chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Mass in right shoulder; deltoid mass; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Allergy: Naproxen". Vaccination history included: bnt162b2 (other vaccine same date details:, [{other vaccine same date product=Pfizer,, Other vaccine same date lot number=FM0173,, Other vaccine same date vaccine date=04Oct2022,, Other vaccine same date dose number=3,, Other vaccine same date vaccine location=Right, arm}]), administration date: 04Oct2022, when the patient was 70-year-old, for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: LIMB MASS (non-serious) with onset 06Apr2023 at 12:00, outcome "recovering", described as "Mass in right shoulder"; MUSCLE MASS (non-serious) with onset 06Apr2023 at 12:00, outcome "recovering", described as "deltoid mass". The events "mass in right shoulder" and "deltoid mass" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb mass, muscle mass.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over on chest and back and spreading down legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 30Oct2023 as dose number unknown, single; AMLODIPINE taken for hypertension (ongoing). Vaccination history included: covid 19 vaccines: moderna (Dose 1), administration date: 30Jan2021, for Immunization; covid 19 vaccines: moderna (Dose 2), administration date: 27Feb2021, for Immunization. The following information was reported: RASH (non-serious) with onset 01Nov2023, outcome "not recovered", described as "Rash all over on chest and back and spreading down legs". Additional information: They just noticed it this morning and it is getting worse because it is spreading down his legs, at first it was just on his chest and back.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 72.0
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 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphpcytic leukemia" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing), notes: Mild; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: KLOR CON, start date: Aug2018, stop date: 01Nov2023; ACYCLOVIR [ACICLOVIR], start date: Aug2018, stop date: 01Nov2023. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline", Vaccination history included: moderna covid-19 vaccine (vaccine dose number=1, vaccine location=Left arm), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization; moderna covid-19 vaccine (vaccine dose number=2, vaccine location=Left arm), administration date: 26Mar2021, when the patient was 70-year-old, for COVID-19 immunization; covid-19 vaccine (vaccine dose number=3, vaccine location=Left arm), administration date: 03Sep2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (vaccine dose number=4, vaccine location=Left arm), administration date: 26Apr2022, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (vaccine dose number=5, vaccine location=Left arm), administration date: 24Oct2022, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 23Oct2023 to 29Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 38.0
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 non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 16Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORA BE, start date: 01Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 23Oct2023 to 28Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: had a burning sensation, ran up the side of the neck on the side that the shot was given and then all left side of the face was numb; had a burning sensation, ran up the side of the neck on the side that the shot was given and then all left side of the face was numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 19Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for immunisation. The patient's relevant medical history included: "hearing issue" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Pfizer covid vaccine (Primary Immunization series complete), for Covid-19 immunization. The following information was reported: BURNING SENSATION (non-serious), HYPOAESTHESIA (non-serious) all with onset 19Oct2023, outcome "recovered" (20Oct2023) and all described as "had a burning sensation, ran up the side of the neck on the side that the shot was given and then all left side of the face was numb". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation, hypoaesthesia.  Additional information: The patient did not have weak bones but they gave her Calcium and Vitamin-D weak bones, just because it was recommended to people of her age. The patient previously had the Pfizer COVID vaccines but did not know when she got the shot, they were the only one to near that have it. Right after the patient had the shot, the patient had a burning sensation, ran up the side of the neck on the side that the shot was given and then all left side of the face was numb for probably a good day. The patient was concerned about it and she took an allergy pill, Loratadine tablet 10mg. The patient was not still experiencing the events, it all disappeared probably by the middle of the next day. It was kind of irate whole side of the face numb. The patient took Loratadine  through when her allergies flare up and see dermatologist by end year.    The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Exposed 05Oct. Symptomatic 07Oct. Headache/body ache/mild fever/ low energy/cold symptoms. Positive home test 08Oct.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HG4680) at the age of 66 years, in right arm for covid-19 immunisation; 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 (non-serious) with onset 07Oct2023, outcome "unknown", described as "Exposed 05Oct. Symptomatic 07Oct. Headache/body ache/mild fever/ low energy/cold symptoms. Positive home test 08Oct.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: Exposed 05Oct. Symptomatic 07Oct. Headache/body ache/mild fever/ low energy/cold symptoms.Positive home test 08Oct.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: Negative; Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: treatment of Paxlovid received. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HG4633) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1), for COVID-19 Immunization; Covid-19 vaccine (Dose:2), for COVID-19 Immunization; Covid-19 vaccine (Dose:3), for COVID-19 Immunization; Covid-19 vaccine (Dose:4), for COVID-19 Immunization; Covid-19 vaccine (Dose:5), for COVID-19 Immunization; Covid-19 vaccine (Dose:6), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Oct2023 to 26Oct2023.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "HPB" (unspecified if ongoing); "hypothyroidism" (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 Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient treat with Paxlovid form 24Oct2023 to 28Oct2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna, Dose: 4; Pfizer, Dose: 1-3; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EH9899), on 10Jan2021 as dose 2, single (Lot number: EL1284) and on 29Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 45 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hx VSD repair in 1979", start date: 1979 (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 18Oct2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose: 4; Pfizer, Dose: 1-3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 18Oct2023 to 22Oct2023.; Sender's Comments: Considering interchange of vaccine, the contributory role of company suspect drug to all the reported events DRUG INEFFECTIVE,  COVID-19 cannot be excluded completely.
Sex: F
Vaccine: COVID19
Symptoms: Heart valve operation
Clinical narrative: she had a heart valve placed in her heart; 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 63-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HEART VALVE OPERATION (medically significant) with onset Oct2023, outcome "unknown", described as "she had a heart valve placed in her heart".  Clinical course: The reporter was asking about the possible side effects of pfizer covid vaccine 2023-2024 related to possible heart inflammation and if possible heart inflammation is a side effect with moderna covid 19 and wondering if it is the same with pfizer covid 19. Her and her doctor have a concern with her receiving a mrna vaccine given the recent heart valve.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; 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 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Lot number: HG4629) at the age of 70 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Parkinsons" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: SINEMET, start date: 03Sep2022; ELIQUIS, start date: 10Jan2023. Vaccination history included: bnt162b2 (DOSE 1, SINGLE Lot no. EL9265 on Left arm), administration date: 05Feb2021, when the patient was 67-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 2, SINGLE Lot no. EN6200 on Left arm), administration date: 01Mar2021, when the patient was 67-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE Lot no. FF8839 on Left arm), administration date: 15Oct2021, when the patient was 68-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE Lot no. FK9896 on Left arm), administration date: 06Apr2022, when the patient was 68-year-old, for Covid-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE Lot no. GH9697 on Left arm), administration date: 24Oct2022, when the patient was 69-year-old, for Covid-19 Immunization. The following information was reported: COVID-19 (medically significant) with onset 22Oct2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 22Oct2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2023) Positive; (30Oct2023) Positive; (01Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid was administered from 23Oct2023 to 28Oct2023. No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Liquid product physical issue
Clinical narrative: A dark particle could be seen inside the solution/It did not mix; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 31Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pf-06928316 (ABRYSVO), as dose number unknown, single (Lot number: HF5016, Expiration Date: 28Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "A dark particle could be seen inside the solution/It did not mix".  Additional information: the reporter said that when they tried to mix the product, it did not mix. Product Quality Group provided investigational results on 31Oct2023 for pf-06928316 (ABRYSVO): Summary of Investigation: The investigation could not indicate a probable root cause for the complaint to be related to the production process. All reviewed deviations indicated that the batches met the established requirements at time of release. However, without lot number and based on the limited available information it is not possible to perform a more profound investigation and/or root cause analysis. No related trend could be identified based on complaint history review. No impact assessment is required according to SOP-67372. No corrective or preventive actions were identified as all reviewed records met the established requirements at time of release. Conclusion: The complaint for "It did not mix." of "Abrysvo Injectable (Vaccine)" was investigated. The investigation included reviewing deviation investigation and an analysis of the complaint history for the product type. The final scope was determined to be the reported product and product type, as no lot was available. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS (Withheld) concludes that the reported defect is not representative of the Pfizer (Withheld) process quality and remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Product Quality Group provided investigational results on 31Oct2023 for pf-06928316 (ABRYSVO): Based on the new information received on "A dark particle could be seen inside the solution", during a sample evaluation associated with site investigation record on 31Oct2023 has changed the reportability from non-reportable to 30-day reportable malfunction. The overall reportability on the case level has changed.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Nervous system disorder, Respiratory disorder
Clinical narrative: neurologic side effects; cardiac and respiratory complications; cardiac and respiratory complications; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (03Nov2023), this case now contains all required information to be considered valid.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 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: RESPIRATORY DISORDER (medically significant), CARDIAC DISORDER (medically significant) all with onset 2022, outcome "unknown" and all described as "cardiac and respiratory complications"; NERVOUS SYSTEM DISORDER (medically significant) with onset 2022, outcome "unknown", described as "neurologic side effects". Therapeutic measures were taken as a result of nervous system disorder, respiratory disorder, cardiac disorder. Within 48 hours the patient experienced neurologic side effects, to be followed by cardiac and respiratory complications. After 5 months of treatment the patient was able to stop medication and return to full normal activity.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events and suspect  bnt162b2, bnt162b2 omi ba.4-5 cannot be excluded.This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: headache; low fever (100 degrees); sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 26Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 26Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 27Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset 27Oct2023, outcome "unknown", described as "low fever (100 degrees)"; PAIN IN EXTREMITY (non-serious) with onset 27Oct2023, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient went to her pediatrician yesterday and received flu and covid vaccine. She woke up today with headache, low fever (100 degrees) and sore arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel sick; 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 41-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick ".  Additional Information: It was reported that the patient feels sick getting them at the same time. The patient considered the event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 15Oct2023 as dose 1, 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: HYPERSENSITIVITY (hospitalization) with onset 2023, outcome "unknown", described as "allergic reaction". Additional information: patient had Pfizer Covid 19 Booster last 15Oct2023 from a pharmacy then she had an allergic reaction which got her hospitalized. She also would like to ask for help with her hospital bills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Pyrexia
Clinical narrative: one of the flu symptoms since she went in and took his temperature and it's like 99.5; one of the flu symptoms since she went in and took his temperature and it's like 99.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (004756).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), PYREXIA (non-serious) all with onset 2023, outcome "unknown" and all described as "one of the flu symptoms since she went in and took his temperature and it's like 99.5". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She's wondering if it's one of the flu symptoms since she went in and took his temperature and it's like 99.5.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a lot of pain in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), administration date: 2022, for COVID-19 immunization, reaction(s): "Severe arm pain that lasted at least 10 days". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "a lot of pain in my arm".  Additional information: The patient just got his/her COVID booster and patient was having a lot of pain in his/her arm where the shot was given. This is his/her 5th COVID shot. He/She had no trouble with the first 3 but his/her booster last year caused severe arm pain that lasted at least 10 days. Patient was querying if this was normal.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; patient got positive with Covid. Patient was vaccinated with Moderna and Pfizer Covid 19 Vaccine already; patient got positive with Covid. Patient was vaccinated with Moderna and Pfizer Covid 19 Vaccine already; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient got positive with Covid. Patient was vaccinated with Moderna and Pfizer Covid 19 Vaccine already". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Caller, an HCP would like to know how long can the patient be vaccinated with Pfizer Covid 19 booster if the patient got positive with Covid. Patient was vaccinated with Moderna and Pfizer Covid 19 Vaccine already.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: just tested positive for COVID; just tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "just tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (2023) Positive. Clinical course: the patient tested positive for COVID using the Abbott at home test and had most recent vaccine on 03Oct2023. The patient returned from two weeks of work related travel in on 27Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: they had multiple vaccine MRNA-injured people in her family.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "they had multiple vaccine MRNA-injured people in her family.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Hypokinesia, Pain in extremity
Clinical narrative: had diarrhea, uncontrollable diarrhea; next morning I woke and I could not get out of bed, could not lift my head off the pillow; got up and I had a pain in my stomach; was very tired all day; was okay that day but then other then my arm hurt a little bit; Initial information received on 25-Oct-2023 regarding an unsolicited valid non-serious Courtesy case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who had diarrhea, uncontrollable diarrhea, next morning i woke and i could not get out of bed, could not lift my head off the pillow, got up and i had a pain in my stomach, was very tired all day and was okay that day but then other then my arm hurt a little bit after receiving vaccines Influenza USP Trival A-B Subviron No Preservative Vaccine [Fluzone] and vacuna pfizer-biontech covid-19.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2023 at 10 in the morning, the patient received a dose of suspect  Influenza USP Trival A-B Subviron No Preservative Vaccine Suspension for injection (lot number, strength, dose ,expiry date not reported) via unknown route in the left arm as prophylactic vaccination and on the same day and time the patient received vacuna pfizer-biontech covid-19 not produced by Sanofi Pasteur (lot number: HG4633, strength, dose, form unknown) via unknown route in the right arm as prophylactic vaccination.  On an unknown date, the patient reported that the next, I was okay that day but then other then my arm hurt a little bit (pain in extremity), next morning I woke and I could not get out of bed. I could not lift my head off the pillow (hypokinesia) and I finally did and I was very tired all day (fatigue) and I did nothing all day. Then next morning, the 4 o'clock in the morning, I got up and I had a pain in my stomach (abdominal pain upper) and I wanted to go to the bathroom I never made it to the bathroom, I had diarrhea, uncontrollable diarrhea (diarrhoea) (Unknown latency) following the intake of Influenza USP Trival A-B Subviron No Preservative Vaccine and vacuna pfizer-biontech covid-19.  It was reported "Well, a couple of days ago I had a flu shot and I also had a Covid booster and I had a very bad reaction. I had, first time I ever took 2 vaccines at a same time because I saw a lot of advertisements and for that you could get both the vaccines at the same time. I went to have them both. I wanted to report this because I don't know if it has anything to do, I have a feeling that it has do something to do with the flu shot. Because I do get that for. When Paraphrased the concern: Consumer stated, "Yes and I just have the feeling that because this is the powerful flu shot that this may have done it. I never had a reaction to a vaccine before."   Action taken: not applicable.  The patient was treated with PARACETAMOL (TYLENOL).  At time of reporting, the outcome was Unknown for the events.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of multiple Flu vaccines in one flu season with no reported adverse event; Initial information received  on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered multiple flu vaccines in one flu season with no reported adverse event with influenza quadrival A-B vaccine [fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2023, the patient received a dose 1, 0.5 ml of suspect influenza quadrival A-B vaccine, Suspension for injection lot UT8134MA, expiry date: 30-Jun-2024 via intramuscular route in the left arm for immunization, was administered multiple flu vaccines in one flu season with no reported adverse event (inappropriate schedule of product administration) (latency same day).  Action taken: not applicable.   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: FLU4
Symptoms: Unevaluable event
Clinical narrative: she received Fluzone HD QIV for the past five years, despite being under the age of 65 with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Adult female patient who received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] for the past five years, despite being under the age of 65 with no reported adverse event.  The patient's past medical history included Lung transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.7 mL of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for immunization. Information on the batch number was not available.  On an unknown date the patient received influenza quadrival A-B high dose HV vaccine for the past five years, despite being under the age of 65 with no reported adverse event (off label use) (latency- same day).  Reportedly, The pharmacist stated that an under 65-year-old female patient presented to his pharmacy and requested a flu shot with Fluzone HD QIV. The patient stated that she has received Fluzone HD QIV yearly for the past five years from her doctor's office. The reason she gave for this off-label use is that her doctor says she needs the high-dose vaccine in order to best protect her as a double-lung transplant recipient. The pharmacist informed the patient that his pharmacy is unable to give Fluzone HD QIV in an off-label manner. He referred her back to her physician.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: MENQUADFI reached 1C and was then administered with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] reached 1c and was then administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (strength not reported, lot U7596AB, Expiry date : 14-Mar-2025) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and menquadfi reached 1c and was then administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Reportedly "Inquiry placed in proxy for final handling. Medical assistant requesting stability information regarding temperature excursion. Products: ACTHIB, PENTACEL, MENQUADFI and IPOL (all unopened). Reason: Occurred during recalibration of new thermometer. Max/low temperature reached: 33.8F minimum and 43.7F maximum. Duration out of labelled range: 47 minutes Human error? NO Does extended stability data cover the excursion? NO If negative advice, was the product administered to a patient? YES verified email address with caller. See associated case 01817531. Attempted to warm transfer caller, but none were available. Caller did not have patient information available at time of call. "  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi reached 1c and was then administered 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 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: 0.58
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADACEL was inadvertently administered to a 7 month old instead of DTAP, with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine  [Adacel] was inadvertently administered instead of dtap, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2022, the patient received a 0.5 ml (once, total) dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot 2CA18C1, expiration date: 29-Nov-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and inadvertently administered to a 7 month old instead of dtap, with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Reportedly, Caller reporting it was just discovered by the parent. Caller with question on whether dose would count as a valis dose of DTAP. Caller reporting patient had previously received one dose of DTAP.   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.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of PENTACEL that has expired on 12Oct2023 to a patient on 24Oct2023 with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves administration of pentacel that has expired on 12oct2023 to a patient on 24oct2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Oct-2023, suspect diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ786AA, expiry date: 12-Oct-2023 via unknown route in unknown administration site for immunization (strength, dose: unknown) was administered administration to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  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.