chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Blepharospasm, Computerised tomogram head, Diarrhoea, Dizziness
Clinical narrative: headache, dizziness, fatigue. eye twitching, pixalated vision, loss of taste, neck pain photophobic, diarrhea
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Magnetic resonance imaging head, Neck pain, Photophobia
Clinical narrative: headache, dizziness, fatigue. eye twitching, pixalated vision, loss of taste, neck pain photophobic, diarrhea
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: headache, dizziness, fatigue. eye twitching, pixalated vision, loss of taste, neck pain photophobic, diarrhea
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Have developed a severe rash on stomach, arms and legs
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles
Clinical narrative: 34 percent PVC after the 5 th dose; This spontaneous case was reported by a patient and describes the occurrence of VENTRICULAR EXTRASYSTOLES (34 percent PVC after the 5 th dose) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No allergy and no diseases.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose lot 029K20A) on 27-Jan-2021, Moderna COVID-19 Vaccine (1st Booster, Lot number 003F21A) on 22-Oct-2021, Moderna COVID-19 Vaccine (2nd booster lot number 054A22A at Walgreens 6165 on June 10th. 2022) on 10-Jun-2022 and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse reaction with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (34 percent PVC after the 5 th dose). At the time of the report, VENTRICULAR EXTRASYSTOLES (34 percent PVC after the 5 th dose) was resolving. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported. It was reported that the Second dose Batch Lot No was 031M20A mentioned in source document. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 34 % Premature ventricular contractions after the 5th dose. No treatment products reported.  Company comment: This regulatory case concerns a 71-year-old male patient with no medical history reported, who experienced the adverse event of special interest of ventricular extrasystoles an unknown time after the fifth dose of mRNA-1273.222. The patient had previously experienced 12.4% premature ventricular contractions, but after the fifth dose the patient experienced an increase to 34%. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-694244 (Patient Link).; Sender's Comments: This regulatory case concerns a 71-year-old male patient with no medical history reported, who experienced the adverse event of special interest of ventricular extrasystoles an unknown time after the fifth dose of mRNA-1273.222. The patient had previously experienced 12.4% premature ventricular contractions, but after the fifth dose the patient experienced an increase to 34%. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "HTN" (unspecified if ongoing), notes: HTN; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "pre-diabetes" (unspecified if ongoing), notes: pre-diabetes; "glaucoma" (unspecified if ongoing); "known allergies crab" (unspecified if ongoing), notes: known allergies crab. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 42 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 10Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for immunisation, on 09Sep2022 as dose number unknown, single. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "unknown" and all described as "severe flu-like symptoms / Home test COVID +". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Home test covid +. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient experienced severe flu-like symptoms on 25Dec2022 and had a home test covid positive (+) on 28Dec2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reported  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: EL3247) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "unknown" and all described as "+ Ag test 31Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 as dose 5 (booster), single at the age of 82 years, in right arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 26Dec2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective which includes Paxlovid on 26Dec2022 to 30Dec2022. Clinical course: the patient had other medication in 2 weeks which was benzonatate. He had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 70 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19: PAXLOVID from 22Dec2022 to 27Dec2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Allergy test, Antibody test, Blood immunoglobulin A, Blood immunoglobulin G
Clinical narrative: This is a spontaneous report received from a contactable reporter.  A 7-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Getting more sick". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "syncopal episode"; SINUSITIS (non-serious), outcome "unknown", described as "Sinus infections a lot"; ILLNESS (non-serious), outcome "unknown", described as "Sick especially after having the second shot of the vaccine"; BRONCHITIS (non-serious), outcome "unknown", described as "She gets bronchitis"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "extreme pain in her belly"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes in her abdominal region, lymph node enlargement"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "leukocytes were low"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "red blood cells were elevated". The patient underwent the following laboratory tests and procedures: Allergy test: (2022) Negative, notes: that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has no allergies; Antibody test: (unspecified date) Unknown results, notes:  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bronchitis, Computerised tomogram, Full blood count, Illness
Clinical narrative: This is a spontaneous report received from a contactable reporter.  A 7-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Getting more sick". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "syncopal episode"; SINUSITIS (non-serious), outcome "unknown", described as "Sinus infections a lot"; ILLNESS (non-serious), outcome "unknown", described as "Sick especially after having the second shot of the vaccine"; BRONCHITIS (non-serious), outcome "unknown", described as "She gets bronchitis"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "extreme pain in her belly"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes in her abdominal region, lymph node enlargement"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "leukocytes were low"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "red blood cells were elevated". The patient underwent the following laboratory tests and procedures: Allergy test: (2022) Negative, notes: that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has no allergies; Antibody test: (unspecified date) Unknown results, notes:  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenopathy, Pyrexia, Red blood cell count, Red blood cell count increased
Clinical narrative: This is a spontaneous report received from a contactable reporter.  A 7-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Getting more sick". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "syncopal episode"; SINUSITIS (non-serious), outcome "unknown", described as "Sinus infections a lot"; ILLNESS (non-serious), outcome "unknown", described as "Sick especially after having the second shot of the vaccine"; BRONCHITIS (non-serious), outcome "unknown", described as "She gets bronchitis"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "extreme pain in her belly"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes in her abdominal region, lymph node enlargement"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "leukocytes were low"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "red blood cells were elevated". The patient underwent the following laboratory tests and procedures: Allergy test: (2022) Negative, notes: that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has no allergies; Antibody test: (unspecified date) Unknown results, notes:  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Syncope, White blood cell count, White blood cell count decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter.  A 7-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Getting more sick". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "syncopal episode"; SINUSITIS (non-serious), outcome "unknown", described as "Sinus infections a lot"; ILLNESS (non-serious), outcome "unknown", described as "Sick especially after having the second shot of the vaccine"; BRONCHITIS (non-serious), outcome "unknown", described as "She gets bronchitis"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "extreme pain in her belly"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes in her abdominal region, lymph node enlargement"; WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "leukocytes were low"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "red blood cells were elevated". The patient underwent the following laboratory tests and procedures: Allergy test: (2022) Negative, notes: that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has that all came back negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has no allergies; Antibody test: (unspecified date) Unknown results, notes:  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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years 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) with onset 02Jan2023, outcome "recovering", COVID-19 (medically significant) with onset 02Jan2023, outcome "recovering" and all described as "positive home Ag". The event "positive home ag" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Positive, notes: positive home Ag 02Jan2023; (03Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure, Weight decreased
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9810), on 27Feb2021 as dose 2, single (Lot number: EN6203), on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: States she went off all her cancer pills because she was afraid and she didn't want to overdose. The patient took concomitant medications (Stated she went off all her cancer pills during PAXLOVID treatment because she was afraid and she didn't want to overdose) The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: Blood test: It all came back fine, notes: Tests: Caller states her Gastro Doctor sent her to get blood work done after to make sure her electrolytes were okay because she had diarrhea for 5 days; SARS-CoV-2 test: Positive, notes: Tested positive for Covid 19 after having the Covid 19 Vaccines and Boosters; Weight decreased: she lost a lot of weight, lost 4 pounds, notes: Height: States she is shrinking she lost a lot of weight, lost 4 pounds in 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes normal, Blood test normal, Decreased appetite, Fatigue, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9810), on 27Feb2021 as dose 2, single (Lot number: EN6203), on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: States she went off all her cancer pills because she was afraid and she didn't want to overdose. The patient took concomitant medications (Stated she went off all her cancer pills during PAXLOVID treatment because she was afraid and she didn't want to overdose) The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: Blood test: It all came back fine, notes: Tests: Caller states her Gastro Doctor sent her to get blood work done after to make sure her electrolytes were okay because she had diarrhea for 5 days; SARS-CoV-2 test: Positive, notes: Tested positive for Covid 19 after having the Covid 19 Vaccines and Boosters; Weight decreased: she lost a lot of weight, lost 4 pounds, notes: Height: States she is shrinking she lost a lot of weight, lost 4 pounds in 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9810), on 27Feb2021 as dose 2, single (Lot number: EN6203), on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: States she went off all her cancer pills because she was afraid and she didn't want to overdose. The patient took concomitant medications (Stated she went off all her cancer pills during PAXLOVID treatment because she was afraid and she didn't want to overdose) The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: Blood test: It all came back fine, notes: Tests: Caller states her Gastro Doctor sent her to get blood work done after to make sure her electrolytes were okay because she had diarrhea for 5 days; SARS-CoV-2 test: Positive, notes: Tested positive for Covid 19 after having the Covid 19 Vaccines and Boosters; Weight decreased: she lost a lot of weight, lost 4 pounds, notes: Height: States she is shrinking she lost a lot of weight, lost 4 pounds in 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: his is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: ER8729), in right arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 32030SD) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Lot number: 04B621A), in left arm and on 12Oct2022 as dose 5 (booster), single (Lot number: 059F22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "unknown", described as "vaccine brand: Pfizer / BioNTech, vaccine dose number: 3/ vaccine brand other: Moderna, vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9810), on 27Feb2021 as dose 2, single (Lot number: EN6203), on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698) 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 30Nov2022, outcome "unknown" and all described as "Tested positive for Covid 19 after having the Covid 19 Vaccines and Boosters".
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6205), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "known allergies", notes: known allergies: penicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Anti-viral Product Paxlovid from 24Dec2022 till 28Dec2022 for treatment of COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 2, single (Lot number: FF8839) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I have a recurrence of symptoms after testing negative for a week; (unspecified date) Positive, notes: COVID 19 Treatment; (03Jan2023) Positive, notes: Yesterday I tested positive again. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid from 24Dec2022 to 29Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing); "colitis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "endometrial cancer in remission" (unspecified if ongoing), notes: endometrial cancer in remission. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Jun2022, outcome "unknown", described as "dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Pfizer / dose #5 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no known allergies. Patient took Paxlovid from 13Dec2022 to 18Dec2022 for Covid-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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), on 05May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "possible IBD and other stomach issues" (unspecified if ongoing), notes: possible IBD and other stomach issues; "possible IBD and other stomach issues" (unspecified if ongoing), notes: possible IBD and other stomach issues; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER2613), on 19Apr2021 as dose 2, single (Lot number: EW0158) and on 01Feb2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing), notes: The only thing she has is obesity. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got my Pfizer Covid Vaccines and I still got Covid/prescribed Paxlovid". The events "got my pfizer covid vaccines and i still got covid/prescribed paxlovid" required emergency room visit. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Consumer reported regarding Paxlovid. Has taken Paxlovid for two days so far. Has trouble swallowing the tablets. Placing that tablet in honey, holding them in her mouth until they dissolve and then swallowing. Has had the Pfizer shots and the booster shots and still got Covid. Was holding the pills in her mouth for a little while until the size went down a little bit, so the pill was thinner. She would do that, then would take the pills out and then swallow it. She called him and said she went to urgent care.  During the time of Covid when the whole thing happened, she was on unemployment and was not working. When she was working, she was tested every week. Now suddenly, she gets Covid, so she is shocked.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Rash macular, Tenderness
Clinical narrative: local reaction with redness, red dots and tenderness in her left thigh; local reaction with redness, red dots and tenderness in her left thigh; local reaction with redness, red dots and tenderness in her left thigh; local reaction with redness, red dots and tenderness in her left thigh; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 10-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOCAL REACTION (non-serious), ERYTHEMA (non-serious), RASH MACULAR (non-serious), TENDERNESS (non-serious), outcome "unknown" and all described as "local reaction with redness, red dots and tenderness in her left thigh".  Additional information: It was reported that this call was regarding a ten-month-old female patient. The caller refered that when the patient got their 2-month dose of Prevnar 13, she had what was deemed a local reaction with redness, red dots and tenderness in her left thigh within 24 hours and has been holding off the patients third dose due to the reactions and wants to know if something like what the patient experienced has been reported and if there is any recommendation.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005752 Same patient and drug, event separated in time;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)   An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2022, outcome "recovered" (08Oct2022) and all described as "I got Covid on 01Oct2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Positive, notes: I got Covid on 01Oct2022; (08Oct2022) Negative, notes: negative on 08Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Caller stated she read/saw there was concern for new Covid-19 variants. Caller asked if Pfizer is coming out with a new vaccine soon specific for new variants. Caller denies awareness of bivalent Omicron BA.4/BA5 formulation. Caller asked, How long after taking Paxlovid for Covid-19 should pt wait to get Pfizer's Covid vaccine. Caller stated, she got Covid on 01Oct2022 and was negative on 08Oct2022. Pt wasn't that sick. pt was just tired, had a little cough, no temperature. Pt will be 82 years old next week. pt had three doses of the Covid vaccine and a booster about five or six months ago.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  An adult female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: CJ6742) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, and all described as "got covid from daughter sx 27Dec and positive AG 27Dec mild sx". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: got very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (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 manufaturer), for COVID-19 Immunization.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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 "she got COVID after getting the Pfizer COVID vaccine". Clinical course: Product: Pfizer Comirnaty vaccine booster. The patient and wife on the line. She got COVID even though she was vaccinated with the Pfizer COVID vaccine. Caller stated they could not talk right now because they were at their appointment. Outbound call made at 248pm on 04Jan2022, Caller answered. They are okay with Pfizer following up. There was a product complaint to report. She got COVID even though she was vaccinated with the Pfizer COVID vaccine.  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: Gait disturbance
Clinical narrative: Limping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Limping".  Additional information: The reporter also stated, Believe it or not, I talked to a friend of mine a few months ago, and his stepson started limping, after he got the Pfizer vaccine, Age of stepson was unknown to reporter.  The lot number for [BNT162b2], was not provided and will be requested during follow up.