chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: a 3rd nurse that works for the agency was hospitalized with a blood clot but is recovering; This is a spontaneous report received from a contactable other healthcare professional. This HCP reported similar events for different patients with the same product; this is the third of three. An adult female of unspecified age received a dose (unspecified dose number) of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date for COVID-19 immunization. Relevant medical history included traveling nurse. There were no concomitant medications or past drug history reported. On an unspecified date the patient developed a blood clot and was hospitalized. The reporter indicated a nurse that worked for the agency was hospitalized with a blood clot but is recovering. There was no laboratory testing reported. The outcome of the blood clot was recovering.   Information on the lot/batch number has been requested; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported thrombosis cannot be totally excluded. Additional information including event onset date, concomitant medications and their indications, concurrent medical conditions, medical history, diagnostic test results, treatment done, is needed to better assess this report.  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.,Linked Report(s) : US-PFIZER INC-2021683252 PFIZER (Same reporter/product/event in different patients);US-PFIZER INC-2021688670 PFIZER (Same reporter/product/event in different patients)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Abnormal postmenopausal uterine bleeding; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6207) via an unspecified route of administration in Arm Right on 18Mar2021 12:00 (age at vaccination: 53-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history reported None. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took metronidazole and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. In Mar2021 (nine days after first dose), the patient experienced abnormal postmenopausal uterine bleeding. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was reported as not recovered.  No follow-up attempts possible. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Dyspnoea, SARS-CoV-2 test, Ultrasound uterus
Clinical narrative: Became pregnant 7 days after 2nd dose of the vaccine (13Jan2021). Viable pregnancy with heartbeat at 6 week ultrasound. Ended in miscarriage; Difficulty breathing; This is a spontaneous report from a contactable nurse (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on (at the age of 31-years-old) 06Jan2021 14:30 (Batch/Lot Number: EK4176) as DOSE 2, SINGLE  for covid-19 immunisation. Facility in which the vaccine was given was a Workplace clinic. The patient had no known medical history or allergies. Concomitant medications were not reported. Historical Vaccine includes bnt162b2 dose 1, Lot Number EH9899, On 16Dec2020 at 14:00 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient Became pregnant 7 days after 2nd dose of the vaccine (13Jan2021). Viable pregnancy with heartbeat at 6 week ultrasound. Ended in miscarriage on 23Mar2021. (medically significant). On 08Jan2021 at 20:00, 2 days after 2nd dose, sudden difficulty breathing, no personal history of asthma. Needed Primary Care Physician to order Albuterol inhaler, which I needed daily for 4 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: (PCP Nasal Swab) negative on 19Jan2021, sars-cov-2 test (PCP Nasal Swab): negative on 23Mar2021.Events difficulty breathing and Miscarriage of pregnancy  required Emergency Room Visit and Physician Office visit. Treatment was given for the events which included Albuterol for difficulty breathing, D+C on 25Mar2021 for miscarriage. The clinical outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cluster headache, Dizziness, Tinnitus, Vertigo
Clinical narrative: Dizziness; Vertigo; Headaches; Tinnitus off and on for 9 weeks, and I'm still suffering; This is a spontaneous report from a non-contactable consumer (patient). A 34-years-old female patient received first dose of bnt162b2 (BNT162B2; Solution injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 11Apr2021 12:00 as single dose (at the age of 34-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took oxycodone. On 14Apr2021 07:00, 3 days after first vaccine shot, patient experienced dizziness, vertigo, cluster headache, tinnitus off and on for 9 weeks, and I m still suffering. The events were reported as disability or permanent damage. She received antibiotics treatment but didn't work. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been not been tested for COVID-19. The patient underwent lab tests and procedures which included blood test which was normal. The outcome of the all the events were not recovered.  Follow-up attempts are not needed as the reporter is a non-contactable. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Monoplegia
Clinical narrative: paralysis of the hand; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer COVID-19 Vaccine Call Center. An unspecified age male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first dose of bnt162b2 on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, patient had paralysis of the hand. He received both Pfizer covid 19 vaccines in the middle east. He was informed the spike protein test was not going to show covid or any antibodies in the system; he was told there is no way to check if he is protected after getting the vaccine. Caller is wondering if this information is true. The event was serious (medically significant). The outcome of the event was unknown.  Information about batch/ lot number has been requested.  Follow-up attempts are completed; information about batch/lot cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Dizziness, Inappropriate schedule of product administration, Off label use
Clinical narrative: first dose 02JAN2021 and second dose on 27FEB2021; first dose 02JAN2021 and second dose on 27FEB2021; loss of hearing as confirmed by hearing test given by audiologist; Dizziness; This is a spontaneous report from a contactable consumer, other health care professional via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). This consumer (patient) reported for herself that:  A 56-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. Medical history included none. The patient concomitant medications were not reported. Patient received other medications within 2 weeks of vaccination. Patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took bnt162b2 (Batch/Lot Number: EL3246), via an unspecified route of administration, administered in Arm Left on 02Jan2021 15:00 (at the age of 56-year-old) as dose 1, single for covid-19 immunisation. On an unknown date in 2021, the patient experienced loss of hearing as confirmed by hearing test given by audiologist, dizziness and first dose 02JAN2021 and second dose on 27FEB2021 (off label use and inappropriate schedule of vaccine administered) on 27Feb2021. The patient underwent lab tests and procedures which included acoustic stimulation tests: loss of hearing on an unknown date in 2021. The events resulted in physician office visit. No treatment was taken as a result of events loss of hearing as confirmed by hearing test given by audiologist, dizziness. The outcome of the events loss of hearing as confirmed by hearing test given by audiologist, dizziness were recovered with sequel (with lasting effects, as reported) on an unknown date in 2021, for other events was unknown.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events Deafness. 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: Cardiac arrest, Hepatic cirrhosis, Internal haemorrhage
Clinical narrative: cardiac arrest; internal bleeding; Cirrhosis; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patients son). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation.  Medical history included cirrhosis. The patient's concomitant medications were not reported. On an unspecified date the patient experienced cardiac arrest, internal bleeding, cirrhosis. The patient was hospitalized for cirrhosis for 7 days. The reporter reported on behalf of his mother who received complete series of the Pfizer-BionTech COVID19 vaccine two months ago. The patient was sent to the hospital last week and stayed for a week. She was sent home but rushed back to the hospital via rescue and had internal bleeding. The patient also went into cardiac arrest. Reporter asked if those has been reported and how should Pfizer treat his mother. He mentioned that his doctors are saying his mother was having advanced cirrhosis. He found on the internet side effects like bleeding and cirrhosis comes up. He said that doctors were just flipping a coin. Reporter stated earlier in the week the doctors were looking at his mothers advanced Cirrhosis since she had Cirrhosis before the vaccine but it was not advanced and she was in the hospital fairly regularly. Reporter stated one of the doctors asked his relative if she had the vaccine and the relative was not sure which vaccine she had. Reporter stated last night the mother went into cardiac arrest and the doctor asked which vaccine she had. Reporter stated he googled the onset of cirrhosis after the vaccine and heart issues after the vaccine in the elderly and both came up with Pfizer. Many doctors all have been cancelled out as people know because the media was heavily controlling and cancels anyone who has an adverse opinion or disagreement. Reporter stated as soon as a doctor makes a statement and if the statement was not in line with the government opinion then the doctor opinion was removed. Outcome of the events were unknown.   Information about batch no/lot no has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Laboratory test
Clinical narrative: My blood pressure is climbing; My pulse is like 119; My weight, it fluctuates; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jun2021 at 14:45 (at 67 years old, Lot Number: EW0179) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated she had a question. She had the vaccination on 09Jun2021 about 2:45 pm and today 10Jun2021, the blood pressure was climbing, pulse was like 119 and blood pressure last checked was '51 over 176' and pulse is 119. She weight was, the last time, put that 140. It's probably about 140 between 136-140, it fluctuates. Other medical condition patient stated "No, not nothing serious. Right now you know I had anxiety stuff but that's not I didn't have it. I am not having anxiety attack I noticed this something after medication the after injection". The patient had lab test by GP doctor but she don't have any result or anything. Probably last month sometime on May2021. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight fluctuation
Clinical narrative: My blood pressure is climbing; My pulse is like 119; My weight, it fluctuates; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jun2021 at 14:45 (at 67 years old, Lot Number: EW0179) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated she had a question. She had the vaccination on 09Jun2021 about 2:45 pm and today 10Jun2021, the blood pressure was climbing, pulse was like 119 and blood pressure last checked was '51 over 176' and pulse is 119. She weight was, the last time, put that 140. It's probably about 140 between 136-140, it fluctuates. Other medical condition patient stated "No, not nothing serious. Right now you know I had anxiety stuff but that's not I didn't have it. I am not having anxiety attack I noticed this something after medication the after injection". The patient had lab test by GP doctor but she don't have any result or anything. Probably last month sometime on May2021. The outcome of the events was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear infection, Glucose tolerance impaired, Headache, Hepatic steatosis
Clinical narrative: not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny nose; congestion; ear infection; Illness; Headache, like someone is poking her head repeatedly, after first vaccine; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 28Apr2021(at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included ongoing viral meningitis (as her older sister had Viral Meningitis), diabetic, Covid-19 from Oct2020 to Dec2020, ongoing food allergies and medication allergies. Concomitant medications included caffeine/codeine phosphate/paracetamol (TYLENOL WITH CODEIN #3) for an unspecified indication from 18May2021 to 20May2021; paracetamol (TYLENOL EXTRA STRENGTH) for headache from 14May2021 to 17May2021. No additional vaccines administered on same date of the Pfizer suspect. On 08May2021 19:00 the patient experienced headache, like someone is poking her head repeatedly, after first vaccine. On 09May2021 the patient experienced ear infection. On 17May2021 the patient experienced weak, pale, couldn't get up, runny nose, congestion. The patient missed second dose, scheduled for 21May2021. On 22May2021 the patient experienced viral meningitis, fatty liver, pre-diabetes and illness. On an unspecified date the patient experienced not feeling well. The patient was hospitalized for events from 18May2021 to 31May2021 except headache and illness. The patient underwent lab tests and procedures which included lumbar puncture: viral meningitis on 19May2021. Therapeutic measures were taken as a result of ear infection. The outcome of events not feeling well, viral meningitis, fatty liver, pre-diabetic and illness was unknown while the outcome of rest all event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Lumbar puncture, Malaise, Meningitis viral
Clinical narrative: not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny nose; congestion; ear infection; Illness; Headache, like someone is poking her head repeatedly, after first vaccine; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 28Apr2021(at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included ongoing viral meningitis (as her older sister had Viral Meningitis), diabetic, Covid-19 from Oct2020 to Dec2020, ongoing food allergies and medication allergies. Concomitant medications included caffeine/codeine phosphate/paracetamol (TYLENOL WITH CODEIN #3) for an unspecified indication from 18May2021 to 20May2021; paracetamol (TYLENOL EXTRA STRENGTH) for headache from 14May2021 to 17May2021. No additional vaccines administered on same date of the Pfizer suspect. On 08May2021 19:00 the patient experienced headache, like someone is poking her head repeatedly, after first vaccine. On 09May2021 the patient experienced ear infection. On 17May2021 the patient experienced weak, pale, couldn't get up, runny nose, congestion. The patient missed second dose, scheduled for 21May2021. On 22May2021 the patient experienced viral meningitis, fatty liver, pre-diabetes and illness. On an unspecified date the patient experienced not feeling well. The patient was hospitalized for events from 18May2021 to 31May2021 except headache and illness. The patient underwent lab tests and procedures which included lumbar puncture: viral meningitis on 19May2021. Therapeutic measures were taken as a result of ear infection. The outcome of events not feeling well, viral meningitis, fatty liver, pre-diabetic and illness was unknown while the outcome of rest all event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pallor, Rhinorrhoea
Clinical narrative: not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny nose; congestion; ear infection; Illness; Headache, like someone is poking her head repeatedly, after first vaccine; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 28Apr2021(at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included ongoing viral meningitis (as her older sister had Viral Meningitis), diabetic, Covid-19 from Oct2020 to Dec2020, ongoing food allergies and medication allergies. Concomitant medications included caffeine/codeine phosphate/paracetamol (TYLENOL WITH CODEIN #3) for an unspecified indication from 18May2021 to 20May2021; paracetamol (TYLENOL EXTRA STRENGTH) for headache from 14May2021 to 17May2021. No additional vaccines administered on same date of the Pfizer suspect. On 08May2021 19:00 the patient experienced headache, like someone is poking her head repeatedly, after first vaccine. On 09May2021 the patient experienced ear infection. On 17May2021 the patient experienced weak, pale, couldn't get up, runny nose, congestion. The patient missed second dose, scheduled for 21May2021. On 22May2021 the patient experienced viral meningitis, fatty liver, pre-diabetes and illness. On an unspecified date the patient experienced not feeling well. The patient was hospitalized for events from 18May2021 to 31May2021 except headache and illness. The patient underwent lab tests and procedures which included lumbar puncture: viral meningitis on 19May2021. Therapeutic measures were taken as a result of ear infection. The outcome of events not feeling well, viral meningitis, fatty liver, pre-diabetic and illness was unknown while the outcome of rest all event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Colitis ulcerative, Colonoscopy
Clinical narrative: Ulcerative Colitis; This is a spontaneous report from a contactable consumer (Patient, reported for self). A 54-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 at 12:15 (at the age of 54-years-old) as dose 2, single for COVID-19 immunization. The patient past Medical history included autoimmune hemolytic anemia (Auto immune hemolytic anemia when I was in my 20s)from an unspecified date and unknown if ongoing and known allergies includes seafood allergy (shell fish). The patient had earlier received first dose of BNT162B2 on 23Mar2021; lot number: EN6198; as single for COVID-19 immunization. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in 2 weeks of vaccination. On 21Apr2021 at 18:00, 1-2 days after the 2nd dose of Pfizer COVID vaccine the patient experienced diarrhea and has lasted for over 8 weeks. Sometimes very sever and bloody. Patient had a colonoscopy last week and was diagnosed with Ulcerative Colitis and never had any digestive issues prior to the 2nd vaccine. However, did have prior auto immune problems. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included colonoscopy: Ulcerative colitis on an unspecified date. The patient had been tested for COVID-19 post vaccination on 29May2021, [COVID test type: Nasal Swab] COVID-19 test result was Negative. The patient was treated with Colonoscopy and now on steroids. The event outcome was reported as Unknown. Device Date : 12Jun2021
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Severe eczema flare up; This is a spontaneous report from a contactable consumer. This 31-year-old female consumer reported for a patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in left arm on 04Jun2021 (at the age 31-year-old), as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not diagnose with COVID-19 prior to vaccination. It was unknown if the patient has not been tested for COVID-19 since the vaccination. Since 11Jun2021, the patient had severe eczema flare up, which requiring steroid shot. Prescribing doctor said she was the second patient to have this reaction to the vaccine that he had seen just that day. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Reporter reported event as non-serious. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695206 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: First shot felt like I had flu for 2 to 3 days; This is a spontaneous report from a contactable consumer (patient). An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 as dose 1, single for COVID-19 immunization. Medical history included post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), depression, anxiety, our age negative, had scarlet fever at age 13, 3 DNC spontaneous abortions, caesarean section, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergies to amoxicillin, morphine, cantaloupe others unknown and experienced allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received 3 other prescriptions daily in two weeks prior to the vaccination. The patient stated that after first shot felt like she had flu for 2 to 3 days on 30Mar2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient received Therapy and possible change in medication as treatment for the adverse events. The outcome of the event was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Poly Myalgia Rheumatica; This is a spontaneous report from a contactable consumer (patient herself).   A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in right arm on 09Feb2021 14:00 (age at vaccination:72 years) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included prednisone. The patient was allergic to demerol. The vaccine was administered in hospital. On 12Feb2021 08:00, the patient experienced polymyalgia rheumatica. The patient received prednisone as treatment for the event. The event required emergency room visit. The event of myalgia was considered to be medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for covid-19. The device date was 12Jun2021. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Myocarditis, SARS-CoV-2 test
Clinical narrative: had his second shot on 21Apr2021 and was in the hospital for chest pains/pressure on April 23-25, diagnosed with Myocarditis,; Myocarditis; had his second shot on 21Apr2021 and was in the hospital for chest pains/pressure on April 23-25, diagnosed with Myocarditis,; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0162), via an unspecified route of administration in left arm on 21Apr2021 (at the age of 17-year-old) and as single dose for COVID-19 immunisation. Medical history reported as none, patient had no known allergies. Concomitant medication included escitalopram, dose: 10 mg taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8732), via an unspecified route of administration in Arm Left on 31Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported that patient received Escitalopram 10 mg within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and patient did not test for COVID-19 since the vaccination. It was reported that patient had his second shot on 21Apr 2021 and was in the hospital for chest pains/pressure on April 23-25, diagnosed with Myocarditis. The patient was hospitalized for the events for 2 days on 23Apr2021 to 25Apr2021. On 24Apr2021, the patient underwent lab tests and procedures which included blood test for covid test and result with negative. Patient received treatment for events with 10+ ekg's or so, ibuprofen. The outcome of the events was recovered on an unspecified date in 2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Hypersensitivity, Loss of consciousness
Clinical narrative: Passing out; ended up passing out hit her head very hard; had an allergic reaction; This is a spontaneous report from a contactable consumer(patient). A 38-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7533, Expiration date was not reported), via an unspecified route of administration on 01May2021 as dose 2, single (at the age of 38-years-old) for COVID-19 immunisation. Medical history included ongoing Crohn's disease and allergy and COVID-19 (prior vaccination) (from an unknown date and unknown if ongoing). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included ustekinumab (Stelara) taken for Crohn's disease, start and stop date were not reported and patient took several other medications within 2 weeks of vaccination. Previously Patient received First dose of  BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8737, Expiration date was not reported), via an unspecified route of administration on 06Apr2021 as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation. Patient had not been tested for COVID-19, since the vaccination. On 08Jun2021, around 15:45 hours on Tuesday, patient took her ustekinumab (Stelara) injection for Crohn's disease, patient had taken this medication for years but this time patient had an allergic reaction around 5-10 mins after taking it and patient ended up passing out hit her head very hard, needed a Computerised tomogram (CT) scan. Patient was still needing liquid Benadryl multiple times a day now. Patient stated that ustekinumab (Stelara) takes a long time to get out of the body. Patient had emergency room/department or urgent care for the events. Patient do not know what her next steps will be. The only new thing that had happened was patient had her 2nd covid injection. Patient will see her health care providers next week. Patient will try to avoid the emergency room (ER). Patient do not want to pass out and hit my head again. The outcome of all the events was resolving.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID in April before they could receive the 2nd dose; Contracted COVID in April before they could receive the 2nd dose; This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on as dose 1, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer COVID Vaccine on 26Mar2021. She and her husband (who also received the vaccine) contracted COVID on an unspecified date of Apr2021 before they could receive the 2nd dose and were hospitalized for 2 weeks. The husband passed away, while the patient recovered from a severe (not mild) COVID infection. She was asking if she could get the 2nd dose and when should she receive the 2nd dose. On an unspecified date of Apr2021 patient underwent lab tests and procedures which included sars-cov-2 test: contracted covid. The outcome of the event was recovered on an unspecified date in 2021.  Information about batch/lot number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events "Drug Ineffective" and "Covid-19" and suspected drug cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, SARS-CoV-2 test
Clinical narrative: double vision; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533), via an unspecified route of administration, in arm left on 11Apr2021 at 13:00 (at the age of 62-years-old) as 2nd dose single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration in arm left on 20Mar2021 at 13:00 (at the age of 62-years-old) as 1st dose single both for COVID-19 immunisation (not pregnant at time of vaccination). The medical history of the patient included type 2 diabetes mellitus. The patient had wheat, corn and soy allergy. Patient did not receive concomitant medications within 2 weeks of vaccination. The patient previously took morphine, codeine and demerol for allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 05Jun2021 at 15:30, the patient experienced double vision. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 05May2021. The outcome of the event was reported as not resolved.  Follow up attempts are possible. further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: I've had to increase dosage on my blood pressure meds since vaccination AND I've had to add another BP med, and still my blood pressure is not controlled; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6208), via an unspecified route of administration on 11Mar2021 at 17:00 hours (at the age of 42-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included HIV infection, aortic valve disease, hypertension (start date and ongoing status unknown). The patient's concomitant medications were not reported. It was mentioned that the patient received other vaccines on 11Mar2021. He did not get other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination, had not been tested for COVID-19 since the vaccination, had no known allergies. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: E19266) via an unspecified route of administration on 18Feb2021 (at the age of 42-years-old) in right arm as dose 1, single for COVID-19 immunization. On 12Mar2021 , patient experienced and had to increase dosage on my blood pressure meds since vaccination and he had to add another BP med, and still his blood pressure was not con-trolled. he believe the correlation might be the vaccine along with his pre-existing heart disease. A bi cuspid aortic valve. Patient had attended doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Congenital anomaly or birth defect. Patient had received treatment for the event as Increase dosage of BP meds and additional BP med a. The Device timestamp was12Jun2021. Outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Pleurisy
Clinical narrative: pt developed SOB, CP, dx with pleurisy; pt developed SOB, CP, dx with pleurisy; pt developed SOB, CP, dx with pleurisy; This is a spontaneous report received from a contactable healthcare professional. A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0165), via intramuscular on 07May2021 at 12:00 PM (at the age of 62-years-old, non-pregnant at the time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history included HTN, elevated cholesterol and new onset DM2. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's concomitant medications within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and atorvastatin. The patient was not pregnant at time of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, on 27May2021, the patient developed SOB, CP, dx with pleurisy and on 28May2021, the patient was seen at local ED and hospitalized for 2 days. No prolonged hospitalization. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was CT scan, labs, IVF, CXR, needed o/p antibiotics. On an unspecified date, the patient underwent lab tests and procedures which included CXR, resulted as unknown and CT scan, resulted as unknown. The outcome of the events was recovering.  Batch/Lot number was obtained. Further information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Costochondritis, Palpitations
Clinical narrative: About 12 hours after 2nd Pfizer dose, my heart started to race and began to hurt; About 12 hours after 2nd Pfizer dose, my heart started to race and began to hurt; chest pain continued; it might be costochondritis; This is a spontaneous report from a contactable consumer (patient).  A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration in Arm Left on 17Apr2021 at 12:30 as single for COVID-19 immunization. The patient did not had any medical history. There were no known allergies. Concomitant medication received within 2 weeks of vaccination included bupropion (BUPROPION). The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration in Arm Left on 27Mar2021at 13:30 as single for COVID-19 immunization. On 18Apr2021 at 12:00, about 12 hours after 2nd Pfizer dose, patient's heart started to race and began to hurt. The racing slowed down, but the next day began again and heart still hurt, the parents took her to emergency room, had an EKG which was normal, but chest pain continued. The patient was followed up with her pediatrician, and she thought it might be costochondritis.The reporter wanted to report because, they saw someone online who had a problem like mine and didn't want anybody else to experience this and not know what was happening like patient did. Adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were not treated. The patient recovered from events in 2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms, Off label use, Perinatal depression, Product use issue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 01:15 PM (at the age of 30-years-old) as a single dose for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medications included sertraline 50mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that after her first dose, experienced intense cramping and her period started the next day (16Apr2021). She was breastfeeding her 2-month-old at the time and milk supply significantly lowered so much that her child wasn't growing enough and had to switch to formula. When she had breastfed her first child, she didn't get a period for 8 months, so she definitely think that it was related to the vaccine. Patient was happy to get vaccine this has been very hard for them and for her postpartum depression. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome for the events was resolved with sequel.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 01:15 PM (at the age of 30-years-old) as a single dose for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medications included sertraline 50mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that after her first dose, experienced intense cramping and her period started the next day (16Apr2021). She was breastfeeding her 2-month-old at the time and milk supply significantly lowered so much that her child wasn't growing enough and had to switch to formula. When she had breastfed her first child, she didn't get a period for 8 months, so she definitely think that it was related to the vaccine. Patient was happy to get vaccine this has been very hard for them and for her postpartum depression. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome for the events was resolved with sequel.  Information on Lot/Batch number was available. Additional information has been requested.