chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bedridden, Diarrhoea, Feeling abnormal, Immunisation
Clinical narrative: Off label use; Booster; He is experiencing severe intestinal discomfort; He is having severe diarrhea; He feels like he is going to vomit, he has not vomited but feels like he should; He is in bed, felling terrible; He is in bed, felling terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (1st booster shot), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 01Apr2022, outcome "unknown"; NAUSEA (non-serious) with onset Apr2022, outcome "unknown", described as "He feels like he is going to vomit, he has not vomited but feels like he should"; ABDOMINAL DISCOMFORT (non-serious) with onset Apr2022, outcome "unknown", described as "He is experiencing severe intestinal discomfort"; DIARRHOEA (non-serious) with onset Apr2022, outcome "unknown", described as "He is having severe diarrhea"; FEELING ABNORMAL (non-serious), BEDRIDDEN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "He is in bed, felling terrible".  Additional Information: Reporter stated, "My husband, he is 76 (Not clarified) he got his fourth Pfizer shot on Friday. He is experiencing severe intestinal discomfort, he feels like he is going to vomit, he has not vomited but feels like he should. He is having severe diarrhea. Yesterday he was fine but today he woke up with it." Reporter was requested to reach to Doctor/Physician in case of any emergency. Reporter stated, "Meanwhile he is in bed, felling terrible and we don't even know if it is a side effect or something more serious.   QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Off label use
Clinical narrative: Off label use; Booster; He is experiencing severe intestinal discomfort; He is having severe diarrhea; He feels like he is going to vomit, he has not vomited but feels like he should; He is in bed, felling terrible; He is in bed, felling terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (1st booster shot), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 01Apr2022, outcome "unknown"; NAUSEA (non-serious) with onset Apr2022, outcome "unknown", described as "He feels like he is going to vomit, he has not vomited but feels like he should"; ABDOMINAL DISCOMFORT (non-serious) with onset Apr2022, outcome "unknown", described as "He is experiencing severe intestinal discomfort"; DIARRHOEA (non-serious) with onset Apr2022, outcome "unknown", described as "He is having severe diarrhea"; FEELING ABNORMAL (non-serious), BEDRIDDEN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "He is in bed, felling terrible".  Additional Information: Reporter stated, "My husband, he is 76 (Not clarified) he got his fourth Pfizer shot on Friday. He is experiencing severe intestinal discomfort, he feels like he is going to vomit, he has not vomited but feels like he should. He is having severe diarrhea. Yesterday he was fine but today he woke up with it." Reporter was requested to reach to Doctor/Physician in case of any emergency. Reporter stated, "Meanwhile he is in bed, felling terrible and we don't even know if it is a side effect or something more serious.   QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: other_medical_history: Covid; other_medical_history: Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1,single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "extremely mild blood in urine (micro something)" (unspecified if ongoing); "some trees" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 12Aug2021; TYLENOL, start date: 12Aug2021. Past drug history included: Novacaine, reaction(s): "known allergies:Novacaine", notes: known allergies:Novacaine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "other_medical_history: Covid". Therapeutic measures were taken as a result of suspected covid-19. Clinical Course : Have taken 3 doses worth. Patient also stated, the metallic taste in her saliva after the body processes the dose is annoying. Stated, "I can tell it comes from the 2 pink pills."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Heart rate increased, Hypoaesthesia, Lethargy
Clinical narrative: increase in heart rate; numbness in the legs; Lethargy; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. Other Case identifier(s): US-PFIZER INC-202200518190.  A 65 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "increase in heart rate"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in the legs"; LETHARGY (non-serious), outcome "unknown", described as "Lethargy"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter would like to know if increase in heart rate was a side effect and numbness in the legs. Also questioned if lethargy or fatigue would be a part. She stated she had a patient come in and was concerned. The patient received the shot "one week ago" and was saying that her heart rate was increasing and they were uncertain if these side effects could occur after one week of having had the product or if this could be caused from another source.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: tested positive for COVID; tested positive for COVID; sore throat; runny nose; headache; Symptoms described as mild, "like a cold"; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 28Mar2022, outcome "recovering", described as "Symptoms described as mild, "like a cold""; HEADACHE (non-serious) with onset 28Mar2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 28Mar2022, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 28Mar2022, outcome "recovering", described as "sore throat"; DRUG INEFFECTIVE (medically significant) with onset 31Mar2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 31Mar2022, outcome "recovering" and all described as "tested positive for COVID". The events "tested positive for covid", "sore throat", "runny nose", "headache" and "symptoms described as mild, "like a cold"" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Mar2022) Positive, notes: Patient was rechecked for COVID on day 3 of symptoms and was positive; (unspecified date) Negative, notes: get another rapid COVID and strep tests, which were both negative; (28Mar2022) Negative, notes: had a rapid COVID test at school which was negative; (unspecified date) Negative, notes: get another rapid COVID and strep tests, which were both negative. It was unknown if therapeutic measures were taken as a result of suspected covid-19, oropharyngeal pain, rhinorrhoea, headache, nasopharyngitis.  Clinical course: Patient had not received any other vaccine within 4 weeks and not diagnosed covid-19 prior to vaccination. On 28Mar2022 had a sore throat and had a rapid COVID test at school which was negative. Pt father took him to urgent care after school to get another rapid COVID and strep tests, which were both negative. Doctor told the patient to take antihistamine as it was likely allergies. His symptoms of sore throat, runny nose, and some headache persisted. Patient was rechecked for COVID on day 3 of symptoms and was positive. His Symptoms described as mild, "like a cold". Patient had visited emergency room with respect to events. No one else in the family has tested positive for COVID nor has any symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive for COVID; tested positive for COVID; sore throat; runny nose; headache; Symptoms described as mild, "like a cold"; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 28Mar2022, outcome "recovering", described as "Symptoms described as mild, "like a cold""; HEADACHE (non-serious) with onset 28Mar2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 28Mar2022, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 28Mar2022, outcome "recovering", described as "sore throat"; DRUG INEFFECTIVE (medically significant) with onset 31Mar2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 31Mar2022, outcome "recovering" and all described as "tested positive for COVID". The events "tested positive for covid", "sore throat", "runny nose", "headache" and "symptoms described as mild, "like a cold"" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Mar2022) Positive, notes: Patient was rechecked for COVID on day 3 of symptoms and was positive; (unspecified date) Negative, notes: get another rapid COVID and strep tests, which were both negative; (28Mar2022) Negative, notes: had a rapid COVID test at school which was negative; (unspecified date) Negative, notes: get another rapid COVID and strep tests, which were both negative. It was unknown if therapeutic measures were taken as a result of suspected covid-19, oropharyngeal pain, rhinorrhoea, headache, nasopharyngitis.  Clinical course: Patient had not received any other vaccine within 4 weeks and not diagnosed covid-19 prior to vaccination. On 28Mar2022 had a sore throat and had a rapid COVID test at school which was negative. Pt father took him to urgent care after school to get another rapid COVID and strep tests, which were both negative. Doctor told the patient to take antihistamine as it was likely allergies. His symptoms of sore throat, runny nose, and some headache persisted. Patient was rechecked for COVID on day 3 of symptoms and was positive. His Symptoms described as mild, "like a cold". Patient had visited emergency room with respect to events. No one else in the family has tested positive for COVID nor has any symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Mar2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID infection". Therapeutic measures were taken as a result of covid-19.  Clinical information: Caller is a pharmacist asking on behalf of one her patient who just finished a 5 day treatment of Antiviral after getting COVID infection on Mar2022. and the patient would like to know how long after the Antiviral treatment they would be able to receive the third booster dose of Pfizer covid vaccine. Pharmacist is unsure if the Antiviral taken by patient is Paxlovid or molnupiravir. Call was not transferred as he AE was recognized after the call had ended. Spoke from the attached document. Use in COVID-19 Vaccinated Patients and informed caller The study excluded individuals with a history of prior COVID-19 infection or vaccination: as part of the protocol the study did not include participants if they had received or were expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit. Informed pharmacist to recommend the patient to consult his HCP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Electrocardiogram ST segment abnormal, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: COVID test result: Positive; COVID test result: Positive; ST; Low O2 sat; High fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 04Mar2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 01Apr2022, outcome "recovering", described as "High fever"; OXYGEN SATURATION DECREASED (non-serious) with onset 01Apr2022, outcome "recovering", described as "Low O2 sat"; ELECTROCARDIOGRAM ST SEGMENT ABNORMAL (non-serious) with onset 01Apr2022 at 18:00, outcome "recovering", described as "ST"; VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 02Apr2022, outcome "recovering" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: Body temperature: (01Apr2022) High; Oxygen saturation: (01Apr2022) Low; SARS-CoV-2 test: (01Apr2022) Negative, notes: COVID test name post vaccination: Home Ag; (02Apr2022) Positive, notes: COVID test name post vaccination: Home Ag. Therapeutic measures were taken as a result of covid-19, pyrexia, electrocardiogram st segment abnormal, oxygen saturation decreased. Clinical information reported as patient exposed at an athletic event 31Mar pm then ST 01Apr 6pm and went on to have high fever and low O2 sat got positive home Ag on 02Apr and started Paxlovid (PCP) same time. Ae resulted in: None of the above. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result: Positive; COVID test result: Positive; ST; Low O2 sat; High fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 04Mar2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 01Apr2022, outcome "recovering", described as "High fever"; OXYGEN SATURATION DECREASED (non-serious) with onset 01Apr2022, outcome "recovering", described as "Low O2 sat"; ELECTROCARDIOGRAM ST SEGMENT ABNORMAL (non-serious) with onset 01Apr2022 at 18:00, outcome "recovering", described as "ST"; VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 02Apr2022, outcome "recovering" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: Body temperature: (01Apr2022) High; Oxygen saturation: (01Apr2022) Low; SARS-CoV-2 test: (01Apr2022) Negative, notes: COVID test name post vaccination: Home Ag; (02Apr2022) Positive, notes: COVID test name post vaccination: Home Ag. Therapeutic measures were taken as a result of covid-19, pyrexia, electrocardiogram st segment abnormal, oxygen saturation decreased. Clinical information reported as patient exposed at an athletic event 31Mar pm then ST 01Apr 6pm and went on to have high fever and low O2 sat got positive home Ag on 02Apr and started Paxlovid (PCP) same time. Ae resulted in: None of the above. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Your old vaccine is worthless against omicron and preventing infection; Your old vaccine is worthless against omicron and preventing infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, (booster), single (Batch/Lot number: unknown) and as dose 4, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Your old vaccine is worthless against omicron and preventing infection".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Jaw operation, Pain in jaw
Clinical narrative: Jaw operation; Jaw pain; Interchange of vaccine products; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. Other Case identifier(s): 22K-163-4341506-00 (AbbVie).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159928) for rheumatoid arthritis. Relevant medical history included: "Interchange of vaccines products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: JAW OPERATION (medically significant), outcome "recovering", described as "Jaw operation"; PAIN IN JAW (non-serious), outcome "recovering", described as "Jaw pain"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine products". The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced Jaw Surgery and Jaw Pain. Moderna Covid-19 Vaccine (Elasomeran) And Pfizer BioNtech Covid-19 Vaccine (Tozinameran) were also considered suspect. Patient reported had jaw surgery and was now recovering. Still some pain but overall doing good. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Jaw Surgery and Jaw Pain with Humira (Adalimumab) Was No reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of Jaw Surgery and Jaw Pain Are Related to Humira (Adalimumab). The reporter's causality for the event(s) of Jaw Surgery and Jaw Pain with Moderna Covid-19 Vaccine was probable. The reporter's causality for the event(s) of Jaw Surgery and Jaw Pain with Pfizer BioNtech Covid-19 Vaccine (Tozinameran)(Tozinameran) was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Jaw operation which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4341426-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive. Clinical Course:It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Event abate after stopping drug  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 03Feb2022 at 17:00 as dose 3 (booster), single (Lot number: FW0698) at the age of 16 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient did not received any other vaccine in four weeks and not received any other medications in two weeks. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 05Apr2022, outcome "recovering" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not received any other vaccine in four weeks and not received any other medications in two weeks. AE resulted was in none of the above. She did not experienced Covid prior vaccination. She was tested Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Caller has been bleeding blood clots out of caller's vagina/Now in the month of Apr and caller is still bleeding blood clots out of vagina.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 09Jan2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 2022, outcome "not recovered", described as "Caller has been bleeding blood clots out of caller's vagina/Now in the month of Apr and caller is still bleeding blood clots out of vagina.". Therapeutic measures were taken as a result of vaginal haemorrhage. Additional information: since the patient received the first dose of the Pfizer covid 19 vaccine, patient had been bleeding blood clots out of her vagina. Now in the month of Apr2022 and patient was still bleeding blood clots out of vagina. She had spent (dollar) 300 dollars on tampons, wipes, and laundry because of this. The patient stated that the blood clots were the size of pancakes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration, Investigation, Systemic infection, Urinary tract infection
Clinical narrative: 2nd dose it spread to systemic infection.; Dose: 2nd Date: 18Nov2021; severe diarrhea for 5-6 days after that I developed UTI'S; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 2, single (Lot number: 32030BD) at the age of 72 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 1980 (unspecified if ongoing); "heart disease", start date: 1980 (unspecified if ongoing); "allergies: food related since birth" (unspecified if ongoing), notes: food releated since birth. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1,SINGLE, Date: 12May2021, Site and route of injection, Anatomical Site of injection: arm, Route of administration: Intramuscular [checked], Batch/Lot number: EW0176), administration date: 12May2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "I developed UTI's", "Feels really awful", "She is achy/achy all over", "Her arm hurt/arm hurts", "Nausea", "Diarrhea", "I threw up. Not only that, it was brown", "feel lazy", "I threw up; I threw up it was brown and my stomach hurt too". The following information was reported: DIARRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "Diarrhea"; URINARY TRACT INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "severe diarrhea for 5-6 days after that I developed UTI'S"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Dose: 2nd Date: 18Nov2021"; SYSTEMIC INFECTION (medically significant), outcome "unknown", described as "2nd dose it spread to systemic infection.". The events "severe diarrhea for 5-6 days after that i developed uti's" and "diarrhea" required emergency room visit. The patient underwent the following laboratory tests and procedures: ER evaluation: (Nov2021) Diarrhea, notes: 6 days diarrhea followed by UTI put on antibiotics. Therapeutic measures were taken as a result of urinary tract infection. Clinical Courses: Vaccination Facility Type was Hospital.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 Immunization. The following information was reported: OSTEOARTHRITIS (medically significant), outcome "unknown", described as "Hip osteoarthritis". Therapeutic measures were taken as a result of osteoarthritis. Additional Information: Caller states she had a steroid injection this morning for hip osteoarthritis and would like to know if the steroid may interfere with her Pfizer Covid-19 booster vaccine because she read that it may interfere with it. She got Steroid injection to hip this morning and thought maybe she should not get it. It is not systemic steroid therapy which she read about not to get. She was a drug rep for 30 years with (Withheld) and was not having any adverse reaction. She did not wish to create a report and wanted to be transferred to find out if Pfizer thinks it is ok for her to get the booster shot having just had the hip steroid injection. She got Steroid injection to hip this morning and thought maybe she should not get it. It is not systemic steroid therapy which she read about not to get. She was a drug rep for 30 years with (Withheld) and was not having any adverse reaction. She did not wish to create a report and wanted to be transferred to find out if Pfizer thinks it is ok for her to get the booster shot having just had the hip steroid injection. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: has a superficial blood clot on the right leg; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 unknown manufacturer), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "has a superficial blood clot on the right leg".  Clinical courses: Reporter reported that has a patient that got their first, second and booster dose of the Covid vaccine and now wanted a second dose the of booster. Wanted to know if they should administer it. Stated that she does not know where the patient got the shot before. Stated that the patient has the blood clot superficial on the leg that she does feel comfortable giving the shot. Clarified that this is for the right leg.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Thrombosis which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood triglycerides, High density lipoprotein, Lipids, Low density lipoprotein
Clinical narrative: arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Sep2021 16:00 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: Overweight prior to vaccine. No any illness at time of vaccination. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "arm sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. Patient received 1st dose and his arm was sore for a few days, no after symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Sep2021 16:00 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: Overweight prior to vaccine. No any illness at time of vaccination. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "arm sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. Patient received 1st dose and his arm was sore for a few days, no after symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: Fever of about 101 degrees; Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 (Lot number: FF2588) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. Concomitant medication(s) included: ATORVASTATIN; FOLIC ACID; BIOTIN; VIT C. Past drug history included: Neomycin, reaction(s): "allergies: topical neomycin", notes: known allergies: topical neomycin; Formaldehyde, reaction(s): "allergies: formaldehyde producers", notes: known allergies: formaldehyde producers. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 03Mar2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Mar2021, when the patient was 67 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Sep2021, outcome "recovering", described as "Fever of about 101 degrees"; MIGRAINE (non-serious) with onset 21Sep2021, outcome "recovering", described as "Migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, migraine.  Additional information: The clinical course was reported as the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination with centrum. Reported stated, fever of about 101 degrees beginning the next morning. Migraine the morning after the third and fourth dose. Severe constipation and nausea the morning after the fourth dose. OTC antipyretics and sumatriptan as treatment was received for the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: severe headache; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 03Apr2022 (Batch/Lot number: unknown) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 16Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 01, Tested positive for COVID 19 on December 16, 2021.), administration date: 13May2021, for Covid-19 Immunization, reaction(s): "COVID-19"; Comirnaty (Dose: 02, Tested positive for COVID 19 on December 16, 2021.), administration date: 03Jun2021, for Covid-19 Immunization, reaction(s): "COVID-19". The following information was reported: HEADACHE (non-serious) with onset 04Apr2022, outcome "unknown", described as "severe headache"; OROPHARYNGEAL PAIN (non-serious) with onset 04Apr2022, outcome "unknown", described as "sore throat"; FATIGUE (non-serious) with onset 04Apr2022, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US022271_OS.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Swelling".  Additional Information: Patient reports that she had swelling about 2 weeks after having her second covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Constipation, Migraine, Nausea, Pyrexia
Clinical narrative: Migraine; Severe constipation; nausea; Fever of about 101 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2022 16:15 (Lot number: FJ9943) at the age of 68 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies:Shellfish" (unspecified if ongoing), notes: Known allergies:Shellfish. Concomitant medication(s) included: ATORVASTATIN; FOLIC ACID; BIOTIN; VIT C. Past drug history included: Neomycin, reaction(s): "Allergies: topical neomycin", notes: Known allergies: topical neomycin; Formaldehyde, reaction(s): "Allergies: formaldehyde producers", notes: Known allergies: formaldehyde producers. Vaccination history included: Bnt162b2 (Dose Number: 3, Batch/Lot No: FF2588, Location of injection: Arm Left, Fever of about 101 degrees), administration date: 20Sep2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "Fever", "Migraine"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Mar2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 03Mar2021, when the patient was 67 years old, for Covid-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 05Apr2022 06:00, outcome "recovering", described as "Migraine"; CONSTIPATION (non-serious) with onset 05Apr2022 06:00, outcome "recovering", described as "Severe constipation"; NAUSEA (non-serious) with onset 05Apr2022 06:00, outcome "recovering", described as "nausea"; PYREXIA (non-serious) with onset 05Apr2022 06:00, outcome "recovering", described as "Fever of about 101 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, constipation, nausea, pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Also she  received medication Centrum within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID 19 on 16Dec2021; Tested positive for COVID 19 on 16Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 14-year-old female patient received BNT162b2 (COMIRNATY), on 13May2021 as dose 1, single (Batch/Lot number: unknown) and on 03Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "unknown" and all described as "Tested positive for COVID 19 on 16Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2021) Positive. Reporter's 14-year-old daughter received booster dose of Comirnaty and experienced adverse events the following day-severe headache, sore throat, fatigue Optional Information included that patient received 1st dose of Comirnaty on 13May2021 did not experience any adverse events, 2nd dose of Comirnaty on 03Jun2021- no adverse events. Tested positive for COVID 19 on 16Dec2021. Received Comirnaty booster on 03Apr2022 and experienced adverse events the following day. Event took place after use of product.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.