chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Burning/burning all over from head to toe under her skin; Itching; Hands and feet got really red and hot; Hands and feet got really red and hot; Thrush; Scalp is itchy; Eyes hurt really bad, they are dry, hurts to blink; Eyes hurt really bad, they are dry, hurts to blink; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 09:00 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included mold allergy, grass allergy, allergy to trees, allergy to cats, Allergy to dogs, penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm right on 10Mar2021 at 19:00 as single dose for covid-19 immunisation and did not experience any event. The patient previously took morphine and experienced allergy. Patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 31MAR2021 and two weeks ago she started having burning all over from head to toe under her skin first stated with itching, turned to burning on her hand and feet and move to all over. She says the burning started in the morning 4 days ago. She was not sure what time of day her hands and feet got really red and hot. She says it started probably about a week ago. She stated that the itching began 2 weeks ago yesterday. She started itching, burning, then it was burning for 4 to 5 days. She says the itching began in the morning. She said her scalp being itchy started 2 weeks ago in the morning. She said she had thrush maybe 4 days ago and it started around lunch time. She said that her eyes hurting really bad, being dry, and hurting to blink started yesterday, 17May2021, in the morning. She stated she went to the emergency room this morning, she has been to an allergy doctor, her primary doctor, and all 3 feels that, because they eliminated everything else, they think it has to be the vaccine. She says nothing happened until she had that. She stated that the physicians asked if it happened to anyone else. The caller says normally they happen a lot quicker than hers and she can't think of anything else it could be; they did a test for literally everything. She would like to know if there have been reports of delayed reactions. The outcome of the event Itching was unknown while the outcome of all other events was not recovered.  Information about batch/lot number has been obtained. Further information is expected.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Candida infection, Dry eye, Erythema, Eye pain
Clinical narrative: Burning/burning all over from head to toe under her skin; Itching; Hands and feet got really red and hot; Hands and feet got really red and hot; Thrush; Scalp is itchy; Eyes hurt really bad, they are dry, hurts to blink; Eyes hurt really bad, they are dry, hurts to blink; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 09:00 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included mold allergy, grass allergy, allergy to trees, allergy to cats, Allergy to dogs, penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm right on 10Mar2021 at 19:00 as single dose for covid-19 immunisation and did not experience any event. The patient previously took morphine and experienced allergy. Patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 31MAR2021 and two weeks ago she started having burning all over from head to toe under her skin first stated with itching, turned to burning on her hand and feet and move to all over. She says the burning started in the morning 4 days ago. She was not sure what time of day her hands and feet got really red and hot. She says it started probably about a week ago. She stated that the itching began 2 weeks ago yesterday. She started itching, burning, then it was burning for 4 to 5 days. She says the itching began in the morning. She said her scalp being itchy started 2 weeks ago in the morning. She said she had thrush maybe 4 days ago and it started around lunch time. She said that her eyes hurting really bad, being dry, and hurting to blink started yesterday, 17May2021, in the morning. She stated she went to the emergency room this morning, she has been to an allergy doctor, her primary doctor, and all 3 feels that, because they eliminated everything else, they think it has to be the vaccine. She says nothing happened until she had that. She stated that the physicians asked if it happened to anyone else. The caller says normally they happen a lot quicker than hers and she can't think of anything else it could be; they did a test for literally everything. She would like to know if there have been reports of delayed reactions. The outcome of the event Itching was unknown while the outcome of all other events was not recovered.  Information about batch/lot number has been obtained. Further information is expected.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: Burning/burning all over from head to toe under her skin; Itching; Hands and feet got really red and hot; Hands and feet got really red and hot; Thrush; Scalp is itchy; Eyes hurt really bad, they are dry, hurts to blink; Eyes hurt really bad, they are dry, hurts to blink; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 09:00 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included mold allergy, grass allergy, allergy to trees, allergy to cats, Allergy to dogs, penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm right on 10Mar2021 at 19:00 as single dose for covid-19 immunisation and did not experience any event. The patient previously took morphine and experienced allergy. Patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 31MAR2021 and two weeks ago she started having burning all over from head to toe under her skin first stated with itching, turned to burning on her hand and feet and move to all over. She says the burning started in the morning 4 days ago. She was not sure what time of day her hands and feet got really red and hot. She says it started probably about a week ago. She stated that the itching began 2 weeks ago yesterday. She started itching, burning, then it was burning for 4 to 5 days. She says the itching began in the morning. She said her scalp being itchy started 2 weeks ago in the morning. She said she had thrush maybe 4 days ago and it started around lunch time. She said that her eyes hurting really bad, being dry, and hurting to blink started yesterday, 17May2021, in the morning. She stated she went to the emergency room this morning, she has been to an allergy doctor, her primary doctor, and all 3 feels that, because they eliminated everything else, they think it has to be the vaccine. She says nothing happened until she had that. She stated that the physicians asked if it happened to anyone else. The caller says normally they happen a lot quicker than hers and she can't think of anything else it could be; they did a test for literally everything. She would like to know if there have been reports of delayed reactions. The outcome of the event Itching was unknown while the outcome of all other events was not recovered.  Information about batch/lot number has been obtained. Further information is expected.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dyspnoea, Erythema, Eye swelling
Clinical narrative: fast heart beat; taste the medication; whole face was swollen including her eyes; whole face was swollen including her eyes; face was itchy and red; face was itchy and red; had hives across her face and eyes; pain in her shoulder and arm; pain in her shoulder and arm; felt tired for a week.; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 04May2021 (age at vaccination was 68 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included heart murmur since an unknown date in 2012 and ongoing, brain tumor since an unknown date and allergic to radioactive contrast dye. Concomitant medications were not reported. On 04May2021, five minutes after getting the vaccine patient experienced a fast heartbeat and could taste the medication in her mouth. She was given water to drink and that helped with the taste. Four to five days later on an unknown date in May2021, her whole face was swollen including her eyes. Her face was itchy and red. She took Benadryl and Calamine lotion which helped with swelling. Her face was still itching and red. She had hives across her face and eyes. She had the usual side effects of pain in her shoulder and arm. She felt tired for a week. Caller was asking if she has to take the second dose? She was scared to take it. She took Benadryl and Calamine lotion which helped with swelling. The outcome of events fast heartbeat had hives across her face and eyes and pain in her shoulder and arm was unknown, for events taste the medication, whole face was swollen including her eyes and felt tired for a week was recovered on an unknown date in May2021 and for event face was itchy and red was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate increased, Magnetic resonance imaging, Myalgia, Pain in extremity
Clinical narrative: fast heart beat; taste the medication; whole face was swollen including her eyes; whole face was swollen including her eyes; face was itchy and red; face was itchy and red; had hives across her face and eyes; pain in her shoulder and arm; pain in her shoulder and arm; felt tired for a week.; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 04May2021 (age at vaccination was 68 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included heart murmur since an unknown date in 2012 and ongoing, brain tumor since an unknown date and allergic to radioactive contrast dye. Concomitant medications were not reported. On 04May2021, five minutes after getting the vaccine patient experienced a fast heartbeat and could taste the medication in her mouth. She was given water to drink and that helped with the taste. Four to five days later on an unknown date in May2021, her whole face was swollen including her eyes. Her face was itchy and red. She took Benadryl and Calamine lotion which helped with swelling. Her face was still itching and red. She had hives across her face and eyes. She had the usual side effects of pain in her shoulder and arm. She felt tired for a week. Caller was asking if she has to take the second dose? She was scared to take it. She took Benadryl and Calamine lotion which helped with swelling. The outcome of events fast heartbeat had hives across her face and eyes and pain in her shoulder and arm was unknown, for events taste the medication, whole face was swollen including her eyes and felt tired for a week was recovered on an unknown date in May2021 and for event face was itchy and red was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Somnolence, Swelling face, Taste disorder
Clinical narrative: fast heart beat; taste the medication; whole face was swollen including her eyes; whole face was swollen including her eyes; face was itchy and red; face was itchy and red; had hives across her face and eyes; pain in her shoulder and arm; pain in her shoulder and arm; felt tired for a week.; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 04May2021 (age at vaccination was 68 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included heart murmur since an unknown date in 2012 and ongoing, brain tumor since an unknown date and allergic to radioactive contrast dye. Concomitant medications were not reported. On 04May2021, five minutes after getting the vaccine patient experienced a fast heartbeat and could taste the medication in her mouth. She was given water to drink and that helped with the taste. Four to five days later on an unknown date in May2021, her whole face was swollen including her eyes. Her face was itchy and red. She took Benadryl and Calamine lotion which helped with swelling. Her face was still itching and red. She had hives across her face and eyes. She had the usual side effects of pain in her shoulder and arm. She felt tired for a week. Caller was asking if she has to take the second dose? She was scared to take it. She took Benadryl and Calamine lotion which helped with swelling. The outcome of events fast heartbeat had hives across her face and eyes and pain in her shoulder and arm was unknown, for events taste the medication, whole face was swollen including her eyes and felt tired for a week was recovered on an unknown date in May2021 and for event face was itchy and red was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: fast heart beat; taste the medication; whole face was swollen including her eyes; whole face was swollen including her eyes; face was itchy and red; face was itchy and red; had hives across her face and eyes; pain in her shoulder and arm; pain in her shoulder and arm; felt tired for a week.; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 04May2021 (age at vaccination was 68 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included heart murmur since an unknown date in 2012 and ongoing, brain tumor since an unknown date and allergic to radioactive contrast dye. Concomitant medications were not reported. On 04May2021, five minutes after getting the vaccine patient experienced a fast heartbeat and could taste the medication in her mouth. She was given water to drink and that helped with the taste. Four to five days later on an unknown date in May2021, her whole face was swollen including her eyes. Her face was itchy and red. She took Benadryl and Calamine lotion which helped with swelling. Her face was still itching and red. She had hives across her face and eyes. She had the usual side effects of pain in her shoulder and arm. She felt tired for a week. Caller was asking if she has to take the second dose? She was scared to take it. She took Benadryl and Calamine lotion which helped with swelling. The outcome of events fast heartbeat had hives across her face and eyes and pain in her shoulder and arm was unknown, for events taste the medication, whole face was swollen including her eyes and felt tired for a week was recovered on an unknown date in May2021 and for event face was itchy and red was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Eye swelling, Fatigue, Heart rate increased
Clinical narrative: fast heart beat; taste the medication; whole face was swollen including her eyes; whole face was swollen including her eyes; face was itchy and red; face was itchy and red; had hives across her face and eyes; pain in her shoulder and arm; pain in her shoulder and arm; felt tired for a week.; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 04May2021 (age at vaccination was 68 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included heart murmur since an unknown date in 2012 and ongoing, brain tumor since an unknown date and allergic to radioactive contrast dye. Concomitant medications were not reported. On 04May2021, five minutes after getting the vaccine patient experienced a fast heartbeat and could taste the medication in her mouth. She was given water to drink and that helped with the taste. Four to five days later on an unknown date in May2021, her whole face was swollen including her eyes. Her face was itchy and red. She took Benadryl and Calamine lotion which helped with swelling. Her face was still itching and red. She had hives across her face and eyes. She had the usual side effects of pain in her shoulder and arm. She felt tired for a week. Caller was asking if she has to take the second dose? She was scared to take it. She took Benadryl and Calamine lotion which helped with swelling. The outcome of events fast heartbeat had hives across her face and eyes and pain in her shoulder and arm was unknown, for events taste the medication, whole face was swollen including her eyes and felt tired for a week was recovered on an unknown date in May2021 and for event face was itchy and red was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product taste abnormal, Pruritus, Swelling face, Urticaria
Clinical narrative: fast heart beat; taste the medication; whole face was swollen including her eyes; whole face was swollen including her eyes; face was itchy and red; face was itchy and red; had hives across her face and eyes; pain in her shoulder and arm; pain in her shoulder and arm; felt tired for a week.; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 04May2021 (age at vaccination was 68 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included heart murmur since an unknown date in 2012 and ongoing, brain tumor since an unknown date and allergic to radioactive contrast dye. Concomitant medications were not reported. On 04May2021, five minutes after getting the vaccine patient experienced a fast heartbeat and could taste the medication in her mouth. She was given water to drink and that helped with the taste. Four to five days later on an unknown date in May2021, her whole face was swollen including her eyes. Her face was itchy and red. She took Benadryl and Calamine lotion which helped with swelling. Her face was still itching and red. She had hives across her face and eyes. She had the usual side effects of pain in her shoulder and arm. She felt tired for a week. Caller was asking if she has to take the second dose? She was scared to take it. She took Benadryl and Calamine lotion which helped with swelling. The outcome of events fast heartbeat had hives across her face and eyes and pain in her shoulder and arm was unknown, for events taste the medication, whole face was swollen including her eyes and felt tired for a week was recovered on an unknown date in May2021 and for event face was itchy and red was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Limb discomfort, Pain in extremity, Swelling
Clinical narrative: swelling on my left hand and armpit; lump in his left armpit same arm he got the vaccine; He had a little fever; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in arm left on 02May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 11Apr2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. On 02May2021, the patient experienced a little fever after the second dose vaccine. On 03May2021, at 11.00 (reported at yesterday at about 11.00), the patient noticed about a 1 cm or more lump in his left armpit same arm he got the vaccine. He had swelling he took it on his left side and he had swelling on his left hand and armpit. It was round and painful but not hard. The patient asked could this was due to the vaccine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site swelling
Clinical narrative: swelling on my left hand and armpit; lump in his left armpit same arm he got the vaccine; He had a little fever; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in arm left on 02May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 11Apr2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. On 02May2021, the patient experienced a little fever after the second dose vaccine. On 03May2021, at 11.00 (reported at yesterday at about 11.00), the patient noticed about a 1 cm or more lump in his left armpit same arm he got the vaccine. He had swelling he took it on his left side and he had swelling on his left hand and armpit. It was round and painful but not hard. The patient asked could this was due to the vaccine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Mydriasis, Pallor, Syncope
Clinical narrative: passed out and kept going in and out of consciousness; passed out and kept going in and out of consciousness; blood pressure plummeted; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA6780), via an unspecified route of administration in left arm on 31Jul2021 14:14 (at the age of 16-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient was not pregnant. The patient experienced passed out and kept going in and out of consciousness and blood pressure plummeted on 31Jul2021 14:15. The events resulted in emergency room/department or urgent care. Patient was treated with two bags of electrolytes; heart monitored. It was reported that a minute or so after the first vaccination, patient passed out and kept going in and out of consciousness. After seeing that her blood pressure plummeted, the ambulance transported her to hospital where she remained for a few hours until stabilized. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved on the same day.  Patient wanted to be fully vaccinated, so when it was time for the second shot, she had it administered at hospital while she was lying down. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0202), via an unspecified route of administration in left arm on 25Aug2021 09:00 as dose 2, single for COVID-19 immunization. She did not have an adverse reaction to the second shot.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Loss of consciousness
Clinical narrative: passed out and kept going in and out of consciousness; passed out and kept going in and out of consciousness; blood pressure plummeted; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA6780), via an unspecified route of administration in left arm on 31Jul2021 14:14 (at the age of 16-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient was not pregnant. The patient experienced passed out and kept going in and out of consciousness and blood pressure plummeted on 31Jul2021 14:15. The events resulted in emergency room/department or urgent care. Patient was treated with two bags of electrolytes; heart monitored. It was reported that a minute or so after the first vaccination, patient passed out and kept going in and out of consciousness. After seeing that her blood pressure plummeted, the ambulance transported her to hospital where she remained for a few hours until stabilized. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved on the same day.  Patient wanted to be fully vaccinated, so when it was time for the second shot, she had it administered at hospital while she was lying down. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0202), via an unspecified route of administration in left arm on 25Aug2021 09:00 as dose 2, single for COVID-19 immunization. She did not have an adverse reaction to the second shot.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on Forearm; Itching on hands and feet; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 21May2021 at 10:30 (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 07May2021 (at the age of 20-year-old) as dose 1, single for COVID-19 immunization. None of the family medical history relevant to events were reported. Patient did not have events following prior vaccinations. 3 to 4 hours after second dose, the patient experienced itching on hands and feet on 21May2021 at 14:00 and patient was still getting itchy. Reporter stated she got a rash once on her forearm on 22May2021, but it went away in 30 minutes and she had no rash anywhere else, but she was still itchy. Reporter stated she wanted to report this, and she wanted to know if there is anything she could do about it (reporter's question). Patient did not receive any other products. None of the additional vaccines administered on same date of the Pfizer Suspect. Events did not require emergency room or physician office visit. Patient did not have any prior vaccinations within 4 weeks and did not underwent for relevant tests. Treatment included Benadryl for the events. Outcome of event itching on hands and feet was not recovered while rash on forearm was recovered on 22May2021.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Salivary hypersecretion, Swollen tongue, Urticaria
Clinical narrative: feeling tired; Tongue swelling; Inability to talk; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 45-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: FC3183; Expiration date was not reported), intramuscularly administered in the arm on 01Sep2021 at 18:55 (however, it was also reported as at approximately 18:30, possibly discrepant) (at the age of 45-years-old) as dose 2, single for COVID-19 immunization at a pharmacy or drugstore. Medical history included Guillian Barre syndrome symptoms & possible multi sclerosis from 2006 to sometime before 2010, uterine tumor/Fibroid (removed with surgery Jan2021) from 2013 to Jan2021, uterine tumor/fibroid removal (surgery) on Jan2021; and allergic reaction to galidinium from an unknown date and unknown if ongoing. The patient has no concomitant medications. The patient was previously administered with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: FC3182; Expiration date was not reported), intramuscularly administered in the arm on 11Aug2021 at approximately 18:30 as dose 1, single for COVID-19 immunization experienced small rash on right side below arm pit, itchy sinus, itchy ears, itchy throat, throat swelling, sore throat, tongue swelling, sneezing, watery eyes, ear pain, runny nose, feeling tired, slow and long breaths, felt warm without a fever, face turned purple in the morning after waking up, legs locked in place and could not walk or move legs for under one minute, headache, sored legs, had the runs all day, fascicullations around left knee, congestion, muscle spasms on both legs and back, muscle spasms from knees to feet during the evening and hives. The patient previously took cefalexin monohydrate (KEFLEX) on 2017 and experienced allergic reaction. The patient had no prior vaccinations within 4 weeks. The patient experienced tongue swelling and inability to talk on 01Sept2021 at approximately 07:10 PM. The patient was given with BENADRYL at first but was not effective, then was given with Epinephrine Pen injection (EPIPEN). The patient also experienced severe allergic reaction on an unspecified date in 2021 with EPIPEN as treatment. From 16Sept2021 to 19Sept2021, the patient experienced tongue swelling and feeling tired. The reporter assessed the events tongue swelling and inability to talk as serious, life-threatening, persistent/ significant disability/incapacity and important medical event. The patient recovered from the events tongue swelling, inability to talk and feeling tired on 19Sep2021 and recovered from severe allergic reaction on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypersensitivity, Mutism, Swollen tongue
Clinical narrative: feeling tired; Tongue swelling; Inability to talk; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 45-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: FC3183; Expiration date was not reported), intramuscularly administered in the arm on 01Sep2021 at 18:55 (however, it was also reported as at approximately 18:30, possibly discrepant) (at the age of 45-years-old) as dose 2, single for COVID-19 immunization at a pharmacy or drugstore. Medical history included Guillian Barre syndrome symptoms & possible multi sclerosis from 2006 to sometime before 2010, uterine tumor/Fibroid (removed with surgery Jan2021) from 2013 to Jan2021, uterine tumor/fibroid removal (surgery) on Jan2021; and allergic reaction to galidinium from an unknown date and unknown if ongoing. The patient has no concomitant medications. The patient was previously administered with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: FC3182; Expiration date was not reported), intramuscularly administered in the arm on 11Aug2021 at approximately 18:30 as dose 1, single for COVID-19 immunization experienced small rash on right side below arm pit, itchy sinus, itchy ears, itchy throat, throat swelling, sore throat, tongue swelling, sneezing, watery eyes, ear pain, runny nose, feeling tired, slow and long breaths, felt warm without a fever, face turned purple in the morning after waking up, legs locked in place and could not walk or move legs for under one minute, headache, sored legs, had the runs all day, fascicullations around left knee, congestion, muscle spasms on both legs and back, muscle spasms from knees to feet during the evening and hives. The patient previously took cefalexin monohydrate (KEFLEX) on 2017 and experienced allergic reaction. The patient had no prior vaccinations within 4 weeks. The patient experienced tongue swelling and inability to talk on 01Sept2021 at approximately 07:10 PM. The patient was given with BENADRYL at first but was not effective, then was given with Epinephrine Pen injection (EPIPEN). The patient also experienced severe allergic reaction on an unspecified date in 2021 with EPIPEN as treatment. From 16Sept2021 to 19Sept2021, the patient experienced tongue swelling and feeling tired. The reporter assessed the events tongue swelling and inability to talk as serious, life-threatening, persistent/ significant disability/incapacity and important medical event. The patient recovered from the events tongue swelling, inability to talk and feeling tired on 19Sep2021 and recovered from severe allergic reaction on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Antibody test, Asymptomatic COVID-19, Chronic lymphocytic leukaemia, Diabetes mellitus, Drug ineffective
Clinical narrative: his INR level during the Prothrombin time test became lower; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown), via an unspecified route of administration, on 15Mar2021 as dose 2, single for Covid-19 immunization and Warfarin from an unspecified date as an anticoagulant. First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown) via an unspecified route of administration, unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to know the reason why his international normalized ratio (INR) level during the Prothrombin time test became lower. Caller was unable to provide the date he received the 1st dose. The patient underwent lab tests and procedures which included prothrombin time: lower on an unspecified date. The action taken in response to the event for warfarin was unknown. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: his INR level during the Prothrombin time test became lower; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown), via an unspecified route of administration, on 15Mar2021 as dose 2, single for Covid-19 immunization and Warfarin from an unspecified date as an anticoagulant. First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown) via an unspecified route of administration, unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to know the reason why his international normalized ratio (INR) level during the Prothrombin time test became lower. Caller was unable to provide the date he received the 1st dose. The patient underwent lab tests and procedures which included prothrombin time: lower on an unspecified date. The action taken in response to the event for warfarin was unknown. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: International normalised ratio decreased
Clinical narrative: his INR level during the Prothrombin time test became lower; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown), via an unspecified route of administration, on 15Mar2021 as dose 2, single for Covid-19 immunization and Warfarin from an unspecified date as an anticoagulant. First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown) via an unspecified route of administration, unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to know the reason why his international normalized ratio (INR) level during the Prothrombin time test became lower. Caller was unable to provide the date he received the 1st dose. The patient underwent lab tests and procedures which included prothrombin time: lower on an unspecified date. The action taken in response to the event for warfarin was unknown. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: itchy eyes started from eyebrows; doesn't feel good; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 69-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14Apr2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in Apr2021, after a week, the patient developed itchy eyes that started from eyebrows. The patient had sought consultation to ophthalmologist on 28Apr2021 or 29Apr2021 and was advised that it might be an allergic reaction to something. As the days went by it became worst. She wants to know if itchiness of her eyes is an allergic reaction from the COVID 19 vaccine that she had. she doesn't feel good and just wants to know if it's a reaction to the vaccine or not. The patient was seen by her primary care doctor and was prescribed cream (unspecified) for itchiness. Therapeutic measures were taken as a result of the itchy eyes started from eyebrows. Outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Malaise
Clinical narrative: itchy eyes started from eyebrows; doesn't feel good; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 69-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14Apr2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in Apr2021, after a week, the patient developed itchy eyes that started from eyebrows. The patient had sought consultation to ophthalmologist on 28Apr2021 or 29Apr2021 and was advised that it might be an allergic reaction to something. As the days went by it became worst. She wants to know if itchiness of her eyes is an allergic reaction from the COVID 19 vaccine that she had. she doesn't feel good and just wants to know if it's a reaction to the vaccine or not. The patient was seen by her primary care doctor and was prescribed cream (unspecified) for itchiness. Therapeutic measures were taken as a result of the itchy eyes started from eyebrows. Outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip erythema, Rash papular, Skin warm
Clinical narrative: TURNED BRIGHT RED FROM HEAD ALL THE WAY DOWN; LIPS STARTED SWELLING; BLISTERS ON OUTSIDE OF LIPS; BLISTERS ON TONGUE; BODY WENT REALLY HOT (TEMPERATURE WAS LOW GRADE TEMPERATURE OF 99 F); HIVES ON OUTSIDE OF LIPS/HIVES ON TONGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced turned bright red from head all the way down. On 02-APR-2021, the patient experienced lips started swelling. On 02-APR-2021, the patient experienced blisters on outside of lips. On 02-APR-2021, the patient experienced blisters on tongue. On 02-APR-2021, the patient experienced body went really hot (temperature was low grade temperature of 99 f). On 02-APR-2021, the patient experienced hives on outside of lips/hives on tongue. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from turned bright red from head all the way down on 05-APR-2021, and lips started swelling, blisters on outside of lips, blisters on tongue, body went really hot (temperature was low grade temperature of 99 f), and hives on outside of lips/hives on tongue on 04-APR-2021. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Erythema, Lip blister, Lip swelling
Clinical narrative: TURNED BRIGHT RED FROM HEAD ALL THE WAY DOWN; LIPS STARTED SWELLING; BLISTERS ON OUTSIDE OF LIPS; BLISTERS ON TONGUE; BODY WENT REALLY HOT (TEMPERATURE WAS LOW GRADE TEMPERATURE OF 99 F); HIVES ON OUTSIDE OF LIPS/HIVES ON TONGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced turned bright red from head all the way down. On 02-APR-2021, the patient experienced lips started swelling. On 02-APR-2021, the patient experienced blisters on outside of lips. On 02-APR-2021, the patient experienced blisters on tongue. On 02-APR-2021, the patient experienced body went really hot (temperature was low grade temperature of 99 f). On 02-APR-2021, the patient experienced hives on outside of lips/hives on tongue. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from turned bright red from head all the way down on 05-APR-2021, and lips started swelling, blisters on outside of lips, blisters on tongue, body went really hot (temperature was low grade temperature of 99 f), and hives on outside of lips/hives on tongue on 04-APR-2021. This report was non-serious.