chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
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). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs" (unspecified if ongoing); "known allergies: Crab" (unspecified if ongoing); "known allergies: Latex" (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 "recovering" 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, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin"; Bactrim, reaction(s): "Allergy: Bactrim". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022, outcome "unknown", described as "Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5"; VACCINATION FAILURE (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: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9683) at the age of 39 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QSYMIA, start date: 22Apr2021; MIRENA intra-uterine, start date: 18Jul2022; SPIRONOLACTONE, start date: 18Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 14:00 as dose 6 (booster), single (Lot number: GJ6665) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2022 at 13:00 as dose 5 (booster), single (Lot number: FK9727), 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: "Pulmonary hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "asthma" (unspecified if ongoing); "murmur" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "stress incontinence" (unspecified if ongoing); "hypercholesterol" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 01Jan2019, stop date: 07Apr2023; LEVOTHYROXINE, start date: 01Jan2019, stop date: 07Apr2023; CRESTOR, start date: 01Jan2019, stop date: 07Apr2023; CO Q10, start date: 01Jan2019, stop date: 07Apr2023; CALCIUM, start date: 01Jan2019, stop date: 07Apr2023; VITAMIN D2, start date: 01Jan2019, stop date: 07Apr2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from 07Apr2023 to 12Apr2023.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 33 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofan for Known allergies: Ibuprofan; Asprin for Known allergies: Asprin. 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 included Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Fluid imbalance, Laboratory test, Mucosal disorder, Pneumocystis jirovecii pneumonia, Saliva altered
Clinical narrative: I have PCP (Pneumocystis jirovecii pneumonia); drastic saliva alteration; Fluid imbalance (all body fluids affected); Mucosal disorder (heavy mucosa); 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: Contracted COVID-19 in Nov2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: PNEUMOCYSTIS JIROVECII PNEUMONIA (medically significant), outcome "unknown", described as "I have PCP (Pneumocystis jirovecii pneumonia)"; SALIVA ALTERED (non-serious), outcome "unknown", described as "drastic saliva alteration"; FLUID IMBALANCE (non-serious), outcome "unknown", described as "Fluid imbalance (all body fluids affected)"; MUCOSAL DISORDER (non-serious), outcome "unknown", described as "Mucosal disorder (heavy mucosa)". The events "i have pcp (pneumocystis jirovecii pneumonia)", "drastic saliva alteration", "fluid imbalance (all body fluids affected)" and "mucosal disorder (heavy mucosa)" required physician office visit. The patient underwent the following laboratory tests and procedures: over 100 tests: Negative, notes: have had over 100 tests performed with negative results over the past 15 months. Clinical course: Patient had severe adverse reactions to Pfizer COVID Vaccine and wanted vaccine reversal antidote.  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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 43 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster ), single (Lot number: FE3590) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Lot number: 037K2OA) and on 07Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (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 "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2023) Negative, notes: Tested negative on day 7 and day9; (16Apr2023) Negative, notes: Tested negative on day 7 and day9; (17Apr2023) Positive, notes: Tested positive on day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products.; Sender's Comments: Considering interchange of vaccine, the role of company suspect drug BNT162b2 to all the reported events  DRUG INEFFECTIVE and COVID19   cannot be excluded completely as efficacy of a drug varies from patient to patient and can be affected by different factors. However the contribution of Moderna to the events cannot be excluded
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose 2, Date: 01Apr2021 / Moderna, Dose 3, Date: 22May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22May2022 as dose 3 (booster), single (Lot number: 057m21a) for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: en6206) and on 01Apr2021 as dose 2, single (Lot number: er8732) for covid-19 immunisation. The patient's relevant medical history included: "mod kidney disease" (unspecified if ongoing), notes: Other Medical History: mod kidney disease; "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022, outcome "unknown", described as "Pfizer, Dose 2, Date: 01Apr2021 / Moderna, Dose 3, Date: 22May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) Negative, notes: neg test on 15Apr2023; (17Apr2023) Positive, notes: pos covid test 17Apr2023. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (lot: 6k2844) from 07Apr2023 to 12Apr2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 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.; 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 to the reported event DRUG INEFFECTIVE cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300159882 Same patient, different drugs and different AE.;
Sex: F
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). 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 20Sep2022 as dose number unknown (booster), single (Lot number: Gj5342), in left arm 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 included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 30Mar2023 to 03Apr2023 for COVID-19 Treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300160027 Same patient, different drugs and different AE.;
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical course: The patient had a stroke within a couple months after getting the Pfizer vaccine at a pretty young age when they had no health issues earlier.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Apr2023): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of below mentioned query: Removed patient's details (age group, gender and non-Study Pt ID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Apr2023): This is a follow-up report to notify that the case 202300145036 and case 202300161896  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300161896.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145035 Same reporter/ drug/ AE, different patients;US-PFIZER INC-PV202300062721 Same reporter/ drug/ AE, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical information: The patient had a stroke within a couple months after getting the Pfizer vaccine at a pretty young age when they had no health issues earlier.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Apr2023): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of below mentioned query: Removed patient's details (age group, gender and non-Study Pt ID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Apr2023): This is a follow-up report to notify that the case  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300161917. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145035 Same reporter/ drug/ AE, different patients;US-PFIZER INC-202300145036 Same reporter/ drug/ AE, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: I had nothing wrong with my heart until I decided to take one of Pfizer little shots.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "I had nothing wrong with my heart until I decided to take one of Pfizer little shots.". The patient was hospitalized for cardiac disorder (hospitalization duration: 14 days). Clinical Course: Caller called in with questions about the medication Estring. During the call caller stated." It's the only one I can use I don't have any insides left I don't have anything because of having children. patient later stated on the call. I had nothing wrong with my heart until I decided to take one of Pfizer little shots. And I'm not the only one it's other people have gotten heart problems from these damn shots. I spent 2 weeks in the hospital a year after I had 2 shots."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: felt unwell; fever; chills; pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "felt unwell"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered".  Additional information: the patient got pain and chills following booster of COVID vaccine. She got flu vaccine on the same day as the booster of COVID vaccine and felt unwell for a day and a half. She had fever and chills. The patient considered the event as caused by the suspect product.  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.
Sex: M
Vaccine: COVID19
Symptoms: Coxsackie virus test, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis; This is a literature report for the following literature source(s) Here we present a case of myocarditis occurring less than 24 hours after the second dose of Pfizer-BioNTech vaccine with 3 month follow up. A 23 year old man received his second dose of the COVID-19 vaccine in the morning. Within a few hours he experienced chest pain, chills, weakness, and fatigue. These dissipated by 7pm. He is a member of the National Guard and during drills the next day experienced stabbing substernal chest pain for which he sought evaluation. The pain radiated into his left jaw, worse with deep inspiration and worse in the left lateral decubitus position. He is a 1 smoker with no personal or family history or cardiac disease. A friction rub was heard on physical exam. His troponin I peaked at 2.6ng/mL. His EKG showed normal sinus rhythm, a TTE showed a normal EF with no pericardial effusion. He was given aspirin 81 mg and started on a heparin drip for possible NSTEMI. The next day his pain decreased and a cardiac MRI demonstrated no inflammation. His serum coxsackie and parvovirus titers were negative. He was instructed to continue the aspirin, limit exercise for 8 weeks, and stop smoking. Upon follow up 3 months later the patient denied any recurrent chest pain and was advised to continue the aspirin. But the original bout of myocarditis limited his participation in the Guard. Our case illustrates that exposure to an immunological trigger, the COVID-19 vaccine, leading to myocarditis was extremely short compared to typical cases of viral induced or vaccine hypersensitivity reaction.; Sender's Comments: The company cannot completely rule out a contributory role of Pfizer-BioNTech vaccine to the onset of myocarditis based on the close temporal association and the compatibility with the known safety profile of the suspect product.  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: M
Vaccine: COVID19
Symptoms: Parvovirus B19 test, Physical examination, Troponin I
Clinical narrative: Myocarditis; This is a literature report for the following literature source(s) Here we present a case of myocarditis occurring less than 24 hours after the second dose of Pfizer-BioNTech vaccine with 3 month follow up. A 23 year old man received his second dose of the COVID-19 vaccine in the morning. Within a few hours he experienced chest pain, chills, weakness, and fatigue. These dissipated by 7pm. He is a member of the National Guard and during drills the next day experienced stabbing substernal chest pain for which he sought evaluation. The pain radiated into his left jaw, worse with deep inspiration and worse in the left lateral decubitus position. He is a 1 smoker with no personal or family history or cardiac disease. A friction rub was heard on physical exam. His troponin I peaked at 2.6ng/mL. His EKG showed normal sinus rhythm, a TTE showed a normal EF with no pericardial effusion. He was given aspirin 81 mg and started on a heparin drip for possible NSTEMI. The next day his pain decreased and a cardiac MRI demonstrated no inflammation. His serum coxsackie and parvovirus titers were negative. He was instructed to continue the aspirin, limit exercise for 8 weeks, and stop smoking. Upon follow up 3 months later the patient denied any recurrent chest pain and was advised to continue the aspirin. But the original bout of myocarditis limited his participation in the Guard. Our case illustrates that exposure to an immunological trigger, the COVID-19 vaccine, leading to myocarditis was extremely short compared to typical cases of viral induced or vaccine hypersensitivity reaction.; Sender's Comments: The company cannot completely rule out a contributory role of Pfizer-BioNTech vaccine to the onset of myocarditis based on the close temporal association and the compatibility with the known safety profile of the suspect product.  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: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered the products ACTHIB but the diluent was expired with no reported adverse event; Initial information was received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 6 months old female patient who experienced administered the products acthib but the diluent was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; POLIO VACCINE INACT (ipv) for Immunisation; and ROTAVIRUS VACCINE for Immunisation.  On 09-Dec-2022, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection dose 1 of 0.5ml lot number 28-MAY-2023, 28-Mar-2023 via intramuscular route in  right thigh. On 09-Feb-2023 she also received a dose of the same vaccine with dose 2 of 0.5ml lot number 28-MAY-2023, via intramuscular route in  right thigh. On 12-Apr-2023 she also received a dose 3 of the same vaccine with an dose 3 of 0.5ml lot number 28-MAY-2023, 28-Mar-2023 via intramuscular route in  right thigh  for Immunisation. DILUENT LOT U7261AA , EXP 07-APR-2023   On 12-Apr-2023 the patient developed a non-serious event of administered the products acthib but the diluent was expired with no reported adverse event (expired product administered) 4 months 3 days following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event administered the products acthib but the diluent was expired with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving a punctured IPOL with no reported adverse event; administration of punctured IPOL after excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA119119, 2023SA119943, 2023SA119961 and 2023SA120330.  This case involves 17 years old male patient who had administration of punctured IPOL after excursion with no reported adverse event and reporter reported temperature excursion involving a punctured IPOL with no reported adverse event for vaccine poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Immunisation.  On 03-Mar-2023, the patient received a standard dose of 0.5 ml total of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot V1B901M, expiry date- 02-JUN-2024) via intramuscular route in the left arm for Immunization.  Caller reported temperature excursion involving a punctured IPOL with no reported adverse event (product storage error) (unknown latency) and on 03-MAR-2023, (latency- same day), the patient had administration of punctured poliomyelitis vaccine (inactivated) IPV (VERO) after excursion with no reported adverse event (poor quality product administered). Caller was asking if the dose is considered a valid one. She stated that the health department wanted them to inquire if dose needs to be repeated  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving a punctured IPOL with no reported adverse event; patient received the punctured IPOL post excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA119943, 2023SA120330, 2023SA119961 and 2023SA119126.  This case involves a 2 months old male patient who received the punctured IPOL post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13), Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP), HIB VACCINE (HIB) and Rotavirus vaccine for Immunisation.  On 30-Mar-2023, the patient received 0.5 ml dose (1x) (dose 1) of suspect IPV (VERO) Suspension for injection (strength: standard) of lot V1B901M and expiry date: 02-Jun-2024 via intramuscular route in unknown administration site for immunization.  On an unknown date, a punctured IPOL underwent temperature excursion with no reported adverse event (product storage error) (unknown latency).  On 30-Mar-2023, the patient developed a non-serious event of patient received the punctured IPV (VERO) post excursion with no reported adverse event (poor quality product administered).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA119943: US-SA-2023SA119943:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Chest X-ray abnormal, Echocardiogram abnormal, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: High Heart rate when resting  Could feel heart racing in chest Did Blood pressure - was high
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: High Heart rate when resting  Could feel heart racing in chest Did Blood pressure - was high
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Rash; Numbness down arm to fingers; This non-serious case was reported by a other health professional and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) and (batch number JN93X, expiry date 07-JUL-2024) for prophylaxis.   On 10-APR-2023, the patient received Shingrix (intramuscular) 50 ug. On 11-APR-2023, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash) and numbness of upper extremities (Verbatim: Numbness down arm to fingers). The patient was treated with famotidine and benadryl (nos) (Benadryl). The outcome of the rash and numbness of upper extremities were unknown.   It was unknown if the reporter considered the rash and numbness of upper extremities to be related to Shingrix.     It was unknown if the company considered the rash and numbness of upper extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2023 This report was submitted via the online direct entry reporting system.  After receiving Shingrix patient had rash and numbness, down from arm to fingers.  Number was reported as 58160-828-03. The symptoms were treated. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This solicited report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2023, the patient experienced blood clots, and was hospitalized on an unspecified date in APR-2023. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. It was reported as "Just last week I had my sister and another friend hospitalized for blood clots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was not related.  This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230433876.; Sender's Comments: V0: 20230434716 - blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Epistaxis, Suspected COVID-19
Clinical narrative: EPISTAXIS; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient (health care professional) via other manufacturer (Pfizer) concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 01-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 40 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1)  The patient additionally received non-company suspect vaccine included: Moderna (elasomeran) (spikevax) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered at left arm on 07-JAN-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). Concomitant medications included Garlic (allium sativum), Calcium magnesium and zinc plus D3. (calcium/colecalciferol/magnesium/zinc), cetirizine, Vitamin D3 (colecalciferol), Turmeric Curcumin(curcuma longa), dextromethorphan hydrobromide/guaifenesin/phenylephrine hydrochloride, diphenhydramine, fish oil, ibuprofen, norethisterone, Psyllium fiber (plantago ovata husk fibre), Black Elderberry (sambucus nigra), Super Vitamin B complex (vitamin b complex) and epicor. On unspecified date in APR-2023, the patient experienced suspected covid-19 infection (Dose number in series 2) and received non-company suspect drugs Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin was not reported, batch number: GG2523 expiry: UNKNOWN) dose and frequency were not reported from 10-APR-2023 to 11-APR-2023 for covid-19 treatment. On 11-APR-2023 at 09:15, the patient experienced epistaxis-nose bleed persistent from right nostril (Dose number in series 2) lasting over 1 hour. Happened after taking first dose Paxlovid. Patient was taking other medications within 2 weeks of starting COVID-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from epistaxis, and the outcome of suspected covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deafness
Clinical narrative: significant hearing loss; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (significant hearing loss) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st Pfizer dose) on 28-Sep-2021 and PFIZER BIONTECH COVID-19 VACCINE (2nd Pfizer dose) on 09-Apr-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included ATORVASTATIN for an unknown indication.    On 24-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In October 2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DEAFNESS (significant hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (significant hearing loss) had not resolved.        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.   Caller explained approximately 2 weeks after getting Moderna vaccine he started noticing significant hearing loss and that was ongoing, it remained the same with no changes.  No treatment information was reported.  Company Comment: This is a spontaneous case concerning a 77 year-old, male patient with no reported medical history and concomitant use of atorvastatin, who experienced the serious (due to medically significant) unexpected, event of Deafness, which occurred approximately 2 weeks after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as the first/second/third/booster/fourth dose of COVID-19 vaccination schedule. The outcome was reported as not recovered. Patient´s advanced age and concomitant use of atorvastatin remain as confounders. Patient received prior two doses of COVID-19 vaccine Tozinameran. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Sex: U
Vaccine: PPV, PPV
Symptoms: Needle issue, Syringe issue
Clinical narrative: no adverse event; needle fell of the syringe; vaccine began leaking out of the syringe; Poor quality vaccine administered; the patient received a smaller than recommended dose; patient with another dose of PNEUMOVAX 23; dripped on the patients arm; This spontaneous report was received from a pharmacist referred to a 68-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 27-MAR-2023, the patient was vaccinated with a smaller than recommended dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, also reported as 0.5 milliliter/ once, lot #U032086, expiration date: 29-AUG-2023, for prophylaxis (strength, and route of administration were not provided). The reporter stated that while the patient administered this dose of PNEUMOVAX 23 (Pre-filled syringe) the vaccine began leaking out of the syringe while reporter was pushing on the plunger to administer the vaccine. A lot of the vaccine leaked out (Syringe issue). The reporter said when she went to put the cover on the needle the entire needle fell of the syringe (Needle issue). The reporter confirmed no defects to the prefilled syringe were noted. The reporter said thought she had secured the needle on correct. The reporter discarded the syringe and so the product was not available for retrieval. No pictures were available, so no pictures were being sent. The syringe needle was attached to the syringe tip before the leaking occurred. The needle able to be attached securely to the syringe. the leaking occurred from the tip of the syringe, and between the syringe hub/Luer lock and syringe needle. When the plunger rod was being pushed forward this defect was noticed.  Thus, the patient received the smaller than recommended dose, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), dripped on the patient's arm, and the reporter then revaccinated the patient with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, lot #, expiry date, and route of administration were not provided) due to the PFS leaking in the same visit. The product was not available for retrieval so no mailer was being sent. (Poor quality device used; Product administration error; Exposure via skin contact). There was no additional adverse event reported (No adverse event).
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received Hib (Hiberix) (batch number CH392, expiry date 23-MAR-2023) for prophylaxis.   On 12-APR-2023, the patient received Hiberix. On 12-APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-APR-2023 The reporter reported that an expired Hiberix dose was administered to a 6 month old female patient. The reporter asked for recommendation about this situation. The patient received an expired dose of Hiberix, which led to expired vaccine used.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: patient only reported flu like symptoms and red swollen sore arm she recovered quickly
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: patient only reported flu like symptoms and red swollen sore arm she recovered quickly
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Hallucination, Heart rate increased, Hypoaesthesia
Clinical narrative: Heart rate increased to the 200s, arms and legs went numb, hallucinations, and chest pain within 24 hours of both shots. I am now on a heart medication for the remainder of my life, at 23 years old.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Ultrasound scan
Clinical narrative: Heart rate increased to the 200s, arms and legs went numb, hallucinations, and chest pain within 24 hours of both shots. I am now on a heart medication for the remainder of my life, at 23 years old.