chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Road traffic accident, Sinus disorder
Clinical narrative: This is a Solicited report based on the information received by Pfizer from a contactable female consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, 1x/day for psoriasis.  The patient medical history and the patient's concomitant medications were not reported. On unknown dates, the patient had diabetes and neuropathy, she had a lot of neck issues from previous car wrecks,  her arm sore for the first day of vaccination, she had sinus issues, eyes watery and a cough a day or two after. The outcome of the events was unknown.   The reporter's causality for the events of diabetes, pain/ neck issues from car wrecks unknown onset and neuropathy with Skyrizi(Risankizumab) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events diabetes, neuropathy, Pain, Sinus disorder, Lacrimation increased, Cough, Musculoskeletal disorder, Road traffic accident and Pain in extremity  cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Dyspnoea exertional, Palpitations
Clinical narrative: congestive heart faillure; symptoms of shortness of breath; dyspnea on exertion; palpitations/ heart racing; drop in ejection fraction; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 18Feb2021 (Batch/Lot number was not reported) (at the age of 66 years old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included adenocarcinoma of lung, anemia, aortic valve replacement, atrial fibrillation, benign essential hypertension and beta thalassemia. The patient previously took hydrogen peroxide and Tylenol, and experienced drug hypersensitivity; and first dose of bnt162b2 in Jan2021 for COVID-19 immunisation. Facility type vaccine: Doctor's office/urgent care. It was unknown if there are other vaccine in four weeks. There were other medications in two weeks. On 28Feb2021, the patient experienced congestive heart faillure, symptoms of shortness of breath, palpitations, heart racing and drop in ejection fraction. She started complaining of symptoms of shortness of breath with dyspnea on exertion 10 days later, 28Feb2021. Also noted palpitations with a heart racing. No chest discomfort, cough, or fever. She presented to MD with congestive heart failure (as reported). Echocardiogram that had been taken 06Aug2020 demonstrated an EF of 60%. Echo 24Jun2021 demonstrated ejection fraction of 25%. Echo 07Aug2021 demonstrated ejection fraction of 35 to 40%. No good explanation for drop in ejection fraction. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment for the events was received. No covid prior vaccination and unknown if  covid tested post vaccination. The patient underwent lab tests and procedures which included echocardiogram: ejection fraction of 60 % on 06Aug2020, echocardiogram: ejection fraction of 25 % on 24Jun2021 and echocardiogram: ejection fraction of 35 to 40 % on 07Aug2021. The outcome of the event 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 reported information ,a causal relationship between the events  and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac imaging procedure, Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: dizziness; can't walk straight; right arm is beginning to hurt/shooting arm pain; she sleeps for 10 hours; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 26Aug2021, as dose 3, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date (at the age of 72 years), as dose 1, and dose 2, both given for COVID-19 immunisation. On unspecified date in 2021, it was reported that the patient experienced a terrible reaction with pain shooting up her left arm (side of injection) and dizziness. She wanted to know what she can do for this and whether or not it's a side effect with the booster. The patient stated that her right arm was beginning to hurt, too. The patient stated that it hurts so badly. She reported that she went to the emergency ward 3-4 days ago for 5 hours and they did every brain scan, heart and blood scan, all kinds of scans and they came up with it is a reaction to booster, and then the patient was sent to her home. She also reported that she was very dizzy; she can't walk straight, walks towards the left. Patient queried is using a heating pad and what can she do. The patient got medication for dizziness, but when she takes it, she sleeps for 10 hours. She had hoped that someone would come to her house and talk to her, and she was just wondering if there is anyone to speak to about the arm pain, shooting arm pain, because she didn't know what to do, and had to get a prescription for dizziness because she can't walk around. She says she wanted to speak to someone who can tell her something she might do to help with the pain and dizziness, what to do, she didn't want to take pills the rest of her life. Patient said that she didn't want to sit and do questions while she is in pain, she wanted to know if she should hold her arm up or down, she needed someone who understands what was happening with her getting the booster shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Scan brain, Sleep disorder
Clinical narrative: dizziness; can't walk straight; right arm is beginning to hurt/shooting arm pain; she sleeps for 10 hours; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 26Aug2021, as dose 3, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date (at the age of 72 years), as dose 1, and dose 2, both given for COVID-19 immunisation. On unspecified date in 2021, it was reported that the patient experienced a terrible reaction with pain shooting up her left arm (side of injection) and dizziness. She wanted to know what she can do for this and whether or not it's a side effect with the booster. The patient stated that her right arm was beginning to hurt, too. The patient stated that it hurts so badly. She reported that she went to the emergency ward 3-4 days ago for 5 hours and they did every brain scan, heart and blood scan, all kinds of scans and they came up with it is a reaction to booster, and then the patient was sent to her home. She also reported that she was very dizzy; she can't walk straight, walks towards the left. Patient queried is using a heating pad and what can she do. The patient got medication for dizziness, but when she takes it, she sleeps for 10 hours. She had hoped that someone would come to her house and talk to her, and she was just wondering if there is anyone to speak to about the arm pain, shooting arm pain, because she didn't know what to do, and had to get a prescription for dizziness because she can't walk around. She says she wanted to speak to someone who can tell her something she might do to help with the pain and dizziness, what to do, she didn't want to take pills the rest of her life. Patient said that she didn't want to sit and do questions while she is in pain, she wanted to know if she should hold her arm up or down, she needed someone who understands what was happening with her getting the booster shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Immunisation, Off label use, Oxygen saturation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:00 (at the age of 50-years-old) at dose 3, booster 0.3ml single for covid-19 immunization. Medical history included High Cholesterol, Over weight, High Heart rate since Covid. Patient had no known allergies. Concomitant medications included aspirin [acetylsalicylic acid], Cholesterol meds, heart meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. Patient was a Covid vent survivor, for first two doses he was already on oxygen support so the dip was not noticed, also he had fever and cold sweats and slept for two days after each dose. As his wife was well versed at this point with his care of just implemented care as needed. After third dose, patient o2 (oxygen saturation) dropped to 85% and required oxygen supplements, had cold sweats, fever of 101.9 on 04Sep2021 04:00. The most recent COVID-19 vaccine was administered at pharmacy or Drug Store. Treatment was given for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101219421 same patient, different dose and similar event
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:00 (at the age of 50-years-old) at dose 3, booster 0.3ml single for covid-19 immunization. Medical history included High Cholesterol, Over weight, High Heart rate since Covid. Patient had no known allergies. Concomitant medications included aspirin [acetylsalicylic acid], Cholesterol meds, heart meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. Patient was a Covid vent survivor, for first two doses he was already on oxygen support so the dip was not noticed, also he had fever and cold sweats and slept for two days after each dose. As his wife was well versed at this point with his care of just implemented care as needed. After third dose, patient o2 (oxygen saturation) dropped to 85% and required oxygen supplements, had cold sweats, fever of 101.9 on 04Sep2021 04:00. The most recent COVID-19 vaccine was administered at pharmacy or Drug Store. Treatment was given for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101219421 same patient, different dose and similar event
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Motor neurone disease, Neuropathy peripheral, Peroneal nerve palsy
Clinical narrative: Motor Neuron Disease; Neuropathy; Foot drop; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Left at the age of 64 years old on 25May2021 11:30 (Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, seizure and hyperlipidaemia The patient previously took first dose of BNT162B2 on 04May2021 (lot number: ER8736) for covid-19 immunisation. Concomitant medications included levothyroxine (LEVOTHYROXINE), phenytoin (DILANTIN [PHENYTOIN]), simvastatin (SIMVASTATIN) and vitamin d3 (VITAMIN D3). On 31May2021, at 8:00, the patient experienced motor neuron disease. neuropathy and foot drop. The patient underwent physical therapy (PT) as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: As per available information, the causal association between the event motor neuron disease and neuropathy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Albumin CSF decreased, CSF immunoglobulin increased, CSF neutrophil count increased, CSF protein increased, CSF red blood cell count positive
Clinical narrative: Motor Neuron Disease; Neuropathy; Foot drop; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Left at the age of 64 years old on 25May2021 11:30 (Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, seizure and hyperlipidaemia The patient previously took first dose of BNT162B2 on 04May2021 (lot number: ER8736) for covid-19 immunisation. Concomitant medications included levothyroxine (LEVOTHYROXINE), phenytoin (DILANTIN [PHENYTOIN]), simvastatin (SIMVASTATIN) and vitamin d3 (VITAMIN D3). On 31May2021, at 8:00, the patient experienced motor neuron disease. neuropathy and foot drop. The patient underwent physical therapy (PT) as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: As per available information, the causal association between the event motor neuron disease and neuropathy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Motor neurone disease, Neuropathy peripheral, Peroneal nerve palsy
Clinical narrative: Motor Neuron Disease; Neuropathy; Foot drop; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Left at the age of 64 years old on 25May2021 11:30 (Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, seizure and hyperlipidaemia The patient previously took first dose of BNT162B2 on 04May2021 (lot number: ER8736) for covid-19 immunisation. Concomitant medications included levothyroxine (LEVOTHYROXINE), phenytoin (DILANTIN [PHENYTOIN]), simvastatin (SIMVASTATIN) and vitamin d3 (VITAMIN D3). On 31May2021, at 8:00, the patient experienced motor neuron disease. neuropathy and foot drop. The patient underwent physical therapy (PT) as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: As per available information, the causal association between the event motor neuron disease and neuropathy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Pancreatitis acute
Clinical narrative: developed acute pancreatitis; abdominal pain; This is a spontaneous report from a contactable physician (patient's grandfather) via medical information team. A 13-year-old male patient received BNT162B2 (COMIRNATY; Lot number and expiration date: Unknown), via an unspecified route of administration in May2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunization but not in a military facility. The patient had no relevant medical history/patient's history. The patient was very healthy with no previous illness. There were no concomitant medications/other products reported. The patient was not on any medication and had no exposure with a viral illness. Historical vaccine included BNT162B2 (COMIRNATY; 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. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks of COVID vaccine. A few days ago in Sep2021, he developed abdominal pain which they thought could have been a kidney stone, but after bloodwork, it was determined that he developed acute pancreatitis. His levels warranted him to be hospitalized and admitted in hospital on 16Sep2021 for these events and was ongoing. He's not currently on any medications but did receive the vaccine approximately three months ago. The patient had an emergency room visit for these events but not to physician's office. No investigation assessment and no relevant tests were reported. The reporter wanted to see if there have been any case reports of patients developing pancreatitis specifically after receiving the vaccine and he doesn't necessarily believe it was caused by the vaccine, but the doctors at hospital asked him that if he had received the vaccine which was three months ago but it could possibly be a delayed reaction. The outcome of acute pancreatitis was not recovered and abdominal pain was unknown at the time of report.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Pancreatitis acute, Abdominal pain cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Deafness, Facial pain, Hypoaesthesia, Impaired work ability
Clinical narrative: felt very weak; could not focus on work and study; felt sore on my right face; migraine on the right side; have no feelings on my (entire) right face (including forehead,cheek, and jaw); hearing loss; could not get up the next day because of fever and sore arm(left); could not get up the next day because of fever and sore arm(left); This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0173), via an unspecified route of administration, in left arm on 29Apr2021 11:00 (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history included cosmetic allergy. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. The patient did not receive any other vaccine within 2 weeks. After taking the vaccine, the patient could not get up the next day because of fever and sore arm on 30Apr2021. She felt very weak on an unspecified date and took ALEVE as treatment and got better. On 04May2021, the patient started to have no feelings on (entire) right face (including forehead, cheek, and jaw) and had migraine on the right side, hearing loss in the right ear. She was so terrified and went to do acupuncture after 2 days of the symptoms. Her hearing recovered after the first acupuncture. The patient did acupuncture twice and then went to do massages. Migraine recovered after several massage treatments and she started to have feelings on her right face gradually, but it was not the end, soon she felt sore on her right face, which made her very upset, and could not focus on work and study and until today (time of report), she was still bothered by it. She has to massage her face every day to alleviate the discomfort. The patient wanted to get some advice and help in order to recover fully from it. She did not take the second shot. The events resulted in doctor/ other healthcare professional visit. The outcome of the events hearing loss was recovered in May2021 and event migraine was recovered on an unspecified date. The outcome of all other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Pyrexia
Clinical narrative: felt very weak; could not focus on work and study; felt sore on my right face; migraine on the right side; have no feelings on my (entire) right face (including forehead,cheek, and jaw); hearing loss; could not get up the next day because of fever and sore arm(left); could not get up the next day because of fever and sore arm(left); This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0173), via an unspecified route of administration, in left arm on 29Apr2021 11:00 (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history included cosmetic allergy. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. The patient did not receive any other vaccine within 2 weeks. After taking the vaccine, the patient could not get up the next day because of fever and sore arm on 30Apr2021. She felt very weak on an unspecified date and took ALEVE as treatment and got better. On 04May2021, the patient started to have no feelings on (entire) right face (including forehead, cheek, and jaw) and had migraine on the right side, hearing loss in the right ear. She was so terrified and went to do acupuncture after 2 days of the symptoms. Her hearing recovered after the first acupuncture. The patient did acupuncture twice and then went to do massages. Migraine recovered after several massage treatments and she started to have feelings on her right face gradually, but it was not the end, soon she felt sore on her right face, which made her very upset, and could not focus on work and study and until today (time of report), she was still bothered by it. She has to massage her face every day to alleviate the discomfort. The patient wanted to get some advice and help in order to recover fully from it. She did not take the second shot. The events resulted in doctor/ other healthcare professional visit. The outcome of the events hearing loss was recovered in May2021 and event migraine was recovered on an unspecified date. The outcome of all other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Speech disorder
Clinical narrative: Stroke; She has trouble getting the right words some times; This is a spontaneous report from a contactable consumer (patient's grandson). A 68-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; Lot number and expiry date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date in Apr2021(at the age of 68-year-old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes diagnosed 15-20 years ago and unknown if it was ongoing. Concomitant medication was not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; Lot number and expiry date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No other Vaccines Administered on Same Date of the Pfizer Suspect and no other vaccine administered within 4 weeks prior Vaccinations. It was reported that on an unspecified date in Apr2021 patient was diagnosed with stroke after receiving the second dose the Pfizer COVID-19 vaccine (3 days later). Age at time of onset of reaction/event: 68 years. Reporter was calling on behalf of his grandmother as she was having trouble getting the words right sometimes on an unspecified date in Apr2021. Reporter had to accompany the patient as she was hospitalized due to some complications after her medical diagnosis from an unknown date and subject was discharged on an unknown date. This happened after she took the second Pfizer vaccine. Reporter wanted to get compensating for the medical bills and injuries due to Pfizer COVID-19 vaccine. Lab test and procedures included blood test: unknown result on an unspecified date. The event Stroke was reported as serious. Adverse events required a visit to: Emergency Room and Physician Office. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Myocarditis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 34-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: FC3181 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 19Aug2021 at 09:00 (at the age of 34-year-old) as DOSE 1, SINGLE for covid-19 immunization in Pharmacy or Drug Store.  No Medical history has been reported. No known allergies. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  The patient experienced tightness in upper left chest and Myocarditis dull pain on 20Aug2021. No treatment was received for the adverse events.  The outcome of the events was not recovered at time of report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: but the patient did received an entire vial of the vaccine instead of one dose; This is a spontaneous report from a contactable nurse.  A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 16Sep2021 a t the age of 67-years-old as dose 1, single for covid-19 immunisation.  Medical history included ongoing end stage renal disease, ongoing heart failure. There were no concomitant medications. The patient did received an entire vial of the vaccine instead of one dose on 16Sep2021. It was states that the patient remains in care at the long term care facility and is being monitored. The reporter wants to know what they need to do with this patient, anything to watch out for. The second dose of the vaccine should still be given as per the recommended schedule.  The lot number for the vaccine, 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 reported events  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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Discomfort, Dyspnoea, Fatigue
Clinical narrative: About 30 minutes after receiving the shot, I was walking and felt a heaviness throughout my entire body starting from the top (face) all the way down to my toes. It felt as if I was walking in slow motion or in quicksand. I became extremely tired. For the next 5-6 days, I was weak with night sweats, pin-cushion like pains on my upper extremities, slight fever, fatigue, palpitations, shortness of breath and slight chest pain on the right side of my sternum. The palpitations were recurrent throughout the day and into the night.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: About 30 minutes after receiving the shot, I was walking and felt a heaviness throughout my entire body starting from the top (face) all the way down to my toes. It felt as if I was walking in slow motion or in quicksand. I became extremely tired. For the next 5-6 days, I was weak with night sweats, pin-cushion like pains on my upper extremities, slight fever, fatigue, palpitations, shortness of breath and slight chest pain on the right side of my sternum. The palpitations were recurrent throughout the day and into the night.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Almost a week later I started breaking out in a rash.  I went to a dermatologist and was dx with an allergic reaction to something I came in contact with.  I did a 3 week regimen of prednisone.  When completed the rash came right back.  I went back to my doctor and was told that people have had reactions to the shot with sun exposure and then was given a shot of prednisone that lasts for 3 months.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Fever 101 for 2 days Body aches, chills,headache Severe site reaction- pain,swollen and red entire upper arm - still 5 days after shot
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever 101 for 2 days Body aches, chills,headache Severe site reaction- pain,swollen and red entire upper arm - still 5 days after shot
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Migraine, Nausea, Pain
Clinical narrative: Nausea Vomiting  Migraine Fever Body aches Chills
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea Vomiting  Migraine Fever Body aches Chills
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Electromyogram normal, Hypoaesthesia oral, Neuropathy peripheral, Paraesthesia
Clinical narrative: within 48 hours felt onset of pins/needles tingling in his toes, worse on the left and subsequently developed left sided ulnar neuropathy (had experienced previously but not in some time) as well as perioral numbness/tingling; his symptoms improved transiently with 600mg ibuprofen and now that we are ~2 weeks out only involve his left foot but do persist.  He underwent an EMG that was essentially normal and has no other symptoms to suggest demyelinating disease.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: within 48 hours felt onset of pins/needles tingling in his toes, worse on the left and subsequently developed left sided ulnar neuropathy (had experienced previously but not in some time) as well as perioral numbness/tingling; his symptoms improved transiently with 600mg ibuprofen and now that we are ~2 weeks out only involve his left foot but do persist.  He underwent an EMG that was essentially normal and has no other symptoms to suggest demyelinating disease.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter
Clinical narrative: Heart fluttering (palpitations), increasingly frequent as time passes. Occuring off/on intermittently daily.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Decreased appetite, Headache, Mobility decreased
Clinical narrative: Second dose of Pfizer Covid vaccine and felt nothing until the same night.  woke up around midnight with extreme chills, shivering and chattering teeth, extreme headache, then developed 102 degree fever and extreme headache.  Was bedridden the entire following day, without appetite or ability to move.  Frankly, this is among the sickest I have ever been in my entire life and it?s troubling to know that it was caused by a vaccine.  Two days later, symptoms have subsided other than a headache.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Second dose of Pfizer Covid vaccine and felt nothing until the same night.  woke up around midnight with extreme chills, shivering and chattering teeth, extreme headache, then developed 102 degree fever and extreme headache.  Was bedridden the entire following day, without appetite or ability to move.  Frankly, this is among the sickest I have ever been in my entire life and it?s troubling to know that it was caused by a vaccine.  Two days later, symptoms have subsided other than a headache.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU)
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error of administration: The patient was 15 years old and was administered Moderna vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tongue biting
Clinical narrative: Seizure while asleep and bit my tongue at the tip in half.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Pain in extremity, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Fever of 101 degrees F.  Pain and swelling in the left arm.  Shaking/ Low blood sugar.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hospitalization (non-ICU)
Age: 12.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received J&J
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalization (non-ICU) Only one dose documented.   Lot number/site not documented.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid, COVID-19, Cough, Dehydration, Full blood count
Clinical narrative: pains and body aches, nonproductive cough Fever of 102.2 on arrival to ED.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, Procalcitonin, Pyrexia, Renal failure
Clinical narrative: pains and body aches, nonproductive cough Fever of 102.2 on arrival to ED.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pains and body aches, nonproductive cough Fever of 102.2 on arrival to ED.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error of administration: The first dose was Moderna and the second dose was Pfizer
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Bright red and painful rash at site, spreading below site, bright red rash on inner upper arm separated from other rash.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dry eye, Eye oedema, Photophobia, Retinal vascular disorder
Clinical narrative: Progressive bilateral panuveitis and retinal vascular is that started 2 days after vaccine administration. Started with dry eye and light sensitivity and progressed to decreased visual acuity and near blindness. Associated with tinnitus.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Slit-lamp tests abnormal, Tinnitus, Uveitis, Visual acuity reduced
Clinical narrative: Progressive bilateral panuveitis and retinal vascular is that started 2 days after vaccine administration. Started with dry eye and light sensitivity and progressed to decreased visual acuity and near blindness. Associated with tinnitus.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Due to miss communication with tech, entire vial was injected, including multiple doses at once.  When error discovered Pfizer profession hot line called.  Pfizer informed us of next steps to take.  Patient then called and informed of error and was told to monitor for exaggerated common side effects and how to treat.  Also informed to contact physician if anything above the common side effects occurs.  After numerous calls to patient,  the last being 12 hours after event, no sign of any side effects of any kind. Patient continuing to be monitored.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Pain
Clinical narrative: I had body aches, severe headaches, loss of taste and smell, fever, and sinus congestion that is still persisting.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I had body aches, severe headaches, loss of taste and smell, fever, and sinus congestion that is still persisting.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Computerised tomogram thorax, Dyspnoea, Electrocardiogram normal
Clinical narrative: Left-sided moderate chest pain began one week after first Moderna shot administered.  Constant pressure in chest, made it a little difficult to breathe.  Continued for approximately 10 days, started to decrease after about day 7.  Went to the emergency room, had elevated d-dimer level (0.55), had CT scan which was normal.  EKG was normal, chest x-ray normal.  As of today, 9/30/21, I no longer feel the chest pain.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer
Clinical narrative: Left-sided moderate chest pain began one week after first Moderna shot administered.  Constant pressure in chest, made it a little difficult to breathe.  Continued for approximately 10 days, started to decrease after about day 7.  Went to the emergency room, had elevated d-dimer level (0.55), had CT scan which was normal.  EKG was normal, chest x-ray normal.  As of today, 9/30/21, I no longer feel the chest pain.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Muscular weakness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Felt sick with flu-like symptoms for 2 days. Slight fever. Body stiffness. Spent most of time in bed. Weakness in legs.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, COVID-19, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Vaccine was administered 6 August. 20 August began running fever that lasted until 21 August. Test for COVID came back positive.  Other symptoms were sneezing and slight congestion. Began accelerated hair loss 23 August which continues to date. Began running fever again on 2 September with no other symptoms. This lasted one day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Vaccine was administered 6 August. 20 August began running fever that lasted until 21 August. Test for COVID came back positive.  Other symptoms were sneezing and slight congestion. Began accelerated hair loss 23 August which continues to date. Began running fever again on 2 September with no other symptoms. This lasted one day.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Tinnitus
Clinical narrative: Tinnitus- constant low pitch frequency worsening when quiet.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Breast tenderness, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: PATIENT HAS LEFT SUPRACLAVICULAR LYMPH NODE SWELLING. LEFT AXILLARY LYMPH NODE SWELLING. AND TENDER LEFT BREAST.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Full blood count, Metabolic function test, Tachycardia
Clinical narrative: Tachycardia short of breath
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Tachycardia short of breath
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Shoulder soreness, fatigue, headache , treatment SIQ and tylenol
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left foot and leg numb
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Irregular menstrual cycles with breakthough spotting.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: breakthrough infection
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine administered, patient planned on receiving Meningitis A vaccine. Patient completed MMR series in past. No adverse outcome, medication error.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cognitive disorder, Feeding disorder, Feeling abnormal, Gait disturbance
Clinical narrative: Severe headache chills fever 103 photophobia inabililty to walk for 8 hours due to severe weakness in legs. No ability to eat of drink x 12 hours . Unable to move out of fetal position x 8 hours . Severe numbness and tingling x 4 hours. Severe headache and photophobia contd x 72 hours . Cognition was limited x 72 hours. Unable to work x 5 days. Severe headache and brain fog contd x 2 weeks . Intermittent headaches still continued at this time.Ny head feels at times still like it is being hit with  a ping pong paddle across the room .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Impaired work ability, Mobility decreased
Clinical narrative: Severe headache chills fever 103 photophobia inabililty to walk for 8 hours due to severe weakness in legs. No ability to eat of drink x 12 hours . Unable to move out of fetal position x 8 hours . Severe numbness and tingling x 4 hours. Severe headache and photophobia contd x 72 hours . Cognition was limited x 72 hours. Unable to work x 5 days. Severe headache and brain fog contd x 2 weeks . Intermittent headaches still continued at this time.Ny head feels at times still like it is being hit with  a ping pong paddle across the room .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia, Photophobia, Pyrexia
Clinical narrative: Severe headache chills fever 103 photophobia inabililty to walk for 8 hours due to severe weakness in legs. No ability to eat of drink x 12 hours . Unable to move out of fetal position x 8 hours . Severe numbness and tingling x 4 hours. Severe headache and photophobia contd x 72 hours . Cognition was limited x 72 hours. Unable to work x 5 days. Severe headache and brain fog contd x 2 weeks . Intermittent headaches still continued at this time.Ny head feels at times still like it is being hit with  a ping pong paddle across the room .
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dry skin, Pruritus
Clinical narrative: Dry, itchy scalp and large amounts of hair loss beginning 4 days after 1st dose of Moderna COVID vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood prolactin, Blood thyroid stimulating hormone, Menstruation irregular, Pregnancy test negative
Clinical narrative: Pt has never had a history of irregular menses. Periods have always been regular and she has been on the same birth control pill for years without issues. States that she had the vaccine on 7/29/21 and then had her menses on 8/9-8/14 and 8/20/8/28 and then on 8/18 when she was due. States that this pattern continued in a similar fashion in September.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: I was 14 weeks pregnant when I received the first dose of the moderna vaccine, on Feb 8, 2021. On February 16 I went for a routine checkup to my OBGYN and the baby was found without a heartbeat. The baby was measured to be 13 weeks 5 days or 13 weeks 6 days, however these are just estimates and are not necessarily exact. I have a history of carrying smaller babies, so it is possible that the baby's gestational age was greater than 13 weeks 5 or 6 days. My original estimated date of delivery was August 9, 2021.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Rhinorrhoea, SARS-CoV-2 test positive, Sinus pain
Clinical narrative: Tested positive for COVID-19 in August with flu-like symptoms including pain in upper sinuses, was not hospitalized. After infection, got sinus infection in lower sinuses (tested negative for COVID), and got antibiotics and that cleared symptoms, but now I have more snot that I suspect is a symptom of an infection somewhere. All the snot and infections could have been a combination of leftover COVID snot and seasonal allergies.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Tested positive for COVID-19 in August with flu-like symptoms including pain in upper sinuses, was not hospitalized. After infection, got sinus infection in lower sinuses (tested negative for COVID), and got antibiotics and that cleared symptoms, but now I have more snot that I suspect is a symptom of an infection somewhere. All the snot and infections could have been a combination of leftover COVID snot and seasonal allergies.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer on 1/22 and 2/12. Positive on 9/29