chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: increased seizure activity; I  had the normal yet severe side effects of sore arm & neck; I  had the normal yet severe side effects of sore arm & neck; stiffness behind the ear, stiffness of the neck; stiffness of the neck and injection site arm; fatigue; fever; headache; sore throat; chills; I started suffering from tinnitus; dizziness; nausea; confusion; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 21Mar2021 14:45 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included epilepsy and asthma. The patient is not pregnant. Concomitant medication included levetiracetam. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN6203) administered in left arm on 28Feb2021 14:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient had the normal yet severe side effects of sore arm & neck, stiffness behind the ear, stiffness of the neck and injection site arm, fatigue, fever, headache, sore throat, chills, for the first few days her 2nd dose. But on day 2, she started suffering from tinnitus, dizziness, nausea, confusion in both ears and increased seizure activity. The events started about 2 days after the second shot on 23Mar2021 12:00 PM; its been a week now and it still hasn't gotten better or gone away. She had an appointment with her pcp tomorrow but so far nothing has helped. Its debilitating and extremely hard to focus & function. She mainly just wanted to know if any other vaccine trial participant/recipients have reported anything similar & if so, how long can she expect this to last. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: increased seizure activity; I  had the normal yet severe side effects of sore arm & neck; I  had the normal yet severe side effects of sore arm & neck; stiffness behind the ear, stiffness of the neck; stiffness of the neck and injection site arm; fatigue; fever; headache; sore throat; chills; I started suffering from tinnitus; dizziness; nausea; confusion; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 21Mar2021 14:45 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included epilepsy and asthma. The patient is not pregnant. Concomitant medication included levetiracetam. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN6203) administered in left arm on 28Feb2021 14:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient had the normal yet severe side effects of sore arm & neck, stiffness behind the ear, stiffness of the neck and injection site arm, fatigue, fever, headache, sore throat, chills, for the first few days her 2nd dose. But on day 2, she started suffering from tinnitus, dizziness, nausea, confusion in both ears and increased seizure activity. The events started about 2 days after the second shot on 23Mar2021 12:00 PM; its been a week now and it still hasn't gotten better or gone away. She had an appointment with her pcp tomorrow but so far nothing has helped. Its debilitating and extremely hard to focus & function. She mainly just wanted to know if any other vaccine trial participant/recipients have reported anything similar & if so, how long can she expect this to last. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Tinnitus, Vaccination site discomfort
Clinical narrative: increased seizure activity; I  had the normal yet severe side effects of sore arm & neck; I  had the normal yet severe side effects of sore arm & neck; stiffness behind the ear, stiffness of the neck; stiffness of the neck and injection site arm; fatigue; fever; headache; sore throat; chills; I started suffering from tinnitus; dizziness; nausea; confusion; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 21Mar2021 14:45 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included epilepsy and asthma. The patient is not pregnant. Concomitant medication included levetiracetam. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN6203) administered in left arm on 28Feb2021 14:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient had the normal yet severe side effects of sore arm & neck, stiffness behind the ear, stiffness of the neck and injection site arm, fatigue, fever, headache, sore throat, chills, for the first few days her 2nd dose. But on day 2, she started suffering from tinnitus, dizziness, nausea, confusion in both ears and increased seizure activity. The events started about 2 days after the second shot on 23Mar2021 12:00 PM; its been a week now and it still hasn't gotten better or gone away. She had an appointment with her pcp tomorrow but so far nothing has helped. Its debilitating and extremely hard to focus & function. She mainly just wanted to know if any other vaccine trial participant/recipients have reported anything similar & if so, how long can she expect this to last. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient came down with A-fib (atrial fibrillation) a week after receiving the vaccine. The patient had the vaccination a week prior to going into the hospital. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A-fib (Atrial fibrillation); This is a spontaneous report from contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced A-fib (atrial fibrillation) and was put on a heart monitor. It was further reported that the patient had the vaccine and she wound up in the hospital with A-fib on an unspecified date and she still had it. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Respiratory arrest
Clinical narrative: passed out/stopped breathing for 15-20 seconds.; passed out/stopped breathing for 15-20 seconds.; Felt faint; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 25Mar2021 11:00 (Lot Number: EN6205) as single dose for covid-19 immunisation at age 40 years old. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medication included loratadine (CLARITIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 14:00 (lot no: EN6200) in left arm for COVID-19 immunization at age 40 years old. On 25Mar2021 11:15, the patient felt faint, had trouble breathing, and passed out/stopped breathing for 15-20 seconds. The adverse events resulted in emergency room/department or urgent care. Treatment for the events included EMT monitoring onsite, saline and other meds (unspecified). The patient recovered from the event passed out/stopped breathing on 25Mar2021; while recovered from other events on an unspecified date in Mar2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), in left arm on 24Feb2021 10:45 AM (at the age of 38-year-old) at single dose for COVID-19 immunisation. The patient's medical history included attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), depression. No COVID was reported prior vaccination. The patient's concomitant medications included losartan potassium, loratadine (CLARITIN), both from unspecified date. Patient had not taken any other vaccines in previous four weeks. It was reported at the time of this report patient had severe tinnitus. He had never had this symptom for prolonged periods of time without explanation. It began after the first shot on 28Feb2021 12:00 AM and got acutely worse after the second. Adverse event was reported as serious resulted in disability or permanent manage. No treatment for the event was received. The patient was not tested positive post vaccination. The outcome of the event was not resolved.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Tough to sleep; Ringing in ears; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: En6201) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) and losartan, both for unspecified indication. On 16Mar2021 at 16:00, the patient experienced ringing in ears and tough to sleep for a couple days. The patient did not received treatment for the events. The events resulted in disability or permanent damage. The outcome of the event was not recovered. The patient did not had COVID prior to vaccination and was not tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Incorrect route of product administration, Paraesthesia, Swelling
Clinical narrative: Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 subcutaneously administered in left arm on 29Mar2021 12:45 (Lot Number: 1239921-00) as a single dose for covid-19 immunisation. Medical history included type 1 diabetes and allergic to tempeh (it's a food). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine subcutaneously in a pharmacy or drug store. On 29Mar2021 14:00, the experienced swelling, numbness and tingling which was considered serious since the patient was hospitalized (unspecified date in 2021) for 1 day (unspecified date in 2021). The adverse event required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events required treatment which included Benadryl. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovered on an unspecified date in 2021 with sequel.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Urinary tract infection
Clinical narrative: Urinary tract infection; She didn't know who she was or what she was doing for 3 days; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6201; expiry: 30Jun2021), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 59-years-old) as single dose for covid-19 immunisation. The vaccine was not administered at a military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient had no medical history, no concomitant medications and no investigation assessment. The patient experienced urinary tract infection in Mar2021 which was considered serious due to hospitalization from Mar2021 to Mar2021 for 5 days. She was diagnosed with a urinary tract infection. She didn't know who she was or what she was doing for 3 days. She was then kept an additional two days. The patient was supposed to go back on 12Mar2021 to receive the second dose. She was in the hospital at that time and did not receive the second dose. She was asking if she needed to start over since it was past the time for her to get the second dose. The event urinary tract infection required an emergency room visit. The outcome of the event urinary tract infection was recovered on 22Mar2021 while for disorientation was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell palsy; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After getting first vaccine, the patient got bell palsy on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Photopsia, Transient ischaemic attack, Vision blurred, Visual impairment
Clinical narrative: mini stroke; having vision issues; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient received the first dose on 02Mar2021 12:15 on the left arm. The patient medical history was not reported. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for birth control. The patient previously took erythromycin and experienced allergies. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 24Mar2021 8:15, patient started having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes, this lasted for about 45 min. Her doctor had the patient go to the ER where they did a CT scan thinking of possible mini stroke, no signs of that scan came back clear. AE resulted in emergency room/department or urgent care. No treatment received for the adverse events. Patient recovered from the events on 24Mar2021 09:00.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left in Mar2021 (Lot Number: EN6205; expiration date unknown), age at vaccination of  53-years-old, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 23Mar2021, the patient experienced tingling on right side, drooping on right side, unable to blink right eye, bells palsy was diagnosed. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included administration of antibiotics. Facility type Vaccine: Public Health Clinic/Veterans; no other vaccine in four weeks, no other medications in two weeks; no Covid prior vaccination and patient was not Covid tested post vaccination. The patient had not recovered from the events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Depressed mood, Tinnitus
Clinical narrative: hearing loss in high frequencies; developed tinnitus; She was very depressed; This is a spontaneous report from a contactable consumer (patient) via Medical information team reported for herself. A 76-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 10Mar2021 09:22 (at the age of 76-years-old) (Batch/Lot Number: EN6206) as SINGLE DOSE for covid-19 immunization. Medical history included immunodeficiency, respiratory disorder, cytogenetic abnormality, endocrine disorder, diabetes mellitus, obesity from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had first shot of vaccine on 10Mar2021 and was due for her second on 01Apr2021. Within 2 days of receiving it, she got Tinnitus and was still experiencing ear ringing. She had already spoke to HCP. She was very depressed that she may have this side effect forever. She asked if anyone else had reported this side effect. She doesn't know if it was a side effect. She was wondering if she should get second shot or will anything worse happen. There was no prescriber. It was either 12Mar2021 or 13Mar2021, that she noticed it. For tinnitus she did not pay a lot of attention until Sunday, so she knew she got it on Saturday, or Friday, unknown time. No ER or physician's office required. She did make an appointment with an ENT and audiologist on 24Mar2021. Patient did not know if it had anything to do with the vaccine. No infection. Somewhat of hearing loss in high frequencies, but she did not need a hearing aid. There were no prior Vaccinations (within 4 weeks) and no lab tests reported. Outcome of event tinnitus was reported as not recovered and outcome of event deafness and depressed mood was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: she developed Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on 05mar2021 as single dose for covid-19 immunisation. Medical history included facial paralysis from Mar2021 to an unknown date.  The patient's concomitant medications were not reported. She was supposed to receive her second dose on 26Mar2021 but the week before on 19Mar2021 she developed Bell's Palsy (medically significant) and her doctor suggested waiting 14 days after finishing her steroids before receiving the second dose.  She is wondering does she have to wait the 14 days after finishing the steroids or can she get it 12 days after finishing the steroids. The patient went to the doctor on 22Mar2021.  She said she had difficulty drinking water from a cup and her mother had Bell's Palsy, so we were familiar with what it was. The event difficulty drinking water from a cup assessed as non-serious. She is going to see a neurologist. Therapeutic measures were taken as a result of she developed bell's palsy. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Face injury, Fall, Haemorrhage
Clinical narrative: she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered.  Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered.  Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Pulmonary embolism
Clinical narrative: developed a small Pulmonary embolism in Lung; Colitis; This is a spontaneous report from a non-contactable consumer (patient, self-reported).   A 84-year-old non pregnant patient female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9264 and expiration date was not reported), via unspecified route of administration in left arm on 11Mar2021 at 09:00, at single dose for COVID-19 immunization. The patient's medical history included Myeloma and concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201 and expiration date was not reported), via unspecified route of administration in right arm on 18Feb2021 at 09:30, at single dose for COVID-19 immunization. On 25Mar2021 at 09:30 AM patient developed a small Pulmonary embolism in Lung and Colitis, 10 days after second dose of Pfizer vaccine. The patient had received the treatment medication for the adverse event. The seriousness of the event considered as serious due to hospitalization of the patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and after vaccination was not tested for COVID-19. The outcome of the events small Pulmonary embolism in Lung and Colitis was recovering.   Information on Lot/Batch number was available. Additional information has been requested
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Limb discomfort, Muscle spasms, Neuropathy peripheral
Clinical narrative: very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown.  Information about on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Pain, Pruritus, Urticaria
Clinical narrative: she has Crohns Disease; My dental hygenist mentioned in conversation that she received the Pfe Vaccine in December 2020 and Jan 2021.  She indicated every day since the second dose, she has experience hives that come and go; hives that come and go and which are painful and itchy.; hives that come and go and which are painful and itchy; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration in Dec 2020 as SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. In Jan2021, The patient experienced crohns disease and indicated every day since the second dose, she has experience hives that come and go and which are painful and itchy. The reporter dental hygienist mentioned in conversation that she received the vaccine in December 2020 and Jan 2021. The patient indicated that she has Crohns Disease and thought perhaps it might be related. The patient said has not sought treatment for the hives. The outcome of events was not recovered. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Headache, Oral discomfort, Peripheral venous disease, Throat irritation
Clinical narrative: her veins were swollen and she had blood clot.; her veins were swollen and she had blood clot.; severe earache; severe headache; her mouth and throat were on fire.; her mouth and throat were on fire.; This is a spontaneous report from a non-contactable consumer (other HCP) via medical information team. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route of administration on 09Mar2021 as single dose for covid-19 immunisation. Reportedly, patient got the first dose of the Pfizer COVID-19 vaccine on 09Mar2021. After that, she had developed severe earache, severe headache, her mouth and throat were on fire. Few days later, her veins were swollen and she had blood clot. She was also afraid to take her medication, Eliquis, since there may be more adverse events from that medication. Patient was scheduled for her second shot of the Pfizer COVID-19 vaccine today, 20Mar2021. She was told that the adverse events after the second dose of the vaccine are worse than the first dose. She has also read that people die from the vaccine. She wants to cancel her appointment today. She wanted to know if the vaccine would be 80-85% effective after a single dose. She wanted to know if she would be ok with just one dose of the vaccine. No PQC was present. The outcome for the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of thrombosis and other events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: her veins were swollen and she had blood clot.; her veins were swollen and she had blood clot.; severe earache; severe headache; her mouth and throat were on fire.; her mouth and throat were on fire.; This is a spontaneous report from a non-contactable consumer (other HCP) via medical information team. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route of administration on 09Mar2021 as single dose for covid-19 immunisation. Reportedly, patient got the first dose of the Pfizer COVID-19 vaccine on 09Mar2021. After that, she had developed severe earache, severe headache, her mouth and throat were on fire. Few days later, her veins were swollen and she had blood clot. She was also afraid to take her medication, Eliquis, since there may be more adverse events from that medication. Patient was scheduled for her second shot of the Pfizer COVID-19 vaccine today, 20Mar2021. She was told that the adverse events after the second dose of the vaccine are worse than the first dose. She has also read that people die from the vaccine. She wants to cancel her appointment today. She wanted to know if the vaccine would be 80-85% effective after a single dose. She wanted to know if she would be ok with just one dose of the vaccine. No PQC was present. The outcome for the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of thrombosis and other events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: passing out; really bad reaction; This is a spontaneous report received from contactable female consumer (wife) on behalf of her husband 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   On 29Mar2021, the reporter stated that patient had a really bad reaction last night and had to go to the emergency room, she stated that overnight her husband kept passing out and states that when he would come to, he would say it's the medicine, the medicine. The reporter thought he was talking about his blood pressure medication because she states she checked and he hadn't taken it yet, but when she asked if what medicine he was talking about, her husband would say the one in my arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood copper, Blood copper increased, Blood folate, Blood folate increased, Breast pain
Clinical narrative: 3 bouts of ulcerative colitis; her B12 was over 2000; copper was 189.2; Folate 16.8; foamy spit; dry mouth; Breast pain in the right side; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Solution for injection, Lot number: unknown), via an unspecified route of administration in right shoulder muscle on 05Mar2021 at the age of 73 years old as SINGLE DOSE for COVID-19 immunization. Patient medical history included Hypothyroidism and high blood pressure. Concomitant medications included levothyroxine sodium (SYNTHRIOD), one half of 25 mcg tablet, once a day, taking the medication many years, it's been like 5 years for Hypothyroidism and hydrochlorothiazide 25mg 1 tablet daily for High blood pressure. On 18Mar2021, she had 3 bouts of ulcerative colitis, foamy spit, dry mouth, breast pain in the right side where she got first dose. The patient reported that, she had the Covid vaccine in March of 5th, she has some lab test drawn on 18th and copper level was extremely high and folate level was high too, plus she has been having Phony stiff in my mouth. It was also reported that, her B12 was high also it never been so high it never been 2000 and I haven't been taking b12 from quite a while, she wonders if this was shot related, had dry month and besides that she had three bout of colitis, ulcerative colitis attacks. The colitis, it started than and went through 24th about had 3 bouts of it 3 different days of terrible pain, started probably the 20th. It was also reported that, she is not eating a lot and not taking any supplements, her doctor told her to stop everything so that's what she did, usually she takes supplement. She said she is hesitant about taking the second dose. Caller wanted to know does the vaccine have copper in it and response. The patient supposed to get her 2nd one on Friday. On 18Mar2021, the patient had performed with lab tests and which included vitamin B12: 2000 pg/mL; Copper: 189.2 ug/dL and folate: 16.8 ng/mL. The patient did not take any treatment for events. There was no PQC involved. The outcome of the events was not recovered.   Information on Lot/Batch number was requested. cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Dry mouth, Foaming at mouth, Vitamin B12, Vitamin B12 increased
Clinical narrative: 3 bouts of ulcerative colitis; her B12 was over 2000; copper was 189.2; Folate 16.8; foamy spit; dry mouth; Breast pain in the right side; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Solution for injection, Lot number: unknown), via an unspecified route of administration in right shoulder muscle on 05Mar2021 at the age of 73 years old as SINGLE DOSE for COVID-19 immunization. Patient medical history included Hypothyroidism and high blood pressure. Concomitant medications included levothyroxine sodium (SYNTHRIOD), one half of 25 mcg tablet, once a day, taking the medication many years, it's been like 5 years for Hypothyroidism and hydrochlorothiazide 25mg 1 tablet daily for High blood pressure. On 18Mar2021, she had 3 bouts of ulcerative colitis, foamy spit, dry mouth, breast pain in the right side where she got first dose. The patient reported that, she had the Covid vaccine in March of 5th, she has some lab test drawn on 18th and copper level was extremely high and folate level was high too, plus she has been having Phony stiff in my mouth. It was also reported that, her B12 was high also it never been so high it never been 2000 and I haven't been taking b12 from quite a while, she wonders if this was shot related, had dry month and besides that she had three bout of colitis, ulcerative colitis attacks. The colitis, it started than and went through 24th about had 3 bouts of it 3 different days of terrible pain, started probably the 20th. It was also reported that, she is not eating a lot and not taking any supplements, her doctor told her to stop everything so that's what she did, usually she takes supplement. She said she is hesitant about taking the second dose. Caller wanted to know does the vaccine have copper in it and response. The patient supposed to get her 2nd one on Friday. On 18Mar2021, the patient had performed with lab tests and which included vitamin B12: 2000 pg/mL; Copper: 189.2 ug/dL and folate: 16.8 ng/mL. The patient did not take any treatment for events. There was no PQC involved. The outcome of the events was not recovered.   Information on Lot/Batch number was requested. cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pain in extremity, Respiratory tract infection
Clinical narrative: she feels like she is having a respiratory tract infection; Diarrhea; pain in the arm; a very bad headache; body pain; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation:Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient stated the side effects she experienced after the administration of the second dose of the Pfizer's COVID-19 vaccine. She felt like she was having pain in the arm, a very bad headache and body pain on an unspecified date in on Mar2021. She experienced a respiratory tract infection and diarrhea on 29Mar2021. Tylenol was given for the management of the symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion
Clinical narrative: concussion symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female (not pregnant) patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Mar2021 08:00 (at the age of 62-years-old) (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included post concussion syndrome from 2020 to an unknown date, drug hypersensitivity from an unknown date and unknown if ongoing, allergy to chemicals from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol taken for an unspecified indication, start and stop date were not reported. Patient reported that, she was in a car accident on 21Jan2020 and suffered a serious concussion. The worst symptoms lessened with time but she was diagnosed with post concussive syndrome. The evening after the first shot on she was ok but definitely feeling the effects. When she woke up on Monday the 29th many of the concussion symptoms were back like speech issues, wobbly walking and brain fog on 28Mar2021 18:00. She was 2 days off work now resting to try to get back to where she was. Patient asked to take this and was wondering maybe people with concussions or post concussive syndrome should not receive this vaccine. Patient was not diagnosed with Covid-19 prior or post to the vaccination. It was unknown if patient was hospitalized due to events. No treatment was received for the adverse event. Outcome of events was reported as recovering.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a contactable physician. A 75-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration, on 12Mar2021 at the age of 75 years old as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 15Mar2021, the patient had experienced pericarditis. Treatment drug NSAIDs colchicine was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was recovering.   Follow-up activities closed as no follow-up attempts required.; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Pericarditis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Ischaemic stroke, Vision blurred, Visual impairment
Clinical narrative: ischemic stroke; vision changes; When looking up her vision was blurry & unclear; fuzzy; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 73-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Lot no: ER0734) on unspecified route of administration on right arm (at the age of 73-year-old) as SINGLE DOSE on 28Mar2021 (between 14:30-15:00) for covid-19 immunization. There were no prior vaccinations within 4 weeks reported. The patient's relevant medical history included ischemic stroke, breast cancer, lymphedema in left arm and tendonitis in her right arm. The patient's concomitant medications were not reported. On 29Mar2021, the patient experienced vision changes. Upon follow-up (30Mar2021); When looking up her vision was blurry & unclear and the symptoms lasted for around one-two hours. On 29Mar2021, the patient looked at the clock on top (about 10' away), all the numbers were fuzzy. The patient said the numbers on the clock were 1 in height & she couldn't read them & her vision was very fuzzy. The fuzzy vision lasted approximately between 1-1/2 to 2 hours. It was reported that the patient vision recovered completely 1-1/2 to 2 hours afterwards. On an unknown date, the patient had ischemic stroke. The outcome of the events ischemic stroke, vision changes and vision blurred was unknown  Follow up was needed, further information has been requested.