chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hangover, Headache, Musculoskeletal stiffness
Clinical narrative: body aches; I had fever; severe chills; diarrhea; nausea; headache; hung over; stiff neck; it prevented me from sleeping; This is a spontaneous report from a contactable consumer. A 25-year-old non-pregnant female received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number/batch number: 59267100001, expiration date: unknown), via intramuscular route of administration in the left arm on 27Jan2021 at 09:00 (at the age of 25-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. 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. Concomitant medications included escitalopram, IUD. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number/batch number: 59267100001, expiration date: unknown), via intramuscular route of administration in the left arm on 06Jan2021 at 02:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jan2021, about 18 hours after the 2nd dose (1 AM), the patient experienced fever, severe chills, diarrhea, nausea, headache, body aches, and I was prevented from sleeping then it lasted about four hours before she got back to sleep. She woke up with a headache, stiff neck and generally felt "hung over" the next day. Advil was relieving at this point. The outcome of all the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Sleep disorder
Clinical narrative: body aches; I had fever; severe chills; diarrhea; nausea; headache; hung over; stiff neck; it prevented me from sleeping; This is a spontaneous report from a contactable consumer. A 25-year-old non-pregnant female received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number/batch number: 59267100001, expiration date: unknown), via intramuscular route of administration in the left arm on 27Jan2021 at 09:00 (at the age of 25-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. 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. Concomitant medications included escitalopram, IUD. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number/batch number: 59267100001, expiration date: unknown), via intramuscular route of administration in the left arm on 06Jan2021 at 02:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jan2021, about 18 hours after the 2nd dose (1 AM), the patient experienced fever, severe chills, diarrhea, nausea, headache, body aches, and I was prevented from sleeping then it lasted about four hours before she got back to sleep. She woke up with a headache, stiff neck and generally felt "hung over" the next day. Advil was relieving at this point. The outcome of all the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Mouth swelling, Ocular hyperaemia, Swelling face
Clinical narrative: eyes were also red; Swelling of the face also in the mouth area, mainly on the right side; Swelling of the face also in the mouth area, mainly on the right side; This is a spontaneous report from a contactable consumer (patient's wife). A 71-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration Date was not reported), via an unspecified route of administration on 26Jan2021 as single dose (at the age of 71-years-old), for COVID-19 immunisation. Medical history included ongoing high blood pressure  (it has been a while since he was diagnosed with this), ongoing high cholesterol  (it has been a while since he was diagnosed with this), type II diabetes mellitus from 2020 and ongoing. The patient's concomitant medications included bunch of unspecified medications but does not had them on hand at the time of report. On 29Jan2021, it had been 3 days, this morning his face was swelled up also in the mouth area, and mainly one side of the face. The entire face was swelled but more on the right side than the left including the mouth area. Like someone popped him in the mouth and knock up the side of head on the jaw area and patient eyes were also red on an unspecified date. The swelling had gone down a little. Patient had received no treatment, but she was getting ready to get Benadryl. The patient was enquiring about Benadryl okay to take or how long it lasts. The outcome of the events was recovering for swelling of the face also in the mouth area, mainly on the right side and unknown for eye were also red.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea for 2 days; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not provided) via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Not tested for COVID post vaccination. On 23Jan2021 patient experienced Nausea for 2 days. The treatment was not received. The outcome of the event was recovered on 25Jan2021.  Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal tenderness, Diarrhoea, Dyschezia, Fatigue
Clinical narrative: Bloating; Lethargic; tired; lower abdomen was tender to touch; loose stools with a lot of water; pain with stool; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 09:00 as 1st dose, single dose for covid-19 immunisation. The patient's medical history included Prediabetes and low d, thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID, 80mcg; take once daily by mouth, taking for 5 or more years) for thyroid disorder and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL], 125mg/5000IU; take once daily by mouth, taking for a year) for Prediabetes and low d and ongoing; multivitamin (taking for 10 years) takes once daily by mouth. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not visit to physician or emergency room. On 27Jan2021, patient experienced extremely tired. The patient went home, had lunch and slept for a couple hours, then when she got up she felt very lethargic, real tired, and noticed her lower abdomen was tender to touch. Patient had loose stools with a lot of water and when she tired to go to the bathroom there was pain in her abdomen with straining with stool. Patient still tender and felt good this morning but now she is not feeling as well, and she adds she feels bloated On 29Jan2021. The outcome of bloating was not recovered, while with other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Bloating; Lethargic; tired; lower abdomen was tender to touch; loose stools with a lot of water; pain with stool; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 09:00 as 1st dose, single dose for covid-19 immunisation. The patient's medical history included Prediabetes and low d, thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID, 80mcg; take once daily by mouth, taking for 5 or more years) for thyroid disorder and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL], 125mg/5000IU; take once daily by mouth, taking for a year) for Prediabetes and low d and ongoing; multivitamin (taking for 10 years) takes once daily by mouth. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not visit to physician or emergency room. On 27Jan2021, patient experienced extremely tired. The patient went home, had lunch and slept for a couple hours, then when she got up she felt very lethargic, real tired, and noticed her lower abdomen was tender to touch. Patient had loose stools with a lot of water and when she tired to go to the bathroom there was pain in her abdomen with straining with stool. Patient still tender and felt good this morning but now she is not feeling as well, and she adds she feels bloated On 29Jan2021. The outcome of bloating was not recovered, while with other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness in my arm; Feeling like when the needle went in when I touch my arm; Hurting; This is a spontaneous report from a contactable consumer ((patient herself). A 72-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, MODERUN number: 013L20A), via an unspecified route of administration on 23Jan2021 at 11:00 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, unspecified date the patient experienced soreness in her arm, feeling like when the needle went in when her touch my arm; hurting. Patient had the COVID shot done on the Saturday at 11'o clock and she was wondering why my arm was sore. she was felt it. she just told you she had the COVID shot done on the Saturday and she can still feel the shot she means the soreness in my arm. When probed if consumer took the Pfizer COVID Vaccine, consumer stated, "Yes, she took the COVID Vaccine on Saturday" (Not appropriately clarified, hence unchecked as Pfizer product). All the number she had on card is one she did give you and 12321. DPCLEESBILE that was with the health clinic. She go back to get my second shot the 20Feb2021. The events were assessed as non-serious. The consumer stated that she received the treatment and rubbed it with some alcohol and took some Tylenol then put hot compress on it as a result of feeling like when the needle went in when her touch my arm, hurting. The outcome of the events was reported as not recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, SARS-CoV-2 test
Clinical narrative: Later that night I noticed a rash on the back of both arms without itchiness; For the first shot I had swelling of my lip one hour after the vaccination, no other symptoms and it went down with Benadryl; This is a spontaneous report received from a contactable other Health Professional (patient). A 21-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ELY9231) via an unspecified route of administration in arm left on 05Jan2021 (at the age of 21-years-old) as single dose for covid-19 immunization at hospital. Medical history included chronic migraines. Patient had reactions to certain things such as changes in laundry detergent, lotions, etc. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination and not received any medications in two weeks. On 05Jan2021, after one hour after the vaccination patient experienced swelling of lip, no other symptoms and it went down with Benadryl. Later that night, patient noticed a rash on the back of both arms without itchiness or raised bumps. On 11Jan2021, patient had nasal swab, covid test with test result as negative. Since the vaccination, the patient had not been tested for COVID-19. Outcome for the event lip swelling was recovering and the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Slight change in taste bud; This is a spontaneous report from a contactable consumer. An 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL9261, expiration date and NDC number were not reported) via an unspecified route of administration on 25Jan2021 at 11:40 in right arm as a single dose for COVID-19 immunization. The patient took the COVID vaccine because she had COPD and was a cancer survivor. The patient's medical history (including any illness at time of vaccination) included blood disorder. Family medical history relevant to adverse event and Investigation assessment was not reported. No other prior vaccination (within 4 weeks) and no additional vaccines were administered on same date of the Pfizer suspect. The patient did not experience any adverse event prior vaccination. There was no history of previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included hydroxycarbamide (HYDROXYUREA) 500mg tablets by mouth twice daily taken for blood disorder, start and stop date were not reported. The chemo pill started may be 4 years ago, when it was discovered she had blood problem. As per the description, it was reported that the patient had Pfizer shot, later clarified as COVID vaccine on last Monday 25Jan2021. On 4th day, 29Jan2021 at 08:10, she woke up in morning and had a slight change in taste bud, not as sharp as it was, she still had her sense of smell. There was no emergency room or physician office visit. She will get her second dose on 15Feb2021. There were no relevant tests reported. The outcome of all events was recovering/resolving.   Follow-up attempts are completed. No further information was expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Lip swelling
Clinical narrative: rash on the back of both arms without itchiness; swelling of lip; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; fever of 100.5 that lasted for about 24 hours; This is a spontaneous report from a contactable other HCP (patient). A 21-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL3249) as 2nd dose, single for covid-19 immunization. Medical history included chronic migraines and seasonal allergy experience reactions to certain things such as changes in laundry detergent, lotions. The patient's concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ELY9231, expiration date unknown), via an unspecified route of administration administered in Arm Left on 05Jan2021 as 1 st single dose for covid-19 immunization and experienced swelling of my lip one hour after the vaccination, no other symptoms and it went down with Benadryl and Later that night noticed a rash on the back of both arms without itchiness or raised bumps. On 11Jan2021, patient underwent lab tests which included Nasal Swab, Covid test with negative result. There was no other vaccine within four weeks and no other medications within two weeks. The patient had Covid prior to vaccination and did not test for Covid post vaccination. On 26Jan2021, after second vaccination the patient experienced swelling of lip that went down with Benadryl and the same rash. In addition, about 10 hours after the vaccine, had a fever of 100.5 that lasted for about 24 hours and also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours. The outcome of all the event recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: rash on the back of both arms without itchiness; swelling of lip; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; fever of 100.5 that lasted for about 24 hours; This is a spontaneous report from a contactable other HCP (patient). A 21-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL3249) as 2nd dose, single for covid-19 immunization. Medical history included chronic migraines and seasonal allergy experience reactions to certain things such as changes in laundry detergent, lotions. The patient's concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ELY9231, expiration date unknown), via an unspecified route of administration administered in Arm Left on 05Jan2021 as 1 st single dose for covid-19 immunization and experienced swelling of my lip one hour after the vaccination, no other symptoms and it went down with Benadryl and Later that night noticed a rash on the back of both arms without itchiness or raised bumps. On 11Jan2021, patient underwent lab tests which included Nasal Swab, Covid test with negative result. There was no other vaccine within four weeks and no other medications within two weeks. The patient had Covid prior to vaccination and did not test for Covid post vaccination. On 26Jan2021, after second vaccination the patient experienced swelling of lip that went down with Benadryl and the same rash. In addition, about 10 hours after the vaccine, had a fever of 100.5 that lasted for about 24 hours and also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours. The outcome of all the event recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: nausea; Subjective fever; chills; shaking; significant muscle and joint pain; significant muscle and joint pain; fatigue; headache; This is a spontaneous report from a non-contactable Physician (patient) reported for himself. This 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021 at 09:00 am (age at vaccination was 32 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications patient received within 2 weeks of vaccination included ibuprofen (MOTRIN [IBUPROFEN]), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) as needed. The patient previously took augmentin [amoxicillin;clavulanic acid] and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 07Jan2021 at 11:00 am (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Hospital. On an unknown date, the patient experienced subjective fever, chills, shaking, significant muscle and joint pain, fatigue, headache, nausea which started 18 hours after injection. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: nausea; Subjective fever; chills; shaking; significant muscle and joint pain; significant muscle and joint pain; fatigue; headache; This is a spontaneous report from a non-contactable Physician (patient) reported for himself. This 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021 at 09:00 am (age at vaccination was 32 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications patient received within 2 weeks of vaccination included ibuprofen (MOTRIN [IBUPROFEN]), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) as needed. The patient previously took augmentin [amoxicillin;clavulanic acid] and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 07Jan2021 at 11:00 am (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Hospital. On an unknown date, the patient experienced subjective fever, chills, shaking, significant muscle and joint pain, fatigue, headache, nausea which started 18 hours after injection. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 27Jan2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history slightly underachieve thyroid otherwise good health and known allergies: Penicillin derived antibiotics - gastric symptoms not full allergic reaction. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 28Jan2021 at 01:00 AM, her symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, and extreme fatigue until the next evening. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 27Jan2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history slightly underachieve thyroid otherwise good health and known allergies: Penicillin derived antibiotics - gastric symptoms not full allergic reaction. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 28Jan2021 at 01:00 AM, her symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, and extreme fatigue until the next evening. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Full Body Aches; Freezing Chills; Headache; Frequent Urination; Constant Yawning; Swollen Lymph Node In Injection Arm; Fatigue; This is a spontaneous report from a contactable Other Health Care Professional, reporting for a 49-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via intramuscular, administered in left arm on 26Jan2021 at 16:45 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1686) intramuscularly in left arm on 05jan2021.The patient medical history includes diabetes mellitus, obesity and smoker and concomitant medications include Metformin, Glipizide, Atorvastatin, Amlodipine, Omeprazole, Vitamin D, Fish Oil, Baby Aspirin. The patient had history of lisinopril allergy. Patient was not tested Covid-19 positive prior vaccination. On 27jan2021, 15hours 30 minutes after the vaccination, the patient experienced Full Body Aches, Freezing Chills, Headache, Frequent Urination, Constant Yawning, Swollen Lymph Node in Injection Arm, Fatigue. The reporter assessed all events as non-serious. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Yawning
Clinical narrative: Full Body Aches; Freezing Chills; Headache; Frequent Urination; Constant Yawning; Swollen Lymph Node In Injection Arm; Fatigue; This is a spontaneous report from a contactable Other Health Care Professional, reporting for a 49-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via intramuscular, administered in left arm on 26Jan2021 at 16:45 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1686) intramuscularly in left arm on 05jan2021.The patient medical history includes diabetes mellitus, obesity and smoker and concomitant medications include Metformin, Glipizide, Atorvastatin, Amlodipine, Omeprazole, Vitamin D, Fish Oil, Baby Aspirin. The patient had history of lisinopril allergy. Patient was not tested Covid-19 positive prior vaccination. On 27jan2021, 15hours 30 minutes after the vaccination, the patient experienced Full Body Aches, Freezing Chills, Headache, Frequent Urination, Constant Yawning, Swollen Lymph Node in Injection Arm, Fatigue. The reporter assessed all events as non-serious. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: her heart started to beat fast, fast, fast; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient experienced her heart started to beat fast, fast, fast on an unspecified date in 2021. She took an anxiety pill but it seems like it is still fast. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: I woke up dizzy; I still don't feel good; probably little weak; This is a spontaneous report was received from a contactable consumer or other non hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 19Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient was taking unspecified concomitant medications. She was fine for the first few days on the 5th day, i.e., on 24Jan2021, she woke up dizzy and she still do not feel very good and still do not feel good. Well patient just don't feel good, nothing can pinpoint it and probably little weak, she did not know and have not been doing much, she don't feel good. Patient do take medications, going to have to go get the list and took Tylenol couple of times as treatment. Patient reported that they scheduled the second one and it is 4 weeks rather than the 3 weeks. The patient was not recovered from "I still don't feel good" and outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Cough, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262) dose 1 via an unspecified route of administration on left arm on 26Jan2021 at single dose for covid-19 immunization. Time the vaccination was around noon. No prior vaccinations within 4 weeks. Medical history included ongoing blood pressure high. Concomitant medications included metoprolol 50mg once a day taken blood pressure from an unspecified start date ongoing. On 27Jan2021, Wednesday he started to feel pain in his arm which he knew was normal. But now he started to feel his temperature rise and usually takes his temperature every day as he works with the fire department. On 28Jan2021, Thursday he started to notice the rise in temperature. Then it was kind of within normal, but it was 98.4. However, this morning when he took his temperature it was 100 degrees. His usual temperature was between 97-98 degrees. He also had a cough last night and did not had the cough this morning. More, or less the main thing bothering him is the temperature. He has taken some Tylenol 500mg. He stated he does not know if he should be taking Tylenol. He was drinking more tea, coffee, and juice. The pain in his left arm was not immediate and was delayed. He does not know what time it started, but it was early in the day. He was coughing last night but he was not doing it on a consistent basis. Later he was doing it all day but did not know what time it started. He said as pretty much has subsided, no additional details provided. The patient underwent lab test which included body temperature resulted as 98.4 on 28Jan2021 and on 29Jan2021, body temperature resulted as 100. The clinical outcome of the event pain in arm and cough was recovering and the clinical outcome of the event rise in temperature was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hypotension, Pain
Clinical narrative: Soarness, low blood pressure and then death.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Organic erectile dysfunction
Clinical narrative: Since getting the shot I have had problems with getting an erection. The first week following the shot I got no erection whatsoever for 5 straight days. I thought it was just a side effect that would subside with time but it has persisted. I got an limp erection on the sixth day but only a limp one. I do not get my morning wood which I have had since I was about 12 or so. Please help
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Before the administration of Pfizer COVID vaccine it was diluted by one of the pharmacists on duty, however she did not dilute it with the correct amount of diluent. The proper dilution amount is 1.8 ml of diluent added to the vial, but it was discovered that the vial was only diluted with 0.8 ml. The error was discovered, after 3 doses had been administered. While determining the number of doses remaining in the vial it was discovered  that only 1 more dose remained instead of 3. This was caused by too little diluent being added resulting in each vaccine dose to be a higher concentration that what is recommended.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram abnormal, Hypoaesthesia, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: A few hours after vaccination, severe pain/numbness/tingling started in left arm.  Severe pain lasted several days.  Pain is now intermittent, sharp shooting, describes as needles.  Pain is often more severe at night, and interrupts sleep for hours.  About 10 days after vaccination, pain began in right arm as well.  Same pain/numbness/tingling.  Currently has symptoms in both arms.  Treatments: tylenol, ice, warm compresses, wrist braces, cortizone injection in left wrist, Meloxicam taken for 14 days in mid April.  All treatments with little to no effect on symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fall, Head injury, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: A 24 y.o female fainted and appeared to have a seizure. She loss consciousness and had muscle contractions.  The seizure was approximately 2 minutes. Patient did not hit her head or injury any part of her body. She was gradually dismounted from the chair and  placed on the floor. 1st B/P reading was 70/40, then 108/63. Patient after waking up was alert and oriented X3. Once EMS arrived she was assessed and encouraged to go to the hospital for follow up. Patient and father refused to go to the hospital. They verbalized "She has an important exam for school". Patient stated she will follow up after her exam.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: A 24 y.o female fainted and appeared to have a seizure. She loss consciousness and had muscle contractions.  The seizure was approximately 2 minutes. Patient did not hit her head or injury any part of her body. She was gradually dismounted from the chair and  placed on the floor. 1st B/P reading was 70/40, then 108/63. Patient after waking up was alert and oriented X3. Once EMS arrived she was assessed and encouraged to go to the hospital for follow up. Patient and father refused to go to the hospital. They verbalized "She has an important exam for school". Patient stated she will follow up after her exam.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: a bit dizzy; This is a spontaneous report from a contactable consumer. An elderly (65+ Years) non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unknown date in Jan2021, as single dose for COVID-19 immunization at Public Health Clinic. It was unknown if the patient received other vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested COVID post vaccination. The patient medical history and concomitant medications were not reported. On an unknown date in Jan2021, the patient felt good after the vaccine and decided to use treadmill but after just few minutes, she felt a bit dizzy and so she stopped and just rested in their chair for the rest of the evening. It was reported that the patient did not know if she was having sinus issues that day or if the dizziness was from the vaccine. No treatment was received in response to adverse event. The outcome of the event was reported as recovered.   Information on the Lot/Batch number has been requested.  Follow-up (16Apr2021): 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinalgia, Throat irritation, Vaccination site discomfort, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262) (Age at the time of vaccination 50), via an unspecified route of administration, administered in Arm Left on 27Jan2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included low thyroid. Concomitant medication included levothyroxine and liothyronine.  No Known allergies. Patient did not receive any other vaccine in four weeks. Patient was not Covid prior vaccination. Patient did not Covid tested post vaccination. On 27Jan2021 16:30 the patient experienced scratchy throat, slight cough, post nasal drip body aches, pinching/soreness in left arm at injection site . The outcome of events was recovered on unknown date in 2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age (Age: 52; Unit: unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had some pain on left arm, Thursday she experienced light headache, shivering, muscle ache all in 2021, took Ibuprofen and was feeling okay. Outcome of the events was recovered in 2021. Information about lot/batch number has been requested.