chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: her head is stopped up; feels really weak; has "gook" in her eyes; cold; headache; sore throat; nausea; feeling sick for the last week; She can't do anything; gastroparesis; sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 30Mar2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. She reported having only a sore arm after getting the vaccine (in 2021) however she has had to cancel the appointment (twice) for her second dose on 20Apr2021. She was feeling sick for the last week (Apr2021) as her head was stopped up, has gastroparesis, felt really weak, has "gook" in her eyes, a real bad cold, headache, sore throat, and nausea.  She can't do anything and has stayed in her bed. Outcome of the events were unknown. She doesn't think the first shot caused it because she didn't get sick until days later.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her head is stopped up; feels really weak; has "gook" in her eyes; cold; headache; sore throat; nausea; feeling sick for the last week; She can't do anything; gastroparesis; sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 30Mar2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. She reported having only a sore arm after getting the vaccine (in 2021) however she has had to cancel the appointment (twice) for her second dose on 20Apr2021. She was feeling sick for the last week (Apr2021) as her head was stopped up, has gastroparesis, felt really weak, has "gook" in her eyes, a real bad cold, headache, sore throat, and nausea.  She can't do anything and has stayed in her bed. Outcome of the events were unknown. She doesn't think the first shot caused it because she didn't get sick until days later.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Sudden Idiopathic Hearing Loss; clogged ear feeling; Hearing whistling noises; approx. 30-50% of hearing in right ear; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 18:30 (Lot Number: EP6955) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  Medical history included eosinophilic oesophagitis, hypertension and enlarged prostate, all from an unknown date and unknown if ongoing. The patient did not test positive to COVID-19, pre or post vaccination. Concomitant medications included clonazepam; lisinopril; omeprazole and tamsulosin, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously took erythromycin and experienced allergy. On 17Apr2021 at 09:00, the patient was diagnosed as "Sudden Idiopathic Hearing Loss" in right ear. He woke up to clogged ear feeling. Hearing whistling noises and approx. 30-50% of hearing in right ear. The events were serious, disabling. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone. The patient outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Exposure during pregnancy, Pulmonary embolism, Ultrasound scan
Clinical narrative: Pulmonary embolism; Is pregnant: yes; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 14:00 (Batch/Lot Number: EL3249) and dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 (Batch/Lot Number: EN6200); both as single dose for covid-19 immunisation. Medical history included pregnancy, allergies to penicillin and Covid prior to vaccination. The patient's concomitant medications were not reported. The patient has no other vaccine in four weeks. The patient experienced pulmonary embolism on 18Apr2021 16:00 which resulted in doctor or other healthcare professional office/clinic visit. CT scan and ultrasound were done, and patient was given lovenox injections. The patient is pregnant with last menstrual cycle on 20Jan2021; delivery date will be on 05Nov2021. The patient was not tested for Covid post vaccination. The outcome of the event pulmonary embolism was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported event Pulmonary embolism cannot be excluded based on a compatible temporal relation. The contribution of pregnancy to thromboembolic events should also be considered. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Epistaxis, Paranasal sinus discomfort, Sinus headache
Clinical narrative: woke up this morning with sinus pressure and a little bit of a nose bleed; woke up this morning with sinus pressure and a little bit of a nose bleed; Can taste blood in his throat and mouth; He has a headache and it seems like a sinus headache; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) at the age of 23-years-old, via an unspecified route of administration in right arm on 22Apr2021 at 14:00 at single dose for COVID-19 immunization. Medical history included being a smoker (he vapes). The patient's sister has Addison's disease. There were no concomitant medications; no additional vaccines administered on the same date as BNT162B2 and there were no prior vaccinations within 4 weeks. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EB8733) at the age of 23-years-old, via an unspecified route of administration in right arm on 01Apr2021 at single dose for COVID-19 immunization. The patient received the second dose of the COVID vaccine on 22Apr2021 at 14:00. He woke up on 23Apr2021 and felt like he had sinus pressure, then he blew his nose and had a bit of a nosebleed. He also felt like he could taste blood in his throat and mouth. The nosebleed stopped, but there was still some pressure in his sinuses. He asked if he needed to go to the hospital. He has a headache and it seemed like a sinus headache. It was more on the right side where he had the nosebleed. He could still kind of taste a little bit of blood in his mouth and throat. There were no relevant tests, but he was trying to figure out if it's needed. The events did not require emergency room or physician office visit. He was not hospitalized but he was trying to decide if he needed to go to the hospital. The outcome of the event nose bleed was recovered on 23Apr2021 and not recovered for all other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (23Apr2021): New information from a contactable consumer (patient) includes: patient details, medical history, historical vaccine, therapy details, reaction data ("Can taste blood in his throat and mouth" and "has a headache and it seems like a sinus headache" were added; outcome and onset were updated), and course of events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Yesterday I tested positive for covid; Yesterday I tested positive for covid; This is a spontaneous report from a contactable (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Jan2021 09:45 (Batch/Lot Number: EL1283) and dose 2 via an unspecified route of administration on 28Jan2021 09:45 (Batch/Lot Number: EL9264) both as single dose for covid-19 immunisation.  The patient medical history included exposure to COVID-19. Concomitant medications were not reported. The patient was not pregnant. The patient tested positive for covid on 22Apr2021 with outcome of not recovered. It was unknown if patient received treatment due to the event. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 22Apr2021.  Clinical course was reported as follow. The patient was healthcare worker and received both doses of the Pfizer vaccine in Jan2021. Last week her mother got COVID and the patient was exposed before knowing she was positive. Yesterday the patient tested positive for covid (22Apr2021). The patient was around her for about an hour and probably only briefly within 6 feet.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Vaccination site pain, Vision blurred
Clinical narrative: within fraction of seconds I fell down (lost conscious); After sometime i woke up I barely could see; On the same night, my left arm (where shot is injected) started paining; This is a spontaneous report from a contactable consumer (patient).    A 26-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 17:45, at the age of 26 years old, (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. The patient previously took Tetanus shot and after 5-10 mins of it he lost conscious for a while. The patient experienced lost conscious on 22Apr2021 07:45 with outcome of recovered, vaccination site pain on 20Apr2021 with outcome of recovered, vision blurred on 22Apr2021 with outcome of recovered.   The clinical course was as follows on the same night of vaccination the left arm (where shot is injected) started pain and became pain relief after a day i.e., 21Apr2021. The next day on 22Apr2021 he woke up and went to bathroom for his daily routines. He stepped in shower and stood under water for sometime then he removed the band-aid from the left arm (where the shot is given) within fraction of seconds he fell down (lost conscious) on the left hand side from the bath tub (him legs still in the bath tub) after sometime he woke up and now fell in the bath tub. After sometime he woke up, and he barely could see, tied him towel and came out to him room and laid down for a while. Then everything went back to normal. The patient didn't receive treatment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient previously took dose 1 of bnt162b2 for COVID-19 immunisation on an unspecified date. On an unspecified date, the patient experienced shingles (hospitalization).  The patient was hospitalized for shingles for 5 days.  The clinical course was reported as follows: The consumer wanted to report a case of shingles for their 90-year-old mother in law approximately 30 days after receiving her second dose of the COVID vaccine. According to the consumer, the patient had a terrible case. The patient ended up in the hospital for five days and was in her second week of rehab. The consumer felt that shingles was probably underreported, and the consumer personally knew three people who had it following their vaccines. The clinical outcome of the event, shingles, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Electrocardiogram, Heart rate, Heart rate increased, Hypersensitivity
Clinical narrative: I read on the fact sheet that may be a sign I had an allergic reaction; Dull pain: Caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt; heart started to beat fast; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration, administered in right arm on 12Apr2021 12:50 (at the age of 42 years old), as single dose for COVID-19 immunization. The patient's medical history included high cholesterol from 2011 and ongoing. Concomitant medications were not reported. Patient stated that he got his shot on Monday 12Apr2021 (he confirmed it was his first dose of the PFIZER-BIONTECH COVID-19 VACCINE) and then went on 14Apr2021 his heart started to beat fast, he read on the fact sheet and he asked if that may be a sign he had an allergic reaction. He went to his doctor, her EKG came back normal, he saw a cardiologist. He asked if he should get second dose. Second was scheduled for 03May2021. He didn't know either. As per response it was reported that as noted in the fact sheet for recipients, patient should not get the PFIZER-BIONTECH COVID-19 VACCINE if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. They referred him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knew his health situation and had access to information that could better help inform this decision. The patient experienced dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt. The patient reported that the dull pain was not as bad. The patient had EKG on 14Apr2021 with abnormal result (as reported). The outcome of the event 'dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt' and 'heart started to beat fast' was recovering; outcome of the remaining event was unknown.  Information about lot/batch number has been requested.  Follow-up (22Apr2021): New information reported from a contactable consumer (patient) includes: reaction data (additional event: 'dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt'), suspect product details (administration site and time), patient details (medical history and lab data) and event details (outcome of the events updated).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Multiple sclerosis, Myelitis
Clinical narrative: This is a spontaneous report from a contactable physician, reporting for a patient.  A 27-year-old non-pregnant female patient received BNT62B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 13Mar2021 (Batch/Lot Number: EN6204) as a single dose (at the age of 27 years old) for covid-19 immunisation.  Medical history included multiple sclerosis from an unknown date. Concomitant medication(s) included dimethyl fumarate (TECFIDERA) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, levonorgestrel (TRI-LEVLEN) taken for an unspecified indication, start and stop date were not reported, and an unspecified Multivitamin taken for an unspecified indication, start and stop date were not reported.  The patient previously took doxycycline and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Two weeks after receiving her first dose of BNT62B2, the patient experienced multiple sclerosis exacerbation (myelitis per MRI of the cervical spine) suggesting that it triggered the exacerbation/myelitis on Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): triggered the exacerbation/myelitis on Mar2021 triggered the exacerbation/myelitis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of multiple sclerosis exacerbation (myelitis per MRI of the cervical spine) suggesting that it triggered the exacerbation/myelitis and include Solumedrol Infusions/ Radiology Testing. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a temporal association, a contributory role of BNT162B2 to the events multiple sclerosis exacerbation and myelitis cannot be completely 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: COVID-19, Drug ineffective, Pain in extremity, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; sore arm; This is a spontaneous report from contactable nurses. This nurse reported similar events for two patients. This case is serious. The other case is non-serious.  An adult female patient (of an unspecified age) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm (upper arm deltoid) on 02Apr2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included obesity, and exposure to COVID from 03Apr2021 to 04Apr2021. The patient was not a smoker/former smoker. The patient's concomitant medications were not reported. The patient received the first dose of the vaccine on 02Apr2021. Over Easter (the weekend of the 4th, on 03Apr2021 and 04Apr2021), she was exposed to the virus by her sister. She took a test 2 to 3 days after exposure but it was negative. The patient did not have symptoms, just a sore arm on an unspecified date in Apr2021. Then this past Monday she woke up feeling really bad and said she felt like she got hit by a truck. It was when the patient started feeling bad that the doctor said to go get tested. The patient tested positive for COVID on 19Apr2021. The patient has been out all week. Clinical signs included a cough and sore throat. The patient was not hospitalized. The patient did not require supplemental oxygen. Therapeutic measures were taken as a result of the event cough. She only took something for her cough, cough syrup (Phenargran and promethazine is the generic version). No additional treatments. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on Apr2021, SARS-CoV-2 test: positive on 19Apr2021. The outcome of the event sore arm was recovered on an unspecified date while for other events was recovering. The events were considered as serious (medically significant). The patient is due for her next vaccine on 23Apr2021 and wants to know if she should get that vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient just went to urgent care when she was not feeling well. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded in a context of LOE.,Linked Report(s) : US-PFIZER INC-2021461201 same reporter, different patients, similar events
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: She will have an emergency patient surgery, she is "losing a nerve from the back" on 28Apr2021; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 05Apr2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She will have an emergency patient surgery, she is "losing a nerve from the back" on 28apr2021 (medically significant) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea
Clinical narrative: atrial fibrillation; shortness of breath; This is a spontaneous report from a contactable consumer reporting for himself. This 69-year-old male consumer received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at 13:15, in left arm, for COVID-19 immunisation. The first dose of BNT162B2  vaccine was given on an unspecified date. No other vaccine was given in 4 weeks. Medical history included bladder cancer, blood pressure controlled by lisinopril and allergy to fentanyl. COVID prior vaccination: no. COVID tested post vaccination: no. Concomitant medication included lisnopril for blood pressure. On 07Apr2021 at 13:00 the patient developed shortness of breath and atrial fibrillation which never had before. No treatment was required. The events resolved on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Drug ineffective
Clinical narrative: high fever/High temperature; tested positive for COVID-19; tested positive for COVID-19; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer via team and Pfizer-sponsored program. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 05Mar2021, the patient tested positive for COVID-19 and has been hospitalized twice with a high fever, high temperature: 103.5. The patient has been in and out of the hospital. The reporter was asking, "Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?" The patient also had no taste or smell on 05Mar2021. The patient was hospitalized from 05Mar2021 to 07Apr2021. The patient recovered from the events fever in Mar2021 and also recovered from the event COVID-19 on unspecified date. The outcome of no taste and smell was not recovered.  Information about lot/batch has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: high fever/High temperature; tested positive for COVID-19; tested positive for COVID-19; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer via team and Pfizer-sponsored program. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 05Mar2021, the patient tested positive for COVID-19 and has been hospitalized twice with a high fever, high temperature: 103.5. The patient has been in and out of the hospital. The reporter was asking, "Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?" The patient also had no taste or smell on 05Mar2021. The patient was hospitalized from 05Mar2021 to 07Apr2021. The patient recovered from the events fever in Mar2021 and also recovered from the event COVID-19 on unspecified date. The outcome of no taste and smell was not recovered.  Information about lot/batch has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Emotional distress, Generalised tonic-clonic seizure, Heart rate
Clinical narrative: vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization.  Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported.  The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%.  At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine)  contributed to the occurrence of the serious event Generalised tonic-clonic seizure. 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Heart rate increased, Hyperventilation, Nausea, Oxygen saturation
Clinical narrative: vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization.  Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported.  The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%.  At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine)  contributed to the occurrence of the serious event Generalised tonic-clonic seizure. 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Respiratory rate increased, Vomiting
Clinical narrative: vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization.  Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported.  The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%.  At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine)  contributed to the occurrence of the serious event Generalised tonic-clonic seizure. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Extremity contracture, Fall, Loss of consciousness
Clinical narrative: seizure; passed out; light headed; fell out of chair and hit floor; making a gurgling/growling sound; his right arm was contracted and tight; his right arm was contracted and tight; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8736), via an unspecified route of administration in the left arm on 23Apr2021 at 09:30 (at the age of 16-years-old) as a single dose for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 23Apr2021 at 09:45 (reported as 13 minutes after the vaccine), the patient said he was lightheaded and then fell out of the chair and hit the floor. He started making a gurgling/growling sound. After the nurses flipped him over, they noted that his right arm was contracted and tight. They were unable to determine if he had passed out or had a seizure. He had no seizure history. He regained consciousness after about 45 seconds to a minute. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of passed out was resolved on 23Apr2021, while of seizure, lightheaded, fell out of chair and hit floor, making a gurgling/growling sound, his right arm was contracted and tight was resolving.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Seizure
Clinical narrative: seizure; passed out; light headed; fell out of chair and hit floor; making a gurgling/growling sound; his right arm was contracted and tight; his right arm was contracted and tight; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8736), via an unspecified route of administration in the left arm on 23Apr2021 at 09:30 (at the age of 16-years-old) as a single dose for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 23Apr2021 at 09:45 (reported as 13 minutes after the vaccine), the patient said he was lightheaded and then fell out of the chair and hit the floor. He started making a gurgling/growling sound. After the nurses flipped him over, they noted that his right arm was contracted and tight. They were unable to determine if he had passed out or had a seizure. He had no seizure history. He regained consciousness after about 45 seconds to a minute. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of passed out was resolved on 23Apr2021, while of seizure, lightheaded, fell out of chair and hit floor, making a gurgling/growling sound, his right arm was contracted and tight was resolving.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received her first dose of the Pfizer COVID-19 vaccine  and then developed COVID-19; received her first dose of the Pfizer COVID-19 vaccine  and then developed COVID-19; This is a spontaneous report received from a Pfizer-sponsored program. The reporter is a  contactable nurse (patient)    A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Dec2020 (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 received her first dose of the pfizer covid-19 vaccine and then developed 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 an  unknown date.  Course of the event. The patient received her 1st dose of Covid vaccine on December 1st. She was suppose to get her 2nd dose but developed Covid. She has not received her 2nd dose and is wondering if she can take it now or if she needs to start over with 1st dose.  Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Oxygen saturation, Respiratory distress, Respiratory rate
Clinical narrative: felt like his throat was being to close up; appeared to be gasping for air; lose sensation in his extremities; extremities tense and contracting; respiratory distress; This is a spontaneous report from a contactable nurse, reporting for her son.   A 17-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 20Apr2021 at 10:15 (Batch/Lot Number: EW0170) as a single dose (at the age of 17 years old) for covid-19 immunisation.  Medical history included anxiety from an unknown date. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included anxious reaction to Hep B two years prior (2019). The patient experienced respiratory distress on 20Apr2021 at 10:21 with outcome of unknown, felt like his throat was being to close up on 20Apr2021 at 10:22 with outcome of unknown, appeared to be gasping for air on 20Apr2021 at 10:22 with outcome of unknown, lose sensation in his extremities on 20Apr2021 at 10:22 with outcome of unknown, and extremities tense and contracting on 20Apr2021 at 10:22 with outcome of unknown.  Chronology of events was as follows: on 20Apr2021 at 1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic immediately radioed and arrived at car at 10:22. At 10:22: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Patient also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. At 10:25: 0.3 mg Epinephrine administer into left vastus lateralis. The patient underwent lab tests and procedures which included blood pressure measurement: 80/52 on 20Apr2021, blood pressure measurement: 111/57 on 20Apr2021 at 10:26, oxygen saturation: 89 % on 20Apr2021, and respiratory rate: 26 on 20Apr2021. The events resulted in Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19; Sender's Comments: Based on current known drug safety profile, the reported events were assess as intercurrent medical events and thus assessed as not related to suspected drug BNT162B2 . Case will be reassessed pending  new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss, Tension, Throat tightness
Clinical narrative: felt like his throat was being to close up; appeared to be gasping for air; lose sensation in his extremities; extremities tense and contracting; respiratory distress; This is a spontaneous report from a contactable nurse, reporting for her son.   A 17-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 20Apr2021 at 10:15 (Batch/Lot Number: EW0170) as a single dose (at the age of 17 years old) for covid-19 immunisation.  Medical history included anxiety from an unknown date. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included anxious reaction to Hep B two years prior (2019). The patient experienced respiratory distress on 20Apr2021 at 10:21 with outcome of unknown, felt like his throat was being to close up on 20Apr2021 at 10:22 with outcome of unknown, appeared to be gasping for air on 20Apr2021 at 10:22 with outcome of unknown, lose sensation in his extremities on 20Apr2021 at 10:22 with outcome of unknown, and extremities tense and contracting on 20Apr2021 at 10:22 with outcome of unknown.  Chronology of events was as follows: on 20Apr2021 at 1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic immediately radioed and arrived at car at 10:22. At 10:22: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Patient also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. At 10:25: 0.3 mg Epinephrine administer into left vastus lateralis. The patient underwent lab tests and procedures which included blood pressure measurement: 80/52 on 20Apr2021, blood pressure measurement: 111/57 on 20Apr2021 at 10:26, oxygen saturation: 89 % on 20Apr2021, and respiratory rate: 26 on 20Apr2021. The events resulted in Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19; Sender's Comments: Based on current known drug safety profile, the reported events were assess as intercurrent medical events and thus assessed as not related to suspected drug BNT162B2 . Case will be reassessed pending  new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Lymphadenopathy, Myalgia
Clinical narrative: blood in stool; muslce pain; a lymph nodes on the left hand side of my neck; This is a spontaneous report from a contactable consumer.   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (vaccine taken at 13:00) (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 39 years) for covid-19 immunisation.  Medical history was none. There are no known allergies.   The patient did not have COVID prior to vaccination.   It is unknown if patient was Covid tested post vaccination.  The patient's concomitant medications were not reported.  The patient experienced blood in stool (medically significant) on 09Apr2021 01:00 with outcome of not recovered and muscle pain on 09Apr2021 01:00 with outcome of not recovered.  The patient noted "a lymph nodes on the left hand side of my neck" on 09Apr2021 01:00 with outcome of not recovered.  Therapeutic measures were taken as a result of blood in stool, muslce pain and "a lymph nodes on the left hand side of my neck".  The patient was seen in the physicians office.  Treatment included pain medication and antibiotics.  It was unknown if the patient had any other vaccines in four weeks besides COVID-19 vaccine.   Information about lot/batch number has been requested.