chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Nausea; Weakness; Stomach hurts/ stomach hurts worsened; Body aches/ body aches worsened; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 15Mar2021 (Batch/Lot Number: EN6205) as DOSE 1, SINGLE (age at vaccination was 53 years old) for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing (Diagnosed 30 years ago). There were no concomitant medications. The patient was calling about the covid vaccine, she had the first dose on Monday with her husband. On 16Mar2021, the patient had body aches and reported her stomach hurted. On 17Mar2021, she experienced fever, nausea and weakness. The patient stated she felt cold, had body aches, a cough and was congested. Today the patient had a fever of 102.5 which she took acetaminophen for and it came down to 100.9. The patient also had body aches, her stomach hurted, she was nauseous and weak. The caller wanted to know if this was normal. Last night the patient was up all night coughing. This morning the patient couldn't get up off the bed. She took her temperature today, not last night, so she is unsure when the fever actually started. The body aches started last night. The caller felt very weak. She takes care of her daughter who is going through cancer. Body aches and Stomach hurts was reported as worsened. The patient underwent lab tests and procedures which included body temperature: 102.5 on 17Mar2021, body temperature: 100.9 on 17Mar2021. Therapeutic measures were taken as a result of fever (acetaminophen). The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: pain in his left arm, predominately in his shoulder and the left side of chest.; pain in his left arm; pain in his left arm, predominately in his shoulder and the left side of chest.; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported. A male patient with an unspecified age received second dose of BNT162b2 (COMIRNATY, formulation: solution for injection, Lot number: unknown) via unknown route of administration on 17Feb2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162b2 (COMIRNATY, formulation: solution for injection, Lot number: unknown) via unknown route of administration on unknown date as Dose 1,Single for COVID-19 immunization. He reported no issues when receiving the first dose. He also stated that under his physician's guidance he is scheduled for an EKG test. Shortly thereafter receiving second dose he developed pain in his left arm, predominately in his shoulder and the left side of chest. He also reported that the pain diminished after several days and then returned, and this cycle has occurred several times since receiving his 2nd dose. At the time of this report the outcome of the events were unknown.  No follow-up attempts were possible; information about lot/batch number cannot been obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: Slight loss of taste for one day; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 18Mar2021 18:45, at the age of 35-years-old, (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included none.   The patient did not have COVID-19 prior the vaccination. The patient's concomitant medications were not reported.  On 20Mar2021 07:00, the patient experienced slight loss of taste.  The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 20Mar2021. The event involved physician office visit. The with outcome of the event was recovered on 21Mar2021. No treatment was received for the event.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction from the 1st shot; This is a spontaneous report from a Pfizer sponsored program. A contactable female of an unspecified age consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 08Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had an allergic reaction from the 1st shot on 08Mar2021. She wanted to know if it was safe to take the 2nd shot. The outcome of event was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: "large bruise" at the vaccination site; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a large bruise at the vaccination site and asked if that was normal. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: tiredness; muscle pain; headaches; chills off and on; joint pain; nausea a little bit; weakness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 13Mar2021 at the age of 91-years-old as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced tiredness, muscle pain, headaches, chills off and on, joint pain , nausea a little bit, weakness. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: tiredness; muscle pain; headaches; chills off and on; joint pain; nausea a little bit; weakness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 13Mar2021 at the age of 91-years-old as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced tiredness, muscle pain, headaches, chills off and on, joint pain , nausea a little bit, weakness. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Cough; Running nose; Fast heart beat; Stuffy nose; Weakness; Tiredness; Headache; Muscle pain/ muscle aches; Fever; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 10Mar2021 (at the age of 72-years-old) in left arm as a single dose for covid-19 immunization. Medical history included blood cholesterol abnormal and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol abnormal, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for anticoagulant therapy, start and stop date were not reported. She stated that she takes both the pills by mouth, once a day. The patient reported that she received the vaccine, and the events did not start until 2-3 days and later she had different things at different time. The patient experienced tiredness, headache, on one night she had muscle pain (real bad), fever, nausea, swollen lymph node, fast heartbeat, dizziness, weakness, cough, stuffy nose, runny nose in Mar2021. The patient underwent lab tests and procedures which included heart rate: fast in Mar2021. The patient was schedule for second dose on 31Mar2021. Investigation assessment was not reported. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Myalgia, Nasal congestion
Clinical narrative: Dizziness; Cough; Running nose; Fast heart beat; Stuffy nose; Weakness; Tiredness; Headache; Muscle pain/ muscle aches; Fever; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 10Mar2021 (at the age of 72-years-old) in left arm as a single dose for covid-19 immunization. Medical history included blood cholesterol abnormal and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol abnormal, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for anticoagulant therapy, start and stop date were not reported. She stated that she takes both the pills by mouth, once a day. The patient reported that she received the vaccine, and the events did not start until 2-3 days and later she had different things at different time. The patient experienced tiredness, headache, on one night she had muscle pain (real bad), fever, nausea, swollen lymph node, fast heartbeat, dizziness, weakness, cough, stuffy nose, runny nose in Mar2021. The patient underwent lab tests and procedures which included heart rate: fast in Mar2021. The patient was schedule for second dose on 31Mar2021. Investigation assessment was not reported. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Dizziness; Cough; Running nose; Fast heart beat; Stuffy nose; Weakness; Tiredness; Headache; Muscle pain/ muscle aches; Fever; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 10Mar2021 (at the age of 72-years-old) in left arm as a single dose for covid-19 immunization. Medical history included blood cholesterol abnormal and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol abnormal, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for anticoagulant therapy, start and stop date were not reported. She stated that she takes both the pills by mouth, once a day. The patient reported that she received the vaccine, and the events did not start until 2-3 days and later she had different things at different time. The patient experienced tiredness, headache, on one night she had muscle pain (real bad), fever, nausea, swollen lymph node, fast heartbeat, dizziness, weakness, cough, stuffy nose, runny nose in Mar2021. The patient underwent lab tests and procedures which included heart rate: fast in Mar2021. The patient was schedule for second dose on 31Mar2021. Investigation assessment was not reported. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: chills and sweats; chills and sweats; fatigue; Fever 100.3 day 102.5 worst; inflamed sore swollen arm; everything hurt; inflamed; arm swelling was sick like the flu; flu; feel bad; shoulder pain; This is a spontaneous report from a contactable consumer (patient) in response to non-HCP letter sent in cross-referenced case.  A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) via an unspecified route of administration in left arm on 11Feb2021 at 08:15 (at the age of 45-year-old) as single dose for COVID-19 immunization at Clinic. Patient medical history was not reported. Concomitant medications included Niacin started in Dec2021 and was ongoing, lisinopril started in 2011 and was ongoing, venlafaxine started in 2012 and was ongoing, Montelukast started in 2018 and was ongoing all taken for unspecified indications. Patient was not sure about prior vaccinations (within 4 weeks). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9261) via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization and experienced Headache, tired, slept 8 hours straight and feel bad [1.5 day]. On 11Feb2021 at 15:00, after second dose of vaccination, patient experienced fatigue, sweats, chills, flu, fever 2 days [fever 101 on/off, 100.3], felt bad for 2days, everything hurt, inflamed, sore and swollen arm, arm swelling was sick like the flu and patient was unable to use arm for 1 week. From 12Feb2021-13Feb2021 patient had worst fever of 102.50 and called nurse and received corrective treatment which included Motrin and Tylenol and cold wash cloth. Patient visited Doctor on 25Feb2021 at 14:00 due to shoulder pain, swelling/swollen arm and received steroid shot and after receiving steroid shot arm swelling down and four hours later pain was gone. Outcome of the events were resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inflammation, Influenza, Pain, Pain in extremity
Clinical narrative: chills and sweats; chills and sweats; fatigue; Fever 100.3 day 102.5 worst; inflamed sore swollen arm; everything hurt; inflamed; arm swelling was sick like the flu; flu; feel bad; shoulder pain; This is a spontaneous report from a contactable consumer (patient) in response to non-HCP letter sent in cross-referenced case.  A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) via an unspecified route of administration in left arm on 11Feb2021 at 08:15 (at the age of 45-year-old) as single dose for COVID-19 immunization at Clinic. Patient medical history was not reported. Concomitant medications included Niacin started in Dec2021 and was ongoing, lisinopril started in 2011 and was ongoing, venlafaxine started in 2012 and was ongoing, Montelukast started in 2018 and was ongoing all taken for unspecified indications. Patient was not sure about prior vaccinations (within 4 weeks). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9261) via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization and experienced Headache, tired, slept 8 hours straight and feel bad [1.5 day]. On 11Feb2021 at 15:00, after second dose of vaccination, patient experienced fatigue, sweats, chills, flu, fever 2 days [fever 101 on/off, 100.3], felt bad for 2days, everything hurt, inflamed, sore and swollen arm, arm swelling was sick like the flu and patient was unable to use arm for 1 week. From 12Feb2021-13Feb2021 patient had worst fever of 102.50 and called nurse and received corrective treatment which included Motrin and Tylenol and cold wash cloth. Patient visited Doctor on 25Feb2021 at 14:00 due to shoulder pain, swelling/swollen arm and received steroid shot and after receiving steroid shot arm swelling down and four hours later pain was gone. Outcome of the events were resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: chills and sweats; chills and sweats; fatigue; Fever 100.3 day 102.5 worst; inflamed sore swollen arm; everything hurt; inflamed; arm swelling was sick like the flu; flu; feel bad; shoulder pain; This is a spontaneous report from a contactable consumer (patient) in response to non-HCP letter sent in cross-referenced case.  A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) via an unspecified route of administration in left arm on 11Feb2021 at 08:15 (at the age of 45-year-old) as single dose for COVID-19 immunization at Clinic. Patient medical history was not reported. Concomitant medications included Niacin started in Dec2021 and was ongoing, lisinopril started in 2011 and was ongoing, venlafaxine started in 2012 and was ongoing, Montelukast started in 2018 and was ongoing all taken for unspecified indications. Patient was not sure about prior vaccinations (within 4 weeks). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9261) via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization and experienced Headache, tired, slept 8 hours straight and feel bad [1.5 day]. On 11Feb2021 at 15:00, after second dose of vaccination, patient experienced fatigue, sweats, chills, flu, fever 2 days [fever 101 on/off, 100.3], felt bad for 2days, everything hurt, inflamed, sore and swollen arm, arm swelling was sick like the flu and patient was unable to use arm for 1 week. From 12Feb2021-13Feb2021 patient had worst fever of 102.50 and called nurse and received corrective treatment which included Motrin and Tylenol and cold wash cloth. Patient visited Doctor on 25Feb2021 at 14:00 due to shoulder pain, swelling/swollen arm and received steroid shot and after receiving steroid shot arm swelling down and four hours later pain was gone. Outcome of the events were resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 (Batch/Lot Number: EN6202) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Caller says that her Pfizer COVID-19 vaccine card is handwritten and does not provide NDC/EXP. Caller says she got her first dose 04Mar at 10:00AM injected in her left arm. She says that her body aches started this past Monday, she thought it was the weather, and then last night she had a fever that did not last very long, and today she is fine. She says it had gradually progressed over Monday and Tuesday from body aches to something else, then she had a fever last night and that did not last too long. She says that her temperature was about 100 degrees Fahrenheit, though it may have been a little over. She says on Monday, Tuesday, and Wednesday she took Tylenol for the body aches. She says for the fever she tried not to because she wanted to see if it would leave on its own, so she did not take Tylenol during the night and when she checked her temperature it was back to normal without Tylenol, then she didn't take Tylenol today. She says that the dosage for the Tylenol she took was two normal Tylenol over the counter, she does not know dosage, it is the normal stuff. Tylenol UPC/LOT/EXP: Not provided. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on. Therapeutic measures were taken as a result of body aches (pain). Caller says she did not see any information on the website, which that is the reason she called today, to ask is this normal or has anyone else had this. Caller says she does not wish to answer any more report questions. No further details captured, reported or documented at this time. Outcome of the events was recovered on unspecified date of 2021 No follow-up attempts are possible; no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Throat irritation
Clinical narrative: throat was kind of raw feeling; I took the temperature and it was like 100.4; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient took the Pfizer shot last week Tuesday and on this past Sunday, on 14Mar2021, the patient started getting, throat was kind of raw feeling and then patient took the temperature and it was like 100.4. Patient told about the Pfizer medical information department, consumer further stated, patient was going to go take the COVID test, the one in the nose, the swab. Patient had an appointment tomorrow at 8:30 in the morning. Limited information available. The patient underwent lab tests and procedures which included body temperature: 100.4 on 14Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Pyrexia, Weight
Clinical narrative: Fever; Headache; warmth across back; achy; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration in left arm (left shoulder) on 18Mar2021 at 09:45 (at the age of 76 years old) as single for covid-19 immunisation. Medical history included diabetes mellitus, under control, always does the A1C with primary care provider and diagnosed about 15 years ago, left breast where she had her surgery from Apr1997 to an unknown date, heart attack from 14Feb2011 to an unknown date, left her with 35% of her heart muscle died, osteoporosis diagnosed years ago, arthritis diagnosed 30 or more years ago, right leg knee replacement from 2013 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not have any additional vaccines on same date of the Pfizer suspect. She had her first dose of the vaccine and then had a bit of a headache on 18Mar2021 at 09:55 then there was like a warmth across her back in her shoulders on 18Mar2021, and that only lasted about 10 minutes, it was like she had a fever go across her back. The headache lasted about 10 minutes, it has gone away but she feels kind of achy on 18Mar2021. She had headache started within 10 minutes of the shot. She was feeling achy but it could be due to the weather. Second dose scheduled for 08Apr2021. The patient underwent lab tests and procedures which included weight: 215 to 225 lbs. The patient did not visit emergency room or physician's office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of headache, warmth across back was recovered on 18Mar2021, achy was recovering, fever was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Rash, Skin irritation
Clinical narrative: Diarrhea; Rash; allergic reaction; irritated her skin; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 (at the age of 78-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had an allergic reaction. She had diarrhea all night and it irritated her skin. She has a rash down there. The outcome of events diarrhea, rash, irritated her skin was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Rash
Clinical narrative: Itching; she has raised bumps on her skin and she peels the tops off; did not feel right; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Right on 08Mar2021 10:15 (Batch/Lot Number: EN6204) as dose 1, single (age at vaccination 72-year-old) for covid-19 immunisation. Medical history included Known allergy: Penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced did not feel right on 09Mar2021 and itching on 10Mar2021 while she has raised bumps on her skin and she peels the tops off on 10Mar2021. She had the Pfizer covid vaccine first dose on 08Mar2021. On 09Mar2021, she didn't feel right, and didn't feel sick, clarifies she did not feel good. She was not upset about it. On Wednesday and Thursday she started itching, she wanted to take finger nails and dig in her skin. On Friday she went to drug store and got Benadryl. She took two Benadryl on Friday, 2 on Saturday, and 2 on Sunday. She was thinking if the Benadryl was not doing anything, she does not know if she should be taking it since it makes her a little fuzzy. She was asking if there is anything she can do to help it. She tried Benadryl and nothing was working. She was scared since she was scheduled for second dose on 07Apr2021. She did not want to experience this with the second dose. She puts her glasses on. She cannot say she feels great, she does not feel sick, she just didn't feel right and it was just one day that the feeling lasted. Itching has worsened and since she has dug at her skin, she has raised bumps on her skin and she peels the tops off. It is worsened. She kept thinking it was going to better. She knows she was allergic to penicillin and she told the nurse that was administering the vaccine and was told it was not an issue. Therapeutic measures were taken as a result of events. The outcome for feeling abnormal was recovered on 10Mar2021 while rest was not recovered.   Product Complaint was added for Benadryl.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Swollen lymph node on collarbone; surrounding tenderness on left side (same side as injection); arm pain; low-grade fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 at the age of 35-year-old as dose 2, single for covid-19 immunisation from workplace clinic.  The patient medical history was not reported. Concomitant medications included vitamins, tri-femyor, metoprolol, Tylenol and allergy to ceclor. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced arm pain, low-grade fever, body aches, chills, headache 17Mar2021 02.00 and swollen lymph node on collarbone and surrounding tenderness on left side on 18Mar2021 12:00. The patient did not receive any treatment in response to the events. The outcome of events arm pain, low-grade fever, body aches, chills, headache was recovered while outcome of others was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness
Clinical narrative: Swollen lymph node on collarbone; surrounding tenderness on left side (same side as injection); arm pain; low-grade fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 at the age of 35-year-old as dose 2, single for covid-19 immunisation from workplace clinic.  The patient medical history was not reported. Concomitant medications included vitamins, tri-femyor, metoprolol, Tylenol and allergy to ceclor. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced arm pain, low-grade fever, body aches, chills, headache 17Mar2021 02.00 and swollen lymph node on collarbone and surrounding tenderness on left side on 18Mar2021 12:00. The patient did not receive any treatment in response to the events. The outcome of events arm pain, low-grade fever, body aches, chills, headache was recovered while outcome of others was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Mild rash, on my neck and my upper chest not raised; Somewhat itchy; Light red; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. On 15Mar2021, the patient developed a rash on her chin/neck and spread to her upper chest. It was a light red rash somewhat itchy, it was not raised. It was not hives. The patient was concerned and called her physician, and after she took diphenhydramine (BENADRYL) 25 mg tablet, 2DF (each one with 6 hours apart) on 18Mar2021 and rash was not resolved and discontinued BENADRYL.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain in extremity, Pyrexia
Clinical narrative: She had sore arm, fever, chills, bad headache, her arm was really hot.; She had sore arm, fever, chills, bad headache, her arm was really hot.; She had sore arm, fever, chills, bad headache, her arm was really hot/When she takes a deep breath she feels a weird chill; She had sore arm, fever, chills, bad headache, her arm was really hot.; She had sore arm, fever, chills, bad headache, her arm was really hot.; This is a spontaneous report from a Pfizer-sponsored program  non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 15Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced she had sore arm, fever, chills, bad headache, her arm was really hot. (pain in extremity), she had sore arm, fever, chills, bad headache, her arm was really hot. (pyrexia), she had sore arm, fever, chills, bad headache, her arm was really hot/when she takes a deep breath she feels a weird chill (chills), she had sore arm, fever, chills, bad headache, her arm was really hot. (headache), she had sore arm, fever, chills, bad headache, her arm was really hot. (feeling hot) on an unspecified date. Medical Information were any unaddressed medical questions referred or forwarded to Medical Information was no.Outcome of the events was recovered.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Fatigue; Chills; Body aches/Pain at location of dermal fillers for 24-36 hours after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no and expiration date: not reported) via an unspecified route of administration, in the left arm on 17Mar2021 at 15:30 (at the age of 48-year-old) as dose 2, single dose for COVID-19 immunization. Medical history included COVID-19. The patient had a history of allergy to sulfa. Since the vaccination, the patient had not been tested for COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and multi vitamin. Historical vaccine included of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no and expiration date: not reported) via an unspecified route of administration, in the left arm on 24Feb2021 at 14:30 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization and experienced fever, chills, fatigue and body ache. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 02:30, the patient experienced fever, fatigue, chills, body aches and pain at location of dermal fillers for 24-36 hours after the second vaccine. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events fever, fatigue, chills, body aches and pain at location of dermal fillers for 24-36 hours after the second vaccine was resolved in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: fever of 99.2; itchy and rash and hives inside legs by knees and elbows; itchy and rash and hives inside legs by knees and elbows; itchy and rash and hives inside legs by knees and elbows; This is spontaneous report received from a contactable consumer (patient) reported from Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included hydrocortisone acetate, neomycin sulfate, polymyxin b sulfat (CORTISPORIN). On 16Mar2021, six hours later started getting itchy and rash and hives inside legs by knees and elbows, today fever of 99.2. The patient underwent lab tests and procedures which included body temperature: 99.2 on 16Mar2021. The clinical 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: Swelling face
Clinical narrative: Face is swollen; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced face was swollen after first covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: pain in the arm; rashes on her both leg and chest area; 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: not provided) via an unspecified route of administration; administered on 09Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date, it was reported that her mother could take the 2nd dose as her mother experienced pain in the arm and rashes on her both leg and chest area on her first dose. 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: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Headache; chills; 101.2 temperature; This is a spontaneous report from a Pfizer-sponsored program SUPPORT from a contactable consumer (reported for herself). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On 16Mar2021, the patient experienced headache, chills and 101.2 temperature. The patient underwent lab tests and procedures which included body temperature: 101.2 on 16Mar2021. The consumer requesting to know if she can take Tylenol now that it has been 24 hours after second dose. 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: Computerised tomogram, Parotid gland enlargement, Salivary gland enlargement, Swelling, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on Feb 22, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Mar 5, 2021, patient experienced swelling on her right-side face, right-side neck swelling with lumps, salivary gland swelling and parotid gland swelling. Patient took antibiotics with no help at all as therapeutic measure for all the events. Patient had CT scan, which resulted in salivary gland and parotid gland swelling. The clinical outcome of the events reported as not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date, the patient experienced fever and chills. Event took place after use of product. The outcome for the events fever and chills was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location 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 unknown. On an unspecified date, after the vaccination the patient experienced fever. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pain
Clinical narrative: headache; fever 100.7 F; malaise; fatigue; aches; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for a patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration on 11Mar2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On Mar2021 the patient experienced headache, fever 100.7 f, malaise, fatigue, aches, and symptoms have not shown signs of getting any better. The patient underwent lab tests and procedures which included body temperature resulted 100.7 Fahrenheit on Mar2021. The clinical outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; fever 100.7 F; malaise; fatigue; aches; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for a patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration on 11Mar2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On Mar2021 the patient experienced headache, fever 100.7 f, malaise, fatigue, aches, and symptoms have not shown signs of getting any better. The patient underwent lab tests and procedures which included body temperature resulted 100.7 Fahrenheit on Mar2021. The clinical outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: It itched and came up as hives and swelling on her hands; It itched and came up as hives and swelling on her hands; It itched and came up as hives and swelling on her hands; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 79-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCIE, Solution for injection, Batch/Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Right on 02Feb2021 (Age at vaccination: 79-years-old) as single dose for covid-19 immunization. (Vaccination facility: hospital). Medical history included allergic to Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. She gets a flu shot every year. It was reported that patient got first shot 02Feb and she received the second one 27Feb. She ended up swelling in face and got like great big hives on her throat and neck and in both hands. She did not know what it was, she went to the doctor they were not sure she got the paper out and was reading and it said injection site swelling and throat and everything and she went again today to the doctor and they came to the conclusion that it probably was the vaccine. It did not put her in the hospital or anything and she is glad she got it but the doctor told her to report it. The swelling and hives started 3-4 days later. It started on her hands after the first dose it itched and came up with hives on her hands and they were swollen and she wondered what bit her and she went to the doctor and he looked and said he did not see any bites. After the first one was when it happened with her hands they could not figure it out what it was. The doctor checked real good and said he could not see any bites it was just hives and swelling. Adverse events resulted in Physician Office it was 10Mar, her face was all swollen and she went to the doctor. Before that she went with her hands. The outcome for the events was reported as resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had small rash on his chest; This is a spontaneous report from a consumer (patient) via a Pfizer-sponsored program COVAX US Support. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced had small rash on his chest. The outcome of event was recovered.  information about lot/batch no has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.