chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Nausea, Vaccination site pain, Vomiting
Clinical narrative: dizzy; She was nauseous and got very hot, like a hot flash; She was nauseous and got very hot, like a hot flash; Did throw up a little one time; Arm got just the least bit sore from injection; This is a spontaneous report from a contactable consumer. This 81-year-old female patient received bnt162b2, dose 1 parenteral, administered in deltoid left on 09Feb2021 10:00 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) at 0.3 ML as single dose for vaccination in Career center nearby hosted by a public county health center. The patient medical history and concomitant medications. The patient experienced arm got just the least bit sore from injection on 09Feb2021, dizzy, she was nauseous and got very hot, like a hot flash and did throw up a little one time; all on 11Feb2021 19:00. The patient stated that she got her first Pfizer vaccine on 09Feb at 10 am and had no reaction until late yesterday around 7 pm, approx. 55 hours after vaccine. She was watching TV and all of a sudden, she felt dizzy. She got up and had to hold onto something. She was nauseous and got very hot, like a hot flash. It all lasted about 15 minutes and then she felt fine. She went to bed right away and got up at night to go to the bathroom and drink a lot of water. Dizzy: Onset time about 19:00. She was sitting her chair and all of a sudden felt dizzy. She tried to stand up and had to hold on to something. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Hot Flash: Onset time about 19:00. Had a hot flash where she could hardly stand her clothes on her. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Nauseous: Onset time about 19:00. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Did throw up a little one time: Onset time about 19:00. She recovered completely event, seemed fine after that duration of roughly about 15 minutes that this event was ongoing. Outcome of recovered of the event injection site pain on 10Feb2021 while rest of the events was recovered on 11Feb2021.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headache; dizzy; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 70-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 12Feb2021 09:00 (Batch/Lot Number: EL8982) as dose 2, single (at age of 70-years old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2, solution for injection, via an unspecified route of administration on 22Jan2021 as single dose (at age of 70-years old) for covid-19 immunization. The patient experienced headache and dizzy on 12Feb2021. Therapeutic measures were taken as a result of headache. Caller stated that he got the second dose this morning at 9AM. Wanted to know if he could drink aspirin for a headache. Stated that his headache was bothering him. Stated that he was reading, and it does not say. Stated that he used take aspirin Excedrin sometimes for headache. Stated that he was dizzy. Stated that he has had the headache for one hour. Stated that he did not have a headache in observation. Stated that the headache and dizziness started when he got home. The outcome of the events was not resolved at time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; pain at injection site; This is a spontaneous report from a non-contactable consumer. A 49-years-old non-pregnant female patient received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not provided. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 11Feb2021 patient experienced sore arm and pain at injection site. The patient did not receive treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a contactable Consumer. A male patient of an unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 05Feb2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine last Friday no symptoms until Thursday. He read he should not have symptoms that far out, so he wants to know if that's true. He is experiencing chills, body aches, muscle aches, not feeling well; all on an unknown date in Feb2021. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; swollen neck glands; fatigue; This is a spontaneous report from a contactable Other HCP via Medical Information Team. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 covid-19 Immunization. The patient medical history and concomitant medications were not reported. After she received her first dose of the Pfizer Covid vaccine and reported that she had a sore arm, swollen neck glands the following day. She says it lasted for several days and also experienced fatigue on an unspecified date. The patient took Naproxen (ALEVE) after the first one as soon as they got in the car. She took Ibuprofen (ADVIL) the next day and diphenhydramine-ibuprofen (ADVIL PM) to go to bed that night. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Flatulence, Headache, Lethargy
Clinical narrative: didn't check for fever until 12pm and fever was 101. Got up to 103.3; body aches; headache; gassy stomach; nausea; lethargy; I had chills; This is a spontaneous report received from a contactable other hcp. A 32-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONECHC COVID-19 VACCINE, Batch/Lot Number: EH9899), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jan2021 16:00 (at the age of  32-year-old) as single dose for covid-19 immunisation. Medical history included asthma and juvenile rheumatoid arthritis. There were no concomitant medications. The patient previously took cardec and experienced cardec allergy. Patient historic vaccine included first dose of bnt162b2 (PFIZER-BIONECHC COVID-19 VACCINE, Batch/Lot Number: EH9899) Solution for injection, via an unspecified route of administration, administered in Arm Left on 30Dec2020 01:45 PM as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medication in two weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vac-cination. On 21Jan2021 03:00, the patient had chills, didn't check for fever until 12pm and fever was 101. got up to 103.3, body aches, headache, gassy stomach, nausea and lethargy. The patient underwent lab tests and procedures which included body temperature: 101 on 21Jan2021 got up to 103.3. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to adverse events. The events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: didn't check for fever until 12pm and fever was 101. Got up to 103.3; body aches; headache; gassy stomach; nausea; lethargy; I had chills; This is a spontaneous report received from a contactable other hcp. A 32-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONECHC COVID-19 VACCINE, Batch/Lot Number: EH9899), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jan2021 16:00 (at the age of  32-year-old) as single dose for covid-19 immunisation. Medical history included asthma and juvenile rheumatoid arthritis. There were no concomitant medications. The patient previously took cardec and experienced cardec allergy. Patient historic vaccine included first dose of bnt162b2 (PFIZER-BIONECHC COVID-19 VACCINE, Batch/Lot Number: EH9899) Solution for injection, via an unspecified route of administration, administered in Arm Left on 30Dec2020 01:45 PM as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medication in two weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vac-cination. On 21Jan2021 03:00, the patient had chills, didn't check for fever until 12pm and fever was 101. got up to 103.3, body aches, headache, gassy stomach, nausea and lethargy. The patient underwent lab tests and procedures which included body temperature: 101 on 21Jan2021 got up to 103.3. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to adverse events. The events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Influenza like illness
Clinical narrative: sick; felt so tired/chronic fatigue; coming down with the flu; This is a spontaneous report from a contactable Other HCP. This 27-year-old female Other HCP reported for herself that.  A 27-years-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 23Jan2021 (at the age of 27-years)  as Dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. It was reported that patient was tested positive for covid in December and got the first dose of the Pfizer covid vaccine on 23Jan2021. After that dose patient got really sick and felt so tired, like she was coming down with the flu. she had chronic fatigue. She had really concerned about getting the second dose of the vaccine and spoke with his doctor about it. From what she understands the side effects after the second dose are harder than after the first. She was asking question if they have any information about getting the second dose in this situation. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Headache, Migraine, Nausea
Clinical narrative: nausea; Migraine; night sweats; achy; clammy; arm pain; weakness; could not sleep well at all; headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received BNT162B2 (BNT162B2, Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (Age at vaccination 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were none. No Known allergies. The patient historical vaccine includes received first dose BNT162B2 (BNT162B2, Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 22Jan2021 04:00 (Age at vaccination 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. No Other medications in two weeks and No other vaccine in four weeks. covid prior vaccination and covid tested post vaccination was No. On 12Feb2021 23:00 the patient experienced Migraine, nausea, night sweats, achy, clammy, arm pain, weakness. Woke up every hour, could not sleep well at all. Pounding headache around 7am. Nausea but not to the point of puking. No treatment was received for events. Outcome of the events was recovering.   : No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity, Sleep disorder
Clinical narrative: nausea; Migraine; night sweats; achy; clammy; arm pain; weakness; could not sleep well at all; headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received BNT162B2 (BNT162B2, Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (Age at vaccination 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were none. No Known allergies. The patient historical vaccine includes received first dose BNT162B2 (BNT162B2, Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 22Jan2021 04:00 (Age at vaccination 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. No Other medications in two weeks and No other vaccine in four weeks. covid prior vaccination and covid tested post vaccination was No. On 12Feb2021 23:00 the patient experienced Migraine, nausea, night sweats, achy, clammy, arm pain, weakness. Woke up every hour, could not sleep well at all. Pounding headache around 7am. Nausea but not to the point of puking. No treatment was received for events. Outcome of the events was recovering.   : No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had a little headache afterwards/ Next day about 24 hours later had headache.; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer-sponsored program.   A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that Received first dose of covid vaccine Wednesday. Had a little headache afterwards. Next day about 24 hours later had headache. Had taken 2 Advil and Benadryl. Then was reading you should not take anything before vaccine. Does not want to mess vaccine up. Wondering what we say about taking anything after vaccine. Therapeutic measures were taken as a result of event with 2 Advil and Benadryl. The outcome for the events was reported as unknown at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (31Mar2021): 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: Erythema, Pain in extremity, Pyrexia
Clinical narrative: sore arm; redness; feverish; This is a spontaneous report from a non-contactable consumer or other non hcp. An 88-years-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered on 11Feb2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an un-specified route of administration, administered on 21Jan2021 as a single dose for covid-19 immunisation. It was reported that patient received second shot of pfizer covid vaccine and patient was having a terrible reaction on arm. started hurting within hours, the puncture site Left Arm, started to turn red, and hard the size of an egg, patient arm started hurting within 15 minutes, that evening it started with redness and feverish feel to it was getting bigger and the redness is now working down the inside of arm. Patient was feeling out of it the day after patient got the vaccine, but only half a day, but it was the reaction that was now bothering. The outcome of the event was unknown at the time of report.   No follow up attempts are possible. information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: sore arm; tiredness required sleeping all weekend starting Friday night; chills; tiredness required sleeping all weekend starting Friday night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 11:45 (at the age of 54 years), (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation at workplace clinic. Medical history included yes from an unknown date and unknown if ongoing. The patient received other medication in two weeks. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 11:45 AM (Batch/Lot Number: EL3249) for covid-19 immunisation. On 12Feb2021 18:00, the patient experienced sore arm, tiredness required sleeping all weekend starting Friday night, chills. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered in 2021.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: Mild upset stomach; Mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262, Expiration date not reported), via an unspecified route of administration, administered in the left arm on 26Jan2021 17:45 (at the age of 73-years-old), as dose 1, single for COVID-19 immunisation. Patient has no relevant medical history. Concomitant medications included amlodipine besylate; hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA), both taken for an unspecified indication, start and stop date were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild upset stomach and mild fatigue on 28Jan2021. Patient did not receive treatment as a result of the events and events did not result to emergency room or physician office visit. The outcome of events was recovered on an unspecified date.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: low grade fever (99 F); nausea; headache; chills; This is a spontaneous report from a contactable consumer reported that a 86-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 86-year-old at the time of vaccination), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included 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. On an unspecified date, the patient experienced low grade fever (99 f), nausea, headache, chills. The patient underwent lab tests and procedures which included fever resulted as 99 Fahrenheit. Reported that she mentioned she gave them Tylenol before the vaccination and read online that it was not allowed. The outcomes of events were unknown.  Information about Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: her arm is aching; has on and off chills; This is a spontaneous report from a contactable consumer(patient) via pfizer-sponsored program.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 11Feb2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced her arm is aching, has on and off chills. She wanted to know if she can take Tylenol or Advil for reported events. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Illness
Clinical narrative: elevated liver function tests; very high lymphocytes; nausea; vomiting; constitutionally ill; shaking chills; joint and muscle pain; headache; maintained her temperature at around 100.5-101.5; This is a spontaneous report from a contactable physician.    A 67-years-old female patient received bnt162b2 (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 27Jan2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration (Batch/Lot Number was unknown) as single dose for covid-19 immunisation.It was Reported, Caller received the second Pfizer shot on 27JAN. A day after she experienced some nausea and vomiting which immediately resolved. Two days after, she was "very constitutionally ill" with shaking chills, joint and muscle pain, and headache centred behind the eye. This lasted severely for 12 days. She took 1 Advil or Tylenol every 6-8 hours and maintained her temperature at around 100.5-101.5. She consulted with her primary physician and she was given a number of tests. She came back with elevated liver function tests (6 times the upper limit) as well as very high lymphocytes. Her physician stated that it may be a reaction to the vaccine, and they are hoping that it will resolve within a month. The outcome of the events Nausea and vomiting on 28Jan2021 with outcome of recovered, constitutionally ill on Jan2021 with outcome of recovered, Rest all other events are on an unspecified date with outcome of unknown  Information about Lot/Batch requested  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: elevated liver function tests; very high lymphocytes; nausea; vomiting; constitutionally ill; shaking chills; joint and muscle pain; headache; maintained her temperature at around 100.5-101.5; This is a spontaneous report from a contactable physician.    A 67-years-old female patient received bnt162b2 (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 27Jan2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration (Batch/Lot Number was unknown) as single dose for covid-19 immunisation.It was Reported, Caller received the second Pfizer shot on 27JAN. A day after she experienced some nausea and vomiting which immediately resolved. Two days after, she was "very constitutionally ill" with shaking chills, joint and muscle pain, and headache centred behind the eye. This lasted severely for 12 days. She took 1 Advil or Tylenol every 6-8 hours and maintained her temperature at around 100.5-101.5. She consulted with her primary physician and she was given a number of tests. She came back with elevated liver function tests (6 times the upper limit) as well as very high lymphocytes. Her physician stated that it may be a reaction to the vaccine, and they are hoping that it will resolve within a month. The outcome of the events Nausea and vomiting on 28Jan2021 with outcome of recovered, constitutionally ill on Jan2021 with outcome of recovered, Rest all other events are on an unspecified date with outcome of unknown  Information about Lot/Batch requested  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Glossodynia
Clinical narrative: Some little bit of dark brown spot little red places on his thigh; red spots in the face; her husband developed a deep cut in the tongue and it was painful./Tongue being painful; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as SINGLE for covid-19 immunization. Patient reported her husband developed a deep cut in the tongue and it was painful/tongue being painful on 14Feb2021 and some little bit of dark brown spot little red places on his thigh, red spots in the face on an unspecified date. Reporter also stated "I just have a question we got our second Covid shot (by Pfizer later clarified) on saturday, sunday night my husband started complaining his tongue being painful. I looked in it, it was like cut on the side of the tongue it was red and deep and I notice this morning that he had some little bit of dark brown spot little red places on his thigh and I didn't know if this was a symptom of possibly the shot that he got". "I think he is getting better but I did want to ask about it." The outcome of event tongue pain was recovering and for other events was unknown.  Follow up (17Feb2021): Follow up information received from a contactable consumer.  Information about the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp.     A 45-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:00 as dose 2, single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 26Jan2021, 04:45 PM, (Batch/Lot Number was unknown) as single dose for covid-19 immunisation.The patient had not known allergies.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced sore arm,fever, fatigue on 17Feb2021 08:00 with outcome of recovering. The patient underwent lab tests and procedures which included pyrexia: unknown results on 17Feb2021.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Cough, Influenza like illness, Malaise
Clinical narrative: very sore arm; felt really sick; started getting sick with like a cold or flu/felt like she was getting a bad cold; started getting sick with like a cold or flu; body aches/achy; joint pain/joints hurt; lost some taste; Cough; 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), via an unspecified route of administration, administered in the right arm, on 29Jan2021 (Batch/lot number unknown), at age 78 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included chronic obstructive pulmonary disease (COPD) from 2015 and ongoing (diagnosed about 6 years ago, been on oxygen for about 4 years). Concomitant medication oxygen taken for COPD, from 2017 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, received on 08Jan2021 (Batch/lot number unknown), at age 78 years old, as dose 1, single, for COVID-19 immunisation. On 28Jun2021, the patient received the second dose of BNT162B2. On an unspecified date, after the second dose, the patient had a very sore arm. The patient stated that the first dose did not hurt at all. On 10Feb2021 (reported as 8-10 days later), the patient felt really sick with body aches and joint pain, but no fever, she lost some taste and had a cough. She started getting sick like a cold or flu, her joints hurt, she was achy, but no fever and she never lost her appetite. She felt like she was getting a bad cold. At the time of the report, the patient was feeling better and the events were going away finally. The patient asked if these could be from the vaccine or if it was cold. She also asked if it was safe for her to go out to the grocery store or out to eat. The outcome of the event very sore arm was unknown. The patient was recovering from the remaining events. The reporter assessed this report as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: very sore arm; felt really sick; started getting sick with like a cold or flu/felt like she was getting a bad cold; started getting sick with like a cold or flu; body aches/achy; joint pain/joints hurt; lost some taste; Cough; 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), via an unspecified route of administration, administered in the right arm, on 29Jan2021 (Batch/lot number unknown), at age 78 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included chronic obstructive pulmonary disease (COPD) from 2015 and ongoing (diagnosed about 6 years ago, been on oxygen for about 4 years). Concomitant medication oxygen taken for COPD, from 2017 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, received on 08Jan2021 (Batch/lot number unknown), at age 78 years old, as dose 1, single, for COVID-19 immunisation. On 28Jun2021, the patient received the second dose of BNT162B2. On an unspecified date, after the second dose, the patient had a very sore arm. The patient stated that the first dose did not hurt at all. On 10Feb2021 (reported as 8-10 days later), the patient felt really sick with body aches and joint pain, but no fever, she lost some taste and had a cough. She started getting sick like a cold or flu, her joints hurt, she was achy, but no fever and she never lost her appetite. She felt like she was getting a bad cold. At the time of the report, the patient was feeling better and the events were going away finally. The patient asked if these could be from the vaccine or if it was cold. She also asked if it was safe for her to go out to the grocery store or out to eat. The outcome of the event very sore arm was unknown. The patient was recovering from the remaining events. The reporter assessed this report as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: her inner thighs were so beet red and rashed; bad reaction of a rash all over her body/her inner thighs were so beet red and rashed; Itchy rash; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 15Feb2021 at 16:30 (Batch/Lot Number: E19162) (at the age of 72-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hysterectomy, ongoing lactose intolerance (can't eat dairy, onset Date: unknown, years ago, over 15 years ago), ongoing gluten sensitivity (can't eat wheat or gluten, onset Date: unknown, maybe 6 years ago) and dysphonia. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; botulinum toxin type a (BOTOX) taken for dysphonia, start and stop date were not reported. On 15Feb2021, while driving home after vaccination, she had a bad reaction of a rash all over her body and itchy rash.  She was itchy while driving home in the car but did not think anything of it. When she got home around 17:30, her inner thighs were so beet red and rashed. Then she started getting itchy all over. She looked later on that night and saw that her whole body was so beet red and rashed all over. She thought she would have to go to the emergency room that night because she was so itchy and covered with a rash. She called the emergency room and they told her to take Benadryl. She took Benadryl and the itchy rash went away. After the Benadryl wore off the itchy rash would come back. She took a Benadryl around 07:00 on 17Feb2021 and the itchy rash is better. She still has the itchy rash here and there. The week prior, she received medicinal Botox in neck for dysphonia.  She stated the Benadryl did help and she is still taking it.  The rash is not half as bad as it was. She didn't know if the reaction was from the Botox or not.  Outcome of events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ligament sprain, Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: If I sit, it stiffens up and gets sore/soreness; there is that pain behind my left knee and sometimes my hamstrings; I felt like a kick on the back on my knee and the muscle was very tight; there is that pain behind my left knee; At the back of my knees was like a cramp like I can feel the muscle sprain; At the back of my knees was like a cramp like I can feel the muscle sprain; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 66-years-old (Batch/Lot number: E19265) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Blood pressure (abnormal), Cholesterol, vaginal disorder ('Bheanin pluronic' (not clarified) and that's a vaginal pill, not in last 2 weeks but had one in Dec). Concomitant medications included olmesartan medoxomil; hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ); fenofibrate; nebivolol hydrochloride (BYSTOLIC).  It was asked if it can cause muscle pain. The patient had her 1st Pfizer COVID shot on 04Feb2021 and she had some problems. She had a catch in the back of her left knee. It got better, she put some Aspercreme on it. It was fine, but it got worse. It moved to her hamstring, then to the back of her knee. If she sits, it stiffens up and gets sore. When she got home (04Feb2021) she felt like a kick on the back on her knee and the muscle was very tight and then it slightly eased up and so it went. And then she would say she would do that (sentence incomplete) and so Sunday, she have been asked, it was still there but nothing threatening. And so after Sunday, it started getting bad again at the back of her knees and it happened, when she sat on floor and when she got up she felt it in her muscle in her hamstring and back of her knees and the soreness and it will be there until she got up and walk a little while. And so, when she sat down and got up it will be happening until she walks, once she walk it's fine but once she sat down again there is that pain behind her left knee and sometimes her hamstrings and it is very difficult when she got up until she started walking. And she didn't know what to do. And her next shot is on 02Mar. the patient is a retired teacher. They were on the same side on the left side, not on the right but the left side, past her knee (not clarified). The first thing started the same day (04Feb2021). The kick in her knees, at the back of her knees was like a cramp like she can feel the muscle sprain. She wasn't bad, it was fine. She did apply some 'Aspercreme'. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: If I sit, it stiffens up and gets sore/soreness; there is that pain behind my left knee and sometimes my hamstrings; I felt like a kick on the back on my knee and the muscle was very tight; there is that pain behind my left knee; At the back of my knees was like a cramp like I can feel the muscle sprain; At the back of my knees was like a cramp like I can feel the muscle sprain; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 66-years-old (Batch/Lot number: E19265) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Blood pressure (abnormal), Cholesterol, vaginal disorder ('Bheanin pluronic' (not clarified) and that's a vaginal pill, not in last 2 weeks but had one in Dec). Concomitant medications included olmesartan medoxomil; hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ); fenofibrate; nebivolol hydrochloride (BYSTOLIC).  It was asked if it can cause muscle pain. The patient had her 1st Pfizer COVID shot on 04Feb2021 and she had some problems. She had a catch in the back of her left knee. It got better, she put some Aspercreme on it. It was fine, but it got worse. It moved to her hamstring, then to the back of her knee. If she sits, it stiffens up and gets sore. When she got home (04Feb2021) she felt like a kick on the back on her knee and the muscle was very tight and then it slightly eased up and so it went. And then she would say she would do that (sentence incomplete) and so Sunday, she have been asked, it was still there but nothing threatening. And so after Sunday, it started getting bad again at the back of her knees and it happened, when she sat on floor and when she got up she felt it in her muscle in her hamstring and back of her knees and the soreness and it will be there until she got up and walk a little while. And so, when she sat down and got up it will be happening until she walks, once she walk it's fine but once she sat down again there is that pain behind her left knee and sometimes her hamstrings and it is very difficult when she got up until she started walking. And she didn't know what to do. And her next shot is on 02Mar. the patient is a retired teacher. They were on the same side on the left side, not on the right but the left side, past her knee (not clarified). The first thing started the same day (04Feb2021). The kick in her knees, at the back of her knees was like a cramp like she can feel the muscle sprain. She wasn't bad, it was fine. She did apply some 'Aspercreme'. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypotension, Malaise, Myalgia
Clinical narrative: muscle pain; joint pain; feeling unwell; low blood pressure; tiredness; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el9265), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 83-years-old). Medical history included high blood diabetes. The patient's concomitant medications were not reported. Patient had not known allergies. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3249), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 83-years-old). Patient visited to doctor or other healthcare professional office/clinic visit for reported events. Patient had not taken any treatment for reported events. On 10Feb2021 (at 12: 00 AM), the patient experienced muscle pain, joint pain, feeling unwell, low blood pressure, and tiredness. The outcome of all the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Oedema peripheral, Peripheral swelling, Pruritus
Clinical narrative: swelling or edema in her arms and legs; swelling or edema in her arms and legs; itchiness in my hand; This is a spontaneous report from a contactable other health professional (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported; Expiration Date: May2021) via an unspecified route of administration, administered in left arm on 27Jan2021 (at the age of 37-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient experienced swelling or edema in her arms and legs and itchiness in her hand on 28Jan2021. Patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included laboratory test: unknown result on an unspecified date. Outcome of event recovered on an unspecified date in 2021.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pruritus, Tenderness, Vaccination site pain
Clinical narrative: having wrist pain/not much of the pain is in her elbow anymore/pain extends into the lower arm and up into the shoulder/pain and aches in her wrist, lower arm, the elbow, upper arm and shoulder; left wrist and went up the inside of her hand/shooting pain up to her fingers; first shot on her left arm/pain extends into the lower arm and up into the shoulder/all of this was occurring in her left arm only; itches and hurts like crazy; Inside the palm area it was very tender; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 21Jan2021 at 10:30 (Lot Number: EL3302) as dose 1, single and on 10Feb2021 12:45 (Lot Number: EL9265) as dose 2, single both intramuscular, administered in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation from an unknown date diagnosed 7 years ago. Concomitant medications included apixaban (ELIQUIS) taken as a blood thinner, start and stop date were not reported. The patient stated that on an unspecified date in Jan2021, 10 days after getting the first shot on her left arm, she started experiencing some symptoms and after getting the second shot, these symptoms haven't stopped. She started having wrist pain. It started in her left wrist and went up the inside of her hand. Inside the palm area it was very tender, it itches and hurts like crazy if she tries to scratch it. If she scratches at all and if she scratches in her sleep or something, it is very painful. The pain extends into the lower arm and up into the shoulder. From there, it went down to the top part of her hand and she experienced shooting pain up to her fingers. She hasn't had the pain shooting from her fingers recently. She has this pain and aches in her wrist, lower arm, the elbow, upper arm and shoulder. The patient explained the elbow hasn't been bothering her as much. It does if she is sleeping on it wrong or something but it is not just aching or throbbing. The patient has not contacted her doctor yet. She was wanting to know if these were signs or symptoms of the vaccine before she called her doctor. The patient clarified that all of this was occurring in her left arm only. The patient explained that it did improve some because not much of the pain is in her elbow anymore, just a little bit, but the pain is still there when it hits. She does take a couple of Tylenol Arthritis. It gets very painful if she doesn't take something. The patient stated that she will call her doctor and see if the doctor can prescribe some kind of medication to get her through. The outcome of the events itches and hurts like crazy and itches and hurts like crazy was unknown while the outcome of the other events was not recovered.   No follow-up attempts are possible. No further information is expected.