chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 30-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2022 as dose 1, single (Lot number: FJ6369) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfadiazine, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other Medication in 2weeks. COVID 19 Treatment, Treatment start date: 29Mar2023, Treatment stop date: 30Mar2023, Administrator route: Oral; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2.,Linked Report(s) : US-PFIZER INC-202300139940 same reporter/patient, different AE;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: METOPROLOL, start date: 15Dec2021. The following information was reported: 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: (Mar2023) Negative; (Mar2023) Positive, notes: 4 days later symptoms resumed and patient tested positive again. Patient continued to test positive with mild symptoms for more than 2 weeks after the rebound; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300139790 Same patient, different product/event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Vaccine brand other Moderna/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 11:30 as dose 5 (booster), single (Lot number: GJ6665) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 at 14:00 as dose 1, single (Lot number: EN6208), in left arm and on 07Apr2021 at 14:00 as dose 2, single (Lot number: EN6208), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 026P21A), in left arm and on 13Jun2022 at 17:30 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "Osteoporosis" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccine brand other Moderna/ vaccine brand=Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19".  Therapeutic measures taken as a result of drug ineffective, covid-19 included PAXLOVID from 16Mar2023 to 21Mar2023.
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 13:00 as dose 5 (booster), single, 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 73.0
Sex: M
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; Dose Number: 4 & 5 Moderna; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EM6199), on 26Mar2021 as dose 2, single (Lot number: EERB732) and on 29Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 73 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24May2022 at 16:00 as dose 4 (booster), single (Lot number: 059M21A), in right arm and on 01Oct2022 at 17:00 as dose 5 (booster), single (Lot number: 055F22B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown", described as "Dose Number: 4 & 5 Moderna"; 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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (medically significant), outcome "unknown". Comments: myocarditis, 4 patients.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event myocarditis. 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.,Linked Report(s) : US-PFIZER INC-PV202300060530 Same article/drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (medically significant), outcome "unknown". Comments: myocarditis, 4 patients.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event myocarditis. 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.,Linked Report(s) : US-PFIZER INC-PV202300060530 Same article/ drug/event and different patient;
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 23Mar2023 to 27Mar2023.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; 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 02Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with nirmatrelvir/ritonavir (PAXLOVID) from 19Mar2023 to 24Mar2023.  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: 31.0
Sex: M
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; Dose 3: Moderna/Dose 1, 2, 4: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 at 15:45 as dose 1, single (Lot number: ER2613) and on 21Apr2021 at 10:45 as dose 2, single (Lot number: EW0171) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 013FZIA) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "overweight/obese" (unspecified if ongoing), notes: other medical history: overweight/obese. The patient's concomitant medications were not reported. The patient has no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021 at 15:00, outcome "unknown", described as "Dose 3: Moderna/Dose 1, 2, 4: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2023) Positive; (21Mar2023) Positive; (28Mar2023) Negative; (30Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  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, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 13:30 as dose 1, single (Lot number: EN6199), in right arm, on 31Mar2021 at 13:30 as dose 2, single (Lot number: ER8733), in right arm, on 14Aug2021 at 14:30 as dose 3 (booster), single (Lot number: EWo180), in right arm and on 18Jan2022 at 14:00 as dose 4 (booster), single (Lot number: FJ5682), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol and Triglycerides" (unspecified if ongoing); "High cholesterol and Triglycerides" (unspecified if ongoing); "Diabetes Mellitus type 2" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 12Apr2018, stop date: 21Mar2023; PREDNISONE, start date: 14Sep2016, stop date: 21Mar2023. Past drug history included: Bactrim ds, reaction(s): "Known allergies: Sulfa meds (Bactrim DS)". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (lot number: 662523) from 21Mar2023 to 26Mar2023.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number 3 . Pfizer Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 at 17:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 20Mar2021 at 16:45 as dose 2, single (Lot number: FF2590), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2022 at 15:00 as dose 3 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). 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 "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose Number 3 . Pfizer Dose Number: 4". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Pyrexia, Sleep disorder
Clinical narrative: Fast Heartbeat - Went to bed at 10:30 pm with chills and slight fever.  Awakened at 2:30 am with higher fever, and could feel rapid heartbeat in my neck.  Timed heart rate was 95 beats per minute. (My usual lying down heart rate is usually closer to 65 beats per minute.)  Threw off blankets and rechecked my heart rate peridocally.  It was down to 85 beats per minute by 3:00 am.  I fell asleep at about 3:15 am and woke up at 7:00 am.  Heart rate at 7:00 am was 76 beats per minute.   Heart rate returned to my normal low 70's by 10:00 am.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood magnesium, Brain natriuretic peptide, Chest X-ray, Computerised tomogram head, Electrocardiogram
Clinical narrative: Syncope
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fibrin D dimer, Full blood count, Metabolic function test, Respiratory pathogen panel, Syncope
Clinical narrative: Syncope
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Troponin
Clinical narrative: Syncope
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: States received 5 doses of Pfizer BioNTech COVID-19 vaccine and has become infected with COVID-19 Mar2023; States received 5 doses of Pfizer BioNTech COVID-19 vaccine and has become infected with COVID-19 Mar2023; This is a spontaneous report received from contactable reporter(s) (Physician). 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) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "States received 5 doses of Pfizer BioNTech COVID-19 vaccine and has become infected with COVID-19 Mar2023". It was reported that, event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).
Sex: U
Vaccine: PNC20
Symptoms: Suspected product contamination
Clinical narrative: one of the syringes, there is a white I guess it likes white particulate. It looks like a bacterial colony/"bacterial colony" seems to have settled into the needle hub; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 20), as dose number unknown, single (batch/lot number: FJ2602, expiration date: 30Jun2023) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED PRODUCT CONTAMINATION (non-serious), outcome "unknown", described as "one of the syringes, there is a white I guess it likes white particulate. It looks like a bacterial colony/"bacterial colony" seems to have settled into the needle hub".  Additional information: On 27Mar2023 product quality complaint group reported with description of complaint, the pharmacist stated, "I was just, see yesterday we were giving the Prevnar 20 vaccine and one of the syringes, there is a white I guess it likes white particulate. It looks like a bacterial colony. So, I just wanted to call to report that." When paraphrased the concern, pharmacist stated, "I didn't administer that the one with the bacteria in it. It is though just in the box. We need to check up the one without it but there was a syringe in there. Correct. They were not administered." The pharmacist informed product NDC# 0005200001, UPC# 300052000103. The pharmacist was informed to not discard the product, as this report would be forwarded for review to our Pfizer Quality Department. If it was needed that product was required for further evaluation, then a prepaid (withheld) mailer might be sent to you within 3 to 10 business days. The sample status, sample availability was unknown. The pharmacist informed additional information was that on 29Mar2023, a callback to reporter was placed. The reporter stated that "bacterial colony" seems to have settled into the needle hub (where the needle was screwed onto the syringe). The pharmacist stated that he will send pictures and hold syringe for mailer kit. When asked, reporter stated that the other Prevnar vaccines they had on hand were all inspected visually and did not notice any other issues beyond this one syringe.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Iritis, Nasopharyngitis
Clinical narrative: Cold; Episodes with iritis; Ankylosing Spondylitis bad flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4328741.  A 46-year-old female patient received BNT162b2 (reported as "Pfizer COVID-19 vaccine"), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), since 06Mar2020 (ongoing) (Lot number: 1172971), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant) with onset 24May2021, outcome "recovered", described as "Ankylosing Spondylitis bad flare up"; IRITIS (medically significant) with onset 02Oct2022, outcome "recovered", described as "Episodes with iritis"; NASOPHARYNGITIS (non-serious) with onset 26Feb2023, outcome "unknown", described as "Cold". The action taken for adalimumab was dosage not changed. Clinical course included: Solicited report from  a consumer of a female with events of and non-serious Ankylosing Spondylitis bad flare up, cold, red bump injection site, episodes with iritis, felt tired, and red bump injection site with Adalimumab Solution for Injection, Single Dose Pen. On 06Mar2020, the patient experienced red bump injection site with outcome recovered on an unknown date. On 07Mar2020, the patient experienced felt tired with outcome recovered on an unknown date.  The reporter's causality for the event(s) of Ankylosing Spondylitis bad flare up, cold and episodes with iritis with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event of "ankylosing spondylitis bad flare up" with BNT162b2 was Reasonable Possibility .   The reporter's assessment of the causal relationship of "episodes with iritis" and "cold" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported event (Ankylosing Spondylitis) cannot be excluded. However, due to limited information there is not a reasonable possibility that the other reported events are related to BNT162b2 (COMIRNATY)  administration. This case will be reassessed should additional information become available.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The patient was asking if that would matter because right now she was only feeling the soreness that she originally felt when she first got the Pfizer booster shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The patient was asking if that would matter because right now she was only feeling the soreness that she originally felt when she first got the Pfizer booster shot.".  Additional information: The patient reported she got the Pfizer booster shot, but she realized that she already got the same booster shot a year and a month ago. The patient was asking if that would matter because right now she was only feeling the soreness that she originally felt when she first got the Pfizer booster shot. The patient mentioned that she neglected to let her provider know that she already had the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300138822 Same patient and events, different dose.;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia
Clinical narrative: cough; hoarseness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: COUGH (non-serious), outcome "recovering"; DYSPHONIA (non-serious), outcome "recovering", described as "hoarseness".  Additional information: The patient reported receiving a covid booster shot (Pfizer) two weeks ago. Patient developed a new onset of cough and hoarseness (present) improved; MD is aware. 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: COVID-19, Drug ineffective, Incorrect route of product administration
Clinical narrative: Respondent was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines; Respondent was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines; Administered subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (COMIRNATY), on 02Mar2021 as dose 1, single (Lot number: EN6204), on 23Mar2021 as dose 2, single (Lot number: EP6955), on 31Aug2021 as dose 3 (booster), single (Lot number: FC3182) and on 22Feb2022 as dose 4 (booster), single (Lot number: FR9729), all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "Diagnosed with DLBCL", start date: 2018 (unspecified if ongoing), notes: Was in remission at the time; "Had undergone CAR-T", start date: Nov2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Mar2021, outcome "unknown", described as "Administered subcutaneously"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" and all described as "Respondent was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines". Clinical course: The patient was diagnosed with Covid in Jun2022 despite having had 4 covid vaccines. He has subsequently had a 5th jab on 28Oct2022.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sickly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient 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: ILLNESS (non-serious), outcome "unknown", described as "sickly". Additional information: Caller asked why Pfizer covid-19 vaccine was being recommended while people are dying and what was the content of the vaccine and her husband became sickly when he took the vaccine too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: made an error and administered IPOL for the ppd test with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16-year-old female patient for whom, made an error and administered IPV (VERO) [IPOL] for the ppd test 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 MENINGOCOCCAL VACCINE B; MENINGOCOCCAL VACCINE A/C/Y/W; and INFLUENZA VACCINE for Prophylactic vaccination.  In the mid to late afternoon on 28-Mar-2023, the patient received a dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot number: V1A024M, expiry date: 17-Feb-2024) via subcutaneous route in the left forearm for TB skin test (Tuberculin test) and on the same day a new medical assistant made an error and administered ipol for the ppd test with no reported adverse event (wrong product administered).  It was reported, Nurse practitioner states that yesterday she ordered a ppd test for a patient. Do you have any information that I can tell them about Ipol given subcutaneously or intradermally? Is there any information to indicate that it could be harmful or a problem for the patient?. It is unknown what volume of Ipol was administered. The caller just found out about the error when the office called her, as she is off work and at home today. The error was discovered when the medical assistant (MA) asked the head nurse, how to document the administration. When the head nurse looked at the numbers, she knew it was Ipol instead of ppd that was given. The exact reason for the error was unknown. The caller stated, "we are thinking the MA just didn't look. It was poor attention to detail. The dose was administered by a Medical Assistant.   Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown.  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: 0.5
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired PENTACEL vaccine was administered with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient and reporter reported an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was administered 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 Rotavirus Vaccine (Rotavirus Vaccine) for Prophylactic vaccination; and Pneumococcal Vaccine Conj 15v (Crm197) (Vaxneuvance) for Prophylactic vaccination.  On 23-Mar-2023, the patient received 0.5 ml Total (1X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Frequency- once; Strength-standard) (with an unknown dose number) (lot number: UJ651AAA, Expiry date: 25-Feb-2023) via intramuscular route in the left thigh for Immunisation.  On 23-Mar-2023, the reporter reported an expired of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was administered with no reported adverse event (expired product administered) (Latency: same day).  It was reported, Medical assistant reporting that an expired PENTACEL vaccine was administered to 3 patients, she then after investigating stated it was only 2 patients. This situation is reported as a medication error due to the administration of an expired vaccine.  Action taken: not applicable.  Outcome: Unknown    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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 0.33
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired pentacel vaccine was administered,with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid  non-serious case from other health professional.  This case is linked to case 2023SA102456.  This case involves a 4 months old male patient to whom expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered,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 rotavirus vaccine pneumococcal vaccine CONJ 15V (CRM197) (vaxneuvance) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (VAXELIS) all for Immunisation.  On 16-Mar-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection at a dose of 0.5 ml once (lot UJ651AAA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh for immunization.  On 16-Mar-2023, expired pentacel vaccine was administered,with no reported adverse event (expired product administered, latency: same day).  It was reported that an expired PENTACEL vaccine was administered to 3 patients, she then after investigating stated it was only 2 patients.  Action taken: Not applicable.  Outcome: Unknown.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 60.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ActHIB on 17MAR2023 that had diluent expiration date of 05MAR2023, with no adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 60 years old male patient and reporter reported that he was administered HIB (PRP/T) vaccine [ACT-HIB] on 17-Mar-2023 that had diluent expiration date of 05-Mar-2023 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (DIP TOX) (menactra) for Immunisation.  On 17-Mar-2023, the patient received 0.5 ml (milliliter) (1x) (once) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection, (lot number: UJ649AAA, expiry date for powder: 03-Apr-2023 and expiry date for diluent: 05-Mar-2023) via intramuscular route in the left deltoid for immunization.  On 17-Mar-2023 the patient was administered HIB (PRP/T) vaccine that had diluent expiration date of 05-Mar-2023, with no adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 11 Nov 2020, 2nd dose did not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 11th November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 11 Nov 2020, 2nd dose did not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The pharmacist was the reporter who called and reported that a patient had not received a second dose administered yet. Lot number and expiration date for the vaccine were asked but declined because administration happened at a different facility. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 002CZ14) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    No concomitant medications were reported. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. No treatment medications were reported.   This case was linked to MOD-2023-716874 (Patient Link).
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired ACT-HIB to a patient with no adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient and reporter reported that an expired HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (expiry date: 11-Mar-2023) (With unknown strength, route, lot number and at unknown administration site) for immunization.     On an unknown date, an expired act-hib was administered to a patient with no adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Systemic: Joint Pain-Medium, Additional Details: Patient called pharmacy on 3/31/23 to inform that since receiving the Shingrix vaccine she has had pain in her right hand, right elbow, and right hip. She said this started after her vaccine. The pain started in her hand then went to her elbow and now has affected her hip. She has not been to the dr. Informed pt if it continues/worsens to see her provider.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient states her received both vaccinations in the right arm on the same day (02/19/20) and that he has had pain in the muscle since receiving. States NO redness or bruising. Has difficulty lifting arm above his head. Pain is still present
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Incorrect route of product administration, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site discharge, Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Skin infection from covid vaccine that began to weep and puss, went to er and given rx for doxycycline, it is currently improving and will be clear
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  all Moderna dose 1  2/26/21  010a21a dose 2  3/26/21  017b21a dose 3  10/23/21  039d21a dose 4  4/21/22  066k21a
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Malaise, Middle insomnia, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I found out I was positive five days after m symptoms started so I did not contact my doctor.  I took over the counter medication to help with my symptoms. As of today, I still have the fatigue that I never feel rested. My sleep habits have changed too. I wake up and have difficulty going back to sleep.