chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: She also had the bleeding under control; She also reported having a period for a week when she has been in menopause for 10 years; She has been having on and off fatigue; Nausea; Headache; Bloating; This is a spontaneous report from a contactable consumer (reported for herself). A 59-years-old female patient received second 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 25May2021 (at the age of 59-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 04May2021 (at the age of 59-years-old) as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient reported that when it started to go downhill. She had been having on and off fatigue, nausea, headache and bloating. She experiences these for 3-4 days out of every week. She has self-medicated with Aspirin and Tylenol. She also reported having a period for a week when she had been in menopause for 10 years. She also had the bleeding under control as she also self-medicated as she cannot get a hold of her gynecologist and it has been frustrating. it has been 6 weeks. The patient is asking whether if this is normal and how long will she experience these. She also added that she doesn't have a primary health care physician and only a gynecologist. Therapeutic measures were taken as a result of events with Aspirin and Tylenol. The event the She also had the bleeding under control was assessed as serious (medically significant). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: with no health conditions died after the vaccine; This is a spontaneous report from a contactable consumer (patient's friend). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A friend's 25 year old daughter (the patient) with no health conditions died after the vaccine. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: with no health conditions died after the vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; This is a spontaneous report from a contactable consumer (patient). A 35 years old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route, administered in Arm Left on 15Jun2021 at 14:30 (age of 35 years old at vaccination) as 1st dose, single for COVID-19 immunization. The patient's medical history included Covid-19. The patient's concomitant medications included Vitamin (unspecified). Vaccination facility was reported as Pharmacy or drug store. Prior to vaccination the patient was diagnosed with Covid-19. The patient had not received any other vaccine prior 4 weeks to Covid-19 vaccine. On 15Jun2021 at 16:30, the patient experienced Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99 percent of "normal side effects". Since vaccination the patient was not tested for Covid-19 infection. The patient had not received any treatment medications for the resulted events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, SARS-CoV-2 test
Clinical narrative: Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; This is a spontaneous report from a contactable consumer (patient). A 35 years old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route, administered in Arm Left on 15Jun2021 at 14:30 (age of 35 years old at vaccination) as 1st dose, single for COVID-19 immunization. The patient's medical history included Covid-19. The patient's concomitant medications included Vitamin (unspecified). Vaccination facility was reported as Pharmacy or drug store. Prior to vaccination the patient was diagnosed with Covid-19. The patient had not received any other vaccine prior 4 weeks to Covid-19 vaccine. On 15Jun2021 at 16:30, the patient experienced Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99 percent of "normal side effects". Since vaccination the patient was not tested for Covid-19 infection. The patient had not received any treatment medications for the resulted events. The outcome of the events was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: We both vaccinated in April, two shots in April. We both had Covid initially in February. He had now tested positive for Covid in June.; SARS-CoV-2 test positive; This is a spontaneous report from a contactable consumer. This consumer (patient wife) reported for a 49-year-old male patient(reporter husband) that received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine Formulation: Solution for injection, Batch/Lot Number: EW0153, Expiration Date: 31Jul2021) via an unspecified route of administration in right arm on 30Apr2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 from Feb2021 to an unknown date (Verbatim We both had Covid initially in February). The patient previously received first dose of BNT162B2 (Formulation: Solution for injection, lot number: ER8730) on 10Apr2021 for Covid-19 immunization. On Jun2021, the reporter stated seriousness for we both vaccinated in april, two shots in april. We both had Covid initially in February and he had now tested positive for Covid in June after being fully vaccinated and the instance was as much, all of its severe as first episode of Covid and reporter stated that showing vaccine was not affective for my husband. We both had Covid in February So we had to wait April to get vaccinated and then he unfortunately had it again in the end of may, 1 week of June. The patient underwent lab tests and procedures which included sars-cov-2 test positive on Jun2021. The outcome of the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electric shock sensation, Electroencephalogram, Hypoaesthesia, Loss of consciousness
Clinical narrative: her body is being faint 3 to 4 times a day; Her oxygen drops from the 99 to an 83; her muscles she is suppose to get numb and then she just controls her muscles and she faint; her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode; This is a spontaneous report from a contactable consumer reporting for sister. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 11May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her body is being faint 3 to 4 times a day on 16May2021, her oxygen drops from the 99 to an 83, her muscles she is supposed to get numb and then she just controls her muscles and she faint, her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode on 16May2021. She stated that patient got vaccinated on 11May2021 and completed 5 days after her first vaccine, she started getting, and was not sure if it was side effect which is why reporter called and not sure if it had been reported before. But patient body was being faint 3 to 4 times a day, but it was quite a little episode when patient faint for second and wakes up, faint wakes up faint there was seconds between 2 and 1 and last sometimes less than a minute sometime a few minutes after 5 minutes. Patient oxygen drops from the 99 to an 83 and basically her muscles she was supposed to get numb and then she just controls her muscles and she faint, but she can still here on brain is aware her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode. So, reporter was calling to ask if this was the possible side effect if it was reported before. Reporter confirmed that patient only had her first dose. She stated that patient had MRI scan an EEG scan and 'AFib' (further not clarified hence not captured in tab) and they all came out normal which was why reporter was assuming it was a side effect. It was reported that second shot was not scheduled yet and reporter was not sure. On further probing, reporter stated that did reporter need to because reporter was in a kind of a rush right then. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call. The patient underwent lab tests and procedures which included atrial fibrillation, electroencephalogram, magnetic resonance imaging on unspecified date which resulted normal and oxygen saturation decreased to 83 on 16May2021. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Oxygen saturation decreased
Clinical narrative: her body is being faint 3 to 4 times a day; Her oxygen drops from the 99 to an 83; her muscles she is suppose to get numb and then she just controls her muscles and she faint; her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode; This is a spontaneous report from a contactable consumer reporting for sister. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 11May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her body is being faint 3 to 4 times a day on 16May2021, her oxygen drops from the 99 to an 83, her muscles she is supposed to get numb and then she just controls her muscles and she faint, her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode on 16May2021. She stated that patient got vaccinated on 11May2021 and completed 5 days after her first vaccine, she started getting, and was not sure if it was side effect which is why reporter called and not sure if it had been reported before. But patient body was being faint 3 to 4 times a day, but it was quite a little episode when patient faint for second and wakes up, faint wakes up faint there was seconds between 2 and 1 and last sometimes less than a minute sometime a few minutes after 5 minutes. Patient oxygen drops from the 99 to an 83 and basically her muscles she was supposed to get numb and then she just controls her muscles and she faint, but she can still here on brain is aware her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode. So, reporter was calling to ask if this was the possible side effect if it was reported before. Reporter confirmed that patient only had her first dose. She stated that patient had MRI scan an EEG scan and 'AFib' (further not clarified hence not captured in tab) and they all came out normal which was why reporter was assuming it was a side effect. It was reported that second shot was not scheduled yet and reporter was not sure. On further probing, reporter stated that did reporter need to because reporter was in a kind of a rush right then. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call. The patient underwent lab tests and procedures which included atrial fibrillation, electroencephalogram, magnetic resonance imaging on unspecified date which resulted normal and oxygen saturation decreased to 83 on 16May2021. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for Covid a week before her scheduled appointment for second dose; tested positive for Covid; This is a spontaneous report from the Pfizer sponsored program. A contactable consumer reported for a patient that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient received the first dose of Pfizer Covid-19 vaccine 3 months before on 11Mar2021 and missed her second dose schedule because she tested positive for Covid a week before her scheduled appointment for second dose. Also, there was a wrong name listed on her vaccination card, and wanted it to be corrected, hence the reason why the facility won't give her the second dose.  Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Bell's palsy, Hypoaesthesia
Clinical narrative: she has a reaction to Covid vaccination that caused Bells's Pasly.; face was numb; her face was numb was having a hard time saying words.; This is a spontaneous report form a contactable consumer (patient). A 74-month-old female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient she had a reaction to Covid vaccination that caused Bells's Pasly. It was reported that patient was in the hospital and her face was numb was having a hard time saying words. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dysphonia, Ear pain, Muscle spasms, Neck pain
Clinical narrative: blood clot; hand and legs cramps/ay 3 and 4 after the shot her cramps moved to both thighs, in lower right leg, in the sides; earache and pain in the right side of her neck; earache and pain in the right side of her neck; felt clammy; her voice is "rafty" now; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included allergy to 6 other medications. The patient's concomitant medications were not reported. The patient stated that she experienced hand and leg cramps after the second dose. The patient further stated that her cramps got really bad and her doctor suggested her to drink tonic water each day. The patient stated that on day 3 and 4 after receiving the shot, her cramps moved to both thighs, in lower right leg, in the sides. The patient stated that she also experienced earache and pain in the right side of her neck, felt clammy. The patient stated that she could not check for fever. The patient thought like she has a blood clot traveling in the body, her voice was rafty now. The patient also stated that the pain in the neck right side, cramps in the legs were similar to her allergic reaction after medication. The case was considered as serious (medically significant). The outcome of the events was unknown.  Information on lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; hand and legs cramps/ay 3 and 4 after the shot her cramps moved to both thighs, in lower right leg, in the sides; earache and pain in the right side of her neck; earache and pain in the right side of her neck; felt clammy; her voice is "rafty" now; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included allergy to 6 other medications. The patient's concomitant medications were not reported. The patient stated that she experienced hand and leg cramps after the second dose. The patient further stated that her cramps got really bad and her doctor suggested her to drink tonic water each day. The patient stated that on day 3 and 4 after receiving the shot, her cramps moved to both thighs, in lower right leg, in the sides. The patient stated that she also experienced earache and pain in the right side of her neck, felt clammy. The patient stated that she could not check for fever. The patient thought like she has a blood clot traveling in the body, her voice was rafty now. The patient also stated that the pain in the neck right side, cramps in the legs were similar to her allergic reaction after medication. The case was considered as serious (medically significant). The outcome of the events was unknown.  Information on lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in the left arm on 19May2021 at 12:00 PM (at the age of 74-year-old) as single dose for COVID-19 immunization. Vaccination facility was a pharmacy or drug store. The patient medical history included heart surgery in Dec2018 and allergy to Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included metoprolol, avorstatin, Omeprazole (PROTONIX), Acetylsalicylic acid (ASPIRIN) and TALAFAD (as reported) - all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 28Apr2021 02:30 PM as single dose for COVID-19 immunization. On 15Jun2021 at 04:45 PM in the emergency room, the patient was diagnosed with Bell's Palsy. A computed tomogram (CT) scan was performed (result unspecified) and the patient was prescribed prednisone and Valtrex (calaciclovir). Reporter considered event as serious (Disability or permanent damage). Outcome of the event was not recovered.  Follow up attempt possible. Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first dose and tested positive for SARs-COV-2 a couple of days later; received first dose and tested positive for SARs-COV-2 a couple of days later; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported, the husband received first dose and tested positive for SARs-COV-2 a couple of days later and states "wife never had it". She had not received first dose of product. She was asking for the recommendation of waiting fourteen days between infection and dose, she does not know if previously reported, but "probably not". The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was reported as unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Drug ineffective and COVID-19 and suspect drug BNT162B2 cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: severe diareah and vomiting
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood test, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Severe chest pain,  shortness of breath,  severe headache & fever. Went to an Emergency room on June 1st and was diagnosed with Pericarditis. Was released the same day and given IBprofen & Colchicine as an antiinflammatory for the fluid buildup around the heart. The pain continued despite medication returned to ER on June 3rd, 2021. Was hospitalized through June 8th. Was released.  Symptoms and pain continued after release. Revisited ER on June 10th, 2021. At this point, ER doctor reevaluated all symptoms and after further consultation determined the immune system was causing adverse symptoms due to the Covid vaccine and started new treatment to suppress the immune system. This proved to help with pain and symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Headache, Laboratory test, Magnetic resonance imaging, Pericardial effusion
Clinical narrative: Severe chest pain,  shortness of breath,  severe headache & fever. Went to an Emergency room on June 1st and was diagnosed with Pericarditis. Was released the same day and given IBprofen & Colchicine as an antiinflammatory for the fluid buildup around the heart. The pain continued despite medication returned to ER on June 3rd, 2021. Was hospitalized through June 8th. Was released.  Symptoms and pain continued after release. Revisited ER on June 10th, 2021. At this point, ER doctor reevaluated all symptoms and after further consultation determined the immune system was causing adverse symptoms due to the Covid vaccine and started new treatment to suppress the immune system. This proved to help with pain and symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Pyrexia, Vaccination complication, X-ray
Clinical narrative: Severe chest pain,  shortness of breath,  severe headache & fever. Went to an Emergency room on June 1st and was diagnosed with Pericarditis. Was released the same day and given IBprofen & Colchicine as an antiinflammatory for the fluid buildup around the heart. The pain continued despite medication returned to ER on June 3rd, 2021. Was hospitalized through June 8th. Was released.  Symptoms and pain continued after release. Revisited ER on June 10th, 2021. At this point, ER doctor reevaluated all symptoms and after further consultation determined the immune system was causing adverse symptoms due to the Covid vaccine and started new treatment to suppress the immune system. This proved to help with pain and symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Migraine
Clinical narrative: Migraine , fatigue, loss of appetite
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophilic fasciitis, Fatigue, Joint swelling, Muscle contracture, Oedema
Clinical narrative: auto- immune disease-eosinophilic faciitis.; Swelling of joints; edema; fatigue; muscle contractures; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EM9809, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 12Feb2021 11:45 as SINGLE DOSE for covid-19 immunisation. No covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. NO covid tested post vaccination. Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Feb2021 07:00 the patient experienced adverse event Triggered a response of auto- immune disease-eosinophilic faciitis, swelling of joints, edema, fatigue, muscle contractures. No covid tested post vaccination. The Therapeutic measures were taken as a result of events includes Steroid shot in joint, fluid removed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome for all the events was reported as recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Vertigo
Clinical narrative: Hearing loss; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2;solution for injection), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as unknown single for COVID-19 immunisation. The patient medical history and concomitant was not reported. The patient experienced hearing loss, vertigo on an unspecified date. It was reported that, While the caller was telling his experience with the Covid 19 vaccine with the hearing loss and vertigo he states his friend's mother received her Covid 19 vaccine and is experiencing the same thing as he done.She had her Pfizer Covid 19 vaccine 3 weeks ago. He's going to encourage his friend to have their mother call and report her experience. Outcome of the event were unknown.    He declines to provide any more information. He declines to file safety report for his friend's mother. No further information is provided or obtained.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her daughter got infected, with Covid, in between her shots.; her daughter got infected, with Covid, in between her shots.; This is a spontaneous report from a contactable nurse (patient's mother). A 15-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date in 2021 (at the age of 15-years-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an 16Jun2021, after the vaccination, the patient experienced covid-19. Caller states her daughter is not having any other symptoms. Caller states may be her daughter got infected, with Covid, in between her shots. Caller states though, that she thought it was a coincidence, that this effect happened about an hour, after her daughter, got her vaccine. On an unspecified date, the patient underwent lab test which included covid 19 test: unknown. The clinical outcome of the her daughter got infected, with Covid, in between her shots were unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on known drug safety profile and the temporal relationship, there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient got COVID-19 after 1st dose; patient got COVID-19 after 1st dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Pfizer sponsored program. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, patient got COVID-19 after 1st dose. On an unknown date patient underwent covid-19 test which resulted as positive. At the time of report event outcome was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left shoulder) on 09Feb2021, early afternoon 15:20 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included Bell's Palsy in the past, but not for years. He doesn't know, but probably 15 years since he last had it. Family Medical History Relevant to AE(s) included his brother had Bell's Palsy after his COVID shot. His brother had Bell's palsy before also. There were no concomitant medications. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient had no additional vaccines administered on same date of the pfizer suspect. The patient did not receive any prior Vaccinations (within 4 weeks). He normally doesn't take vaccines. The patient had no AE(s) following prior vaccinations. Patient wanted to report Bell's Palsy is directly caused by Pfizer COVID shot. Caller clarified that he is the patient that experienced Bell's Palsy. He understands that Pfizer has denied that. He was not sure of the date. It was the date he got the shot. It happened the same date got first COVID shot. He did not get second COVID shot. Facility called him today to follow up because he didn't get second shot and they told that's what it was and gave him Pfizer's phone number. When caller got his vaccination card, he states the date was 09Feb2021 that he got the shot and developed Bell's Palsy. Immediately afterwards, the patient experienced Bell's Palsy. The next day his wife noticed it. The patient clarified the date Bell's Palsy started was 09Feb2021. It was bad enough the next day, 10Feb2021, that his wife noticed it. The patient just went directly to the doctor and did not go to ER. He would have gone to the ER to get the thing he needed for Bell's Palsy, but he went to the doctor instead. The doctor gave him the medication he needed. He went to the doctor because the doctor had treated his brother. His brother had the same reaction. That is how caller knows it was caused by the Pfizer COVID shot. Caller clarified that his brother got Bell's Palsy immediately too but didn't recognized it until after he had the second shot. That is how they know for sure it was caused by Pfizer COVID shot. The outcome of the event was not recovered.  Follow-up attempts are needed, Other additional information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021725674 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Condition aggravated
Clinical narrative: Bell's palsy; The patient got first and second COVID shots, but he developed Bell's Palsy after the first one. He didn't realize it was caused by the vaccination,; This is a spontaneous report from a contactable consumer (Reporter's brother). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ,Batch/Lot number was not reported) via an unspecified route of administration (Shoulder, but not sure which one. Probably gave them all in the left shoulder) on an unspecified date (but before 09Feb202) as 2nd Dose, Single for COVID-19 immunization. The patient's Medical history included Bell's Palsy before, but it has been a long time ago. Reporter would say probably more than 6 or 7 years ago. Reporter is not aware of AEs following prior vaccinations,if his brother had and he normally doesn't take vaccines. Information on prior vaccinations within 4 weeks is not provided The patient's concomitant medications were not reported.  Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient got first and second COVID shots, but he developed Bell's Palsy after the first one. He didn't realize it was caused by the vaccination, so he got the second one or he never would have gotten the second one. Immediately after the 2nd dose of vaccination, the patient experienced Bell's Palsy which is ongoing and has stayed about the same on an unspecified date, but before 09Feb2021. The patient went to the ER and they treated him and sent him to the doctor there. Therapeutic measures were taken as a result of bell's palsy. The outcome for the events was not recovered.  Information about lot/batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: partial face paralysis; This is a spontaneous report from a contactable consumer. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported he was never allergic to anything before vaccination. On an unspecified date, after the vaccination, after having a piece of Chocolate that he used to eat for the past 30 years, he had a partial face paralysis and he doesn't know if it was due to the vaccine. Patient went to hospital due to event. The outcome of event was unknown.  Information on the Batch/Lot number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease, COVID-19, Myocardial infarction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient had a heart attack from 90% blockage of artery; patient had a heart attack from 90% blockage of artery; 10Mar2021 10:30 1st dose/31Mar2021 10:30 2nd dose/ COVID-19 sentinel type of nasal swab on 07Jun2021 result was positive; COVID-19 sentinel type of nasal swab result was positive; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 10Mar2021 10:30 (Lot Number: EN6199) (at the age of 63-year-old) as dose 1, single, via an unspecified route of administration, administered in Arm Right on 31Mar2021 10:30 (Lot Number: EP6955) (at the age of 63-year-old) as dose 2, single for COVID-19 immunization.  The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC); mometasone furoate (FLONASE); naproxen; omeprazole (PROTONIX).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There were no known allergies.  The most recent COVID-19 vaccine was administered in pharmacy or drug store.  The patient had a heart attack from 90% blockage of artery on 20Apr2021 21:00, with placement of 2 stents which resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The patient was hospitalized for 2 days in 2021.  Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient had COVID-19 sentinel type of nasal swab on 07Jun2021 result was positive.  Outcome of 'patient had a heart attack from 90% blockage of artery' was resolved in 2021 while outcome of the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He had Covid/ him catching or having Covid-19; He had Covid/ him catching or having Covid-19; This is a spontaneous report via Pfizer sponsored program and from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose on 26May2021 and was scheduled to receive second dose on 16Jun2021, however the patient missed the appointment due to catching or having Covid-19. The patient wanted to know if the patient should wait a specific time before the second vaccine and reschedule the appointment. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was positive. The outcome of both events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diabetes mellitus, Feeling abnormal, Neck pain, Pulmonary pain
Clinical narrative: Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; He said it feels like a bug is eating inside or by his head; This is a spontaneous report from a contactable consumer (Patient's daughter).      A 62-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 30Jul2021), via an unspecified route of administration on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose bnt162b2 (BNT162B2, solution for injection, lot # EN6199 expiration date: 30Jun2021), via an unspecified route of administration single for covid-19 immunisation. It was reported that, the caller is the caregiver of the patient, her father. The caller was called to report an adverse event from the Covid-19 Vaccine. The patient received his second dose of the Pfizer covid-19 vaccine at the end of March. The patient's neck has been hurting, his back has been hurting on the left side and his lung has been hurting. It felt like a bug is eating inside or by the patient's head. The patient was diagnosed with diabetes a couple of weeks ago. The caller clarified and confirms that the patient was diagnosed with diabetes 1-2 weeks ago. The patient has had the pains for a while now, he got the second dose around 29Mar2021. The patient's neck that has been hurting is the same but getting worse. The patient's lung pain comes from time to time. The caller later clarifies and confirms that the patient is 62 years old, not 61 years old as previously reported. The outcome of the events was Not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Right before the second shot she got Covid and had antibodies in the hospital; Right before the second shot she got Covid and had antibodies in the hospital; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a dose of the vaccine on 27Feb2021. Right before the second shot, on an unspecified date in 2021, she got Covid and had antibodies in the hospital. The doctor told her to go ahead and get her second shot. It had been almost 4 months since the first dose. The pharmacist asked if it will be going to be effective and if it should be given to her. The seriousness of event was reported as non-serious by the reporter. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on known Vaccine safety profile and as patient received only one shot of vaccine there is reasonable possibility of drug ineffective for Covid-19.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: a massive stroke; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose at the age of 83-year-old for covid-19 immunization. Historic vaccine was bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. Concomitant medications were not reported. The patient had 2 terrible reaction followed by a massive stroke within a week of the 2nd shot. She was still recovering (as reported) from the stroke. It was terrible. Stroke was too much to handle. She was still going to Dr. She had a caregiver paid at home. The seriousness of event was reported as life threatening and hospitalization. The patient was hospitalized duration of stay: 3 days. AE required visit to: Intensive care unit (3 Days). The outcome of event was not recovered.  Information on the Lot/Batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes ophthalmic
Clinical narrative: eye herpes; This is a spontaneous report from a contactable consumer (patient's mother). A 14-years-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 14-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecifies date, the patient experienced eye herpes after the first shot of the Pfizer-BioNTech COVID-19 Vaccine. Caller stated she read on the internet an article published from a health site. The researchers found that six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. A National Institute also said that it's triggered by the same virus that causes chickenpox. Caller is asking if she should take a Shingles shot before getting the vaccine. Caller is surprised that we don't have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these and her daughter also experienced it. The outcome of the event was unknown.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: I did get Shingles in my right eye.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose 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 an unspecified date, as a single for COVID-19 immunisation. It was reported that "It just occurred to me that I should let Pfizer know that after my 2nd Covid 19 vaccination, I did get shingles in my right eye". The reporter gave consent to contact if additional information is required. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.