On 19Feb2021 at 12:30 the patient experienced 15 hours after the second dose COVID 19 vaccine I had painful muscle and joint aching, temperature of 99.4, injection site pain, dizziness and general feeling of malaise. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 99.4 on 12Feb2021. The outcome of the events was recovering.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Shoulder joint pain; muscle pain in left and right arms from my shoulder down to my hands; muscle pain in left and right arms from my shoulder down to my hands; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received first dose of bnt162b2 (Solution of injection, Lot Number: EI8982), via an unspecified route of administration, administered in left arm on 11Feb2021 12:30 (at an age of 79-years-old) as single dose for covid-19 immunisation. Medical history included lumpectomy from 17Nov2020, type 2 diabetes mellitus, hypertension, heart attack 20/12, 2 stents. The patient's concomitant medications were not reported. On 11Feb2021 14:30, the patient experienced shoulder joint pain, muscle pain in left and right arms from my shoulder down to my hands. The clinical outcomes of the shoulder joint pain, muscle pain in left and right arms from my shoulder down to my hands were not recovered.  No follow-up attempts are possible.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bronchitis, Cough, Fatigue, Headache
Clinical narrative: Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9263, Expiration date not reported), via an unspecified route of administration in left arm on 31Jan2021 09:30 (at the age 77-year-old), as a single dose for COVID-19 immunization. Medical history included Type 2 Diabetes. The patient previously took ondansetron (ZOFRAN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin degludec (TRESIBA), insulin aspart (NOVOLOG), Bupropion, Alprazolam and Estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 14:00, the patient experienced headache, backache, fever, nausea, exhaustion, sore throat, dry cough and bronchitis. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was tested for COVID twice by covid test type: one Nasal Swab test, on 08Feb2021, the result was negative. The treatment received for the events were antibiotics and steroid. Outcome of the events were reported as recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9263, Expiration date not reported), via an unspecified route of administration in left arm on 31Jan2021 09:30 (at the age 77-year-old), as a single dose for COVID-19 immunization. Medical history included Type 2 Diabetes. The patient previously took ondansetron (ZOFRAN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin degludec (TRESIBA), insulin aspart (NOVOLOG), Bupropion, Alprazolam and Estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 14:00, the patient experienced headache, backache, fever, nausea, exhaustion, sore throat, dry cough and bronchitis. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was tested for COVID twice by covid test type: one Nasal Swab test, on 08Feb2021, the result was negative. The treatment received for the events were antibiotics and steroid. Outcome of the events were reported as recovering.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Nasal congestion, Oxygen saturation, Respiration abnormal, SARS-CoV-2 test
Clinical narrative: After 07 (seven days) of 2nd vaccine i.e. from January 29Jan2021 night my frequent nasal congestion; breathing problem; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: PFIZER EL3248) via an unspecified route of administration in left arm on 22Jan2021 at 11:00 as single dose for COVID-19 immunization. Medical history included blood pressure and cervical spondylitis. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. Patient's allergies were not known. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: PFIZER 3756) via an unspecified route of administration in left arm on 01Jan2021 at 11:00. On 29Jan2021, at night (after seven days of vaccine), the patient experienced frequent nasal congestion and breathing problem and it was still continuing even after three weeks of vaccination. On 17Feb2021, the patient was tested for SARS-CoV-2 Semi-Quant Total Ab; test results showed SARS-CoV-2 Semi-Quant Total Ab greater than 250.00 Abnormal i.e. antibody level was abnormally very high (normal less than 0.8 U/ml). Patient wanted to know if patient's nasal congestion and breathing problem was due to abnormally very high level of antibody, developed after Pfizer Covid-19 vaccination and if so, how long it would continue and what measures/precaution/remedies patient could take to reduce side effects. On 17Feb2021, patient also mentioned that oxygen level in oximeter and chest ray were ok. Outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Malaise, Nausea, Pain
Clinical narrative: Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetite; sleepy; upper body aches; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 11 Feb 2021 at 01:30 PM (at the age of 66-years), as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 19 Jan 2021 at 02:30 PM, as a single dose for Covid-19 immunization. Medical history included polymyalgia rheumatica. Patient was allergic to ibuprofen and opiates. Concomitant medication was not reported. On 11 Feb 2021 at 01:00 AM, patient experienced short lasting fever & chills, malaise, sharp but short-lasting headaches, nausea w/o vomiting, very sleepy, loss of appetite and upper body aches. The events were long term side effects which were from 2-9 days post second dose of vaccination. Patient did not receive treatment for events. Patient did not receive any other vaccine in four weeks prior vaccination. Patient does not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of all the events of was not recovered.   Information on the lot/ batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetite; sleepy; upper body aches; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 11 Feb 2021 at 01:30 PM (at the age of 66-years), as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 19 Jan 2021 at 02:30 PM, as a single dose for Covid-19 immunization. Medical history included polymyalgia rheumatica. Patient was allergic to ibuprofen and opiates. Concomitant medication was not reported. On 11 Feb 2021 at 01:00 AM, patient experienced short lasting fever & chills, malaise, sharp but short-lasting headaches, nausea w/o vomiting, very sleepy, loss of appetite and upper body aches. The events were long term side effects which were from 2-9 days post second dose of vaccination. Patient did not receive treatment for events. Patient did not receive any other vaccine in four weeks prior vaccination. Patient does not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of all the events of was not recovered.   Information on the lot/ batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives all over the body, beginning about 48 hours after vaccine; This is a spontaneous report received from a non-contactable consumer (reporting on herself). A 71-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Right on 06Feb2021 09:15 as single dose for COVID-19 immunization. Medical history included contrast media allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. On 08Feb2021 01:00, patient experienced severe hives all over the body, beginning about 48 hours after vaccine. Patient did not received any treatment for adverse event. The outcome of the event was recovering.   No follow-up attempts are possible. Information on the lot/batch number can not be obtained . No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient's husband). A 28-year-old female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3247, expiration date May2021) via intramuscular administered in left arm on 08Feb2021 (at the age of 28 years old) as single dose for COVID-19 immunisation. The patient medical history included Chronic kidney disease  (May2018), helps to lower protein in urine, iron was low, autoimmune disease, to stabilize the kidney. Patient got flu shot last year, months ago. Concomitant medications included Losartan50mg tablet twice a day by mouth used for chronic kidney disease, helps to lower protein in urine, Ferrous sulfate 325mg tablet, one tablet twice a day by mouth and Azathioprine 50mg tablet once a day by mouth. On 11Feb2021, the patient had experienced hives. The adverse event was not resulted in emergency room. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. Additional Context included Caller is the husband of the patient. His wife received the first dose of the vaccine on Monday 08Feb2021. She woke up today with itchy bumps around 7am this morning. She went to the dermatologist today at 1330 and the dermatologist confirmed it was hives. States nothing has changed with her aside from getting the vaccine. She has never had hives before. Treatment: She is prescribed a topical cream which has not been picked up yet, she was told take a Zyrtec Outcome: The hives are moving into different areas, some areas of the the itchiness has gone away and she is getting new bumps in different areas. HCP: declined to provide, she is going to see a different primary, she usually just sees her nephrologist Her nephrologist and rheumatologist work together in regards to her medications. She got the flu shot last year, months ago. The outcome of the event was not resolved.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Urticaria, Vertigo
Clinical narrative: Latent hives; flashing; vertigo; This is a spontaneous report from a non-contactable Other HCP. This 35-year-old non-pregnant female Other HCP reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on left arm on 27Jan2021 12:00 PM at single dose for COVID-19 Immunization. The patient's medical history and Concomitant medication were not reported. Historical vaccine included first dose of COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. On 29Jan2021, the patient experienced Latent hives, flashing, vertigo. The patient did not receive any treatment but resulted in doctor or other healthcare professional office/clinic visit. The outcome for the event was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives; fever; This is a spontaneous report received from a non-contactable other hcp. An 22 year old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021 patient experienced hives and fever. The outcome of the events was recovered.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives  appeared on both inner forearms, stomach, bilateral upper legs; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 67-years-old female (non pregnant) patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 08:15 (Batch/Lot Number was EL9262) as single dose (at the age of 67-years-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had not known allergies. Medical history included hypertension. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 30Jan2021 08:30 AM (Batch/Lot Number was EL99265) as single dose for covid-19 immunisation. Concomitant medications (other medications in two weeks) included atenolol and chlorthalidone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 21Feb2021 00:30, the patient experienced hives appeared on both inner forearms, stomach, bilateral upper legs. Patient stated that at 67 years of age, this was her first experience with hives. Therapeutic measures were taken a Benadryl cream for hives appeared on both inner forearms, stomach, bilateral upper legs. The outcome of event was recovered on an unspecified date in 2021..
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site rash
Clinical narrative: Dose number-2 Administration date:17-Feb-2021 Dose number-1 administration date:31-Jan-2021; had a rash near the injection site; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EL9296 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 17:00 (at the age of 66-year-old) as single dose for COVID-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration on left arm on 31Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included, hypertension, hypercholesterolemia, coronary artery disease, neoplasm malignant. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and received other vaccine within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 5 days after receiving the second dose. On 22Feb2021, the patient had a rash near the injection site and an area lower on that arm where she had basal cells removed that was swollen and itchy. The patient did not receive any treatment. Outcome of the events was not recovered.  No follow-up attempts are needed. No further Information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Swelling face
Clinical narrative: I awoke at 3:15 am, with my face swollen, including eyes, cheeks, below jaw line and lips.; Minor headache; slight nausea; This is a spontaneous report received from a contactable consumer. A 70-year old-female patient received first dose of bnt162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EM9809) via an unspecified route of administration on left arm on 22Feb2021 at 21:00 as single dose for covid-19 immunization. Concomitant medications included: Calamine lotion, benefiber, calcium600/vitamin D. Medical history included allergies to Penicillin, statins, metals. The patient underwent lab tests and procedures, which included elbow replacement on an unspecified date in 2016. It was reported that 18 hours after injection, on 23Feb2021 at 3:15 am, patient woke up with face swollen, including eyes, cheeks, below jaw line and lips. There was no indication of swollen tongue, no difficulty breathing or swallowing. Minor headache and slight nausea. The adverse events required emergency room visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. Therapeutic measures were taken as a result of events and included treatment with: Benadryl, Famotidine. Outcome of the events was recovering
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report from a contactable physician. An 81-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 02Feb2021 16:00 as single dose and had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 12Jan2021 16:00 as single dose for covid-19 immunization. Patient medical history included known allergies: Penicillin and concomitant medications were not reported. No immediate effect for 2 days. The patient began to have headaches and now severe headaches lasting up to 8 hours at a time and persistent on 05Feb2021 14:00. No other vaccine in four weeks. No treatment given for the adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gingival discomfort, Pruritus, Rash, Skin irritation
Clinical narrative: rash with raised bumps and redness; rash with raised bumps and redness; Facial irritation; Swelling of eyelids and area underneath eye brows; Itchiness where rash is; Irritation of gums; This is a spontaneous report from a contactable nurse.  A 58-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscularly, administered in left arm on 15Feb2021 at 14:30 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. No Known allergies. She received first dose intramuscularly administered in left arm on 25Jan2021, at 02:30 pm, as single dose for covid-19 immunization. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 15Feb2021 at 08:00 pm, she had Facial irritation and rash with raised bumps and redness. Swelling of eyelids and area underneath eyebrows. Itchiness where rash is present. Irritation of gums resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken of hydrocortisone cream to face. All events were assessed as non-serious with outcome of not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: rash with raised bumps and redness; rash with raised bumps and redness; Facial irritation; Swelling of eyelids and area underneath eye brows; Itchiness where rash is; Irritation of gums; This is a spontaneous report from a contactable nurse.  A 58-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscularly, administered in left arm on 15Feb2021 at 14:30 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. No Known allergies. She received first dose intramuscularly administered in left arm on 25Jan2021, at 02:30 pm, as single dose for covid-19 immunization. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 15Feb2021 at 08:00 pm, she had Facial irritation and rash with raised bumps and redness. Swelling of eyelids and area underneath eyebrows. Itchiness where rash is present. Irritation of gums resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken of hydrocortisone cream to face. All events were assessed as non-serious with outcome of not recovered.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: headache; nausea; vertigo; This is a spontaneous report from a contactable other-HCP (Patient). This 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in left arm on 16Feb2021 at 15:45 (at the age of 53-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 19Feb2021, at 12:00 AM, patient had headache, nausea and vertigo. On 21Jan2021, the patient had received other unspecified vaccine within four weeks into the left arm and other unspecified supplement medications in two weeks. No treatment was received for the adverse events.  Patient not had COVID prior vaccination and was not tested for COVID post vaccination. The outcome of all the events was not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program. A patient with unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine; Solution for injection; Lot Number and expiration date: not reported), dose 1 on an unspecified route of administration and location on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles after the first dose. The reporter is calling on behalf of the patient, said her patient experienced shingles after the first dose, and she wants to know if it's okay to take the second dose next week. The outcome of the event was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 immunisation, Chills, Dizziness, Dysstasia
Clinical narrative: The evening after receiving the vaccine I experienced extreme vertigo (unable to sit upright or stand); The evening after receiving the vaccine I experienced extreme vertigo (unable to sit upright or stand); nausea; headache; chills; dizziness; weakness; This is a spontaneous report from a contactable consumer. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in arm left on 13Feb2021 at 09:30 as single dose for COVID-19 immunization (at the age of 38-years-old). The patient medical history included known allergies to Compazine, Rocephin, Penicillin, Erythromycin, Mushrooms and Arugula. Patient concomitant medication(s) included Multivitamins/CBD Oil (equilibria). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Feb2021, at 18:00, the patient stated that the evening after receiving the vaccine she experienced extreme vertigo (unable to sit upright or stand), nausea, headache, weakness, dizziness and chills. Patient was pescribed meds to stop vertigo but nausea, weakness, dizziness and headache persisted for 11 days following vaccination. The patient received treatment of Scopalomine patch for vertigo. On 21Feb2021, the patient underwent lab tests and procedures which included Nasal Swab and ID NOW were negative. On 23Feb2021, Nasal Swab and PCR test were negative. The outcome of events was recovered with Sequel.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: The evening after receiving the vaccine I experienced extreme vertigo (unable to sit upright or stand); The evening after receiving the vaccine I experienced extreme vertigo (unable to sit upright or stand); nausea; headache; chills; dizziness; weakness; This is a spontaneous report from a contactable consumer. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in arm left on 13Feb2021 at 09:30 as single dose for COVID-19 immunization (at the age of 38-years-old). The patient medical history included known allergies to Compazine, Rocephin, Penicillin, Erythromycin, Mushrooms and Arugula. Patient concomitant medication(s) included Multivitamins/CBD Oil (equilibria). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Feb2021, at 18:00, the patient stated that the evening after receiving the vaccine she experienced extreme vertigo (unable to sit upright or stand), nausea, headache, weakness, dizziness and chills. Patient was pescribed meds to stop vertigo but nausea, weakness, dizziness and headache persisted for 11 days following vaccination. The patient received treatment of Scopalomine patch for vertigo. On 21Feb2021, the patient underwent lab tests and procedures which included Nasal Swab and ID NOW were negative. On 23Feb2021, Nasal Swab and PCR test were negative. The outcome of events was recovered with Sequel.   No follow-up attempts are possible. No further information is expected.