chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for EBV; This is a spontaneous report from a contactable pharmacist. A 49-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 49-years-old, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Pharmacist stated that a patient received the first dose of the Pfizer Covid-19 vaccine on 23APR2021 and a week after he presented fever, rigors and persistent rash. He was the discharged and then presented acute renal failure and hypotension on 19May2021. He had an IgG and PCR positive for EBV. Pharmacist would like to know if there are reports of EBV (Epstein-Barr virus) reactivation. They have a patient who was admitted to the hospital and was wondering if Pfizer has any reports of reactivation of EBV after receiving the vaccine.  She is not sure if it is related to the vaccine or not. The first hospital admission was because of continued fevers, rigors and rash. Patient received first dose on 23 Apr 2021, and then rash started on 29 Apr 2021. It is unknown when fever and rigors started. Patient was readmitted for same thing and is sicker. She then clarified that this admission was for hypotension with acute renal failure. The patient is now in ICU. The rash is still there and it is worse. The patient still has fevers. Reporter seriousness for Persistent Fevers, Rigors and Rash: Hospitalization. Patient was in hospital for Persistent Fevers, Rigors and Rash from 2 May 2021 to 15 May 2021. Reporter seriousness for Hypotension and acute renal failure: Hospitalization. Patient was in hospital for Hypotension and acute renal failure from 19 May 2021 to Ongoing. Event outcome of fever and rash was not recovered, the other events was unknown.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Pyrexia, Chills and Rash are considered as related to bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine).  A causal association between the reported events Hypotension and Acute kidney injury and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood count, Blood count abnormal, Fatigue, Feeling cold, Haematocrit
Clinical narrative: She has seen that sometimes he appears to be cold and he is tired.; She has seen that sometimes he appears to be cold and he is tired.; RBC 3.80/the counts were significantly low; blood count to be low; HgB 11.3; HCT 33.8; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm left on 28Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, coronary heart disease, intestinal polyp removed from 2014 she believes it was maybe a duodenal polyp. Concomitant medication included apixaban (ELIQUIS) took since 2018 or 2019 and ongoing. The patient historical medicine includes received first dose of BNT162B2 for COVID-19 Immunisation. It was reported that her husband received the first vaccination 28Jan2021 and approximately 3 weeks later received the second vaccination. They both got it at the same time. They were pleased and had no problems. It was reported that on 11Feb2021, they went to the primary care physician for a regular follow up and her husband's blood count was low. The doctor didn't tell them about her husband's low blood count in Feb2021. He did call attention to a seriously low count this past week. Also reported that Low blood count: Results from 11Feb2021, Red blood count: 3.80, Hemoglobin: 11.3, Hematocrit: 33.8, Does not have the paperwork from the results from last week, which indicated that the counts were significantly low. Treatment: None, he is scheduled to have an endoscopy and a colonoscopy 04Jun2021. Also reported he had Second dose and Unable to read the date, stated that it looked scratchy. Stated that is was something, 1, 2021. She is pretty sure she knows it was in a 3 week period. It was administered by the Fire Dept, LOT: EN620, thinks it is a zero, or 2 zeros mushed together. First dose was in the left arm and the second dose was in the right arm. Has read about anemia recently since Friday, She has seen that sometimes he appears to be cold and he is tired. Doesn't know what fatigue is but they are not 25 any longer and things change. He sleeps well during the night. He did have a surgical procedure 16Apr2021. They released an ulnar nerve in his wrist and elbow of his left hand. The patient underwent lab tests and procedures which included blood count: low on 11Feb2021, haematocrit: 33.8 on 11Feb2021, haemoglobin: 11.3 on 11Feb2021, red blood cell count: 3.80 on 11Feb2021. Th outcome of the events was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin, Haemoglobin decreased, Red blood cell count, Red blood cell count decreased
Clinical narrative: She has seen that sometimes he appears to be cold and he is tired.; She has seen that sometimes he appears to be cold and he is tired.; RBC 3.80/the counts were significantly low; blood count to be low; HgB 11.3; HCT 33.8; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm left on 28Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, coronary heart disease, intestinal polyp removed from 2014 she believes it was maybe a duodenal polyp. Concomitant medication included apixaban (ELIQUIS) took since 2018 or 2019 and ongoing. The patient historical medicine includes received first dose of BNT162B2 for COVID-19 Immunisation. It was reported that her husband received the first vaccination 28Jan2021 and approximately 3 weeks later received the second vaccination. They both got it at the same time. They were pleased and had no problems. It was reported that on 11Feb2021, they went to the primary care physician for a regular follow up and her husband's blood count was low. The doctor didn't tell them about her husband's low blood count in Feb2021. He did call attention to a seriously low count this past week. Also reported that Low blood count: Results from 11Feb2021, Red blood count: 3.80, Hemoglobin: 11.3, Hematocrit: 33.8, Does not have the paperwork from the results from last week, which indicated that the counts were significantly low. Treatment: None, he is scheduled to have an endoscopy and a colonoscopy 04Jun2021. Also reported he had Second dose and Unable to read the date, stated that it looked scratchy. Stated that is was something, 1, 2021. She is pretty sure she knows it was in a 3 week period. It was administered by the Fire Dept, LOT: EN620, thinks it is a zero, or 2 zeros mushed together. First dose was in the left arm and the second dose was in the right arm. Has read about anemia recently since Friday, She has seen that sometimes he appears to be cold and he is tired. Doesn't know what fatigue is but they are not 25 any longer and things change. He sleeps well during the night. He did have a surgical procedure 16Apr2021. They released an ulnar nerve in his wrist and elbow of his left hand. The patient underwent lab tests and procedures which included blood count: low on 11Feb2021, haematocrit: 33.8 on 11Feb2021, haemoglobin: 11.3 on 11Feb2021, red blood cell count: 3.80 on 11Feb2021. Th outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Slight anaphylactic reaction; This is spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; amifampridine phosphate (FIRDAPSE, tablet, 10 mg, Lot number was not reported), via an unspecified route of administration from Feb2019 and ongoing, at 10 mg for Lembert-Eaton myasthenic syndrome (LEMS). Medical history included myasthenic syndrome. The patient's concomitant medications were not reported. On an unspecified date, after starting the product, the patient experienced a bad reaction to the covid vaccine, described as a slight anaphylactic reaction to Pfizer vaccine. Seriousness criteria was reported as important medical event. As on 10May2021, treatment with amifampridine phosphate continued, and the slight anaphylactic reaction had resolved. The action taken in response to the event for BNT162B2 was not applicable, for amifampridine phosphate was reported as unknown. The outcome of event was recovered on 10May2021.  Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event shortness of breath cannot be excluded.  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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event shortness of breath cannot be excluded.  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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Pain, Thrombosis
Clinical narrative: and multiple golf ball-sized clots.; Extreme menstrual period; High pain, extremely heavy flow; High pain, extremely heavy flow; This is spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 07Apr2021 11:15 (Lot Number: ER8734) at the age of 35-year-old, as 2nd dose, single for covid-19 immunisation. Medical history included known allergies Latex and Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 (lot number: EN6206) on 17Mar2021 11:15, administered in right arm, for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had extreme menstrual period (unlike her typical cycle) experienced about 18 days after the second shot. High pain, extremely heavy flow (more than an oz and hour sustained for almost two full days), and multiple golf ball-sized clots. Events occurred on 25Apr2021 07:30. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker test, Polymyalgia rheumatica
Clinical narrative: Developed polymyalgia rheumatica; This is a spontaneous report received from a contactable Physician. A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Apr2021 at the age of 40-years-old (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension, known allergies: Sulfa drugs. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1 for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE). Event on 26Apr2021: Developed polymyalgia rheumatica 2 weeks after second vaccination. Diagnosed via symptoms, elevated inflammatory markers, and abrupt response to prednisone. AE resulted in Doctor or other healthcare professional office/clinic visit. AE treatment was prednisone. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "polymyalgia rheumatica" 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.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Disease recurrence
Clinical narrative: Diabetes came back after second dose of the Covid Vaccine; " Disease recurrence"; This is a spontaneous report from a Pfizer sponsored program  from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation. Medical history included pancreatic transplant for diabetes, the patient was fine for 2 years. The patient's concomitant medications were not reported. The patient experienced diabetes came back after second dose of the covid vaccine on an unspecified date with outcome of unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: -Based on the current limited available information a possible contributory role of the suspect product BNT162B2 to the development of event diabetes cannot be totally excluded  "The impact of this report on the benefit-risk profile of the Pfizer productand 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 Committees, and Investigators, as appropriate."
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fracture
Clinical narrative: fracture; This is a spontaneous report from a contactable consumer reported for self. This 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 03May2021 12:30 at the age of 76-year-old as 1st dose, single for covid-19 immunisation. Vaccine Administered at Facility. Medical history included cancer. Concomitant drug included ongoing palbociclib (IBRANCE) by mouth take 1 DF, cyclic (one pill daily for 3 weeks then takes zero pills for 1 week) for Neoplasm malignant. She was supposed to schedule her second Covid 19 vaccine for 24May2021 but she forgot and when she went to schedule the appointment, there were no more appointments on that day of 24May2021. She was able to schedule her second Covid 19 vaccine for 26May2021 which is 23 days after the first vaccine. She is asking if this is ok. It is her fault, the people at the facility where she had the Covid 19 vaccine told her to schedule her second appointment right away but she had a doctor's appointment on 25May2021 and she received a bone infusion that day to help heal a bone from a previous fracture and she wasn't sure if she should get the Covid 19 vaccine with the bone infusion because she wasn't sure it would be effective. No emergency room and physician office visit. Outcome of the event was unknown.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dermatomyositis, Gait inability, Weight decreased
Clinical narrative: Dermatomyositis: which includes rash, that is attacking her mother's body. Caller states that her mother's muscles in her arms and thighs have lost muscle mass; lost weight; her mother cannot walk; got weaker; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (reporter's mother) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Since patient got the vaccine, she has been diagnosed with dermatomyositis. It was reported she was diagnosed when she was checked out of the hospital and states the date of 07May2021. This condition gave her a rash that is attacking her body. Patient's hands and feet still function, but her muscles in her arms and thighs have lost muscle mass and she has lost weight. Because of this, she cannot walk. Reporter stated that her mother (patient) was bowling, cutting grass, and was totally vital until she got the vaccine. Patient was in the hospital for a week and then they sent her home. She followed up with a rheumatologist and her doctor. The doctor gave patient steroids and they did not work. The doctor also gave patient intravenous steroids and she showed no improvement. She got worse with the intravenous steroids and got weaker. She took intravenous steroids for 3 days. Reporter stated that she is not sure if her mother is just getting weaker from the condition or it is the medicine. Patient has prednisone 10 mg tablets by mouth and was instructed to take 30mg by mouth twice a day, unless she is getting intravenous steroids. The intravenous medication was specified as Methyl Prednisolone Sodium Succinate, 1000 mg in normal saline 250 ml, in an intravenous bag. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Haemorrhage, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Bleeding; Spotting; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 08-FEB-2021 12:00 at the 66 years old at single dose for COVID-19 immunisation.  The medical history and concomitant medications were not reported. The patient was not pregnant.There was no other vaccine in four weeks. On 22Feb2021 the patient experienced Bleeding, Spotting with outcome recovered in 2021. All of events resulted in Physician Office Visit. There was treatment for events. The patient underwent lab tests and procedures, which included Biopsy : Unknown results; Ultra sounds: Unknown results. There was no COVID prior vaccination. There was no COVID tested post vaccination.   Information about Lot/Batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Diplopia, Disorientation, IVth nerve paralysis, Nausea
Clinical narrative: I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th nerve palsy of my left eye; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176), via an unspecified route of administration at the age of 43-year-old administered in arm left on 18May2021 10:30 AM at single dose for covid-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient's concomitant medications included ibuprofen received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), at the age of 43-year-old at the arm left on 27Apr2021 01:30 PM for COVID-19 immunisation. The patient had his second dose of the Pfizer COVID vaccine at 10:30am on 18May2021. By 2:30am on 19May2021, he woke up disoriented and realized that he had severe double vision resulting in loss of balance and severe nausea. A 19May2021 visit with his primary care doctor diagnosed a 4th nerve palsy of my left eye. This was confirmed by a 19May2021 visit to an ophthalmologist. It is now 21May2021 and nothing has improved and an MRI (Magnetic resonance imaging) was pending. The adverse events result in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: HZ starting in my hands; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand name provided as "Comernity", pending clarification), dose 1 via an unspecified route of administration, administered in Arm Right on 04May2021 10:30 (Lot Number: 1B003A) as 1st dose, single for covid-19 immunisation. The patient medical history was none. No Known Allergies. concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced HZ starting in his hands on 12May2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient underwent lab tests and procedures which included Combined nasal throat RT-PCR have proof: negative on 17Apr2021 (Other).  treatment received for the adverse event included AV. outcome of the events was not recovered. It was a serious case, Seriousness criteria of Results in death, Caused/prolonged hospitalization and Congenital anomaly/birth defect were no, Seriousness criteria of Disabling/Incapacitating was yes.  information about lot/batch number was available. Further information was expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: : Pt received both doses of the pfizer covid vaccine; 23Feb2021 and 22Mar2021 (lot EN6207) and diagnosed with covid on 21May2021; Diagnosed with covid on 21May2021; This is a spontaneous report from a contactable other healthcare profession (HCP). A 64-year-old male patient at the age of 64 years old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 23Feb2021 (Lot Number: EN6200) as 1st dose, single, dose 2 via an unspecified route of administration on 22Mar2021 (Lot number: EN6207) as 2nd dose, single for covid-19 immunisation.  Medical history included diabetes mellitus (DM), hypertension (HTN), Granulomatosis, rhinitis allergic. Concomitant medications within 2 weeks of vaccination included amlodipine; lisinopril; fexofenadine; metformin; spironolactone; rituximab. The patient previously took allopurinol and experienced drug hypersensitivity (Known allergie-Allopurinol). Patient received both doses of the Pfizer covid vaccine; 23Feb2021 and 22Mar2021 (lot EN6207) and diagnosed with covid on 21May2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient been undergoing lab tests and procedures which included Rapid PCR: positive on 21May2021 (Nasal Swab). No treatment received for the events. Outcome of the events was unknown. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, there is reasonable possibility that the reported events Vaccination failure and COVID-19 are related to BNT162B2.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Patient has been diagnosed w/ Polymyalgia Rheumatica.; This is spontaneous report from a contactable other-HCP.  A 61-year-old female patient received the second dose of BNT162B2 (Lot Number: EW0161) at single dose for COVID-19 immunisation on 15Apr2021 at 02:30 PM. Relevant history included HTN, Hypothyroidism, HLD, Hyperglycemia, Vit D Deficiency, Radiculopathy Lumbar Region. Relevant concomitant drug included ascorbic acid, retinol, tocopherol (OCUVITE), Enalapril 5mg, Vitamin D3 50000 IU, Atorvastatin 10mg, Bisoprolol/HCTZ 10/6.25mg, levothyroxine sodium (SYNTHROID) 200mcg. Past drug included NKDA (as reported). The patient previously received the first dose of BNT162B2 (Lot Number:EP7534) at single dose for COVID-19 immunisation on 18Mar2021 at 02:30 PM, without side effects after 1st vaccine. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Approx 7-8 hours after 2nd vaccine (as reported),  the patient started to experience intense leg and arm cramps and pain in her joints with a 10/10 pain level.  She needed assistance getting into an upright position.  The pain continued to worsen.  She was put on Meloxicam without relief.  Then Prednisone 10mg was started which had significantly help with her symptoms.  She still had some pain in her knees.  Patient had been diagnosed with polymyalgia rheumatica. The patient visited the doctor or other healthcare professional office/clinic due  to the events. The outcome of events was  resolving.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between 'polymyalgia rheumatica' with symptoms of 'leg and arm cramps' and 'pain in joints' and suspect product cannot be ruled out.  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Drug ineffective
Clinical narrative: weak; headache; chills; fever; broke out with sweats a couple times; cough; not eating; got diagnosed with COVID-19; got diagnosed with COVID-19; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (Patient). A 63-year-old female patient received first dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 18Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included diabetes and blood pressure from unknown date and unknown if ongoing. Concomitant medications includes; metformin (METFORMIN) taken for diabetes mellitus, lisinopril (LISINOPRIL) taken for blood pressure, acetylsalicylic acid (ASPIRIN 81), atorvastatin (ATORVASTATIN), amlodipine (AMLODIPINE) taken for an unspecified indication from 19Apr2021, vitamin d3 (VITAMIN D3)  and zinc (ZINC). The patient got diagnosed with covid-19 on 31Mar2021, weak, headache, chills, fever, broke out with sweats a couple times, cough and not eating all on unspecified dates. Reporter states she is fine. She was weak from not eating. She was weak for a week after the fourteen days. Once she started eating back on a regular basis she was fine. She doesn't have lasting effects. She doesn't remember exact days, she started feeling a little more strength around the 16apr2021 or 17apr2021. She was gaining her strength back. She wasn't feeling bad or anything. She is not a doctor or a nurse but when Covid came out she got her and her daughters on a vitamin regimen. She is adamant about taking it everyday and feels that it helped her. She was weak, had headache and chills. She didn't have breathing trouble. She had a little fever and little chills. The headache was off and on. She also broke out with sweats a couple times. The shirt would wet with sweat when she woke up. She states she had a little cough, but not a lot. At first caller states that she took Mucinex pills but then clarified that she couldn't take it because the pills were too big. Caller clarified it was not brand name Mucinex. It was pharmacy brand. She does not have a problem swallowing pills. States she lives in two bedroom apartment. She was really weak. She would be very tired when walking from bedroom to the kitchen. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. Outcome of the event Covid-19 was recovered. Outcome of all the other events was unknown.  Information about lot/batch number was available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test
Clinical narrative: weak; headache; chills; fever; broke out with sweats a couple times; cough; not eating; got diagnosed with COVID-19; got diagnosed with COVID-19; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (Patient). A 63-year-old female patient received first dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 18Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included diabetes and blood pressure from unknown date and unknown if ongoing. Concomitant medications includes; metformin (METFORMIN) taken for diabetes mellitus, lisinopril (LISINOPRIL) taken for blood pressure, acetylsalicylic acid (ASPIRIN 81), atorvastatin (ATORVASTATIN), amlodipine (AMLODIPINE) taken for an unspecified indication from 19Apr2021, vitamin d3 (VITAMIN D3)  and zinc (ZINC). The patient got diagnosed with covid-19 on 31Mar2021, weak, headache, chills, fever, broke out with sweats a couple times, cough and not eating all on unspecified dates. Reporter states she is fine. She was weak from not eating. She was weak for a week after the fourteen days. Once she started eating back on a regular basis she was fine. She doesn't have lasting effects. She doesn't remember exact days, she started feeling a little more strength around the 16apr2021 or 17apr2021. She was gaining her strength back. She wasn't feeling bad or anything. She is not a doctor or a nurse but when Covid came out she got her and her daughters on a vitamin regimen. She is adamant about taking it everyday and feels that it helped her. She was weak, had headache and chills. She didn't have breathing trouble. She had a little fever and little chills. The headache was off and on. She also broke out with sweats a couple times. The shirt would wet with sweat when she woke up. She states she had a little cough, but not a lot. At first caller states that she took Mucinex pills but then clarified that she couldn't take it because the pills were too big. Caller clarified it was not brand name Mucinex. It was pharmacy brand. She does not have a problem swallowing pills. States she lives in two bedroom apartment. She was really weak. She would be very tired when walking from bedroom to the kitchen. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. Outcome of the event Covid-19 was recovered. Outcome of all the other events was unknown.  Information about lot/batch number was available. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Pain, Pericarditis, Pyrexia
Clinical narrative: Pericarditis: inflammation of heart's lining; Stabbing pain shooting from upper-mid back through to sternum; Fever; Overall weakness; Severe pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (lot number: EW0175), via an unspecified route of administration in arm left on 26Apr2021 15:30 at single dose for COVID-19 immunisation. Medical history included endometriosis, no recent issues. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included estradiol, progesterone, and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis:  inflammation of heart's lining, stabbing pain shooting from upper-mid back through to sternum, fever, overall weakness, and severe pain on 12May2021 10:00. Facility the most recent COVID-19 vaccine administered was in hospital. Adverse events resulted in emergency room/department or urgent care. Patient was hospitalized for these events. Treatments included morphine, colchicine, and indomethacin. Outcome of the events was not resolved. Patient also received the second dose of BNT162B2 (lot number: EW0169) on 17May2021 15:45 in left arm.  Follow up needed, further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blindness, Blood test, Body temperature, Breast mass
Clinical narrative: loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Lymphadenopathy, Mammogram, Pyrexia
Clinical narrative: loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Tremor, Ultrasound scan, Vomiting
Clinical narrative: loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no.  Information on the lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Malaise, Nausea, Pain
Clinical narrative: blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she's getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient's mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient's legs, she had a bunch of bruises. Reporter was just really nervous about her daughter's bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn't go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient's whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn't really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.