chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Underdose
Clinical narrative: received half the dose of the vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number A2JX7, expiry date 31-OCT-2026) for prophylaxis.   Concurrent medical conditions included down's syndrome.   On 21-MAY-2024, the patient received Bexsero (left deltoid). On 21-MAY-2024, an unknown time after receiving Bexsero, the patient experienced underdose (Verbatim: received half the dose of the vaccine). The outcome of the underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-MAY-2024 During administration of Bexsero a patient moved a lot and only received half the dose of the vaccine. Licensed practical nurse mentioned they were administering the Bexsero in the left deltoid but the patient pulled away across health care professional's body to the right to the patient's left and the syringe only had half the dose left, which led to underdose. Licensed practical nurse called to inquire: would this count towards patient's dosing? would we have to readminister? The reporter did not consent to follow-up.
Age: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: she gave a 3 year old a dose of Kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 20-MAY-2024, the patient received Kinrix (intramuscular, left thigh). On 20-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: she gave a 3 year old a dose of Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-MAY-2024 The reporter was a registered medical assistant for a health center. The reporter reported that she gave a dose of Kinrix vaccine to the 3 year old patient. The reporter declined to providing any patient demographics. The patient received Kinrix vaccine who was younger than the indicated age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: 17-year-old patient received an expired dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 21-MAY-2024, the patient received Engerix B. On 21-MAY-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: 17-year-old patient received an expired dose of Engerix-B). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2024 The reporter was a medical assistant. The reporter reported that the patient received an expired dose of Engerix-B, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Facial pain
Clinical narrative: Facial pain; inadvertently got the Shingrix vaccine 3 times instead of 2; This non-serious case was reported by a physician via call center representative and described the occurrence of facial pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included root canal procedure (already had 2 root canals, 2 caps). Previously administered products included Shingrix (received first dose of Shingrix on unknown date). Concurrent medical conditions included sensitivity of teeth. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial pain (Verbatim: Facial pain) and extra dose administered (Verbatim: inadvertently got the Shingrix vaccine 3 times instead of 2). The outcome of the facial pain was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the facial pain to be related to Shingrix.     It was unknown if the company considered the facial pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2024 The physician reported her husband inadvertently got the Shingrix vaccine 3 times instead of 2 doses. The patient had bad facial pain and he already had 2 root canals and 2 caps, and he had sensitivity since treatment and now thought that was TMJ (Temporomandibular joint dysfunction) but then just the other day he went back to the dentist and the dentist mentioned that sometimes they could had shingles without the rash but the only way to really figure it out was with a lab test. The patient asked did the Shingles vaccine throw that lab test up. The reporter thought there was a 2 to 3 months window in between 2nd and 3rd dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Inner ear disorder, Pyrexia, Vertigo
Clinical narrative: Fever; Dizziness; Muscle aches in left deltoid; vertigo; This non-serious case was reported by a physician via call center representative and described the occurrence of dizziness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ramsay-hunt syndrome (had 2 years ago), facial paralysis and vertigo.   On 03-MAY-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 03-MAY-2024, 2 hrs after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle aches in left deltoid). In MAY-2024, the patient experienced fever (Verbatim: Fever) and vertigo (Verbatim: vertigo). On 17-MAY-2024, the patient experienced dizziness (Verbatim: Dizziness). On 06-MAY-2024, the outcome of the muscle pain was resolved (duration 3 days).  In MAY-2024, the outcome of the fever was resolved. The outcome of the dizziness was resolving and the outcome of the vertigo was not reported.   It was unknown if the reporter considered the dizziness, muscle pain, fever and vertigo to be related to Shingrix.     It was unknown if the company considered the dizziness, muscle pain, fever and vertigo to be related to Shingrix.   Additional Information: GSK Receipt date: 23-MAY-2024 A physician reported that after the Shingrix first dose patient experienced muscle aches and a fever but was fine then a week ago patient complained of dizziness (inner ear causing dizziness) and vertigo. Reporter also mentioned this patient had a history of Ramsay Hunt Syndrome 2 years ago which the patient had left side facial paralysis and vertigo with.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Investigation, Visual impairment, X-ray
Clinical narrative: VISION CHANGES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bell's palsy, and long covid. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. Concomitant medications included prednisone for bell's palsy, and metformin for long covid symptoms. On APR-2021, the patient experienced vision changes Dose in series 1). On OCT-2021, Laboratory data included: Blood test negative, Investigation all negative, and X-ray negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vision changes was not reported. This report was non-serious. This report was associated with product quality complaint number 90000323760 and 90000323761. The suspected product quality complaint has been confirmed to be 90000323761 was voided: this record describes multiples adverse events such as ( numbness, tingling, and pain), which does not meet the definition of a product quality complaint or explicitly allege a potency issue. this record will be voided as no pqc. forwarding this record to pqv management review to void approval. records 90000323760 and 90000323761 are linked reports from the same reporter for different lots of the covid vaccine reporting medical adverse events for the patient. there was no product quality issue described in the information reported therefore both records will be void. Approval to void due to no PQC identified. Based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20240510147.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cancer (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Neoplasm malignant. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Having aches; does not feel well; Sore arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Having aches), MALAISE (does not feel well), PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2022, received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Jan-2024, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN (Having aches), MALAISE (does not feel well) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN (Having aches), MALAISE (does not feel well), PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: Positive. On 17-Jan-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered PAIN (Having aches), MALAISE (does not feel well) and PAIN IN EXTREMITY (Sore arm) to be related. No further causality assessment was provided for COVID-19 (COVID-19).    No concomitant and treatment medication were provided.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 060F22A and 017H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Eczematous rash (A lot of eczema-type skin rashes sees a dermatologist regularly (3 to 4 times a year) starting in college;), Melanoma (had 3 melanomas), House dust mite allergy (allergies to dust mites), Allergy to molds (allergies to certain molds), Pollen allergy (allergies to certain pollens) and Polyps (couple polyps) since 2021. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for House dust mite allergy, Allergy to molds and Pollen allergy.   On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The suspect dosage text was reported as unknown. The patient had experienced just what he thought to be a normal reaction to a vaccine, sore arm and 24 hours after, he would have a headache (for only about half the time).  No treatment medication was reported.   This case was linked to MOD-2021-064473 (Patient Link).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruising not at the injection site in numerous different places. Looked similiar to warfarin bruises that people get
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Pt developed Guillain-Barre confirmed by neurology and treated with IVIG and Gabapenten 2 1/2 wks after the vaccine.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Injection site urticaria, Urticaria
Clinical narrative: After immunizations, Patient left clinic.  Before the family could leave the parking lot, he started coughing continuously.  Mother was able to get him to drink some water, which calmed his cough minimally.  However, in doing so, she noted a hive at his temple.  He came back into clinic where he was observed to have a small hive at the MMR injection site in addition to several small hives in various places on his body (left chest near his nipple, right medial thigh, back).  He was placed in a room, vitals were checked, and the provider was called into the room immediately.  He was then given 12.5mg of Benadryl and observed for 30 minutes.  His cough and hives resolved within in that time and he was allowed to leave clinic.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Intense itching and red spots on body, mainly on torso, back, neck and head lasting over 3 weeks Still dealing with the severe itching. Began within 24 hours of receiving the vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Drug ineffective; COVID 19; vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 at 12:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Oct2023 at 16:00 as dose number unknown, single), in right arm for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Oct2022 at 12:30, outcome "unknown", described as "vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech"; COVID-19 (medically significant) with onset Apr2024, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Apr2024 to 03May2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar level increased; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21May2024 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 22May2024, outcome "unknown", described as "Blood sugar level increased". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that she was administered with the vaccine Prevnar 20 on Tuesday at 02:00 in the afternoon, and after that she found on Wednesday night that her blood sugar level was very high on 243 units, when usually she is 100 units below that level. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Mar2024 as dose 1, single (Lot number: HN0478) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Known allergies was None. Other medical history: No chronic medical conditions diagnosed. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14May2024 to 19May2024. This case was reported as non-Serious.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event vaccination failure (COVID-19) with BNT162b2 omi xbb1.5 can not be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Positive, notes: tested positive again 7 days after 2 negative tests; (May2024) Negative; (May2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13May2024 to 18May2024. This case was reported as non-Serious. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment included Paxlovid from 15May2024 to 21May2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, stop date: 16May2024. Vaccination history included: BNT162b2 (Dose Number: 7, Location of injection: Arm Right), administration date: 03Oct2023, when the patient was 78-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 6, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 5, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 4, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 3, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid as event treatment from 18May2024 to 22May2024.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid from 17May2024 to 22May2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Menstrual disorder
Clinical narrative: Insomnia; Unusual menstrual cycle; This is a spontaneous report received from a Nurse.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine pfizer inc (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious), outcome "not recovered"; MENSTRUAL DISORDER (non-serious), outcome "not recovered", described as "Unusual menstrual cycle". Additional information: The patient claims to experience insomnia and unusual menstrual cycle after taking the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (COVID-19 VACCINE NOS 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: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath". The action taken for BNT162b2 was unknown.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait inability, Rheumatoid arthritis
Clinical narrative: he collapsed and admitted to hospital; could not walk; diagnosed with Rheumatoid Arthritis; This is a spontaneous report received from a Consumer or other non HCP.  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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: FALL (hospitalization), outcome "unknown", described as "he collapsed and admitted to hospital"; GAIT INABILITY (hospitalization), outcome "unknown", described as "could not walk"; RHEUMATOID ARTHRITIS (hospitalization), outcome "unknown", described as "diagnosed with Rheumatoid Arthritis". Clinical course: Patient had a family member who took 1st and 2nd dose. Then 1st booster, 2nd booster and after 3rd booster he collapsed and admitted to hospital could not walk and diagnosed with Rheumatoid arthritis. Never took another Booster again.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878801 same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Breakthrough COVID-19, Vaccination failure
Clinical narrative: vaccine failure; breakthrough COVID-19; This is a literature report for the following literature source(s).  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), 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; methotrexate sodium (METHOTREXATE SODIUM), for polychondritis; prednisone (PREDNISONE) for polychondritis; tocilizumab (TOCILIZUMAB) for polychondritis; cilgavimab;tixagevimab (CILGAVIMAB;TIXAGEVIMAB) at 300+300mg for covid-19 prophylaxis. The patient's relevant medical history included: "relapsing polychondritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "vaccine failure"; BREAKTHROUGH COVID-19 (medically significant), outcome "unknown". The action taken for methotrexate sodium, prednisone, tocilizumab and cilgavimab;tixagevimab was unknown. Clinical courses is as follows:  A 57-year-old woman with relapsing polychondritis had been receiving methotrexate, prednisone and tocilizumab.She had received 4 doses of tozinameran [BNT162b2] and pre-treatment with cilgavimab/tixagevimab 300+300mg for COVID-19 prophylaxis.However, she developed breakthrough COVID-19 despite prophylaxis with tozinameran and cilgavimab/tixagevimab indicating vaccine failure and lack of efficacy, respectively. It was reported that, her immunosuppression with methotrexate, prednisone and tocilizumab contributed to breakthrough COVID-19.  The reporter considered "vaccine failure" and "breakthrough covid-19" related to BNT162b2 and methotrexate sodium.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (breakthrough CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. The other suspect drugs [METHOTREXATE SODIUM (Pfizer drug); and [PREDNISONE, TOCILIZUMAB, and CILGAVIMAB; TIXAGEVIMAB (non-Pfizer drugs)] may have contributed to the failure in vaccination and development of breakthrough CoVID-19 infection by rendering the patient immunocompromised. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: PNC20
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: joint pain; stiffness that started in my knees and has spread most of my joints; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Sep2023 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: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "stiffness that started in my knees and has spread most of my joints". Additional information: the patient stated, "Hello! I am reaching out looking for guidance or a recommendation if you could point me toward where to get help. In September 2023 I got the Prevnar 20 pneumonia shot and began getting side effect in early October of joint pain and stiffness that started in my knees and has spread most of my joints. Not looking for anything other than guidance of what can be done to relieve the pain."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 0.17
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Ipol reached 34.3F for 21 mins due to a human error with no reported adverse event; Ipol was administered to the patient post excursion with no reported adverse event; Based on information received on 24-May-2024 case was upgraded from Non-valid case to Valid case.   Initial information was received on 22-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 9 weeks old female patient (4.1 cm and 30.345 kg) to whom IPV (VERO) [Ipol] that reached 34.3f for 21 mins due to a human error was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Mar-2024,  the suspect IPV (VERO) (Suspension for injection) reached 34.3f for 21 mins (minutes) due to a human error (product storage error) and after this time patient received 0.5 ml dose of Vaccine (lot W1C751M, expiry date:18-Nov-2025, strength: unknown) via intramuscular route in the left deltoid for prophylactic vaccination (Immunization) (poor quality product administered) (Latency: same day).  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.  Additional information was received on 24-May-2024: patient demographic, vaccination dosing details and route, anatomical location added. Text amended. Based on this information, the case initially considered as non-valid was upgraded to valid.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered after its expiration date with no adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] after its expiration date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and administered after its expiration date with no adverse event (expired product administered) (latency: same day). The information on batch number was requested.   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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/Lowest Temp reached: 10.76F -13hrs 50minutes for 10.69F - 8hrs 21 mins, with no reported adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old female patient who had received HIB (PRP/T) Vaccine [ACT-HIB] max/lowest temp reached: 10.76 Fahrenheit for 13 hours 50minutes for 10.69 Fahrenheit - 8hrs 21 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Apr-2024, the patient received a unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization. and max/lowest temp reached: 10.76f -13hrs 50minutes for 10.69f - 8hrs 21 mins, with no reported adverse event (poor quality product administered) (latency: same day). Information on the batch number was requested.   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: 35.0
Sex: F
Vaccine: IPV, TYP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered the typhim vi vaccine instead of ipol with no reported adverse event; Initial information received on 24-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 35 years old female patient was administered the TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] vaccine instead of IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 23-May-2024, the patient received a  dose of 0.5 ml of suspect TYPHOID VI POLYSACCHARIDE VACCINE  (Solution for injection) (lot W1A991M,Expiry date: 01-Jun-2025, strength was unknown) via intramuscular route in the left arm and dose of suspect IPV (VERO) (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (Immunization) and patient was administered the typhim vi vaccine instead of ipol with no reported adverse event (wrong product administered) (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.   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 and Regulatory Authority 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: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Metabolic function test, Rash, Rash pruritic, Urinary sediment
Clinical narrative: Symmetric bilateral pruritic rash involving upper extremities as well as back of neck, no other areas involved, no other associated symptoms.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: + LT ARM PAINFUL, REDNESS, ITCHINESS, AND FEELS HOT X 1 DAY.
Age: 29.0
Sex: F
Vaccine: COVID19, VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccines were given outside recommendation for expiration. Both Vaccines were expired by week and week and half.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Localized redness and swelling of right thigh at injection site of pneumococcal vaccine starting about 6 hours after immunization, along with immunization site pain and fussiness. Per mother, redness from injection site spread to involve "entire thigh" of infant. Dr. received a phone call at about 8:30 pm from mother with information. Mother reports temperature of infant 100.0 F. Mother was advised to give pt a dose of infant/children's Tylenol (2.5 mL) and apply a cool compress to the area. Mother called back about 30 min after medication and compress with resolution of symptoms and infant much more comfortable.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Echocardiogram abnormal, Ejection fraction
Clinical narrative: The Client was admitted to the Hospital for Myocarditis on 6/7/2021 and discharged on 6/10/2021. The Client was admitted to Hospital. Unknown if a VAERS form was completed in 2021. The Client was re-admitted on 5/26/2024 with Myocarditis. The Client did recover after the initial illness in 2021 and had been well until experiencing viral symptoms on 5/24/2024 of chills, HA, and weakness in the lower back, legs, and neck. This Client is an athlete and played in 2 soccer games on 5/25/2024. On 5/25/24 developed Chest Pain similar to pain in 2021.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment elevation, Headache, Illness, Muscular weakness, Myocarditis
Clinical narrative: The Client was admitted to the Hospital for Myocarditis on 6/7/2021 and discharged on 6/10/2021. The Client was admitted to Hospital. Unknown if a VAERS form was completed in 2021. The Client was re-admitted on 5/26/2024 with Myocarditis. The Client did recover after the initial illness in 2021 and had been well until experiencing viral symptoms on 5/24/2024 of chills, HA, and weakness in the lower back, legs, and neck. This Client is an athlete and played in 2 soccer games on 5/25/2024. On 5/25/24 developed Chest Pain similar to pain in 2021.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: The Client was admitted to the Hospital for Myocarditis on 6/7/2021 and discharged on 6/10/2021. The Client was admitted to Hospital. Unknown if a VAERS form was completed in 2021. The Client was re-admitted on 5/26/2024 with Myocarditis. The Client did recover after the initial illness in 2021 and had been well until experiencing viral symptoms on 5/24/2024 of chills, HA, and weakness in the lower back, legs, and neck. This Client is an athlete and played in 2 soccer games on 5/25/2024. On 5/25/24 developed Chest Pain similar to pain in 2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I was injured by the Pfizer covid vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Joint swelling, Muscle tightness, Pain in extremity
Clinical narrative: Patient had swelling in knee 2 days after and swelling went down to ankle, feet and toes, event lasted 11 days total
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient had swelling in knee 2 days after and swelling went down to ankle, feet and toes, event lasted 11 days total
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Patient had swelling in knee 2 days after and swelling went down to ankle, feet and toes, event lasted 11 days total
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HBP called to report that a 12-month-old received a GARDASIL 9 vaccine. No Symptoms have been reported. Permission to contact HCP was granted. Operator of device = HCP. No Additional AE/PQC.; HBP called to report that a 12-month-old received a GARDASIL 9 vaccine. No Symptoms have been reported. Permission to contact HCP was granted. Operator of device = HCP. No Additional AE/PQC.; This spontaneous report was received from an office manager concerning to a 12-month-old patient of unspecified gender.The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 10-APR-2024, the then 12-month-old patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #2014790, expiration date: 22-APR-2026, as prophylaxis , by a health care professional (strength, anatomical location, and route of administration were not provided)  (Inappropriate age at vaccine administration). No Symptoms have been reported.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Visual snow syndrome
Clinical narrative: SNOW VISION; AUTOIMMUNE PHENOMENON; This solicited report received from a patient via PPSCVM000196: Janssen Social Media Account concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylactic vaccination (dose series 1). No concomitant medications were reported.  On an unspecified date, the patient experienced snow vision, and autoimmune phenomenon. It was reported snow vision caused from vaccine induced autoimmune phenomenon has taken over 80 percent of patient's vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the snow vision and autoimmune phenomenon was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and snow vision, and autoimmune phenomenon was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Visual snow syndrome, Autoimmune disorder. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 22-MAY-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2024 The patient self-reported this case. The patient received Shingrix 2 doses back in 2018 and developed Shingles. This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.