chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 59-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 immunization.    Co-suspect products included non-company products TREPROSTINIL tablet for Pulmonary arterial hypertension and TREPROSTINIL DIOLAMINE (ORENITRAM) tablet for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included RIOCIGUAT (ADEMPAS) for an unknown indication.   On 14-Jul-2017, the patient started TREPROSTINIL (Oral) 3.5 milligram three times a day. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMINE (ORENITRAM) (Oral) 2.5 milligram. On an unknown date, TREPROSTINIL DIOLAMINE (ORENITRAM) (Oral) dosage was changed to 1 milligram. On 21-Dec-2022, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Patient began therapy with Orenitram (treprostinil diethanolamine), on 14 Jul 2017 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 2.5 mg and 1 mg and the current dose was reported as 3.5 mg, oral, three times a day.  The reporter did not provide causality for the event of vaccination site pain with Orenitram. The reporter's causality for the event of vaccination site pain with COVID-19 vaccine was considered to be possibly related.  No treatment information was provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial) and NO ADVERSE EVENT (No Adverse Event) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial).    No concomitant medications were reported.   No treatment details were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Wrong product administered
Clinical narrative: patient reports that she wasn't feeling the best; gave Moderna monovalent doses to two people who should have gotten the bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (patient reports that she wasn't feeling the best) and WRONG PRODUCT ADMINISTERED (gave Moderna monovalent doses to two people who should have gotten the bivalent booster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE from 27-Dec-2022 to an unknown date for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (gave Moderna monovalent doses to two people who should have gotten the bivalent booster). On an unknown date, the patient experienced FEELING ABNORMAL (patient reports that she wasn't feeling the best). At the time of the report, FEELING ABNORMAL (patient reports that she wasn't feeling the best) and WRONG PRODUCT ADMINISTERED (gave Moderna monovalent doses to two people who should have gotten the bivalent booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 1st patient out of 2 patients described by the reporter. The reporter is a nurse manager. Another nurse given Moderna monovalent doses to patient who should have gotten the bivalent booster on 27Dec2022. The patient reports that patient wasn't feeling the best, but could still make it to work. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-694810 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694810:2nd patient out of 2
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes; No adverse event; second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A12/29/2022 -excursion time:90minutes,12/30/2022: excursion:140 minutes).    No concomitant medications were reported. It was reported that vaccine received and stored at 36f to 46f in refrigeration on 05-Dec-2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-694885 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2023: Non-significant follow-up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694885:Same reporter
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes; no adverse event; second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes), PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and NO ADVERSE EVENT (no adverse event) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes), PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes) and PRODUCT STORAGE ERROR (second excursion details requested lot 011H22A 12/29/2022 excursion time 90 minutes).    No Concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-694391, US-MODERNATX, INC.-MOD-2023-694859 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2023: Follow-up received no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694391:Same reporter US-MODERNATX, INC.-MOD-2023-694859:Same reporter
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Axillary pain, Burning sensation, Myalgia, Off label use, Product use issue
Clinical narrative: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Same date vaccine BNT162B2 and FLU on 12Oct2022; Same date vaccine BNT162B2 and FLU on 12Oct2022; BNT162B2 bivalent vaccine administered as primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:00 as dose 1, single (Lot number: GJ6665) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 12Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Oct2022, outcome "unknown", described as "BNT162B2 bivalent vaccine administered as primary series"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2022, outcome "unknown" and all described as "Same date vaccine BNT162B2 and FLU on 12Oct2022"; AXILLARY PAIN (non-serious), MYALGIA (non-serious), BURNING SENSATION (non-serious) all with onset 15Oct2022 at 07:00, outcome "not recovered" and all described as "Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm". The events "excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of axillary pain, myalgia, burning sensation.  Additional information: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm and adverse event traveled to the upper muscles in the right arm and across the back. I'm taking Tylenol which the doctor recommended. It's doing me no good. Patient was applying heat and other soothing ointments. No Known allergies. No covid prior vaccination. Adverse events resulted in: Emergency room/department or urgent care.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005938 Same product, patient and different AEs;
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Wrong product administered
Clinical narrative: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Same date vaccine BNT162B2 and FLU on 12Oct2022; Same date vaccine BNT162B2 and FLU on 12Oct2022; BNT162B2 bivalent vaccine administered as primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:00 as dose 1, single (Lot number: GJ6665) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 12Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Oct2022, outcome "unknown", described as "BNT162B2 bivalent vaccine administered as primary series"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2022, outcome "unknown" and all described as "Same date vaccine BNT162B2 and FLU on 12Oct2022"; AXILLARY PAIN (non-serious), MYALGIA (non-serious), BURNING SENSATION (non-serious) all with onset 15Oct2022 at 07:00, outcome "not recovered" and all described as "Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm". The events "excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of axillary pain, myalgia, burning sensation.  Additional information: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm and adverse event traveled to the upper muscles in the right arm and across the back. I'm taking Tylenol which the doctor recommended. It's doing me no good. Patient was applying heat and other soothing ointments. No Known allergies. No covid prior vaccination. Adverse events resulted in: Emergency room/department or urgent care.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005938 Same product, patient and different AEs;
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm; Same date vaccine BNT162B2 and FLU on 12Oct2022; Same date vaccine BNT162B2 and FLU on 12Oct2022; BNT162B2 bivalent vaccine administered as primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:00 as dose 1, single (Lot number: GJ6665) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 12Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Oct2022, outcome "unknown", described as "BNT162B2 bivalent vaccine administered as primary series"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2022, outcome "unknown" and all described as "Same date vaccine BNT162B2 and FLU on 12Oct2022"; AXILLARY PAIN (non-serious), MYALGIA (non-serious), BURNING SENSATION (non-serious) all with onset 15Oct2022 at 07:00, outcome "not recovered" and all described as "Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm". The events "excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of axillary pain, myalgia, burning sensation.  Additional information: Excruciating pain and burning in right arm pit and down under arm muscles and a few days later it traveled to the upper muscles in the right arm and adverse event traveled to the upper muscles in the right arm and across the back. I'm taking Tylenol which the doctor recommended. It's doing me no good. Patient was applying heat and other soothing ointments. No Known allergies. No covid prior vaccination. Adverse events resulted in: Emergency room/department or urgent care.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005938 Same product, patient and different AEs;
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Axillary pain, Burning sensation, Myalgia, Off label use, Product use issue
Clinical narrative: Covid -19; Covid -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 1 (bivalent), single (Lot number: GJ6665) at the age of 79 years, in left arm 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 24Nov2022, outcome "unknown" and all described as "Covid -19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002074 Same product, patient and different AEs;
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Wrong product administered
Clinical narrative: Covid -19; Covid -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 1 (bivalent), single (Lot number: GJ6665) at the age of 79 years, in left arm 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 24Nov2022, outcome "unknown" and all described as "Covid -19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002074 Same product, patient and different AEs;
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid -19; Covid -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 1 (bivalent), single (Lot number: GJ6665) at the age of 79 years, in left arm 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 24Nov2022, outcome "unknown" and all described as "Covid -19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002074 Same product, patient and different AEs;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 17:30 as dose 5 (booster), single (Lot number: G22524) at the age of 51 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK5730), on 19Jan2021 as dose 2, single (Lot number: EL3247), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2587) and on 06Jun2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: Positive, notes: COVID 19 Treatment; Negative, notes: testing negative twice; Negative, notes: testing negative twice; Positive, notes: new positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment of COVID-19 with Paxlovid from 21Dec2022 to 26Dec2022.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Bone marrow transplant
Clinical narrative: Has received bone marrow transplant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: BONE MARROW TRANSPLANT (medically significant), outcome "unknown", described as "Has received bone marrow transplant".  Clinical course: Caller stated that they had a patient who had received bone marrow transplant and had received the Pfizer COVID-19 vaccine primary series and booster dose over a year ago. He mentioned that the patient can now be able to get the vaccine again and the doctor informed the patient to restart the primary series. He also clarified that the patient has not yet been re-administered with the primary series. He wanted to know, for this particular instance, what formulation should the patient receive, the monovalent primary series or the bivalent formulation? What interval, 3 weeks apart or 2 months?  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 information provided by the reporter, it appears unlikely that subject product contributed to the event BM transplant.  The reported event is likely associated with intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I  was positive on 23Dec / We tested positive again; I  was positive on 23Dec / We tested positive again; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 60-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster),single (Batch/Lot number: unknown) for covid-19 immunisation; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2022, outcome "unknown" and all described as "I  was positive on 23Dec / We tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) Positive; (31Dec2022) Negative; (02Jan2023) Positive, notes: Our symptoms came back today 02Jan and we tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  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.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "Total cholesterol greater than 200" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: Blood cholesterol: Total cholesterol greater than 200; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient received Paxlovid on 19Dec2022 for the event and the treatment stopped on 24Dec2022. The patient 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Decreased appetite, Tinnitus
Clinical narrative: since receiving the bivalent vaccine, caller experiences tinnitus "a little bit more."; feeling a lose of appetite and he can't eat too much; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 69 years, in right hand for covid-19 immunisation. The patient's relevant medical history included: "tinnitus on his right side" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 1, lot: ENS318, expiration: Unknown, Route of administration: left hand), administration date: 22Feb2021, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (DOSE: 2, lot: EL9266, NDC: Unknown, expiration: Unknown, route of administration: left hand), administration date: 15Mar2021, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (DOSE: 3 (BOOSTER), lot: FJ8762 , NDC: Unknown, expiration: Unknown, route of administration: right side of hand), administration date: 07Dec2021, when the patient was 68-year-old, for Covid-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 27Dec2022, outcome "unknown", described as "feeling a lose of appetite and he can't eat too much"; TINNITUS (non-serious), outcome "not recovered", described as "since receiving the bivalent vaccine, caller experiences tinnitus "a little bit more."". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient was asking if there have been reported side effects for the Pfizer Covid bivalent booster and stated that he "had no problem with the booster before. Patient stated that he experienced tinnitus on his right side prior to receiving any of the Pfizer Covid vaccines, however since receiving the bivalent vaccine, patient experienced tinnitus "a little bit more." Patient also reported that he is "feeling a lose of appetite and he can't eat too much. Caller is asking if tinnitus and loss of appetite is a reported side effect. Patient stated that his doctor says his blood tests are normal. Patient was asking if the vaccine has created these side effects or if something else could be. Patient asked if the loss of appetite is a temporary side effect or a permanent side effect. Patient was worried about the vaccine he took.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: platelets had dopped down to nothing/platelets down to a 1; 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 male patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 virus", start date: Jan2021, stop date: Jan2021. The patient's concomitant medications were not reported. Past drug history included: Regeneron treatment for COVID-19 virus. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number Unknown), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "platelets had dopped down to nothing". The following information was reported: PLATELET COUNT DECREASED (hospitalization), outcome "unknown", described as "platelets had dopped down to nothing/platelets down to a 1". The event "platelets had dopped down to nothing/platelets down to a 1" required physician office visit. The patient underwent the following laboratory tests and procedures: Platelet count: down to a 1. Therapeutic measures were taken as a result of platelet count decreased. Clinical information: Reporter stated that he and his wife both got covid 19 virus in Jan2021 and had the regeneron treatment right after that. They were vaccinated in Jul2021 and in Aug2021 he had a check up, fine looked great, then got booster 12Jan2022, another appt 2nd week of Feb2022 and platelets had dopped down to nothing. He has been in hospital 1-3 times a week since going into almost a year starting in Feb2022 for dealing with this. He was put on 2nd oral medication because 1st did not work, just had a check up yesterday and platelets down to a 1, obviously new oral med hasn't worked. Patient asked if there were any steps or what they have to do about this other than what his oncologist or hematologist has suggested.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005105 same reporter/patient, different vaccine dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Pain, Skin disorder
Clinical narrative: bump or bulge on his back end; bump feels very sore; 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 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Dec2022 as dose 4 (bivalent), 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 (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, first boosted dose in May and didn't have any problems at all.), for Covid-19 immunization.  The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "bump or bulge on his back end"; PAIN (non-serious), outcome "unknown", described as "bump feels very sore".  Patient got the shot on 26Dec2022 and few days later a bump came on his back, and it was sore. Two or three days later, he noticed a bump or bulge on his back end. The bump feels very sore. Asks if this is a side effect of the vaccine. He states he had the first two of the primary series and the first boosted dose in May and did not have any problems at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: has stopped walking on his own / unable to walk by himself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 2022, outcome "unknown", described as "has stopped walking on his own / unable to walk by himself". Additional information: A father was calling on behalf of his son. His son received 3 Pfizer COVID vaccines and son has stopped walking on his own. The reporter requested information on the side effects of the Pfizer COVID 19 vaccine. It was reported that the patient was a special needs patient, but was walking before, from couch to chair and chair to couch. His son has been in a rehabilitation center. The reporter stated that when he visited his son before COVID (pandemic), his son was walking on his own before he got the vaccine. After COVID (pandemic), the reporter has been unable to visit his son so only was able to check on him via phone every day. His son has received 3 doses of the Pfizer vaccine. The reporter found out about 4 months ago that his son was now unable to walk by himself and needs someone to hold him up otherwise he falls and loses his balance. The providers don't know why this was happening and if it's the vaccine or not.  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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid antigen test positive; covid antigen test positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: CJ6742) at the age of 44 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Dec2021 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2022, outcome "not recovered" and all described as "covid antigen test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (04Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FL3197) 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 was not reported. There were no concomitant medications. 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 patient did not take any other medication within 2 weeks. It was reported that the patient received treatment of Paxlovid from 21Dec2022 to 26Dec2022, for treatment of COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, 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's relevant medical history included: "Thrombophilia" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "ADHD" (unspecified if ongoing), notes: other medical history: ADHD. Date of last menstrual period: 27May2022. The patient was 14 weeks pregnant at the time of exposure to BNT162b2, BNT162b2 omi ba.4-5. The patient is expected to deliver a baby(s) on 03Mar2023. Concomitant medication(s) included: LOVENOX [LEVOFLOXACIN], start date: 29Jul2022. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor; Pediazole, reaction(s): "known allergies: pediazole", notes: known allergies: pediazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with Paxlovid from 29Dec2022 to 03Jan2023. The patient received other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Wrong product administered
Clinical narrative: Headache; chills; muscle aches; fatigue; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 at 12:45 as dose 1 (bivalent), single (Lot number: GJ5342), in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "COPD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 03Jan2023 at 12:45, outcome "unknown", described as "Wrong vaccine administered"; HEADACHE (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered"; CHILLS (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered"; FATIGUE (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered"; MYALGIA (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered", described as "muscle aches". Therapeutic measures were not taken as a result of headache, chills, myalgia, fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right 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), 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: "Asthma" (unspecified if ongoing). There were no concomitant medications (reported as no other medication in 2weeks). 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 included Paxlovid.  Clinical course: Patient had no known allergies. Patient received COVID-19 Treatment with oral Paxlovid from 26Dec2022 to 31Dec2022. Patient stated he was experiencing "Paxlovid Rebound" symptoms. He was symptom free and out of self isolation on 01Jan2023. Reported as Yesterday, 04Jan2023 patient started experiencing symptoms again: sever runny nose, aches, congestions and rough night on 04Jan2023. No fever. No treatment received for rebound symptoms.  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.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.