chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Eczema, SARS-CoV-2 test
Clinical narrative: Weeping eczema of toes started.Especial exacerbation began after second vaccination. Now it is crossing on fingers.; This is a spontaneous report from a contactable consumer(patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: ER 8736 and expiration date was not reported) at dose 1, single and via unspecified route of administration on an unspecified date (Lot Number and expiration date were not reported) dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included nifedipine (NIFEDIPINE); hydralazine (HYDRALAZINE); rivaroxaban (XARELTO). Patient had no known allergies. The patient experienced weeping eczema of toes and exacerbation began after second vaccination and it is crossing on fingers (hospitalization) on 08Apr2021 17:00. The patient was hospitalized for 5 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal swab: PCR test: negative on 06May2021. The events resulted in Physician or other HCP visit. No treatment was given for events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Limb discomfort, Off label use, Vaccination site rash
Clinical narrative: I have a rash at the injection site; Covid arm; This is the third shot; This is the third shot; This is a spontaneous report from a contactable physician (patient). A 38-years-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration on 09Jan2021 at 13:00 as a dose 1, single in the left arm and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC2181) via an unspecified route of administration on 09Jan2021 at 15:00 as a dose 1, single in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Sep2021, the patient experienced rash at the injection site that showed up 2 weeks after the shot and was likely Covid arm and on unspecified date of 2021 patient received third shot of Covid vaccine. Patient did not received treatment for events. The patient underwent lab tests and procedures which included Covid test Unknown- saliva test was negative on 16Sep2021. The outcome of the events rash at the injection site that showed up 2 weeks after the shot and was likely Covid arm was resolving, and other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: bilateral T; This is a spontaneous report from a non-contactable consumer and a non-contactable other HCP. This report was received via a sales representative.   A female patient of an unspecified age received bnt162b2 (BNT162B2), 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.  The patient experienced a bilateral T and she was on Eliquis after her vaccination. The outcome of event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Cerebrospinal fluid leakage, Headache, Investigation, Myalgia
Clinical narrative: but a slight headache started/headaches got extremely strong and unbearable; I had two days of muscular and joint pain.; I had two days of muscular and joint pain.; Around May 7th the body pain was mostly gone; it was determined I had a CSF leak.; This is a spontaneous report from two contactable consumer. A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 04May2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), on 13Apr2021 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunization. On May2021, After the 2nd dose of Pfizer vaccine patient had two days of muscular and joint pain. Around May 7th the body pain was mostly gone but a slight headache started. During the week of May 10th to 14th the headaches got extremely strong and unbearable, and patient went to the emergency room on the 15th of May. After coming back to the Emergency room again a couple days later, many tests and seeing a few neurologists, it was determined patient had a CSF leak. The patient was initially treated with steroids, the headaches subsisted, one blood patch at lower back that solved 50% of the issue. Finally, a second blood patch at upper back by July 29th, that solved the problem. The outcome of the event CSF leakage was recovered, while the events Muscular pain and Joint pain was unknown, body pain was recovering, and Headache was not recovered at time of report.   The lot number for BNT162B2, was not provided and will be requested during follow up
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: but a slight headache started/headaches got extremely strong and unbearable; I had two days of muscular and joint pain.; I had two days of muscular and joint pain.; Around May 7th the body pain was mostly gone; it was determined I had a CSF leak.; This is a spontaneous report from two contactable consumer. A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 04May2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), on 13Apr2021 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunization. On May2021, After the 2nd dose of Pfizer vaccine patient had two days of muscular and joint pain. Around May 7th the body pain was mostly gone but a slight headache started. During the week of May 10th to 14th the headaches got extremely strong and unbearable, and patient went to the emergency room on the 15th of May. After coming back to the Emergency room again a couple days later, many tests and seeing a few neurologists, it was determined patient had a CSF leak. The patient was initially treated with steroids, the headaches subsisted, one blood patch at lower back that solved 50% of the issue. Finally, a second blood patch at upper back by July 29th, that solved the problem. The outcome of the event CSF leakage was recovered, while the events Muscular pain and Joint pain was unknown, body pain was recovering, and Headache was not recovered at time of report.   The lot number for BNT162B2, was not provided and will be requested during follow up
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Feeling that she actually have symptoms of COVID; Feeling like there is symptoms of COVID; Feels like she is experiencing COVID symptoms after having the vaccine; This is a spontaneous report from a contactable consumer (patient husband). A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm, on 22Sep2021 (Batch/Lot Number: FF2588) as dose number unknown, single for Covid-19 immunisation.Medical history included impaired gastric emptying and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient got the vaccine a couple days ago and she is feeling that she actually have symptoms of COVID in Sep2021 and she wanted to know what she should do like if this is from the vaccine or like is it something normal or should she go to a doctor. She is feeling like there is symptoms of COVID. Feels like she is experiencing COVID symptoms after having the vaccine. There was no lab test recently, she did with the COVID Vaccine couple days ago (further clarification unknown). She has other medical condition. The patient did not receive any treatment for the event. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Atrial fibrillation within 24 hours along with high heart rate 135; Atrial fibrillation within 24 hours along with high heart rate 135; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 31-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 21Sep2021 16:45 (lot number: EW0186) at the age of 31 years old as single dose for COVID-19 immunization. Medical history included known allergies: Penicillin. Concomitant medications were not reported. The patient experienced Atrial fibrillation within 24 hours along with high heart rate 135 on 22Sep2021 17:30. The events result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. COVID test post vaccination: Nasal Swab, Pcr on 22Sep2021 with Negative results. The outcome of the events were unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Atrial fibrillation, heart rate increased and BNT162B2.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neck pain, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe pain in the neck that travels in to the right arm. The pain is so severe that nothing I have tried is releaving it and it's just getting worse.; a crippling pain was reported as worsened; Pain started in left arm and moved up to neck; Can't do anything, it hurts so bad; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection, Batch/Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 14Sep2021 at 16:45 (at the age of 30-years-old) single dose for covid-19 immunisation. Medical history was none. Concomitant medications included bupropion and buspirone. The patient previously took codeine. 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. On 15Sep2021 at 19:00, patient experienced severe pain in the neck that travels into the right arm. She stated it was not so bad at first, and she thought it would go away. The pain was so severe that nothing she had tried was relieving it and it's just getting worse. A crippling pain was reported as worsened. Pain started in left arm and moved up to neck. She can't do anything, it hurts so bad. This resulted to emergency room visit at physician office. She stated that the doctors cannot figure out what is going on. She was treated with muscle relaxers and anti-inflammatory medication. She reported being twice at medical health center for these symptoms. Caller stated that she just had an X-Ray, but they refused to do any blood work on her. She stated she has an appointment tomorrow for an MRI. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was negative on 18Sep2021. Therapeutic measures were taken as a result of severe pain in the neck that travels in to the right arm and the pain is so severe that nothing i have tried is relieving it and it's just getting worse and patient was treated with muscle relaxers and anti-inflammatory medication.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dermatitis acneiform, Injected limb mobility decreased, Nausea, Pain
Clinical narrative: Severe nausea; Violently vomiting; Fever; Extremely achy from waste up; Could not move my left arm; Could not move my left arm. It also had a massive lump that was dark black and blue for a week with a red welt underneath it; My back was in so much pain; a pimple resemblance/ almost looked like measles; a pimple resemblance/ almost looked like measles; This is a spontaneous report from a contactable consumer (the patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 30135BA) via an unspecified route of administration in Left arm on 12Sep2021 16:00 at age of 41-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient began with severe nausea that evening then began violently vomiting for 2 days (events start date:12Sep2021 22:30). Was running fever, extremely achy from waste up. Could not move her left arm. It also had a massive lump that was dark black and blue for a week with a red welt underneath it. She thought the aches were normal, but her back was in so much pain. She finally decided to look at it and was horrified that it was covered from top to bottom with a pimple resemblance/ almost looked like measles. Some had white heads they varied in size and were so painful. Events start date: 12Sep2021 22:30. The next morning her left thigh began getting them along with her face and chest. She had to go to her primary that Wednesday where he gave her IV steroids. It was 27Sep2021 and her back, chest and face are still a mess. She was fearful her back will scar due to the amount that was covered and that it was not going away. Her doctor did not want her getting the second dose not does the pharmacist who she went to speak with and show the reaction to that Thursday. Need more room to write. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment "IV steroid" received for the events. The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash morbilliform, Vaccination site mass, Vomiting
Clinical narrative: Severe nausea; Violently vomiting; Fever; Extremely achy from waste up; Could not move my left arm; Could not move my left arm. It also had a massive lump that was dark black and blue for a week with a red welt underneath it; My back was in so much pain; a pimple resemblance/ almost looked like measles; a pimple resemblance/ almost looked like measles; This is a spontaneous report from a contactable consumer (the patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 30135BA) via an unspecified route of administration in Left arm on 12Sep2021 16:00 at age of 41-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient began with severe nausea that evening then began violently vomiting for 2 days (events start date:12Sep2021 22:30). Was running fever, extremely achy from waste up. Could not move her left arm. It also had a massive lump that was dark black and blue for a week with a red welt underneath it. She thought the aches were normal, but her back was in so much pain. She finally decided to look at it and was horrified that it was covered from top to bottom with a pimple resemblance/ almost looked like measles. Some had white heads they varied in size and were so painful. Events start date: 12Sep2021 22:30. The next morning her left thigh began getting them along with her face and chest. She had to go to her primary that Wednesday where he gave her IV steroids. It was 27Sep2021 and her back, chest and face are still a mess. She was fearful her back will scar due to the amount that was covered and that it was not going away. Her doctor did not want her getting the second dose not does the pharmacist who she went to speak with and show the reaction to that Thursday. Need more room to write. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment "IV steroid" received for the events. The outcome of the events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: itchy hive about 24 hours after the injection at the injection site; itchy hive about 24 hours after the injection at the injection site; This is a spontaneous report from a non-contactable physician (patient). A 62-year-old female patient received the second dose of BNT162B2 (COVID 19 ) via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: EW0162) at the age of 62-year-old as single dose for COVID-19 immunization. Medical history included allergy. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medication was none. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 27May2021 (Batch/Lot Number: EW0179) at the age of 62-year-old as single dose for COVID-19 immunization. On 24Jun2021,  about 24 hours after the injection, the patient developed a large very itchy hive at the injection site, even with antihistamines and pepcid (allergist suggested this). This took 4 days to go away and required topical steroids in addition to oral antihistamines to overcome the pruritis. Treatment was received. Caused/prolonged hospitalization was no. The outcome of events was recovered on 28Jun2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Retinal tear
Clinical narrative: I ended up having a Retinal tear and I had to get like an emergency procedure because of it; I got I have been given emergency eye surgery; Eye pain; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via intramuscular route in left arm in Apr2021 as dose 2, single for COVID-19 immunization in a pharmacy/drug store but not in a military facility. The patient's medical history was not reported. There were no concomitant medications/other products reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient didn't receive any other vaccines prior to COVID vaccine. The patient received the second dose of vaccination in early April around 08Apr2021. In the end of May, the patient started to have eye pain around 28May2021 and ended up having a retinal tear for which she got an emergency procedure/surgery in Jun2021. After that surgery, the patient didn't need anything but at the time of report, the patient started to hurt again and going to have a call with that doctor. It was reported as there was no investigation assessment. The patient was wondering if this could be a side effect from the vaccine since she was reading it on the website which showed there were some instances in the same way which resolved right away. The outcome of the events was recovered in 2021 but also reported as the events been persisting for about a week from the day of report.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events retinal tear and eye pain and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: Heart started pounding so hard; I had my heart pounding, absolutely pounding; Elevated blood pressure; Heart rate was 135; Heart rate was faster than normal and I still could feel it; This is a spontaneous report from a contactable other health care professional (nurse practitioner) (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number 30145BA and expiry date not reported), via an unspecified route of administration, on 25Sep2021 14:30 (at the age of 74-year-old), as dose 2, single, for COVID-19 immunisation. Patient had no medical history. Concomitant medication included vitamins. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FC3183 and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as 19Aug around 14:00 (not clarified), as dose 1, single, for COVID-19 immunisation and flu shot on last year. On 25Sep2021 14:35, five minutes after vaccination, the patient heart rate was 135. On 26Sep2021, the patient went to church at 11:00 clock, and the patient could hardly get through it, so the patient went home to rest and suddenly, heart started pounding so hard and had elevated blood pressure. The patient lies down and put feet up against the wall to try to make it better and when it got better, the patient called the doctor. The patient was taken to emergency room with a pounding heart and elevated blood pressure. When the patient reached emergency room, the patient didn't have another pounding heart, but the blood pressure was elevated the whole time, heart rate was faster than normal, and the patient could feel it. The patient had increased heart rate and some palpitations and a little bit of pounding right before the patient was going to sleep on 26Sep2021 (reported as last night). It was reported that, the patient was not on any cardiac medication at all and did not have cardiac history, and did not have history of hypertension. It was reported that, they just said that probably the immune system was causing blood pressure elevation. The patient underwent lab tests and procedures which included EKG, Troponin, Chest X-Ray, Cardiac Enzymes, BMP, CBC, and Cardiac studies (not clarified further), and everything was normal. Covid test showed negative on 26Sep2021. The outcome for the events was unknown. The reporter stated that the events were related to vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Myocardial necrosis marker, Palpitations, Troponin
Clinical narrative: Heart started pounding so hard; I had my heart pounding, absolutely pounding; Elevated blood pressure; Heart rate was 135; Heart rate was faster than normal and I still could feel it; This is a spontaneous report from a contactable other health care professional (nurse practitioner) (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number 30145BA and expiry date not reported), via an unspecified route of administration, on 25Sep2021 14:30 (at the age of 74-year-old), as dose 2, single, for COVID-19 immunisation. Patient had no medical history. Concomitant medication included vitamins. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FC3183 and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as 19Aug around 14:00 (not clarified), as dose 1, single, for COVID-19 immunisation and flu shot on last year. On 25Sep2021 14:35, five minutes after vaccination, the patient heart rate was 135. On 26Sep2021, the patient went to church at 11:00 clock, and the patient could hardly get through it, so the patient went home to rest and suddenly, heart started pounding so hard and had elevated blood pressure. The patient lies down and put feet up against the wall to try to make it better and when it got better, the patient called the doctor. The patient was taken to emergency room with a pounding heart and elevated blood pressure. When the patient reached emergency room, the patient didn't have another pounding heart, but the blood pressure was elevated the whole time, heart rate was faster than normal, and the patient could feel it. The patient had increased heart rate and some palpitations and a little bit of pounding right before the patient was going to sleep on 26Sep2021 (reported as last night). It was reported that, the patient was not on any cardiac medication at all and did not have cardiac history, and did not have history of hypertension. It was reported that, they just said that probably the immune system was causing blood pressure elevation. The patient underwent lab tests and procedures which included EKG, Troponin, Chest X-Ray, Cardiac Enzymes, BMP, CBC, and Cardiac studies (not clarified further), and everything was normal. Covid test showed negative on 26Sep2021. The outcome for the events was unknown. The reporter stated that the events were related to vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blindness, Cerebrovascular accident, Facial paralysis, Hypoaesthesia
Clinical narrative: my left side from my face became numb; my facial muscles began to droop; could not feel my left side until my hand; I feared I was having a stroke; I was diagnosed with Bells Palsy; I sometimes lose vision in my left eye; numbness; nerve pain; migraines; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm in Mar2021 as single dose for COVID-19 immunization. Medical history included endometriosis, hit by a car as pedestrian in 2008, past migraines and sensitive to latex. Known allergies: gluten intolerant (no celiac disease). The patient performed Nasal Swab in Sep2021 and result was negative. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm in Feb2021 at the age of 34-year-old as single dose for COVID-19 immunization. Four days after the shot, the patient left side from face became numb and facial muscles began to droop. The patient also could not feel left side until hand. The patient went to the emergency room because he feared he was having a stroke. The patient was diagnosed with Bells Palsy, and was told it was perhaps due to the 2nd shot he received. The patient had since visited neurologist, as he sometimes lose vision in left eye, continue to have numbness and nerve pain, and migraines only on that side of face. The patient wear an eye patch at times to rest eye. The patient had also followed up with primary physician who had prescribed Gabapentin for nerve pain. The patient also had O-blood. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Treatment was received included toridol, steriod shot, nerve pain and migraine meds. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neuralgia, SARS-CoV-2 test
Clinical narrative: my left side from my face became numb; my facial muscles began to droop; could not feel my left side until my hand; I feared I was having a stroke; I was diagnosed with Bells Palsy; I sometimes lose vision in my left eye; numbness; nerve pain; migraines; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm in Mar2021 as single dose for COVID-19 immunization. Medical history included endometriosis, hit by a car as pedestrian in 2008, past migraines and sensitive to latex. Known allergies: gluten intolerant (no celiac disease). The patient performed Nasal Swab in Sep2021 and result was negative. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm in Feb2021 at the age of 34-year-old as single dose for COVID-19 immunization. Four days after the shot, the patient left side from face became numb and facial muscles began to droop. The patient also could not feel left side until hand. The patient went to the emergency room because he feared he was having a stroke. The patient was diagnosed with Bells Palsy, and was told it was perhaps due to the 2nd shot he received. The patient had since visited neurologist, as he sometimes lose vision in left eye, continue to have numbness and nerve pain, and migraines only on that side of face. The patient wear an eye patch at times to rest eye. The patient had also followed up with primary physician who had prescribed Gabapentin for nerve pain. The patient also had O-blood. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Treatment was received included toridol, steriod shot, nerve pain and migraine meds. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: strong allergy; strong itchiness; Rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 51 years old) via an unspecified route of administration, administered in Arm Left on 26Sep2021 16:45 (Batch/Lot Number: 30145BA, also reported as "30145PA") as dose 1, single for covid-19 immunisation. Medical history included allergy to insects. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included prednisolone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced strong itchiness and rash on 28Sep2021 02:00, and strong allergy on an unspecified date. The patient stated that she got the vaccine on Sunday 4 PM and she got a very very strong allergy last night (unspecified date) and she doesn't really know what to do. She was going to take allergy medicine, and she just wanted to know what's going to happen next vaccination, if she has to take next vaccination which is in two weeks. The patient wanted to know if it is normal to have allergy or if she just has to stop and not take the second vaccine or if she has to go to the doctor. Therapeutic measures were taken as a result of strong allergy. The events strong itchiness and rash were not treated. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Feeling hot, Hypersensitivity, Urticaria, Weight
Clinical narrative: allergic reaction after the second dose within 5-10 minutes; warm sensation in his ears; hives; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0151), intramuscular, administered in Deltoid Left on 09Apr2021 (at the age of 53years) as dose 2, single for Covid-19 immunization. Historical vaccine included BNT162B2 (lot number: EL9266) on 13Mar2021 for Covid-19 immunization; he did not have any issues after the first dose. Medical history included allergy to shellfish, asthma/asthmatic (since birth), immunocompromised, and Behcet's disease (years ago, never treated for it continuously); Hodgkins Cancer (father), non-small cell (as reported) (brother), and breast cancer (mother). The patient's concomitant medications were not reported. It was reported that the patient had an allergic reaction after the second dose within 5-10 minutes with a warm sensation in his ears and hives. Hives that started in neck and forehead then went to throat and chest; the patient also had warm sensation in ears. He clarified that he started having a warm sensation in his ears. He then got hives which started in neck and had a little on forehead but closer to throat and chest. It was very mild. The patient was sent to the Emergency Room and received two doses of Benadryl. When he took 1st dose of Benadryl, it helped a little bit and he was still itching, but it was not intensive. Then the doctors came in and gave another dose of Benadryl. He added the event was caught in time and he was given 2 doses of Benadryl in Emergency room. He stayed for 3 hours and everything was fine after that. The patient asked if it is safe to receive the booster dose. He stated that one of his doctor's said not to get it, 1 doctor said to get it and then the other doctor said to get it and be monitored slowly.  He wanted to get his own research from Pfizer. The outcome of events was unknown. The reporter seriousness for Hives that started in neck and forehead then went to throat and chest was unspecified.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Renal vasculitis
Clinical narrative: I recently was diagnosed with kidney vasculitis; Other vaccine same date vaccine date 26Feb2021; This is a spontaneous report from a contactable consumer. A 70-year-old male consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en6200) via an unspecified route of administration on 26Feb2021 (at the age of 70-year-old) in arm left at 05:00PM at single dose for COVID-19 immunisation. The patient received also the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en6204) via an unspecified route of administration on 26Feb2021 (at the age of 70-year-old) in arm left at single dose for COVID-19 immunisation. Relevant medical history included diabetes and high blood pressure. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient had not known allergies, nor COVID prior vaccination. He was not tested for COVID post vaccination. The patient had normal kidney function prior to the injection and was recently diagnosed with kidney vasculitis, on 21Aug2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not recovered from vasculitis, outcome for overdose was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; anaphylaxis shock; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient got anaphylaxis shock and COVID-19 on an unspecified date. Outcome of the events was unknown.  The Lot number for the vaccine BNT162b2 was not provided and will be requested during follow-up. Linked Report(s): US-PFIZER INC-202101281145 same reporter, different patient. US-PFIZER INC-202101281146 same reporter, different patient; US-PFIZER INC-202101281147 same reporter, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all of the vaccinated I know ALL are getting covid-19; all of the vaccinated I know ALL are getting covid-19; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, The patient experienced all of the vaccinated know all are getting covid-19 on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test positive on now what about all of the vaccinated I know ALL are getting covid-19. The outcome of event was Unknown   The lot number for [BNT162B2], was not provided and will be requested during follow up. Linked Report(s): US-PFIZER INC-202101281144 same reporter, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrospinal fluid leakage, Computerised tomogram head, Computerised tomogram spine, Headache, Magnetic resonance imaging head
Clinical narrative: Subdural hematoma; CSF leak; headache; This is a spontaneous report from a non-contactable consumer.   A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8731), via intramuscular on 04Sep2021 as dose 1, single for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included diphenhydramine hydrochloride (ZZZQUIL) taken for an unspecified indication, start and stop date were not reported. On 04Sep2021, patient developed headache a few hours after receiving first dose. Over the subsequent days and weeks, the headaches worsened. Ultimately presented to Emergency Room (ER) and was admitted with Subdural hematoma and Cerebrospinal Fluid (CSF) leak. The patient treat with an epidural blood patch. The patient underwent lab tests and procedures which included Computed tomography (Ct) and magnetic resonance imaging (MRI) of head and spine (no results). The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Subdural haematoma
Clinical narrative: Subdural hematoma; CSF leak; headache; This is a spontaneous report from a non-contactable consumer.   A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8731), via intramuscular on 04Sep2021 as dose 1, single for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included diphenhydramine hydrochloride (ZZZQUIL) taken for an unspecified indication, start and stop date were not reported. On 04Sep2021, patient developed headache a few hours after receiving first dose. Over the subsequent days and weeks, the headaches worsened. Ultimately presented to Emergency Room (ER) and was admitted with Subdural hematoma and Cerebrospinal Fluid (CSF) leak. The patient treat with an epidural blood patch. The patient underwent lab tests and procedures which included Computed tomography (Ct) and magnetic resonance imaging (MRI) of head and spine (no results). The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus very bad in both ears; Very tired for months; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number Er87321phzer as reported) via an unspecified route of administration in right arm on 19Apr2021 (at the age of 56-year-old) at 15:15 for COVID-19 immunisation. Relevant medical history included COVID-19 prior vaccination and enlarged prostate. The patient had no known allergies. Concomitant medications were not reported. On 20Apr2021 at 12:00AM the patient experienced fatigue and tinnitus. Events were described as follows: very tired for months and tinnitus very bad in both ears. Went to multiple doctors, had MRI (unknown results) but no relief. No treatment was received, but the events resulted in Energency room/physician office visit, disability or permanent damage. Patient was treated for COVID-19 post vaccination through blood test on 05Jul2021 and result was negative. Nasal swab on 19Aug2021 was negative. The events were not resolved at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Burning sensation, Central nervous system lesion, Cerebrospinal fluid leakage, Epidural blood patch
Clinical narrative: Hemiparesis; legion on my left frontal temporal lobe; spinal fluid leak.; weakness in my right arm and leg; telangiectasia on my pons; Central nervous system lesion; Vitreous floaters; Epidural blood patch; shingle blisters; tingling; twitching in my arm and face; burning sensation; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249 and expiration date was not reported), intramuscular, administered in Arm Left on 20Jan2021 at dose 2, single for covid-19 immunization. The patient had no medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone; cyanocobalamin (VITAMIN B-12); fish oil (OMEGA 3 FISH OILS). The patient experienced hemiparesis on an unspecified date. On 02Feb2021, patient started experiencing tingling and twitching in her arm and face. On the 3feb2021, she developed shingle blisters on the left side of abdomen. A week later (Feb2021), she had the burning sensation of shingles all over her body. She continued to have weakness in right arm and leg, tingling in right hand and sparkling floaters in her vision. She also had Central nervous system lesion on an unspecified date. She had a MRI of brain and was identified telangiectasia on her pons and also found a legion on left frontal temporal lobe. Patient's neurologist ordered a MRI of her neck which came back clear. On 06Jul2021, she had a lumbar cap analysis of spinal fluid and on 12Jul2021, she had to have a blood patch because she had a spinal fluid leak. The patient underwent lab tests and procedures which included Lab Work, lumbar puncture, magnetic resonance imaging neck: unknown results, magnetic resonance imaging head: abnormal. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Herpes zoster, Laboratory test, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Hemiparesis; legion on my left frontal temporal lobe; spinal fluid leak.; weakness in my right arm and leg; telangiectasia on my pons; Central nervous system lesion; Vitreous floaters; Epidural blood patch; shingle blisters; tingling; twitching in my arm and face; burning sensation; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249 and expiration date was not reported), intramuscular, administered in Arm Left on 20Jan2021 at dose 2, single for covid-19 immunization. The patient had no medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC); buspirone; cyanocobalamin (VITAMIN B-12); fish oil (OMEGA 3 FISH OILS). The patient experienced hemiparesis on an unspecified date. On 02Feb2021, patient started experiencing tingling and twitching in her arm and face. On the 3feb2021, she developed shingle blisters on the left side of abdomen. A week later (Feb2021), she had the burning sensation of shingles all over her body. She continued to have weakness in right arm and leg, tingling in right hand and sparkling floaters in her vision. She also had Central nervous system lesion on an unspecified date. She had a MRI of brain and was identified telangiectasia on her pons and also found a legion on left frontal temporal lobe. Patient's neurologist ordered a MRI of her neck which came back clear. On 06Jul2021, she had a lumbar cap analysis of spinal fluid and on 12Jul2021, she had to have a blood patch because she had a spinal fluid leak. The patient underwent lab tests and procedures which included Lab Work, lumbar puncture, magnetic resonance imaging neck: unknown results, magnetic resonance imaging head: abnormal. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.