chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Pain in extremity
Clinical narrative: Bell's palsy; sore arm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0151), via an unspecified route of administration on 14Apr2021 at 11:00 (at the age of 39-year-old), as 2nd dose, single dose in right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8727), via an unspecified route of administration on 24Mar2021 as single dose in left arm for COVID-19 immunization. On 14Apr2021, after the second shot of vaccine, the patient experienced a sore arm. Patient felt sore arm for 2-3 days and then recovered completely. On 31May2021 Monday, morning around 07:00 or 08:00, the patient visited Emergency room because he thought he was having a stroke. But it was not stroke, and the ER told him he had Bell's Palsy. Patient thought it was a side effect and was given with medication for the event but was not able to afford it. The patient was not under any medications before the vaccine, but he continued medications for Bell's Palsy. Patient has not received any vaccines since the Pfizer vaccine. The clinical outcome of the event Bell's palsy was resolving, and the clinical outcome of the event sore arm was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (caregiver). A male patient (in his 60s) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number, Expiration date and NDC number: Unknown) via an unspecified route of administration in May2021 (about 3 weeks-1 month ago) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was completely healthy before the vaccine. On 08Jun2021 (post vaccination), patient's left side of the face was completely dropping and was later diagnosed as Bell's Palsy (this morning). The event led to hospitalization from 08Jun2021 to an unspecified date. The clinical outcome of the event was unknown. Investigation assessment: not provided.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Burning sensation, Dyspnoea, Erythema, Fatigue
Clinical narrative: lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Staphylococcal infection
Clinical narrative: Turned into MRSA infection; Severe allergic reaction; Little bit of a rash that started going all over body; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot# and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on unknown date, she had a severe allergic reaction to the vaccine. She has been out of work. It has been a 2-month struggle. Also stated that, it started out like a little bit of a rash that started going all over her body. From that point, it turned into Methicillin-resistant Staphylococcus aureus (MRSA) infection. She has needed so many medications. Her pharmacist let her know that she can get reimbursement for medical bills and lost wages, she wanted to know how to go about getting it. Caller stated there was a study that she was connected to now regarding how the vaccine affecting some people's skin. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood glucose abnormal, Blood glucose decreased, Blood glucose increased, Loss of consciousness
Clinical narrative: Bells palsy; I have severe low blood sugar where I pass out 3 or 4 times a month; I have severe low blood sugar where I pass out 3 or 4 times a month; After shot blood sugar went to 350! Fasting 220; I have severe low blood sugar where I pass out 3 or 4 times a month; This is a spontaneous report from a contactable consumer (reported for herself). A 50-years-old female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW6206/Batch number was not reported), via an unspecified route of administration administered in the left arm on 03Jun2021 (at the age of 50-years-old) as unknown, single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing, ischaemia from an unknown date and unknown if ongoing and diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received cafeine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month. After shot blood sugar went to 350, Fasting 220. She was always tested her blood daily for 10 plus years. She was still diabetic 3 months later and her blood sugar was extremely high. The reporter stated the events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose abnormal: 350 on an unspecified date, blood glucose decreased: 220 on an unspecified date. Therapeutic measures were taken for the events with diabetic medication. The events Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month assessed as serious (medically significant). The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Bells palsy; I have severe low blood sugar where I pass out 3 or 4 times a month; I have severe low blood sugar where I pass out 3 or 4 times a month; After shot blood sugar went to 350! Fasting 220; I have severe low blood sugar where I pass out 3 or 4 times a month; This is a spontaneous report from a contactable consumer (reported for herself). A 50-years-old female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW6206/Batch number was not reported), via an unspecified route of administration administered in the left arm on 03Jun2021 (at the age of 50-years-old) as unknown, single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing, ischaemia from an unknown date and unknown if ongoing and diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received cafeine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month. After shot blood sugar went to 350, Fasting 220. She was always tested her blood daily for 10 plus years. She was still diabetic 3 months later and her blood sugar was extremely high. The reporter stated the events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose abnormal: 350 on an unspecified date, blood glucose decreased: 220 on an unspecified date. Therapeutic measures were taken for the events with diabetic medication. The events Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month assessed as serious (medically significant). The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: I was tested positive for COVID on April 18; I was tested positive for COVID on April 18; I also had pneumonia after; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i was tested positive for covid on april 18 on 18Apr2021, i also had pneumonia after, if she choose to get the second dose of the vaccine does she need to restart the vaccination series all over again on unspecified date in 2021. Patient stated that when could she receive the Pfizer COVID-19 vaccine after catching the COVID infection. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Apr2021. The seriousness of the i was tested positive for covid on april 18 on 18Apr2021, i also had pneumonia after was medically significant. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Lyme disease, Toothache
Clinical narrative: triggered lyme disease; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; This is a spontaneous report from a contactable consumer or other non hcp.    A 72-year-old female patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, states he had the first shot and second one due this week however he had some family guests.  Caller added that his wife received first dose of pfizer covid vaccine 19May2021 and the shot triggered Lyme disease. She believes she had covid one year ago however it was never confirmed via testing. States her shot also triggered the same 'covid ' she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough. It took 2 weeks for her sense of smell and taste to come back after the covid vaccine shot. Also her teeth hurt a few days after the first shot for 2 days then it resolved. The outcome of the events lyme disease was unknown and tooth ache, cough, ansomia, aguesia was recovered.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fall, Haemorrhage, Potentiating drug interaction, Swelling
Clinical narrative: I fell down and I started to bleed and I had some swelling; I fell down and I started to bleed and I had some swelling; Two medications are overlapping; I fell down and I started to bleed and I had some swelling; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose single for covid-19 immunisation. Medical history included Haemophilia type A ongoing. The patient's concomitant medications included antihemophilic factor, human recombinant (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT), (Batch/Lot number was not reported) to an unspecified date, for factor viii deficiency.  It was reported that, Consumer stated, that took the second dose for the Pfizer Biotech dose, and second dose was at the last Sunday. However in the next few days had to take my own Pfizer antihemophilic factor recombinant because had a Haemophilia type A and just wanted to know if there is any complex with taking both the dose in short period of time because recently had to take the Antihemophilic Factor 8 because fell down and started to bleed and had some swelling and have not seen that much complex and she wanted to know two medications are overlapping or there is anything to worry. The out come of the events was unknown  Information about lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out twice on the 2nd day after vaccination; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Jun2021 (at the age of 14-year-old) as an unknown, single dose for COVID-19 immunisation. The patient's medical history was reported as none. No known allergies were reported. There were no concomitant medications or other medication within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 since the vaccination. It was reported that, on 08Jun2021, the patient passed out twice on the 2nd day after vaccination. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event. The outcome of the event was reported as resolved on an unspecified date in Jun2021.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Illness, Pain, Peripheral swelling, Pulmonary embolism
Clinical narrative: They thought I had pulmonary embolism, constant stress/I had to go into the hospital, they had me on a heart monitor as they thought I was dying; I am really sick; Have lesions from my head to my toe bilateral on my body like lesions and sores and holes; Have lesions from my head to my toe bilateral on my body like lesions and sores and holes; My legs were so swollen that I have like there were blisters forming in; My legs were so swollen that I have like there were blisters forming in; They thought I had pulmonary embolism, constant stress; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date  as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had pulmonary embolism, constant stress had to go into the hospital, had on a heart monitor as patient was dying, really sick, have lesions from head to toe bilateral on body like lesions and sores and holes and legs were so swollen that have like there were blisters forming in. Patient stated, patient just found online or whatever about adverse reaction to the Covid vaccine and patient have had one. Patient have been hospitalized over this (further hospitalization details were unknown), patient really sick, patient very sick and don't know what to do. It got patient hospitalized and they are trying to get patient better but patient not getting better. Patient have lesions, from head to toe bilateral on body like lesions and sores and holes and legs were so swollen that patient have like there were blisters forming in and it is really keeping out of patient way (not clear). Patient had to go into the hospital, they had patient on a heart monitor as they thought patient was dying. They thought patient had pulmonary embolism, constant stress (further clarification unknown) patient was very sick. Patient further stated, cannot we go where patient need to speak with? So, patient can get some help because patient do feel like dying. It can probably be anything, patient cannot even picture themself at the time of report. The outcome of the events was unknown.  Information about batch/Lot number Is requested.
Sex: U
Vaccine: COVID19
Symptoms: Skin lesion, Stress
Clinical narrative: They thought I had pulmonary embolism, constant stress/I had to go into the hospital, they had me on a heart monitor as they thought I was dying; I am really sick; Have lesions from my head to my toe bilateral on my body like lesions and sores and holes; Have lesions from my head to my toe bilateral on my body like lesions and sores and holes; My legs were so swollen that I have like there were blisters forming in; My legs were so swollen that I have like there were blisters forming in; They thought I had pulmonary embolism, constant stress; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date  as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had pulmonary embolism, constant stress had to go into the hospital, had on a heart monitor as patient was dying, really sick, have lesions from head to toe bilateral on body like lesions and sores and holes and legs were so swollen that have like there were blisters forming in. Patient stated, patient just found online or whatever about adverse reaction to the Covid vaccine and patient have had one. Patient have been hospitalized over this (further hospitalization details were unknown), patient really sick, patient very sick and don't know what to do. It got patient hospitalized and they are trying to get patient better but patient not getting better. Patient have lesions, from head to toe bilateral on body like lesions and sores and holes and legs were so swollen that patient have like there were blisters forming in and it is really keeping out of patient way (not clear). Patient had to go into the hospital, they had patient on a heart monitor as they thought patient was dying. They thought patient had pulmonary embolism, constant stress (further clarification unknown) patient was very sick. Patient further stated, cannot we go where patient need to speak with? So, patient can get some help because patient do feel like dying. It can probably be anything, patient cannot even picture themself at the time of report. The outcome of the events was unknown.  Information about batch/Lot number Is requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Achy; Stomach hurts; Nauseous; Lymph nodes under the armpit where he got got the shot is swollen; This is a spontaneous report from a contactable consumer (patient mother). A 15-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiration date was not reported), via an unspecified route of administration on 09Jun2021, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as 1st dose, single dose for COVID-19 immunization. Reporter was calling about the covid shot. Her son (patient) got his second dose yesterday (09Jun2021) and he woke up this morning (on10Jun2021) with a fever, achy, his stomach hurts and he's nauseous. His lymph nodes under the arm-pit where he got got the shot was swollen and she (reporter) has been reading through the information and its common to have these side effects she just would like to confirm and he was 15. Asking if have any advise for the next little bit or does it last longer than 24 hours. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymph node pain
Clinical narrative: Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after vaccination. Lump is tender to the touch and hurts when not touched. about the size of two golf ball; Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after vaccination. Lump is tender to the touch and hurts when not touched. about the size of two golf ball; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0172; expiration date: not reported) via an unspecified route of administration in left arm on 08Jun2021 at 14:45 (at the age of 41-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included allergy (unspecified) and mono about 7 months ago (unspecified). Other medications (concomitant) received by the patient in two weeks included birth control, venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported for all medications.Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172; expiration date: not reported) via an unspecified route of administration in right arm on 18May2021at 16:00 as first dose, single dose for COVID-19 immunization. On 09Jun2021, at 21:00, about 24 hours after, patient noticed lump in armpit area of left arm (arm in which vaccine was recently given). Lump was tender to the touch and hurts when not touched. It was about the size of two golf balls. No fever, no redness. Patient did not receive any treatment for the event. Outcome of the events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear congestion, Hypoacusis, Tinnitus
Clinical narrative: hearing loss; 2 weeks after the 1st dose she had ringing in her right ear. she experienced hearing loss with that day being the peak of the ringing; She started with ringing and fullness and muffled hearing in the right ear; 2 weeks after the 1st dose she had ringing in her right ear. She started with ringing and fullness and muffled hearing in the right ear; This is a spontaneous report from a contactable consumer. A 34-years-old female patient (wife) received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), dose 1 via an unspecified route of administration on 15Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. 2 weeks after the 1st dose, patient had ringing in her right ear. She started with ringing and fullness and muffled hearing in the right ear. and on 05May2021 she experienced hearing loss with that day being the peak of the ringing. Patient seen by 2 ENT providers. Therapeutic measures were taken as a result of events with high dose of steroids. Patient reported her hearing only recovered 85 percent in her right ear. The outcome of events was unknown.  Information on the lot/batch number has been requested
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Hypoaesthesia oral, Pain in jaw
Clinical narrative: The caller states he still has pain around the head and what not and underneath the caller's jaw; tongue:gave the numbing sensation not a tongue pain.; got a headache, an all around headache; What is more concerning is the tongue has tongue pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, in Arm Left on 09Jun2021 10:35 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunisation.  The patient medical history were not reported.concomitant medications included Repatha  for cholesterol, start and stop date not mentioned.09Jun2021, the patient had all round headache, tongue pain. The tongue pain lasted for an entire day. the tongue pain had subsided, when he woke in the morning. On an unspecified date, the patient felt like a distant pain around the tongue area. He had pain around the head and underneath the jaw. The pain around head and underneath jaw is not as severe as it was on 09JUN2021. The patient still had pain in his tongue. The patient had Repatha shot for cholesterol earlier in the year and it went straight to the tongue and gave the caller a numbing sensation not a tongue pain. The physician had advised not to take after that first time, suspecting tongue swelling.10 minutes after the vaccine the patient felt tongue discomfort and he had to wait 15 minutes after vaccine and he started to feel the pain in tongue and headache all round. Th patient second dose was scheduled in coming weeks and he was wondering whether he should take a the second dose. The patient also stated that the tongue pain had improved but still has like as if the caller has connected like a sinus kind of pain around head and it is connected with the tongue. The patient's headache started about an hour after receiving the first dose Pfizer Covid Vaccine.  The headaches are ongoing but are not as severe as 09Jun2021.  The outcome of the events headache and tongue pain was recovering and other events outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death, Malaise, Myocardial infarction
Clinical narrative: died, received the Pfizer vaccine; massive heart attack; she wasn't feeling well; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 74-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccine on an unspecified date and within one day, the patient stated she wasn't feeling well. It was reported that she had massive heart attack. The reporter reported that the patient died on an unspecified date and do not know what happened. The patient died on an unspecified date for an unspecified reason. It was unknown weather autopsy was performed or not. The outcome of she wasn't feeling well and massive heart attack was unknown.  Request Name: REQ-347122 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Has anyone reported Heart attack or stroke? Response: Spoke from attached document: In the all-enrolled population of (total N=43,448), the proportions of participants who reported at least 1 SAE during the time period from Dose 1 to the data cutoff date (November 14, 2020) were 0.6% in the BNT162b2 vaccine group and 0.5% in the placebo group. The most common SAEs in the vaccine group which were numerically higher than in the placebo group were acute myocardial infarction (0.02%), and cerebrovascular accident (0.02%), and in the placebo arm numerically higher than in the vaccine arm were pneumonia (0.03%), atrial fibrillation (0.02%), and syncope (0.02%). Occurrence of SAEs involving system organ classes and specific preferred terms were otherwise balanced between treatment groups, including no imbalance overall in cardiovascular serious adverse events. Offered to email for review, caller declined.    No follow-up attempts are possible, No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm was so sore after the first one; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he received first dose of vaccine and on an unspecified date, his left arm was so sore after the first one, but the soreness went away after a few days. It was reported that the patient received his second dose on 07Jun2021. The outcome of the event was reported as resolved on an unspecified date.  Information on lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inflammation, Rash
Clinical narrative: I am experiencing herpes zoster reactivation/ shingles; Right side of my face is inflamed with shingles rash; Right side of my face is inflamed with shingles rash; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EW0171: Expiration date: was not reported), via an unspecified route of administration in left arm on 12May2021 15:00 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previous vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EWO162: Expiration date: was not reported), via an unspecified route of administration in left arm on 21Apr2021 at 17:00 as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received medication MULTI VITAMIN within two weeks of vaccination. On 06Jun2021 (with in four weeks), I am experiencing herpes zoster reactivation/ shingles, Right side of my face is inflamed with shingles rash, the patient received treatment included valacyclovir (x3 10days) & amoxicillin (x3 7days) for the events. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: left side facial paralysis/left half of her face became paralyzed; numbness on the left side part of her face; her tongue is still numb; cannot blink her left eye; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route on 26May2021 (at the age of 37-years) at left shoulder as single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179), via an unspecified route on 05May2021 as single dose in the left arm for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not took any other products. On 07Jun2021, the patient experienced left side facial paralysis/ left half of her face became paralyzed which was facial paralyzed. It started to have numbness on the left side part of her face and it already went out since yesterday, but her tongue was still numb. She has been experiencing numbness but not painful. She also cannot blink her left eye. Patient stated that numbness went away but the look got worse and sometimes feels numbness but not all the time. Patient stated that she started drinking B complex vitamins yesterday. She wanted to know if this was a recorded side effect of the vaccine and if she needs to see a doctor for treatment. Patient stated that she just searching online probable connection to Pfizer and facial paralyzed and saw there were some studies that connected the two. The patient did not went to Emergency Room. Patient stated she just had a phone consultation from her country it was just a virtual consultation to a doctor, but she did not go to a doctor here. Patient stated she decided to get it to be protected since she has never been infected with COVID and when it was available, she got it to feel safe. The outcome of events was left side facial paralysis and her tongue was still numb, cannot blink her left eye was not recovered, numbness on the left side part of her face was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache about 2 hours post injection; pain spread throughout her entire body; This is a spontaneous report from a contactable other non-health care professional (nurse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient stated that she had recovered from contracting COVID-19 a few months prior. She began having a headache about 2 hours post injection this pain spread throughout her entire body. She presented at the Emergency Room later. She was treated by an  physician (Released after a few days. Event took place after use of product. The adverse events resulted in emergency room visit. The clinical outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I received both Pfizer Covid vaccines and I tested positive for covid yesterday after experiencing symptoms the last couple of days; I tested positive for covid yesterday; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received second 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, as a 2nd dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Patient historical vaccine included 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, as a 1st dose single dose for COVID-19 immunisation. On an unknown date, the patient stated that I received both Pfizer Covid vaccines and I tested positive for covid yesterday after experiencing symptoms the last couple of days. I would like to speak to someone to see if I should be reporting my positive result as this is a new vaccine. Outcome of the event was reported as unknown.  Information about batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac stress test, Catheterisation cardiac, Echocardiogram
Clinical narrative: Heart Problems; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733, Expiration date: Unknown), via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 68-year-old) as first dose, single dose; second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733, Expiration date: Unknown), via an unspecified route of administration in the left arm on an unknown date (at the age of 68-year-old) as single dose for COVID-19 immunisation in doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included AMOUR at 90 MG taken for an unspecified indication from unknown date and unknown if ongoing. The patient previously took penicillin b, sulfur; all from unknown dates to unknown dates for unknown indications. The patient experienced heart problems now (at the time of reporting) seeing cardiologists on 07May2021. Device date: 11Jun2021. The event resulted to physician's office visit. The events were assessed as serious (medically significant). The patient was received an unknown treatment for event. The patient underwent tab test and procedures included nuclear stress test, echocardiogram, heart cath (Cardiac catheterization) on an unknown date with unknown result. The outcome of the event was reported as reported as not resolved.  Follow up attempts are needed; information about lot/batch number has been requested as both lot/batch numbers are same and further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Lymphadenopathy
Clinical narrative: The vaccine is causing Bell's palsy; The first shot actually gave me, every lymph node has swollen in my body and I ended up in the ER; there was a problem and then ended up getting Bell's palsy 2 weeks later; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 19Mar2021 13:00 (Lot number: EN6207) on right arm as single dose for COVID-19 immunisation. The patient medical history included plaque around the heart, nothing else and Covid-19 on 11Feb2021. Prior Vaccination (4 weeks prior) no other vaccination. Concomitant medications included Nadolol, Trazodone, Atorvastatin, Cyclobenzaprine from an unspecified date to unspecified date and unknown indication. It was reported that that the vaccine was causing bells palsy 2 weeks later from first shot. The first shot gave him, every lymph node has swollen in his body and he ended up in the ER; he thought he have a heart attack and that was the first time there was a problem and then ended up getting bells palsy. Due to this patient was hospitalized (tried to think it was Monday 2 weeks ago, 3 weeks ago Monday). In the hospital had blood work and found out that he has bells palsy so, three Monday back from this last Monday he thought this was the Monday right before the Memorial day (further not clarified hence not captured in tab). The patient was treated with Prednisone and the Meclizine. The outcome of the events were unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Nucleic acid test, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patients mother) via medical information team.   A 17-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown) via an unspecified route of administration on 20Apr2021 (age at vaccination 17-year-old) as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown) via an unspecified route of administration on 13May2021 (age at vaccination 17-year-old) as single dose for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. Patient did not receive any other vaccines on same day of covid vaccine. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Patient tested positive for Covid 19 on 03Jun2021. Reporter said her daughter has no symptoms and no one in their home was sick. States her daughter has not been around anyone who was sick that they know of. Caller stated she was trying to find out if this was possibly a false positive test and asked was it still possible to get Covid 19 after having both doses of the vaccine. Adverse event not resulted into emergency room visit and physician office visit. The patient underwent lab tests and procedures which included nucleic acid test: negative on 04Jun2021 the nucleic acid amplification test (NAAT) test results were negative, polymerase chain reaction: positive on 03Jun2021, sars-cov-2 test: positive on 03Jun2021. The outcome of event was unknown.  Information on the batch/lot number has been requested.