chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: bad sore throat; felt unwell; tired; groggy; This is a spontaneous report from a contactable other health care professional (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0198, Expiration date: Unknown), via an unspecified route of administration, administered in left shoulder on 30Jun2021 10:53 (at the age of 79-year-old) as single dose for COVID-19 immunisation at Pharmacy/Drug Store. Medical history included diabetes, blockages in her leg (Just found out she has blockages in her leg and has to go see a vascular surgeon), thyroid, blood pressure, glaucoma and cholesterol; all from an unknown date. Patient did not have relevant family medical history. The patient previously took flu shot (FLU VACCINE VII) on an unknown date for immunization and experienced needle stick and soreness in the arm. Concomitant medication(s) included insulin human (NOVOLIN R) from an unknown date and ongoing taken for diabetes mellitus (Has been taking for 2 years); insulin aspart (NOVOLOG) from an unknown date and ongoing taken for diabetes mellitus (Has been taking over 2 years); levothyroxine (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for thyroid (Has been taking at least a year); valsartan (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for hypertension (Has been taking at least a year); chlorthalidone (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for blood pressure; ezetimibe (MANUFACTURER UNKNOWN) from an unknown date and ongoing taken for cholesterol (Has been taking for probably 3 months) and brimonidine tartrate, timolol maleate (COMBIGAN) from an unknown date and ongoing taken for glaucoma. Additional vaccines were not administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jul2021, the patient experienced bad sore throat, felt unwell, tired and groggy. The patient underwent lab tests and procedures which included blood pressure measurement: suddenly 248/117 and ultrasound scan: some blockages; both on an unspecified date. Patient was received treatment for event felt unwell. It was reported that, On 30Jun2021, she had her first shot. It gave her a really bad sore throat. She just felt really tired and had to go to bed. She felt really unwell. She is getting the second shot 21Jul2021. She wanted to know whether the second one going to be worse than the first one. She noticed really bad sore throat in the next morning. She gargled salt water and mouth wash the second day, then it subsided, somewhat. She took Tylenol for that unwell feeling. Started the same time as the sore throat. It was not instantaneous or anything. By the second day, it was actually not lingering. She was going to a vascular surgeon on 19Jul2021. Does not know if this is pertinent or not. Patient was not visited to emergency room and physician office. The clinical outcome of event bad sore throat was resolving and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable consumer (mothers friend). A 9-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration as dose 2, single for Covid-19 immunization. Medical history and concomitant medications were not reported. Caller stated patient was a frail older woman and went to hospital for something and tested positive for covid. Caller was asking how she can be positive if she had had the 2 vaccines from Pfizer. Caller states she was not allowed to leave the hospital and go to a rehab centre to get the help she needed because she was positive. Caller declined to make a report and stated she needs to get herself taken care of first. Caller stated she does not have all of the information on her mothers friend. States she was concerned because patient was hospitalized and lives in the building her mother lives in. No further information provided to include NDC, lot or expiry dates. Patient was immunocompromised and cannot remember that she was exposed to anyone who was positive for Covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The outcome of event was unknown.  No follow-up attempts are needed. No further information expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Myocarditis, SARS-CoV-2 test
Clinical narrative: I believe these symptoms are consistent with the reports of myocarditis; Headache; Shortness of breath; Chest tightness all sustained between 12-24 hours after receiving 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EWO198), via an unspecified route of administration, administered in Arm Left on 05Jul2021 at 20:15 (at the age of 24-years-old) as single dose for covid-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history included known allergies to Penicillin from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). There were no concomitant medications. Historical vaccine included previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 20:15 (at the age of 24-years-old) (Batch/Lot Number: EWO181) as single dose for covid-19 immunization and did not experience any adverse reaction. No other vaccine administered in four weeks. Adverse event description stated by patient as on 06Jul2021 at 08:00 was headache, shortness of breath, and chest tightness all sustained between 12-24 hours after receiving 2nd dose. Took 2 Tylenol 24hrs after 2nd dose, symptoms dissipated, reappeared next morning, albeit reduced severity. I believe these symptoms are consistent with the reports of myocarditis (though the symptoms are admittedly nondescript) experienced by others in my demographic group following the 2nd dose. Patient was tested covid post vaccination. The patient underwent lab tests and procedures which included Nasal Swab test on 07Jul2021 with unknown result. The patient received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: after second dose, erratic period for 3 months; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955) via intramuscular route of administration on an unknown date in Apr2021 (age at vaccination: 30 years) in left arm (at 30-year-old) as dose 2, single dose for COVID-19 immunization. Medical history included penicilin allergy from an unknown date and unknown if ongoing. It was mentioned that patient did not receive any other vaccine in four weeks, no medications in two weeks, the patient was not diagnosed with COVID-19 prior to vaccination and the patient had not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient previously took lactose and experienced lactose intolerant-drug allergy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955) via intramuscular on 23Mar2021 at 11:30 AM in left arm (at 30-year-old) as dose 1, single dose for COVID-19 immunization. On 14Apr2021, the patient experienced after second dose, erratic period for 3 months (medically significant). The patient administered COVID-19 vaccine at Workplace clinic. The patient did not take treatment for the event. On an unknown date in 2021, the outcome of the event was recovered.  Follow-Up (12Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: second dose, when the nurse took out the needle from the injection site there was blood.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number and Expiration date not reported) intramuscular on 19Jun2021 (age at vaccination 12-year) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) as dose 1, single on May2021 (at the age of 12 years) for COVID-19 immunization. On19Jun201 the patient experienced after the second dose, when the nurse took out the needle from the injection site there was blood. The nurse said that she might have nicked a vein or a blood vessel. The nurse cleaned it up with alcohol and band aid to stop the bleeding. Re-porter was concerned it may affect the vaccine although patient did seem fine. Reporter was also asking if there was a danger on the vaccine going into your blood stream or if the vaccine will still work. Reporter said that patient was vaccinated from a vaccination site and they cannot talk to the nurse. Reporter called about the Pfizer Covid-19 Vaccine. She has a question because her 12-year-old daughter received her vaccine back at the end of May and in June for the second dose. The clinical outcome of vaccination site bleeding was recovered on an unspecified date in 2021.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Cough, Nasopharyngitis, Oropharyngeal pain, Oxygen saturation
Clinical narrative: sore throat; cough; cold type symptoms; This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported for a patient that: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: was not reported), via an unspecified route of administration, administered on Jan2021as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: unknown), via an unspecified route of administration on unspecified date in Dec2020as dose1, single for COVID-19 immunization. Reporter states he as a patient that received his first dose of the Pfizer COVID-19 vaccine in Dec2020 and the second dose of the Pfizer COVID-19 vaccine in Jan2021. Patient has been tested for the spike antibodies and he has them and is fully protected. Reporter states his patient has been extremely careful with wear the mask and gloves but the patients now has symptoms that started on Tuesday of sore throat, cough, no fever and Oxygen saturation has been 99-100%. Caller would like to know if this could be a breakthrough COVID-19 case. Reporters doctor friend (patient) did the labs and it does show immunity to the virus but now he has cold type symptoms and his friend is "freaking" out that he may have the variant and he was asking if this was what was going on. The patient underwent lab tests and procedures which included spike antibody test: fully protected on an unspecified date in 2021, oxygen saturation: 99-100 % on an unspecified date in 2021. The outcome of event was recovering.    Information about batch/ lot number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood count abnormal, Blood test, Haematocrit, Haematocrit decreased, Red blood cell count
Clinical narrative: low white blood count; low red blood count; low hematocrit; blood test showed minor drop in one other thing that he cannot remember; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613, Expiration date and NDC number was not reported), via an unspecified route of administration on 28Mar2021 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization 2 months ago. Medical history included Large Cell Non-Hodgkin's Lymphoma from 1994 to unknown if ongoing and because of it his immune system dropped/knocked down (ongoing). Patient stated that due to a prior cancer, his immune system drops down sometimes for no apparent reason. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Lot number: either EN6198 or FN6198), dose 1 via an unspecified route of administration on 07Mar2021 as dose 1, single (at the age of 67-years-old) for COVID-19 immunization. On 28Apr2021, patient had a last blood test and results showed minor drop in white blood count, red blood count, hematocrit and one other thing that he cannot remember (4 results that are below normal indicating that his immune system was not up to par), doctor told him this indicates a little low immune system/ weakened immune system. Patient stated it was not a major drop, but it was lower than a normal one. Patient mentioned that some of his doctors stated that the vaccine would help him fight the virus and others stated that the vaccine would build up his immunity. Patient wanted to know which statement was most accurate with the Pfizer BioNTech COVID-19 vaccine and wanted to know the effect of the vaccine especially if his immune system was low. Patient was concerned if his immune system will be knocked down, what precautions should he take. The outcome of all the events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count decreased, White blood cell count, White blood cell count decreased
Clinical narrative: low white blood count; low red blood count; low hematocrit; blood test showed minor drop in one other thing that he cannot remember; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613, Expiration date and NDC number was not reported), via an unspecified route of administration on 28Mar2021 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization 2 months ago. Medical history included Large Cell Non-Hodgkin's Lymphoma from 1994 to unknown if ongoing and because of it his immune system dropped/knocked down (ongoing). Patient stated that due to a prior cancer, his immune system drops down sometimes for no apparent reason. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Lot number: either EN6198 or FN6198), dose 1 via an unspecified route of administration on 07Mar2021 as dose 1, single (at the age of 67-years-old) for COVID-19 immunization. On 28Apr2021, patient had a last blood test and results showed minor drop in white blood count, red blood count, hematocrit and one other thing that he cannot remember (4 results that are below normal indicating that his immune system was not up to par), doctor told him this indicates a little low immune system/ weakened immune system. Patient stated it was not a major drop, but it was lower than a normal one. Patient mentioned that some of his doctors stated that the vaccine would help him fight the virus and others stated that the vaccine would build up his immunity. Patient wanted to know which statement was most accurate with the Pfizer BioNTech COVID-19 vaccine and wanted to know the effect of the vaccine especially if his immune system was low. Patient was concerned if his immune system will be knocked down, what precautions should he take. The outcome of all the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Myalgia, Pain
Clinical narrative: A fever started this morning; Right sore arm; Aches; I have relatively good health all my life, I can't stand to feel this way; Bad muscle soreness; Chills/ On and off chills; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178 and Expiration Date: unknown), via an unknown route of administration, administered in right arm on 07Jul2021 at 13:30 (at the age of 75-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified blood thinner. The patient previously took first dose of bnt162b2 (Lot number: EW0168), administered in right arm on 16Jun2021 at 12:30 PM (at the age of 74-years-old) for covid-19 immunisation and experienced sore right arm and a passing twingy headache on an unknown date in Jun2021. The patient reported that she received her 2nd covid-19 vaccine dose yesterday on 07Jul2021 at 1:30 PM. She saw there were somewhat common side effects for the covid-19 vaccine. Her side effects were really bad muscle soreness and aches, on and off chills started on an unknown date in Jul2021 and a fever that started morning on the day of reporting on 08Jul2021. On 08Jul2021, her first temperature was 99.6 degrees Fahrenheit, and her temperature went to 100.6 degrees Fahrenheit. She took Tylenol at 10:00 AM morning on 08Jul2021 and now at the time of reporting the time was about 3:45 PM. She would like to take a second Tylenol dose and wanted asked if it was OK for her to take the second dose of Tylenol for her side effects. Her right sore arm had eased up with her first vaccine dose, as well as today on an unknown date in Jul2021 with her second covid-19 vaccine shot. Patient reported that, she had relatively good health all her life, she could not stand to feel this way. She did not do anything today (as reported) on an unknown date in Jul2021. The case was assessed as non-serious. Therapeutic measures were taken as a result of aches, bad muscle soreness, chills/ on and off chills, a fever started this morning (pyrexia) and right sore arm. Outcome of events was unknown.  No follow-up attempts needed. No further information is expected, batch/lot.no. has already been reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: A fever started this morning; Right sore arm; Aches; I have relatively good health all my life, I can't stand to feel this way; Bad muscle soreness; Chills/ On and off chills; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178 and Expiration Date: unknown), via an unknown route of administration, administered in right arm on 07Jul2021 at 13:30 (at the age of 75-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified blood thinner. The patient previously took first dose of bnt162b2 (Lot number: EW0168), administered in right arm on 16Jun2021 at 12:30 PM (at the age of 74-years-old) for covid-19 immunisation and experienced sore right arm and a passing twingy headache on an unknown date in Jun2021. The patient reported that she received her 2nd covid-19 vaccine dose yesterday on 07Jul2021 at 1:30 PM. She saw there were somewhat common side effects for the covid-19 vaccine. Her side effects were really bad muscle soreness and aches, on and off chills started on an unknown date in Jul2021 and a fever that started morning on the day of reporting on 08Jul2021. On 08Jul2021, her first temperature was 99.6 degrees Fahrenheit, and her temperature went to 100.6 degrees Fahrenheit. She took Tylenol at 10:00 AM morning on 08Jul2021 and now at the time of reporting the time was about 3:45 PM. She would like to take a second Tylenol dose and wanted asked if it was OK for her to take the second dose of Tylenol for her side effects. Her right sore arm had eased up with her first vaccine dose, as well as today on an unknown date in Jul2021 with her second covid-19 vaccine shot. Patient reported that, she had relatively good health all her life, she could not stand to feel this way. She did not do anything today (as reported) on an unknown date in Jul2021. The case was assessed as non-serious. Therapeutic measures were taken as a result of aches, bad muscle soreness, chills/ on and off chills, a fever started this morning (pyrexia) and right sore arm. Outcome of events was unknown.  No follow-up attempts needed. No further information is expected, batch/lot.no. has already been reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Diarrhoea
Clinical narrative: serious daily diarrhea; This is a spontaneous report form a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine, solution for injection, batch/lot number: EW0170, expiry date: 31Aug2021), via intramuscular route of administration, in arm, on 11Jun2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation. The patient medical history was Eosinophilic esophagitis (EOE) in 2019 which was ongoing. EOE confirmed by multiple biopsies of oesophagus. Concomitant medication included Estradiol (Estrogen), Hydroxyprogesterone Caproate (Hydroxyprogesterone), PROGESTERONE and testosterone; all were taken as bioidentical hormone therapy from an unknown date and ongoing. The patient received first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine, solution for injection, batch/lot number: EW161RA, expiry date: 31Jul2021), via an unspecified route of administration, in arm, on 21May2021 (at the age of 56-years-old) as historical vaccination as single dose for COVID-19 immunisation and experienced severe headaches with outcome recovered 28May21 and serious daily diarrhoea with outcome not recovered. Vaccine facility type was reported as clinic (Site). There was no prior vaccinations within 4 weeks. On 11Jun2021, the patient experienced serious daily diarrhoea. The outcome of the adverse event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Pain in extremity
Clinical narrative: arm hurt; head feels swooshy; ears were clogged up; This is a spontaneous report from a contactable consumer. A 30-year-old male patient (reporter's son) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) dose 1 via an unspecified route of administration on 05Apr2021 as DOSE 1, SINGLE for covid-19 immunisation, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date in Apr2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient experienced arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. The outcome of events was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021863091 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Pain in extremity
Clinical narrative: Arm hurt, of course, and it was really weird; Head feels swooshy; Ears were clogged up; This is a spontaneous report from a contactable consumer received via medical information team. This consumer (patients friend) reported for a female patient (reporters girlfriend). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient's arm hurt and it was really weird, head felt swooshy and ears were clogged up. Reporter proceeded to share AE information regarding herself, her son, and her girlfriend. She said her "son's arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. Her girlfriend experienced the same thing". Caller asked about if the vaccine will protect her from the new variant. When asked which specific variant, she said "the big one, I think delta". She was responded that Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. The Centers for Disease Control and Prevention (CDC) states that information about the characteristics of these variants is rapidly emerging. Scientists are working to learn more about how easily they spread, whether they could cause more severe illness, and whether currently authorized vaccines will protect people against them (Delta). So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021863089 same reporter/drug/AE, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: Fever for 2 days; Muscle ache only on the left side; Headache; Sudden UTI; This is a spontaneous report from a non-contactable other healthcare professional (patient).   A 25-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180 and expiration date was not reported), via unknown route administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization (Age at vaccination 25 years). The patient medical history included COVID-19 and concomitant medication was not reported. The patient was not pregnant at the vaccination time. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03JUL2021, the patient experienced headache, fever for 2 days, sudden urinary tract infection and muscle ache only on the left side. The patient was not received any treatment for adverse event. The patient had COVID test post vaccination Nasal Swab and COVID test result was Negative. The outcome of event fever was recovered on an Jul2021 and headache, urinary tract infection and muscle ache was recovering.,   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, Oxygen saturation abnormal, SARS-CoV-2 test
Clinical narrative: Physician is fully vaccinated with Pfizer vaccine/ but both physician and mother contracted COVID-19.; Physician is fully vaccinated with Pfizer vaccine/ but both physician and mother contracted COVID-19.; His O2 saturations were 92-93%. It started mild but got worse; This is a spontaneous report from a contactable physician. A adult male patient received BNT162B2 (Formulation: Solution for injection: Batch/Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date 2021 as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date of 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021 the patient (physician) is fully vaccinated with Pfizer vaccine. His wife was pregnant and not vaccinated, contracted Covid-19. Her mother was also fully vaccinated, but both physician and mother contracted COVID-19. Physician stated that his symptoms were worse than his wife, mother and lasted for weeks. His O2 saturations were 92-93 percent. It started mild but got worse. No one needed to be hospitalized, but he is very apprehensive on the efficacy of vaccines against the variant and is a bit worried we are letting our guard down too fast with re-opening and removing mask mandates. He believes the efficacy of Pfizer vaccine is in 50 percent for variant based on information he is seeing from another country. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included oxygen saturation as 92-93 percent on an unspecified date of 2021, sars-cov-2 test as unknown on an unspecified date of 2021. The events drug ineffective and COVID-19 considered as medically significant. The outcome of the event was recovered.  Information on the lot/batch number has been requested.; Sender's Comments:  The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I contracted Covid-19 again.  Was diagnosed positive on July 7th, 2021; I contracted Covid-19 again.  Was diagnosed positive on July 7th, 2021; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: CR8727) via an unspecified route of administration, administered in left arm on 30Mar2021 at 12:00 (at the age of 55-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 06Jul2021 at 07:00, the patient contracted covid-19 again, was diagnosed positive on 07Jul2021. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included rapid test nasal swab: negative on 22Jun2021, positive on 07Jul2021. Events resulted in emergency room/department or urgent care. No treatment received for the events. The clinical outcome of events was recovered on unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Caller received first dose yesterday and noticed "baseball" bruise on right calf after shower/ a co-worker that works security indicated a parallel AE where keys on belt hit body; This is a spontaneous report from a contactable consumer. This consumer reported for a 29-year-old male patient. A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received Hepatitis C shot and experienced stiffness arm. On an unspecified date, after the vaccination, the patient noticed "baseball" bruise on right calf after shower. Indicated that he works for the city of (Withheld) and a co-worker that works security indicated a parallel AE where keys on belt hit body. Stated that he has not experienced any injury or pressure to the area. He stated everything was fine. Vaccination was voluntary, deals with the general public. He did research and indicated that the Pfizer was the best one. The outcome of the event was unknown at the time of this report.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for the Covid virus after getting the Covid vaccine in Apr2021; Tested positive for the Covid virus after getting the Covid vaccine in Apr2021.; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported for her sister a female patient that a female patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified, Expiry date: unknown), via an unspecified route of administration on an unspecified date in Apr2021 at as dose number unknown, single for COVID-19 immunization. The patient' medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for the covid virus after getting the covid vaccine in Apr2021. Patient underwent lab test I was covid test result was positive on unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Palpitations, Pyrexia, Rash, Vein disorder
Clinical narrative: heart palpitation very bad; like a really weird sign like an electrical current went through my body; like there is a cervical urgency in my veins, in my heart and in my body and heart palpitations; Weird things happening like rash all kinds of things happening; even fever; Weird things happening like rash all kinds of things happening; even fever; This is a spontaneous report from a contactable patient (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jun2021, the patient had heart palpitation very bad, like a really weird sign like an electrical current went through my body, like there is a cervical urgency in my veins, in my heart and in my body and heart palpitations, weird things happening like rash all kinds of things happening, even fever and even fever. Reporter stated that, "I had the first dose two weeks ago and having like since then heart palpitation very bad and like a really weird sign like an electrical current went through my body. So, I didn't get the second one because the first one had been rough on me and my husband both but still it's been two weeks, I feel like an electrical current going through my veins, I don't know how to spell it, like there is a cervical urgency in my veins, in my heart and in my body and heart palpitations." Patient stated, "Yes report it because I am afraid to get the second one, I don't have to get the second dose or any other vaccine." Patient stated, "I am not going to wait for you when I am having heart palpitations and weird things happening like rash all kinds of things happening even fever, and nobody is helping me." Reporter seriousness for the event was Unspecified. Outcome of the events were unknown.  QR Comment: This case was split however the split was not made as the information was not available over the call, as patient hung up the call abruptly.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Skin disorder
Clinical narrative: White bumps/whiteheads/bumps with white pimples inside; swelling mostly to the upper lip; This is a spontaneous report from a contactable consumer or other Non-health care professional. This report is based on the information received by Pfizer from Galderma (Reference: GL-061621-14617).  A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Feb2021 (at the ag of 48-years-old) as dose 2, single for covid-19 immunization. Medical history included allergies to sulfa, Ibuprofen and aspirin. She had Juvaderm in Feb2021. The flu shot in the fall of 2020. Concomitant medications included hyaluronic acid (RESTYLANE) taken from 27May2021; botulinum toxin (BOTOX) type a from 27May2021; probiotics; loratadine (CLARITINE); cetirizine hydrochloride (ZYRTEC). The patient previously took ibuprofen and experienced drug hypersensitivity, aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, juvederm, BNT162B2 (formulation: solution for injection, Batch/lot no was not reported) via unspecified route of administration on 06Feb2021 as dsoe1, single for covid-19 immunization. On 31May2021, the patient experienced white bumps/whiteheads/bumps with white pimples inside, swelling mostly to the upper. Patient sister stated that the patient had Restylane injected into her lips on 27may2021. On 31May2021 begin having a reaction looks like whiteheads/bumps with white pimples inside and swelling mostly to the upper lip. Patient saw the injecting HCP and gave her Prednisolone, then reporter went back again two days ago and he gave her Hylenex injection 60 units but it did not help the patient. The patient had no illness recently and no dental procedures in the last 6 to 12 months. Therapeutic measures were taken as a result of white bumps/whiteheads/bumps with white pimples inside (skin disorder), swelling mostly to the upper lip (lip swelling). The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Swelling face, Tenderness
Clinical narrative: Large red swollen spot on the right cheek; Large red swollen spot on the right cheek; Tenderness; This is a spontaneous report from a contactable other hcp (Nurse). This report based on the information received by Pfizer.   A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 03Apr2021 as dose 2, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), via an unspecified route of administration from 14Jun2021 (Batch/Lot number was not reported) to 14Jun2021, at unspecified dose for an unspecified indication. The patient's medical history included leukaemia for 7 years and had gotten clearance from her oncologist to receive HA Fillers. The patient is currently taking multiple medications. Patient is a female that smokes daily. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tenderness; On 15Jun2021, large red swollen spot on the right cheek. It was reported that the patient was injected on 14Jun2021 with Restylane Refyne and Restylane Defyne into her nasal labial folds and Restylane Kysse injected in her lips. On 15Jun2021 she developed a large red swollen spot on the right cheek. It was treated with ice, Tylenol, and Augmentin 875/125/ po BID for 10 days. No fever was noted. Tenderness subsided and swelling was improving. The outcome of event tenderness was recovered on an unspecified date in 2021, while outcome of event large red swollen spot on the right cheek was recovering.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cold sweat, Urticaria
Clinical narrative: cold sweets; hives in both legs; stomachache; This is spontaneous report from Pfizer colleague. This Pfizer colleague reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, Single for COVID-19 immunization. The patient's medical history and patient's concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported)via an unspecified route of administration on an unspecified date as dose 1, Single for COVID-19 immunization and experienced tired, Weakness, Whole body aches. It was reported that the patient got her second shot recently and experienced cold sweets, hives in both legs and stomach ache on an unspecified date in 2021. Outcome of the events was reported as Unknown.   Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore right arm; Had a passing "twingy" headache; This is a spontaneous report from a contactable consumer or other non-health care professional. A 75-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 16Jun2021 12:30 (at the age of 74-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After first dose patient experienced sore right arm. She clarified she also had a passing "twingy" headache on unspecified date Jun2021, beside her right sore arm. Her right sore arm had eased up with her first vaccine dose, as well as, today with her second COVID-19 Vaccine shot. It was reported that patient received her 2nd COVID-19 Vaccine dose yesterday. Reported she had called to get her question answered, and really wanted to know if she could take a second Tylenol. Caller was transferred to Pfizer Medical Information for further assistance. The outcome of the events was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Product administered at inappropriate site, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Gave me the shot  closer to my elbow rather than my shoulder; Swollen, it started swelling but it was red, it's still red and it's swollen but it's swollen quite a bit; Swollen, it started swelling but it was red, it's still red and it's swollen but it's swollen quite a bit; Have swelling and it has increased quite a bit and it's warm; Have swelling and it has increased quite a bit and it's warm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number W7602805, Expiration date: was not reported), via an unspecified route of administration on 05Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the Pfizer shot on 05Jul2021 and I didn't pay much attention as to where she gave me the shot but it's closer to my elbow rather than my shoulder. So, I'm just wondering if and then I have, it was swollen, it started swelling but it was red, it's still red and it's swollen but it's swollen quite a bit, it's actually right across my shoulder like a band halfway around my arm. And I was wondering if I could send you a picture for you to see it. When confirmed about the swelling around shoulder, consumer stated, It's not on patients shoulder, it's down by patients bicep it's not up on patients shoulder at all. It's closer to patinets elbow maybe like 2 inches away from my elbow. She gave it to me at the wrong spot, so I'm just trying to find out if that's okay or was she supposed to do it higher or what to do. And my sister in the hospital and she's having Chemo therapy and one of the nurses, I sent her a picture so she could see because I wanted to go and visit her and the nurse said that, that was really strange as to how or where I've had the shot. And she suggested why don't you better call on the website and know if there's a problem with that. I do have swelling and it has increased quite a bit and it's warm. And that's one of the side effects that I'm just concerned as to where she gave me the shot. Hopefully on the shoulder, above my elbow, on my arm up high and it's down near my elbow almost. I wasn't watching her do it because I can't stand needles so I was looking the other way I didn't see where she put the shot and she's rubbing alcohol on my arm it feel like a little higher than where she gave me the shot. The outcome of the events was reported as not recovered for vaccination site erythema and vaccination site swelling, while for the other events its was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a contactable Consumer. A patient of unspecified age and gender reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced a metallic taste in the mouth, which was immediately followed by a fainting feeling and palpitations. The patient's medical history and concomitant medications were not reported. After the second dose, tiredness for about one week which had been subsided (recovered).  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Inflammation
Clinical narrative: I have been suffering with a lot of inflammation and joint pains.; In my bones, my fingers, my elbows, my ribs. I am feeling a lot of pain in my knees and my foot.; Outcome of Event: Consumer stated, "Worsening"; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as a single dose via an unspecified route of administration, and the first dose administered in Arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. In Apr2021, patient experienced a lot of inflammation and joint pains. Patient have never had it before, not an ounce of it. Patient stated that patient was feeling a lot of pain in joints right now that's why patient called. In bones, fingers, elbows, ribs. Patient was feeling a lot of pain in knees and foot. On an unspecified date in 2021, Patient stated that events was worsening. It was reported that no therapeutic measures were taken for the events experienced. The outcome of event condition worsened was unknown and for all rest events was not recovered.  Information on lot/ batch number has been requested.