chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomited; Still queasy stomach and Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 70-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Feb2021 11:50 (Batch/Lot Number: EM9809, Expiration date was not reported) (at the age of 70-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced vomited. On an unspecified date in 2021, the patient experienced still queasy stomach and nausea. Reporter stated that the patient (husband) got the shot yesterday around 11:50 AM in the morning (the virus shot of Pfizer). And last night 2:35 AM, he vomited and about two hours later at 4:25 AM he vomited again and right now have still queasy stomach. When paraphrased the concern, reporter stated that at 11:50 am in the morning, but he did vomit but now he is experiencing a queasy stomach, but he vomited this morning at 2:35 AM in the morning and 4:25AM twice. The patient received Emetrol for nausea (Expiration date: 05May2023). The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Fever developed 12 hours after the second dose of the vaccine and lasted till 36 hours after second dose vaccination. Persistent 100 degree F temperature reported for the duration.; Severe body aches; headache; This is a spontaneous report from a contactable consumer. A 30-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, on 17Feb2021 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, on 26Jan2021 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. Patient had no known allergies. On 18Feb2021 04:00, the patient experienced Fever developed 12 hours after the second dose of the vaccine and lasted till 36 hours after second dose vaccination. Persistent 100 degree F temperature reported for the duration; Severe body aches; and headache. On 18Feb2021, the patient underwent lab tests and procedures which included body temperature: 100 degree F temperature. The patient spoke to Nurse over the phone who recommended Acetaminophen for the treatment of fever and body aches. The outcome for all the events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Severe headache; Fever; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A non-pregnant 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:15 (Batch/Lot Number: EL3248) as dose 2, single (at the age of 27 years old) for COVID-19 immunization. The patient's medical history included Hashimotos and allergies with sulfa in antibiotics. Concomitant medication included levothyroxine, taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Lot number: EL3248) on 14Jan2021 at 08:15 AM  in the left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The facility type vaccine where the patient received the vaccine was in the workplace clinic. On 02Feb2021 at 13:00, the patient experienced severe headache, fever, chills, and fatigue. No therapeutic measures were taken as the result of the events. Outcome of the events was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat clearing, Throat irritation, Throat tightness, Wheezing
Clinical narrative: throat tightness; wheezy; throat itching; frequent throat clearing; This is a spontaneous report from a non-contactable other healthcare professional. A 38-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9266) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy, allergies including anaphylaxis to shellfish, peanut oil and sulfa drugs , food allergy, drug hypersensitivity and asthma. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]). It was reported that she did not take any Benadryl prior to her injection as patient reported that her sister who was a nurse told her not to take Benadryl in case it masks a reaction. Patient complained of frequent throat clearing (slightly upon arrival. With throat itching) and wheezing. Patient denied chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath. During her 30 min waiting period after the injection the patient experienced throat tightness, wheezy. She reported above symptoms about 20 minutes after receiving vaccine. She denied facial swelling, tongue swelling. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lip swelling
Clinical narrative: 1 hour later had trouble swallowing; 20 minutes after injection my lips started swelling; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 69-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 17:00 (Batch/Lot Number: EL1283) as DOSE 1, SINGLE for covid-19 immunisation (at the age of 45-year-old). The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported (received within two weeks of vaccination). The patient had not received any other vaccine within 4 weeks. The patient previously took botox and experienced known allergies. The patient experienced 20 minutes after injection her lips started swelling and 1 hour later had trouble swallowing on 19Jan2021. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID since the vaccination. No treatment received for events. The outcome of events reported as recovered on an unspecified date of 2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm only got sore 4-5 hours; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 17Jan2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing limb deformity, surgery from an unknown date and unknown if ongoing. On an unspecified date of Jan2021 patient reported that the first dose I didn't even know when the needle went in, the first one my arm only got sore 4-5 hours. The outcome of the event was recovered.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Jan2021, at 13:30 (Lot Number: EL3246, at the age of 27 years old) as dose 1, single for COVID-19 immunisation. The patient has no known allergies and no other medical history. She was not pregnant at the time of report. Concomitant medications included meloxicam. She did not receive any other vaccine in four weeks prior to vaccination. On an unspecified date in 2021, the patient experienced pain and swelling at injection site for 36 hours. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on an unspecified date in 2021. The patient also received the second dose of BNT162B2, administered in the left arm on 08Feb2021, at 16:00 (Lot Number: EM9810, at the age of 27 years old) for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue
Clinical narrative: Fatigue; mouth so dry; This is a spontaneous report from a contactable consumer. An 85-year-old female patient (mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL8982; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in Arm Right (once to upper right arm) on 07Feb2021 08:57 (at the age of 85-year-old) as dose 1, single for COVID-19 immunization. Medical history included has allergies, cannot hear very well from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not have any history of all previous immunization with the Pfizer vaccine and not received any additional vaccines administered on same date of the Pfizer suspect. Patient prior vaccinations (within 4 weeks) were none reported. Patient family medical history relevant to adverse events were none reported. On 07Feb2021, patient experienced mouth so dry, fatigue on 07Feb2021 12:00. Reporter that it showed the fatigue was listed, but the dry mouth was most concerning. The dry mouth started day one, and her mother was still had it. Fatigue started the afternoon, about 12PM. Stated that her mother cannot hear very well either and no further details provided. Reporter wanted to know that her mother should just keep hydrated. Patient did not visit emergency room and physician office for adverse events. There was no investigation assessment and no relevant tests. The clinical outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral herpes, Oropharyngeal pain, Rhinorrhoea, Stomatitis
Clinical narrative: Sores in mouth and on tongue was reported as worsened; Tired; Sores in mouth and on tongue; Sores in mouth and on tongue; Sore throat; Cold sores; Runny nose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9809), via an unspecified route of administration in right arm on 06Feb2021 at 16:10 (at the age of 67 years old) as single for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Ulcerative Colitis diagnosed in 1990, obesity diagnosed unknown, genetic Alpha 1 antitrypsin deficiency diagnosed a few years ago. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not have any event following prior vaccinations. The patient had the vaccine on 06Feb2021, Saturday afternoon. On Sunday night, she started with sores in her mouth and tongue on 07Feb 2021 at 19:00; sore throat, cold sores, runny nose on 07Feb 2021 and wondered if it could be related. The patient also experienced tired on 08Feb2021 at 11:00. The sores in mouth and on tongue was reported as worsened. No family medical history relevant to adverse events was provided and no relevant tests were performed. No emergency room or physician's office required. The outcome of sores in mouth and on tongue was reported as worsened was unknown, while with other events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), 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. Reporter was asking for the list of symptoms and how the reported side effects were differently experienced from the first to the second dose. Reporter stated patient experienced a slight fever after getting her first covid vaccine shot on an unspecified date. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia, Sensation of foreign body
Clinical narrative: 5 mins after shot numbness on both sides of my face mainly in the jaw areas/ Within 15 minutes had bilateral cheek numbness; a fullness in throat; face felt stressed; This is a spontaneous report from a contactable other HCP. This other HCP reported for a 57-year-old male patient.   A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3247), via intramuscularly, administered in arm left on 19Feb2021 11:15 (age at the time of vaccination 57-year-old) as single dose for COVID-19 immunization. Medical history included hypertension (mild hypertension, very healthy and active lifestyle) from an unknown date and unknown if ongoing, food allergy (mild peanut allergy) from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (known allergies: sulfa based antibiotics). Concomitant medications included olmesartan and lot of daily vitamins taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that five mins after the shot numbness on both sides of his face mainly in the jaw areas on 19Feb2021 11:30. It lasted for five hours face felt stressed. There were no remaining results on Saturday. It was also reported that within fifteen minutes the patient had bilateral cheek numbness and a fullness in throat on 19Feb2021 11:30. There was no rash, shortness of breath, nausea, vomiting, or throat swelling. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event. Outcome of all the events was reported as recovered 19Feb2021 16:30.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: low grade fever even with ibuprofen; Severe Chills; trembling; muscle aches; Ocular headache; spasms all over; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Jan2021 at 09:00 hours as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation and received other unspecified vaccine (formulation: unknown, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in left deltoid on 29Jan2021 as dose 2, single (at the age of 38-years-old) for an unknown indication. Patient had no medical history and known allergies. The patient concomitant medications were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination. On 30Jan2021, at 03:00 hours, patient experienced severe chills, trembling, muscle aches, spasms all over, ocular headache and low-grade fever even with ibuprofen. Patient received ibuprofen as treatment for low-grade fever and no treatment for rest of the events. The outcome of all the events was recovered on an unspecified date of 2021.  Information about lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: low grade fever even with ibuprofen; Severe Chills; trembling; muscle aches; Ocular headache; spasms all over; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Jan2021 at 09:00 hours as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation and received other unspecified vaccine (formulation: unknown, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in left deltoid on 29Jan2021 as dose 2, single (at the age of 38-years-old) for an unknown indication. Patient had no medical history and known allergies. The patient concomitant medications were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination. On 30Jan2021, at 03:00 hours, patient experienced severe chills, trembling, muscle aches, spasms all over, ocular headache and low-grade fever even with ibuprofen. Patient received ibuprofen as treatment for low-grade fever and no treatment for rest of the events. The outcome of all the events was recovered on an unspecified date of 2021.  Information about lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Joint swelling
Clinical narrative: arthritis flare-up and swollen knees after 1st dose; arthritis flare-up and swollen knees after 1st dose; This is a spontaneous report from a Pfizer. A Non-contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, 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 included arthritis. Concomitant medication(s) included meloxicam (MOBIC); aspirin [acetylsalicylic acid] (ASPIRIN, ACETYLSALICYLIC ACID) and arthritis medications a day before first dose. On an unspecified date, the patient experienced arthritis flare-up and swollen knees after 1st dose. The outcomes of events was unknown.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache on the second and third day. Today is the third day and heavier than yesterday.; My arm is till sore as well; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6200, patient was 44-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 04:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included metoprolol (METOPROLOL, 50 mg) taken within 2 weeks of vaccination. No other vaccine received in four weeks, no covid prior vaccination, not tested covid post vaccination, no Known allergies reported. On 11 Feb2021, the patient experienced headache on the second and third day. today is the third day and heavier than yesterday., my arm is still sore as well. No treatment was received for events. The outcomes of events were not recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: running a fever last night, 18Feb2021 of 101 to 102; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 20Jan2021 as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. On 18Feb2021, the patient experienced running a fever last night, 18feb2021 of 101 to 102. The patient wanted to know if that could be a side effect one month post vaccine. This case was reported as non-serious. The patient underwent lab tests and procedures which included fever: 101 to 102 on 18Feb2021. The outcome of the event was reported as unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Chills, Feeling hot, Feeling of body temperature change
Clinical narrative: Nausea; fluctuated from cold and warm; heavily runny nose; higher than normal blood sugar/going up to three hundred; Chills; warm; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 17Feb2021 13:30 as DOSE 1, SINGLE (at the age of 71-year-old) for covid-19 immunisation. The patient medical history included diabetes. Concomitant medications included clopidogrel (CLOPIDOGREL), gabapentin (GABAPENTIN), hydroxyzine (HYDROXYZINE), insulin (INSULIN), lamotrigine (LAMOTRIGINE) taken from 2021, levothyroxine (LEVOTHYROXINE), lisinopril (LISINOPRIL), and spironolactone (SPIRONOLACTONE). On 18Feb2021, the patient experienced chills, heavily running nose, blood sugar higher than normal after the first dose. It was reported that, nausea started at 04:00 am on 18Feb2021. It stopped sometime when she was sleeping. Chills started in the evening on the day she got the shot. She was warm then. She was busy that day, but she would fluctuated from cold and warm on 18Feb2021. On 18Feb2021, in the morning the patient had heavily runny nose was just dripping. The patient noticed higher than normal blood sugar. She had diabetes and checks her blood sugar. Normally her blood sugar was between 100 and 200. It was going up to three hundred. She was on eye drops, but they don't matter. The patient underwent lab tests which included blood sugar: going up to three hundred on 18Feb2021 (she had higher than normal blood sugar). The seriousness reported as non-serious. Her only question is with the second dose should she expect to have the same side effects or worse or none. Patient did not any AE(s) require a visit to Emergency Room and Physician Office. The outcome of the events nausea, chills, feeling warm and fluctuated from cold and warm were recovered on Feb2021 and heavily runny nose and higher than normal blood was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea
Clinical narrative: Nausea; fluctuated from cold and warm; heavily runny nose; higher than normal blood sugar/going up to three hundred; Chills; warm; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 17Feb2021 13:30 as DOSE 1, SINGLE (at the age of 71-year-old) for covid-19 immunisation. The patient medical history included diabetes. Concomitant medications included clopidogrel (CLOPIDOGREL), gabapentin (GABAPENTIN), hydroxyzine (HYDROXYZINE), insulin (INSULIN), lamotrigine (LAMOTRIGINE) taken from 2021, levothyroxine (LEVOTHYROXINE), lisinopril (LISINOPRIL), and spironolactone (SPIRONOLACTONE). On 18Feb2021, the patient experienced chills, heavily running nose, blood sugar higher than normal after the first dose. It was reported that, nausea started at 04:00 am on 18Feb2021. It stopped sometime when she was sleeping. Chills started in the evening on the day she got the shot. She was warm then. She was busy that day, but she would fluctuated from cold and warm on 18Feb2021. On 18Feb2021, in the morning the patient had heavily runny nose was just dripping. The patient noticed higher than normal blood sugar. She had diabetes and checks her blood sugar. Normally her blood sugar was between 100 and 200. It was going up to three hundred. She was on eye drops, but they don't matter. The patient underwent lab tests which included blood sugar: going up to three hundred on 18Feb2021 (she had higher than normal blood sugar). The seriousness reported as non-serious. Her only question is with the second dose should she expect to have the same side effects or worse or none. Patient did not any AE(s) require a visit to Emergency Room and Physician Office. The outcome of the events nausea, chills, feeling warm and fluctuated from cold and warm were recovered on Feb2021 and heavily runny nose and higher than normal blood was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. This is 1st of 2 reports. A 61-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 for COVID-19 immunization. The patient experienced fever on Feb 19, 2021. The patient underwent lab tests and procedures, which included body temperature: 99-100ºF on Feb 19, 2021. The patient wanted to know if she can take Tylenol after taking the COVID-19 vaccine. She received the 2nd dose of the Pfizer COVID-19 vaccine yesterday. Today she and her husband developed a fever, one ranged from 99-100ºF (and the other ranged 100.4-100.5ºF). As per the documentation received form the facility they received the vaccine, they were advised to call their doctor if they had a fever, loss of taste, etc as they may need to take a COVID-19 test. But as for other symptoms, they make take pain medication. She asked how high a fever could go after taking the COVID-19 vaccine. The case reported non-serious, with outcome of unknown. Follow-up (Feb 19, 2021): This is a follow-up to a spontaneous report from a contactable consumer. This consumer (patient) reported no new information. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): INC-2021210314 similar report from same reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: shortness of breath; asthma reaction; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration (at the age of 57-years), administered in arm left on 19Feb2021 at 16:00 as dose number unknown, single for COVID-19 immunization. Medical history included asthma and known allergies to fish, seafood, iodine from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL), esomeprazole magnesium (NEXIUM 24HR), esomeprazole (ESOMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient took other vaccine in four weeks. Patient did not have covid prior vaccination and had not been tested for covid post vaccination. On 19Feb2021 at 16:15, the patient experienced shortness of breath and asthma reaction. The treatment was not received for all the events. The clinical outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Capillary fragility, Petechiae, Platelet count
Clinical narrative: Tiny blood capillaries that burst under the skin on her legs within 4.5 hours of her receiving the Pfizer covid vaccine; petechiae; This is a spontaneous report from a contactable consumer (reported herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included, hereditary blood disorder from an unknown date and unknown if ongoing, she was allergic to penicillin (She was allergic to penicillin/amoxycillin, which she took 25-26 years ago.) from an unknown date and unknown if ongoing. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxycillin and experienced swellon throat, amoxycillin for but her throat and experienced broke out in hives, swelled shut and she was allergic to amoxycillin. She had been on a 5-day treatment of amoxycillin/penicillin and required treatment at the hospital. The patient stated that tiny blood capillaries that burst under the skin on her legs within 4.5 hours of her receiving the pfizer covid vaccine and petechiae on an unspecified date. The patient wanted to know whether petechiae was reported before after receiving the Pfizer covid vaccine. The patient would like to know how long she was protected with one dose of the Pfizer covid vaccine, if she needs to hold off on getting the 2nd dose. The patient lab tests included blood test was normal and platelet count was normal on an unspecified date. The outcome of the events was unknown. The reported did not wish to report  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Tremor
Clinical narrative: about an hour was rough; chills / shivering; turned into shaking that wouldn't stop; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A female patient of an unspecified age 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 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that 12 hours after the shot, for about an hour was rough. The patient had chills (but not feverish), shivering and turned into shaking that wouldn't stop. 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: Arthritis
Clinical narrative: My arthritis has been acting up bad and has spiked; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation 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 immunization. Medical history included ongoing arthritis. The patient's concomitant medications were not reported. The patient stated that she was out of medication and her arthritis has been terrible, she just got her COVID shot three weeks ago and on an unspecified date her arthritis has been acting up bad and has spiked. Patient was prescribed with Xeljanz 5mg. The outcome of the event was unknown.   Information on the lot batch number has been requested.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A patient of unspecified age and gender 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 number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The outcome of 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: Arthralgia, Back pain, Pain in extremity
Clinical narrative: his lower body (lower back, hips, legs) are ach; his lower body (lower back, hips, legs) are ach; his lower body (lower back, hips, legs) are ach; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (47: Age, Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history included Type 1 diabetes. The patient's concomitant medications were not reported. The day after getting second dose of Pfizer COVID-19 vaccine, his lower body (lower back, hips, legs) are achy. Event took place after use of product. Reporter does not wish to be contacted for follow-up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia
Clinical narrative: shoulder pain; low grade fever; This is a spontaneous report received from a contactable consumer. A 43-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution injection), via an unspecified route of administration on 10Feb2021 (at the age of 43-year-old) as single dose for covid-19 immunisation. Patient previously took first dose of bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were unknown. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On the same day, patient experienced shoulder pain for 24 hours and potential low grade fever. The patient underwent lab tests and procedures which included body temperature which showed low grade fever. Therapeutic measures were not taken due to the events. The outcome of the events was recovered on unspecified date.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling at sites of dermal filler; This is a spontaneous report from a contactable nurse (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 18Feb2021 08:45 (at the age of 38-year-old) as dose 2, single dose for COVID-19 immunisation was in hospital. Medical history included headaches. Patient had no known allergies. Concomitant medication included sumatriptan and cyanocobalamin (B12). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered on an unspecified date as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On 19Feb2021 15:00, patient experienced facial swelling at sites of dermal filler. Patient did not receive treatment in response to the event. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Red erythema; soreness at the site of injection.; Fatigue; headache; myalgias; fever; chills; This is a spontaneous report from a contactable other hcp.  A 26-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Lot Number: EM9809), via an unspecified route of administration, administered in left arm on 18Feb2021 03:45 (age at vaccination 26-year-old) as single dose for COVID-19 immunisation.  Medical history included ehlers-danlos syndrome, psoriasis from an unknown date and unknown if ongoing. She did not have any known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. On 19Feb2021 03:00, the patient experienced red erythema, soreness at the site of injection, fatigue, headache, myalgias, fever, chills. Therapeutic measures were taken as a result of red erythema, soreness at the site of injection, fatigue, headache, myalgias, fever, chills. Treatment included Tylenol temporarily relieved arm soreness. It was reported that there was no COVID prior vaccination. and did not had COVID tested post vaccination.The seriousness of events was non-serious. The outcome of all the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Red erythema; soreness at the site of injection.; Fatigue; headache; myalgias; fever; chills; This is a spontaneous report from a contactable other hcp.  A 26-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Lot Number: EM9809), via an unspecified route of administration, administered in left arm on 18Feb2021 03:45 (age at vaccination 26-year-old) as single dose for COVID-19 immunisation.  Medical history included ehlers-danlos syndrome, psoriasis from an unknown date and unknown if ongoing. She did not have any known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. On 19Feb2021 03:00, the patient experienced red erythema, soreness at the site of injection, fatigue, headache, myalgias, fever, chills. Therapeutic measures were taken as a result of red erythema, soreness at the site of injection, fatigue, headache, myalgias, fever, chills. Treatment included Tylenol temporarily relieved arm soreness. It was reported that there was no COVID prior vaccination. and did not had COVID tested post vaccination.The seriousness of events was non-serious. The outcome of all the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Headache, Pain, Paraesthesia, Pyrexia
Clinical narrative: lack of tasting hot spice food; have a Tingling right hand slight but noticeable.; 101.9 fever; headache; severe sore body aches for 35 hrs; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el 9266, patient was 55-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 16Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure, blood pressure, diabetes, mitral valve prolapse. Concomitant medication(s) included atenolol (ATENOLOL); metformin (METFORMIN); triamterene (TRIAMTERENE); lisinopril (LISINOPRIL); glimepiride (GLIMEPIRIDE) all taken for an unspecified indication, start and stop date were not reported in 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: en5318), via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:45 as DOSE 1, SINGLE for covid-19 immunisation. No COVID prior vaccination, no COVID tested post vaccination. No known allergies. No other vaccine received in four weeks. Reported that patient had indian food spice level 3 very hot couldn't taste it but can smell and taste most everything else. On 16Feb2021 at 20:00, the patient experienced 101.9 fever, headache, severe sore body aches for 35 hrs, on 19Feb2021, the patient experienced lack of tasting hot spice food, have a tingling right hand slight but noticeable. No treatment for AE received. The patient underwent lab tests and procedures which included Fever resulted as 101.9 fever. The outcomes of events were not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm; chills; This is a spontaneous report from a contactable consumer from a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, 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 medical history and concomitant medications were not reported. The patient experienced sore arm, chills on an unspecified date. Reported as, patient took steroids injection after the 1st dose. Patient had no side effects other than a sore arm and on the first shot had few chills on 2nd day. Outcome of all the events were unknown.  Follow-up needed. Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: pain; fever; This is a spontaneous report from a Pfizer. A non-contactable consumer reported for a male patient (friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain and fever on an unspecified date. Reporter was reported about elderly friend that she was taking care of. Patient had 1st dose of covid vaccine after vaccine had pain and fever. Patient was supposed to get 2nd dose but caller was concerned about getting covid virus and wanted to know what she should do in regards of taking care of elderly person. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Oedema
Clinical narrative: only side effect was severe wrist pain, and mild adema on the left hand.; only side effect was severe wrist pain, and mild adema on the left hand.; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's only side effect was severe wrist pain, and mild edema on the left hand. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: got redness and itchiness on both arms and legs; got redness and itchiness on both arms and legs; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program COVAX US support. The consumer reported for a female patient (mother) who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and itchiness on both arms and legs on an unknown date in 2021. Her second dose was schedule on 19Feb2021. The outcome of both the events was unknown.  Follow-up attempts completed. No further information expected.