chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Headache, Herpes zoster, Rash papular, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles / which presented as a quarter sized area of bumps/pain; pain on either my lower back or forehead; pain on either my lower back or forehead; Bumps; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mouth ulcer (suffered since childhood, and about 20 years).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, low back pain, forehead headache and raised rash. On an unknown date, the outcome of the vaccination failure, shingles, low back pain, forehead headache and raised rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, low back pain, forehead headache and raised rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  A number of years ago from the reporting date, the patient was diagnosed with shingles which presented as a quarter sized area of bumps/pain on either of his/her lower back or forehead. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up was not required, as no contact details were available.
Sex: F
Vaccine: DTP
Symptoms: Mobility decreased, Product administered to patient of inappropriate age, Skin tightness
Clinical narrative: couldn´t get out of bed; her skin was so tight / though it was gonna rip; Inappropriate age at vaccine administration; This case was reported by a nurse via other manufacturer and described the occurrence of mobility decreased in a child female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   The patient's past medical history included fluid retention (Family History), heart disorder (Family History) and heartbeats irregular (Family History). Concurrent medical conditions included asthma (Family History) (mother uses three inhaler a day since 2000), allergy to animal (Family History) (cat and dogs) and allergy (Family History) (Horse serum).   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced mobility decreased, skin tightness and inappropriate age at vaccine administration. On an unknown date, the outcome of the mobility decreased, skin tightness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the mobility decreased and skin tightness to be related to DTP vaccine.  Additional details were provided as follows: The case was reported by patient's parent. Age at vaccination was not reported. The patient's parent had received Flu vaccine, Pneumonia vaccine and Tetanus vaccine. The patient's parent received concomitant medication included salbutamol sulphate (Albuterol), salmeterol xinafoate (Serevent), budesonide (Pulmicort) and torasemide.  The reporter stated that her daughter received DTP vaccine when she was 8 or 9 years old and the shot was delayed as the patient could not get out of bed, her skin was too tight as it gonna rip. The case was linked with the case US2021AMR022067 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR022067:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: My arm is super sore; Had a little bit of fever; Made it difficult to sleep; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced pain in arm, fever and difficulty sleeping. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, fever and difficulty sleeping were unknown.   The reporter considered the pain in arm, fever and difficulty sleeping to be possibly related to Shingrix.  Additional details were reported as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient stated that the social media informed him that the vaccine would be rough him up a little bit and they were not wrong. The patient reported that just 24 hours from the 1st of 2 shots, the patient had side effects were pretty, his arm was super sore and he event had a little bit of fever, both of which made it difficult to sleep. The patient took Tylenol as treatment medicine for fever, sore arm and difficult sleep. The information regarding consent to follow up was not reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Sensitive skin, Vaccination failure
Clinical narrative: skin on her stomach around to her back is sensitive; skin on her stomach around to her back is painful; Vaccination failure /  7-8 days ago she developed a mild case of shingles; mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 2nd dose of Shingrix. On 18th September 2019, the patient received the 1st dose of Shingrix. On 13th January 2021, 421 days after receiving Shingrix and 483 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced sensitive skin and skin pain. On an unknown date, the outcome of the vaccination failure, shingles, sensitive skin and skin pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sensitive skin and skin pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received 1st and 2nd dose of Shingrix and now 7 to 8 days ago she developed a mild case of shingles. The patient stated that she had no rash or blisters but between 1 and 2 year after receiving 1st and 2nd dose of Shingrix, the skin on her stomach around to her back was sensitive and painful. The physician offered to prescribe antiviral medication, but patient did not want to take antiviral medication. The patient stated that her case was mild. The reporter did not gave consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Episode of angioedema; A spontaneous report was received from a healthcare professional concerning two patient's who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an episode of angioedema.  The patients' medical histories included both patients receiving dermatological fillers. No relevant concomitant medications were reported.  On unknown date, prior to the event , both patients received their first of two planned doses of mRNA-1273 intramuscularly of prophylaxis of COVID-19 infection.  On an unknown date, after vaccine administration, both patients experienced an episode of angioedema.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, episode of angioedema, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The Patient's history of having dermatological fillers could be a contributing factor. Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure diastolic increased
Clinical narrative: Atrial fibrillation; elevated diastolic blood pressure; A spontaneous report was received from a consumer, who is a 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sustained atrial fibrillation and elevated diastolic blood pressure.  The patient's medical history or concomitant medications were not provided.  On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (037M20A) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection.  On 14-Feb-2021, the patient experienced the sustained atrial fibrillation and elevated diastolic blood pressure, which were considered medical significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event was unknown.  The patient believe the events, sustained atrial fibrillation and elevated diastolic blood pressure, may be related to the vaccine.  Consent given for Safety Division to follow up with her, if needed.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Illness, Pain, Syncope
Clinical narrative: Fainted; dizziness; All night she was sick; Chills; Aches; A spontaneous report was received from a consumer concerning a 57 years old, female patient who experienced chills, aches, dizziness, fainted and was sick all night.  The patient's medical history was not provided. Concomitant products included cetirizine and an unspecified nasal spray for allergies.   On 20-JAN-2021 the patient received their first of two planned doses of mRNA-1273 (Batch number: 012120A) on 20-JAN-2021. On 17-FEB-2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number 016M20A) for prophylaxis of COVID-19 infection.  On 17-FEB-2021, the patient was sick for all night, on the same day patient experienced chills and aches.  On 18-FEB-2021, the patient had dizziness and fainted.  Treatment information was not provided/unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, chills, aches, dizziness, was sick all night were considered unknown. The event, fainting, was recovered on 18-FEB-2021.; Reporter's Comments: This case concerns a male of unknown age who experienced a serious unexpected event of SYNCOPE along with NS unexpected events of dizziness, illness, pain, and a NS expected event of chills.  The events occurred 45 minutes after the first dose of mRNA-1273. Syncopal event reported as resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia; A spontaneous report was received from a NURSE, concerning a 74-Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25-Jan-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (lot/batch: 042L20A) for COVID-19 infection prophylaxis.  On an unspecified date in 2021, the patient experienced the event thrombocytopenia and presented to emergency room and was hospitalisation on an unspecified date in 2021. His platelets dropped down to 2. The event was also considered to be medically significant. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event was considered unknown.  The reporter assessed the event thrombocytopenia as related to study drug.; Reporter's Comments: Very limited information regarding this event of thrombocytopenia has been provided at this time. onset date of event, patient's medical history full blood count results with reference ranges are lacking.   Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Urinary tract infection
Clinical narrative: UTI; Fall; A spontaneous report was received from a consumer (caregiver)  concerning a 93 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced urinary tract infection (UTI) and fall.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the UTI and fall. The patient is currently in a rehab facility due to the fall. The patient received treatment medication with unspecified antibiotics for the UTI. The patient was re-scheduled for the second vaccine on 12 Mar 2021, which falls outside the 42-day timeframe (which would be 49 days after the first vaccine). No further information was provided.   Action taken with second dose of mRNA-1273 in response to the events was unknown.   The outcome of the events, UTI and fall, were not reported.; Reporter's Comments: This case concerns a 93 year old, female patient, who is in a rehab facility due to fall, experienced a serious unexpected event of urinary tract infection, after receiving mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: Aspirated some vomit in lungs; Light-headed; Vomited; Nausea; Soreness; Tired; A spontaneous report was received from a consumer who was also a 94-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, tiredness, vomiting, aspiration, lightheadedness, and nausea.   The patient's medical history included major depression. Concomitant medications included fluoxetine 5 mg and celecoxib 200 mg.   On 08-feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 8411201) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, the patient began to experience soreness following vaccination. Soreness resolved within half an hour. The patient also reported feeling tired.   On 18 Feb 2021, the patient experienced vomiting, lightheadedness, and nausea. He felt as if he aspirated some vomit into his lungs.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, soreness and vomiting, were considered resolved on 18 Feb 2021.    The outcome of events, lightheadedness, aspiration, nausea, and tiredness, was unknown.; Reporter's Comments: This case concerns a 94-year-old male who experienced Serious unexpected events of Aspiration along with NS unexpected events of dizziness, pain and NS expected events of nausea, vomiting, fatigue.  The events occurred 11 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes recovered.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Aspirated some vomit in lungs; Light-headed; Vomited; Nausea; Soreness; Tired; A spontaneous report was received from a consumer who was also a 94-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, tiredness, vomiting, aspiration, lightheadedness, and nausea.   The patient's medical history included major depression. Concomitant medications included fluoxetine 5 mg and celecoxib 200 mg.   On 08-feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 8411201) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, the patient began to experience soreness following vaccination. Soreness resolved within half an hour. The patient also reported feeling tired.   On 18 Feb 2021, the patient experienced vomiting, lightheadedness, and nausea. He felt as if he aspirated some vomit into his lungs.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, soreness and vomiting, were considered resolved on 18 Feb 2021.    The outcome of events, lightheadedness, aspiration, nausea, and tiredness, was unknown.; Reporter's Comments: This case concerns a 94-year-old male who experienced Serious unexpected events of Aspiration along with NS unexpected events of dizziness, pain and NS expected events of nausea, vomiting, fatigue.  The events occurred 11 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes recovered.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Doesn't feel well; Heart rate 97; Blood pressure went to 150/91 at 6pm, at 7pm 192/101; Heart rate fluctuating; Fatigued; A Spontaneous report was received from Consumer concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Blood pressure went to 150/91 at 6pm, at 7pm 192/101, heart rate 97/elevated heart rate or his heart rate was fluctuating, was fatigued and he did not feel well.  The patient's medical history included prostate cancer and bone cancer.   The concomitant medication was not reported.  On 20-Jan-2021 prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 030L20A, Expiration date: not provided), on 17-Feb-2021 second dose was received at 9:00 am (Lot number: 030M20A, Expiration rate: unknown) via intramuscular route for prophylaxis of COVID-19 infection.   On 17-Feb-2021, after administration of vaccine patient experienced Blood pressure went to 150/91 at 6pm, at 7pm 192/101, heart rate 97/elevated heart rate or his heart rate was fluctuating, was fatigued but was not sure if that was part of the vaccine or heart medication. On an unknown date patient did not feel well.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome was unknown for all events. Treatment was included Clonidine 0.2ml.; Reporter's Comments: This case concerns a 77 Y/O M with PMHx of prostate cancer and bone cancer who had serious unexpected Blood pressure increased and Heart rate increased along with a NS unexpected Heart rate irregular, malaise, and NS expected fatigue.  Event onset 29 days after first dose mRNA-1273. Treated with clonidine. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Malaise
Clinical narrative: Doesn't feel well; Heart rate 97; Blood pressure went to 150/91 at 6pm, at 7pm 192/101; Heart rate fluctuating; Fatigued; A Spontaneous report was received from Consumer concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Blood pressure went to 150/91 at 6pm, at 7pm 192/101, heart rate 97/elevated heart rate or his heart rate was fluctuating, was fatigued and he did not feel well.  The patient's medical history included prostate cancer and bone cancer.   The concomitant medication was not reported.  On 20-Jan-2021 prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 030L20A, Expiration date: not provided), on 17-Feb-2021 second dose was received at 9:00 am (Lot number: 030M20A, Expiration rate: unknown) via intramuscular route for prophylaxis of COVID-19 infection.   On 17-Feb-2021, after administration of vaccine patient experienced Blood pressure went to 150/91 at 6pm, at 7pm 192/101, heart rate 97/elevated heart rate or his heart rate was fluctuating, was fatigued but was not sure if that was part of the vaccine or heart medication. On an unknown date patient did not feel well.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome was unknown for all events. Treatment was included Clonidine 0.2ml.; Reporter's Comments: This case concerns a 77 Y/O M with PMHx of prostate cancer and bone cancer who had serious unexpected Blood pressure increased and Heart rate increased along with a NS unexpected Heart rate irregular, malaise, and NS expected fatigue.  Event onset 29 days after first dose mRNA-1273. Treated with clonidine. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Delirium, Illness
Clinical narrative: Got senior delirium syndrome; Very sick; A spontaneous report  was received from a consumer who was also a male patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced senior delirium syndrome(delirium) and was very sick (illness).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unspecified date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date the patient received vaccine and experienced the senior delirium syndrome and patient was very, very, very sick and patient was hospitalized for events. Treatment information was not provided.  Action taken with the drug in response to the events is not applicable as the patient received both scheduled doses of mRNA-1273 prior to the events  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, COVID-19, Chest X-ray, Drug ineffective, Pulmonary embolism
Clinical narrative: pulmonary embolism; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was admitted with pulmonary embolism and Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after the 1st dose of Pfizer vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject product contributed to the events. The reported events may likely represent intercurrent medical conditions.  Pulmonary embolism is known to be a potential complication of COVID 19 infection, including COVID 19 associated pneumonia.   There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan and coagulation panel, counteractive treatment measures and concomitant medications.  This case will be reassessed upon receipt of follow-up information.   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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pulmonary embolism; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was admitted with pulmonary embolism and Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after the 1st dose of Pfizer vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject product contributed to the events. The reported events may likely represent intercurrent medical conditions.  Pulmonary embolism is known to be a potential complication of COVID 19 infection, including COVID 19 associated pneumonia.   There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan and coagulation panel, counteractive treatment measures and concomitant medications.  This case will be reassessed upon receipt of follow-up information.   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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Echocardiogram, Electrocardiogram, Headache, Hypertension
Clinical narrative: Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Ischaemic stroke, Magnetic resonance imaging, Neurological examination, Visual impairment
Clinical narrative: Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Eye inflammation, Eye pain, Iritis, Ocular hyperaemia
Clinical narrative: classic symptoms in my right eye - pain, significant/redness/inflammation; some loss of visual acuity; uveitis/prior episodes of iritis/uveitis, but was symptom free; iritis/uveitis/prior episodes of iritis/uveitis, but was symptom free; iritis/prior episodes of iritis/uveitis, but was symptom free; iritis/prior episodes of iritis/uveitis, but was symptom free; classic symptoms in my right eye - pain, significant/redness/inflammation; classic symptoms in my right eye - pain, significant/redness/inflammation; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm on 16Feb2021 15:00 at a single dose for COVID-19 immunisation. The patient's medical history included HLA-B27 gene mutation and iritis/uveitis. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. There were no concomitant medications. On 18Feb2021 23:00, the patient experienced iritis/uveitis. He had prior episodes of iritis/uveitis, but was symptom free and not taking any medications for it as of his innoculation date. He have now developed the classic symptoms in his right eye - pain, significant/redness/inflammation and some loss of visual acuity. Therapeutic measures were taken as a result of prednisone eye drops and ibuprofen (ADVIL) for pain. Outcome of the events was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Uveitis, Visual acuity reduced
Clinical narrative: classic symptoms in my right eye - pain, significant/redness/inflammation; some loss of visual acuity; uveitis/prior episodes of iritis/uveitis, but was symptom free; iritis/uveitis/prior episodes of iritis/uveitis, but was symptom free; iritis/prior episodes of iritis/uveitis, but was symptom free; iritis/prior episodes of iritis/uveitis, but was symptom free; classic symptoms in my right eye - pain, significant/redness/inflammation; classic symptoms in my right eye - pain, significant/redness/inflammation; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm on 16Feb2021 15:00 at a single dose for COVID-19 immunisation. The patient's medical history included HLA-B27 gene mutation and iritis/uveitis. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. There were no concomitant medications. On 18Feb2021 23:00, the patient experienced iritis/uveitis. He had prior episodes of iritis/uveitis, but was symptom free and not taking any medications for it as of his innoculation date. He have now developed the classic symptoms in his right eye - pain, significant/redness/inflammation and some loss of visual acuity. Therapeutic measures were taken as a result of prednisone eye drops and ibuprofen (ADVIL) for pain. Outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Lip swelling, Rash pruritic, Swelling face, Urticaria
Clinical narrative: swelling migrated from right lower jaw region over lips and stopped at the left side of lips; slurred voice; rash with whelps across his back and down both legs with itching irritation; rash with whelps across his back and down both legs with itching irritation; swelling migrated from right lower jaw region over lips and stopped at the left side of lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 06Feb2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included metformin, gabapentin, atorvastatin, and alprenolol hydrochloride (ATENENOL). The patient previously took Demerol and aspirin experienced allergies (known allergies). 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. On 18Feb2021 06:30, the patient experienced swelling migrated from right lower jaw region over lips and stopped at the left side of lips, some swelling has continued, and slurred voice (more pronounced when standing). On the same day at 06:30, the patient experienced rash with whelps across his back and down both legs with itching irritation. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Zyrtec and Kenalog. The patient has not been tested for COVID-19 since the vaccination. The patient has not recovered from the events.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Headache, Heart rate, Neck pain
Clinical narrative: Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervousness, Nightmare, Oxygen saturation
Clinical narrative: Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Neck pain, Nervousness
Clinical narrative: Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Nightmare
Clinical narrative: Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: ITP (Immune Thrombocytopenia); This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had since returned to the clinic with ITP (Immune Thrombocytopenia) with a platelet count of 10/abnormal, which they were treating with steroids. The doctor had already prescribed; Prednisone 20mg, 3 tablets daily, 100 count. The reporter asked it ITP was a reported AE and if there was a protocol for treatment besides the steroids. The provider already directed caller not to get the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the event immune thrombocytopenia and suspect vaccine BNT162B2. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure 3 days after vaccine; This is a spontaneous report from a contactable other health professional. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included seizure. The patient had known allergies: Risperidone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced seizure 3 days after vaccine on 25Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported seizure 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.