chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Pain in extremity, White blood cell count
Clinical narrative: arm soreness and more fatigue the day after the vaccine; arm soreness and more fatigue the day after the vaccine; voice hoarseness; This is a spontaneous report received from a contactable other healthcare professional and a contactable consumer (Patient)from a Pfizer Sponsored Program. A 65-year-old female patient received second dose of BNT162B2 (reported as covid vaccine), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunisation. Medical history included muscle tightness in shoulder and neck causing shoulder pain (had bone metastasis)- improved, breast cancer. Concomitant medication included palbociclib (IBRANCE, 125 mg) taken for breast cancer from 04Jan2021 and ongoing. After start of palbociclib therapy, tiredness- more tired on "third week/off week and first week of cycle''; low white blood cell count from 2.3 to 2.0. MD aware. Per MD, she was off palbociclib 2 days before and 2 days after second dose of covid vaccine (Mar2021)- had "left arm soreness and more fatigue the day after the vaccine". No other adverse effects reported while off palbociclib. Had new report of voice hoarseness at times. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: blood in her eye, like it busted; This is a spontaneous report from a non-contactable consumer reported for herself. A 56-year-old female patient 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 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient got her first Pfizer covid vaccine this morning she was doing fine but when she came home and looked in the mirror, it looks like there is blood in her eye, like it busted.  It doesn't hurt or anything on unknown date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Body temperature, C-reactive protein, COVID-19, Chills
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever 101-104 ongoing 8 days after vaccine; rigors; fatigue; This is a spontaneous report received from a contactable consumer (patient, self-reported).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8730 and expiry dates were not reported), via unspecified route of administration in left arm on 25Mar2021 at 02:30 PM, as single dose for COVID-19 immunization. The patient's medical history includes occasional migraine and remote pneumonia. The concomitant medication included Multivitamin and Vitamin D. It reported that, on 26Mar2021 the patient experienced Fever 101-104 ongoing 8 days after vaccine, rigors and fatigue. The patient underwent lab test 24 hours post vaccine that was COVID test negative, also negative COVID Ab, increased inflammatory markers CRP, ESR, Ddimer, abnormal CBC and large platelets, mild hemolyzed blood in urine with otherwise negative UA, blood cultures x 2 negative. Vaccination facility: Pharmacy or Drug Store. 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 (Nasal Swab) and after the vaccination the patient been tested for COVID-19. The patient received ongoing tx with antipyretics, monitoring ongoing as corrective treatment for the adverse event. The outcome of the patient's event drug ineffective and COVID-19 was unknown and other events (fever, rigors, and fatigue) were not recovered.   Follow-up (02Apr2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported for her son (Patient). The non-significant information updated.  Additional information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Fibrin D dimer, Full blood count, Platelet count
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever 101-104 ongoing 8 days after vaccine; rigors; fatigue; This is a spontaneous report received from a contactable consumer (patient, self-reported).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8730 and expiry dates were not reported), via unspecified route of administration in left arm on 25Mar2021 at 02:30 PM, as single dose for COVID-19 immunization. The patient's medical history includes occasional migraine and remote pneumonia. The concomitant medication included Multivitamin and Vitamin D. It reported that, on 26Mar2021 the patient experienced Fever 101-104 ongoing 8 days after vaccine, rigors and fatigue. The patient underwent lab test 24 hours post vaccine that was COVID test negative, also negative COVID Ab, increased inflammatory markers CRP, ESR, Ddimer, abnormal CBC and large platelets, mild hemolyzed blood in urine with otherwise negative UA, blood cultures x 2 negative. Vaccination facility: Pharmacy or Drug Store. 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 (Nasal Swab) and after the vaccination the patient been tested for COVID-19. The patient received ongoing tx with antipyretics, monitoring ongoing as corrective treatment for the adverse event. The outcome of the patient's event drug ineffective and COVID-19 was unknown and other events (fever, rigors, and fatigue) were not recovered.   Follow-up (02Apr2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported for her son (Patient). The non-significant information updated.  Additional information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 test, Urine analysis
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever 101-104 ongoing 8 days after vaccine; rigors; fatigue; This is a spontaneous report received from a contactable consumer (patient, self-reported).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8730 and expiry dates were not reported), via unspecified route of administration in left arm on 25Mar2021 at 02:30 PM, as single dose for COVID-19 immunization. The patient's medical history includes occasional migraine and remote pneumonia. The concomitant medication included Multivitamin and Vitamin D. It reported that, on 26Mar2021 the patient experienced Fever 101-104 ongoing 8 days after vaccine, rigors and fatigue. The patient underwent lab test 24 hours post vaccine that was COVID test negative, also negative COVID Ab, increased inflammatory markers CRP, ESR, Ddimer, abnormal CBC and large platelets, mild hemolyzed blood in urine with otherwise negative UA, blood cultures x 2 negative. Vaccination facility: Pharmacy or Drug Store. 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 (Nasal Swab) and after the vaccination the patient been tested for COVID-19. The patient received ongoing tx with antipyretics, monitoring ongoing as corrective treatment for the adverse event. The outcome of the patient's event drug ineffective and COVID-19 was unknown and other events (fever, rigors, and fatigue) were not recovered.   Follow-up (02Apr2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported for her son (Patient). The non-significant information updated.  Additional information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: headache; Total bodyache; fatigue; feeling unwell; fever; Chills; Joint pain; Fogginess of mind; This is a spontaneous report received from Pfizer-sponsored program. A contactable female consumer(patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/lot no: EK5730) second dose via an intramuscular administered in left arm 19Jan202 0.3ml as single dose for COVID-19 immunization. The patient family medical history Father- Deceased was Diabetic, HPN, Kidney Transplant, Dialysis. Mother- Alive-Osteoporosis, Mild Dementia. Sister-Diabetic, HPN. The patient concomitant medications were not reported. The patient experienced with second dose - 19Jan2021 - 1st Day foolness of mind,2nd day -Chills, joint pain,3rd day- Fever, 4th day- feeling unwell,5th day fatigue total body ache, 6th day -feeling unwell' 7th day then 11th day Headaches-pain score-4-5,12th day feeling back to normal about 50-90, 13th day-back to normal. First dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. 1st Dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: headache; Total bodyache; fatigue; feeling unwell; fever; Chills; Joint pain; Fogginess of mind; This is a spontaneous report received from Pfizer-sponsored program. A contactable female consumer(patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/lot no: EK5730) second dose via an intramuscular administered in left arm 19Jan202 0.3ml as single dose for COVID-19 immunization. The patient family medical history Father- Deceased was Diabetic, HPN, Kidney Transplant, Dialysis. Mother- Alive-Osteoporosis, Mild Dementia. Sister-Diabetic, HPN. The patient concomitant medications were not reported. The patient experienced with second dose - 19Jan2021 - 1st Day foolness of mind,2nd day -Chills, joint pain,3rd day- Fever, 4th day- feeling unwell,5th day fatigue total body ache, 6th day -feeling unwell' 7th day then 11th day Headaches-pain score-4-5,12th day feeling back to normal about 50-90, 13th day-back to normal. First dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. 1st Dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Disabling muscle spasms in right to center neck and upper shoulder/back; This is a spontaneous report from a contactable consumer (patient).   A 96-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 96-year-old via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included High blood pressure.  No known allergies. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. Concomitant drug included unspecified other medications in two weeks. The patient experienced disabling muscle spasms in right to center neck and upper shoulder/back on unspecified date, resulted in Emergency room/department or urgent care, hospitalization and disability. Treatment was included OTC pain reliever. The outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achy and tired; achy and tired; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), as a single dose for COVID-19 immunization. It was reported that, got my second Pfizer shot yesterday (29Mar2021) and patient was achy and tired today (30Mar2021). The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive using a Binx spit test on 31Mar2021; tested positive using a spit test on 31Mar2021; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 1st dose (lot number: EL9262) on Jan2021, the 2nd dose (lot number: EN6202) on 25Feb2021; both via an unspecified route of administration in the left arm at single dose for COVID-19 immunisation. Medical history included hypertension (well controlled). Concomitant medications were unknown. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient tested positive using a spit test on 31Mar2021. No treatment was received for events. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid via PCR test on 28Mar2021; tested positive for Covid via PCR test on 28Mar2021; This is a spontaneous report from a Non-contactable Consumer (Patient). The female patient of an unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot and batch number not reported), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. patient received both doses of the Pfizer BioNTech Covid 19 vaccine, second dose on 21Mar2021. She then tested positive for Covid via PCR test on 28Mar2021. She was calling to see if she needs to get a booster shot. (AE due to potential lack of efficacy) (possible PQC due to potential lack of efficacy). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dystonia
Clinical narrative: 12 hours after receiving the vaccination I was speaking to my husband and my neck and face started to uncontrollably move and spasm. This was painful and concerning. It got violent and much worse over; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en2613) on 23Mar2021 11:30 at single dose in right arm for COVID-19 immunisation. Medical history included Covid-19, asthma, gastroparesis, surgeries, gastric pacemaker, allergies to Penicillin, soya. Concomitant medications included dicyclomine, sucralfate, famotidine, and ondansetron. The patient previously received cefalexin monohydrate (KEFLEX) and Amoxicillin and had drug allergy. The patient previously received first dose of BNT162B2 (Lot number: en6202) on 02Mar2021 11:30AM in right arm. 12 hours after receiving the vaccination the patient was speaking to her husband and her neck and face started to uncontrollably move and spasm. This was painful and concerning. It got violent and much worse over the next few minutes, She could not control the movements. She called emergency responders and got an ambulance to the hospital. She was given muscle relaxers and sent home. Over the next two days it got worse and more painful so she went to the ER hospital again and they did a CT and blood work and said it was dystonia. She was given ativan and it stopped the convulsions. Again she was sent home. The dystonia continued to happen all day every day. She had returned to the ER one more time and needed medical intervention to control the awful, life changing adverse reaction. This was a horrible experience. She was completely devastated. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID tested post vaccination. The outcome of convulsions was resolved. The outcome of other events was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive today for covid 19; tested positive today for covid 19; This is a spontaneous report from a non-contactable other hcp (Hospital worker) reported for him/herself.  A patient of unspecified age and gender received series of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient completed Pfizer Covid vaccine series in January (as reported) and tested positive today (31Mar2021) for Covid 19, also reported that "This is my second report in two days of positive Covid post vaccination with Pfizer Covid vaccine." The outcome for the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, SARS-CoV-2 test
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:30 (Lot Number: ER8733), at the age of 57-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included High blood pressure. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; amoxicillin  taken for an unspecified indication, start and stop date were not reported.  On 29Mar2021 12:15, the patient experienced atrial fibrillation 4 days after injection.  The event includes emergency room visit and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 29Mar2021.  The outcome of the event was unknown.  Therapeutic measures were taken as a result of the event which includes IV medication.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Decreased appetite, Dizziness, Headache
Clinical narrative: dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Syncope
Clinical narrative: dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, auditory, Headache, Sinus pain, Tinnitus
Clinical narrative: unusual sensation of sharp tinny sound when she was talking/ hear someone talking nonstop causing her irritation; Tinnitus like symptoms; mild headache; mild sinus irritation; This is a spontaneous report received from a contactable consumer(patient).   A 53-year-old female patient(not pregnant) received BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 02:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was none. Concomitant medication included estradiol, progesterone (BIJUVA) taken for hormone replacement therapy. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 15:00, She experienced tinnitus like symptoms, unusual sensation of sharp tinny sound when she was talking. First time was in a restaurant and she could hear someone talking nonstop causing her irritation and onset of a mild headache. She was also feeling mild sinus irritation. There was no treatment. Outcome of events was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune issues; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated she experienced autoimmune issues and she had received the first dose of the Covid-19 vaccine. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe Vertigo about a day after the shot; This is a spontaneous case received from two contactable consumers. An adult male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The 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. The patient experienced severe vertigo about a day after the shot on 29Mar2021. It was unknown if the treatment received for the adverse event or not. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.  No follow up attempts are needed. information about lot/batch number can not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The individual received the Pfizer vaccine on January 6th and January 27th and tested positive for Covid this week (exact date unknown).; The individual received the Pfizer vaccine on January 6th and January 27th and tested positive for Covid this week (exact date unknown).; This is a spontaneous report from a contactable other hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The clincal curse was reported as follows: the individual received the pfizer vaccine on january 6th and january 27th and tested positive for covid in Mar2021 (reported as : this week (exact date unknown) .The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Mar2021  .      No follow-up attempts are needed. No further information is expected. .; Sender's Comments: Based on information provided, the events of "tested positive for covid in Mar2021" is related to bnt162b2 inherent to the therapy.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache
Clinical narrative: Stroke; Headache; This is a spontaneous report from a contactable healthcare professional through a Pfizer sales representative. A 7-decade-old (60 to 61 years old) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 28Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included migraine; was COVID-19 positive from 06Dec2020 to an unspecified date; and was sick from Dec2020 to an unknown to an unspecified date. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) for COVID-19 immunization. On 16Mar2021, the patient had stroke; assessed as serious (medically significant). On an unspecified date in 2021, the patient had headache. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event stroke most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. 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: M
Vaccine: COVID19
Symptoms: Cardiac fibrillation
Clinical narrative: started fibrillating; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the patient started fibrillating on an unspecified date. The patient got the vaccine and a couple hours later he started fibrillating and was still dealing with it. The consumer's seriousness assessment for started fibrillating was unspecified. The patient visited the doctor and the doctor adjusted his medications a bit, seems to be healing. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza A virus test, Influenza B virus test, SARS-CoV-2 test
Clinical narrative: positive COVID 19 with symptoms; positive COVID 19 with symptoms; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 61-year-old, on 12Mar2021 09:00, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was reported as none. The patient's concomitant medications were not reported.  The patient had a scratchy throat on 23Mar2021; then she got a cough on 24Mar2021 and had not slept very well; she got a low grade fever of 99.9 and 100.2; then on 25Mar2021 she had a teladoc appointment because she thought she had a sinus infection. The doctor ask her to come in for tests. On 26Mar2021, she had the influenza A and B test and both were negative; and the COVID test which was positive for COVID 19 infection. By 26Mar2021, the cough had become a barking cough. Mentions she lost her taste on about the 27Apr2021 (as reported); she remembers because she was trying to eat a grilled cheese sandwich with lots of butter; adds she could just taste bitter on the edge of the tongue. Even sweet tasted bitter on the middle of her tongue. Her friend sent her something to try; she a roasted orange until it was black on the outside, and ate the warm orange mixed with brown sugar and it tasted like sweet grapefruit and then drank some water; after that her taste was there. When she got the COVID 19 test that was positive she couldn't believe it because she had had the vaccine, but her son told her the vaccine is working because you are not dead. Patient wanted to change her second dose appointment because the patient is now in quarantine and has COVID 19 infection. The events required physician office visit. The patient did not receive other vaccines the same date COVID-19 vaccine was administered and 4 weeks prior vaccination. Outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Depression, Fatigue, Memory impairment
Clinical narrative: mind and memory depression; mind and memory depression; tired; sleepy; back pain got worse; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, intramuscular in right arm on 26Feb2021 10:15, at 65 years of age, (Batch/Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included knee surgery on 23Jan2019, some tiredness, disability (reported 40% on back and 30% on mental) and mental depression since 1978 and ongoing. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 05Feb2021 at 10:15 AM (Batch/Lot number: E23247), via intramuscular route in left arm and one dose of Flu vaccine on 14Jan2021 in left arm. Concomitant medications included acetaminophen 500 mg twice daily for back pain, lithium carbonate 1 tablet 300 mg for depression and lamotrigine 25 mg 1 tablet daily for depression, all taken since an unknown date and an unspecified medicine for Disability 40% since an unknown date. On 26Feb2021, 8 hours after the second vaccine dose, the patient experienced tired and sleepy "skeleton" and back pain got worse and shoulder pain and, on an unspecified date, he experienced mind and memory depression. No treatment was administered to the patient for the reported events. The events tired and sleepy resolved on 28Feb2021, the event shoulder pain was resolving, whereas the outcome of the events back pain got worse, mind and memory depression was unknown at the time of the report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: mind and memory depression; mind and memory depression; tired; sleepy; back pain got worse; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, intramuscular in right arm on 26Feb2021 10:15, at 65 years of age, (Batch/Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included knee surgery on 23Jan2019, some tiredness, disability (reported 40% on back and 30% on mental) and mental depression since 1978 and ongoing. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 05Feb2021 at 10:15 AM (Batch/Lot number: E23247), via intramuscular route in left arm and one dose of Flu vaccine on 14Jan2021 in left arm. Concomitant medications included acetaminophen 500 mg twice daily for back pain, lithium carbonate 1 tablet 300 mg for depression and lamotrigine 25 mg 1 tablet daily for depression, all taken since an unknown date and an unspecified medicine for Disability 40% since an unknown date. On 26Feb2021, 8 hours after the second vaccine dose, the patient experienced tired and sleepy "skeleton" and back pain got worse and shoulder pain and, on an unspecified date, he experienced mind and memory depression. No treatment was administered to the patient for the reported events. The events tired and sleepy resolved on 28Feb2021, the event shoulder pain was resolving, whereas the outcome of the events back pain got worse, mind and memory depression was unknown at the time of the report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid on 28Mar 2021.; I tested positive for Covid on 28 Mar 2021.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA 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 immunisation.  The patient medical history and concomitant medications were not reported. Patient took the first dose of the Pfizer Covid 19 vaccine and scheduled to the second dose on 7Apr2021. patient tested positive for Covid on 28Mar2021. Patient questioned can he still take the second dose even though he tested positive. Patient also questioned can he receive the vaccine if he have a current or past diagnosis of covid-19 infection. It was reported that pfizer-biontech covid-19 vaccine does not contain sars-cov-2 and cannot give you covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.  These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is an initial spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported. A female patient with an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient had first shot of vaccine. She said had a headache, but that it could be just allergies. Want to know if she can take aspirin (Excedrin). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypoaesthesia, Pain, Rash, SARS-CoV-2 test
Clinical narrative: dead arm; Feels achy; feels like he has a rash; he has Covid; This is a spontaneous report from a contactable reporter via Pfizer-sponsored program.  Amale patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient got his 1st dose on 18Mar2021 and he had no side effects until recently. In Mar2021, the patient was experiencing no fever, but felt achy and a dead arm. In Mar2021, the patient felt he has a rash but no visible rash was on the outside of the skin. The patient did get tested for Covid and it was negative in Mar2021, but it was reported that then the patient had Covid (in Mar2021, sars-cov-2 test unknown results; patient had Covid). The outcome of the events was unknown. Follow-up attempts are completed. The batch/lot number is not available despite the follow-up attempts made. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Had heart flips four days after the first shot; This is a spontaneous report from a contactable consumer, reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient had heart flips four days after the first shot, continued through the whole vaccinated month. No treatment was received. 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. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. The outcome of the event was recovered on an unspecified date.  Information on the batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Ear discomfort, Feeling abnormal, Head discomfort
Clinical narrative: shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unsettled stomach ( a little queasy).; Felt pressure with slight headache; Felt pressure with slight headache/felt pressure in my head; Loud Ringing in both ears; dizzy/dizzy spell; nauseated/unsettled stomach ( a little queasy)/sick to my stomach; body felt uneasy like it was fighting something inside; pain at injection site and side of left neck; pain at injection site and side of left neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included vitiligo and known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient has no other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 22Mar2021, the patient got the shot and later (at 18:00) had pain at injection site and side of left neck. On 23Mar2021 10:30, the patient experienced loud ringing in both ears, felt dizzy and nauseated, and body felt uneasy like it was fighting something inside. On 24Mar2021, the patient was still having ringing in both ears, feel nauseated on and of lasting at least 30 seconds or so. From 25Mar2021 to 29Mar2021, ringing in ears sometimes get louder than other times, he also felt pressure with slight headache. On 30Mar2021, ringing in ears intensified and had a hard time falling asleep. The patient felt pressure in her head. She also had slight headache and an unsettled stomach (a little queasy). On 31Mar2021, ringing seems lower today; ears feel clogged. She still has pressure in head with slight headache and had one episode of dizzy spell for a few seconds only. At night, ringing in ears intensified. On 01Apr2021, lower ringing in ears noted. On 02Apr2021, the patient had pressure in head, clogged ears, sick to her stomach, shaky inside her body, and felt like passing out. Ringing was intensified at night. On 03Apr2021, headache and pressure in head were noted. The events resulted in doctor or other healthcare professional office/clinic visit but were not treated. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.