chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "poliomyelitis osteopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Patient was received COVID 19 antiviral treatment with Paxlovid oral from 19Jul2023 to 24Jul2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Investigation
Clinical narrative: heart is messed up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart is messed up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266051 same patient/vaccine/event, different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got positive in COVID-19; he got positive in COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he got positive in COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he got positive in COVID19 and was told to quarantine. Clinical course: Caller asked if taking Plavix would help him because he got positive in COVID-19 and was told to quarantine. He mentioned that his friends said that medicine will help people who have been tested positive and have taken the Pfizer COVID-19 vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: first two doses given too close from each other with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Caregiver).  This case involves an unknown age and unknown gender patient who experienced first two doses given too close from each other with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   the patient had first two doses of Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection with unknown strength, batch number & expiry date via unknown route in unknown administration site given too close from each other the first one on 06/05 and the second dose on 06/29 for prophylactic vaccination (Immunisation) with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Information on batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient given a Menquadfi when he was due for a MenB vaccine. He had a Menquadfi on 06/14/2023, when a booster if needed is not recommended for 3 years. Extra dose given, we have been unable to reach patient to confirm if he had any complications from this extra dose and to notify him of this error.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: colleague developed slightly raise pink itchy area around the injection site
Age: 12.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Musculoskeletal stiffness, Syncope, Tremor
Clinical narrative: Covid vaccine administered on right deltoid at 3:03 pm. Tdap vaccine administered on left deltoid at 3:04 pm. Patient had a fainting episode at 3:05 pm, right after Tdap vaccine was administered. Patient began syncope episode and then became stiff and had a tremor episode lasting for about 30 seconds. Vital signs taken right away. Blood pressure 134/90, Heart rate: 104, Oxygen Saturation: 100%, Temperature: 99.2, Respirations 32.  Patient was examined by Dr. Blood pressure was taken again at 3:11 pm, reading 125/88, Heart rate: 82 Oxygen Saturation: 100%
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing of ears
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pateint received vaccine after BUD
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pateint received vaccine after BUD
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complication associated with device, Endometrial ablation, Heavy menstrual bleeding, Hysterectomy, Transfusion
Clinical narrative: After the covid vaccines I started heavy mentrual bleeding while having an IUD placed with no bleeding previously while the IUD was inserted.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: The patient received her HPV vaccine @1049 07/24/23. After a few minutes, the patient started to look mildly pale and started to feel dizzy. RN assisted the patient in lying down. The patient was alert and oriented, had no SOB, vitals stable, and was feeling better. The patient was wheeled to the car and discharged. The patient and mother were provided with information and signs and symptoms to bring to the emergency room.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: chronic on-and-off swelling and itching at both injection sites, persisting 2+ years after vaccine doses administered
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: there is no adverse event reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Slightly raised, slightly itchy red rash fading to tiny bumps on both sides of neck and left top of chest.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Patient had redness that was size of her palm which was warm to touch just below the shingles injection site. Reaction happened 1-2 days after the vaccine and rash lasted for 5 days
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022 FOR DOSE #3 PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 03/02/2023 FOR DOSE #2
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: inadvertent administration of only the diluent of Menveo to a patient; Only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) for prophylaxis.   On 21-JUL-2023, the patient received the 1st dose of Menveo. On 21-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertent administration of only the diluent of Menveo to a patient) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-Jul-2023 The health care professional (HCP) told that it had not been determined who was the patient that inadvertent received only the diluent. The nurse called to inform about the inadvertent administration of only the diluent of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The case is linked with US2023103563, by same reporter.; Sender's Comments:  US-GSK-US2023103563:Different patient, same reporter, same product
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: flu like symptoms; felt achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms) and pain (Verbatim: felt achy). The outcome of the influenza-like symptoms and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms and pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR103832   Additional Information: GSK receipt date: 28-JUL-2023 The reporter was the patient.  After the first dose, the patient felt achy, and experienced flu like symptoms (but did not remember having a fever). The reporter consented to follow up. For tolerance to the 2nd dose, refer case US2023AMR103832, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR103832:Case for 2nd dose
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Breakthrough Covid-19 Infection
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid-19 Infection
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Covid Breakthrough Infection
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid Breakthrough Infection
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Bradycardia, Hyperhidrosis, Syncope
Clinical narrative: Pt has an incident of syncope approx 5 mins after immunizations were given. B/p was 117/77 and pulse was 44 when pt returned to office. Pt give a granola bar and water. He hadn't eaten prior to the appointment. 2nd  B/P 105/73 pulse 46. Condition continued to improve. 20 minutes after incident  B/P was 100/65 and pulse was 51.  Pt left the dept. Ambulating without assistance
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Pt has an incident of syncope approx 5 mins after immunizations were given. B/p was 117/77 and pulse was 44 when pt returned to office. Pt give a granola bar and water. He hadn't eaten prior to the appointment. 2nd  B/P 105/73 pulse 46. Condition continued to improve. 20 minutes after incident  B/P was 100/65 and pulse was 51.  Pt left the dept. Ambulating without assistance
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Nausea/vomiting, lightheadedness, dizziness, tingling in limbs, muscle weakness, fatigue that began 24 hours after injection and continue 10 days later with no diagnosis
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: Nausea/vomiting, lightheadedness, dizziness, tingling in limbs, muscle weakness, fatigue that began 24 hours after injection and continue 10 days later with no diagnosis
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vomiting
Clinical narrative: Nausea/vomiting, lightheadedness, dizziness, tingling in limbs, muscle weakness, fatigue that began 24 hours after injection and continue 10 days later with no diagnosis
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reported VARIVAX was administered after a temperature excursion to patient. Date of administration: Jul 10, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VARIVA; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not provided.  On 10-JUL-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, once (lot# W034708 has been verified to be a valid lot number, expiration date reported as 02-NOV-2024, but upon internal validation established as 01-NOV-2024) administered for prophylaxis (strength, exact dose, anatomical location, and route of administration were not provided). The varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion under -13.4 degree Celsius for 15 minutes (Product storage error) with no previous temperature excursion. No further information provided. No additional adverse events (AEs) were reported, and no product quality complaints (PQCs) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report that a patient was administered a improperly stored vaccine.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 28-JUN-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number W035460, expiration date reported and validated as 06-MAY-2024) as prophylaxis (product storage error). No additional adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: Hard lump at the injection site; This spontaneous report has been received from a pharmacist via company representative regarding a 13-year-old male patient.  The patient's concurrent conditions, historical conditions, and concomitant therapies were not reported.  On an unspecified date (reported as several months ago), the patient received the first dose of HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL 2 or 3 dose series (patient route of administration, anatomical location, lot number and expiration date was not provided) as HPV prevention.   Later on an unspecified date after the patient's vaccination, he had a hard lump at the injection site (vaccination site mass). Later, the vaccination site had remained free for symptoms other than the hard bump experienced, and the patient had not had any other report of symptoms since the vaccine was administered; consequently on an unspecified date he recovered from the event vaccination site mass.  The causal relationship between the event and HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a possible temperature excursion on GARDASIL 9 that was then administered to a patient on 07/11/2023; This spontaneous report was received from a licensed practical nurse, referring to a 12-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W002614, expiration date reported and validated as 15-SEP-2024) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Vaccines experienced TE and then administered to a patient with no reports of side effects.; Vaccines experienced TE and then administered to a patient with no reports of side effects.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter.  On 24-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHa) lot # X007086, expiration date: 04-SEP-2024, administered for prophylaxis (strength, route, and site of administration were not provided). Temperature excursion and time frame were not specified by the reporter, and there was no report of side effects nor product quality complaint was involved.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2307USA011469:
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Vaccines experienced TE and then administered to a patient with no reports of side effects.; Vaccines experienced TE and then administered to a patient with no reports of side effects.; This spontaneous report was received from a medical assistant, referring to a patient of unspecified age and gender.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 24-JUL-2023, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) (involved lot # was X004814, expiration date: 10-OCT-2024); with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant Human albumin (rHa) (involved lot # was X012186, expiration date: 19-JUL-2024); and with varicella virus vaccine live (oka/merck) (VARIVAX) (involved lot # was X007372, expiration date: 12-MAR-2025) all administered for prophylaxis (strength, route, and site of administration were not provided). Temperature excursion and time frame were not specified by the reporter, and there was no report of side effects, nor product quality complaint was involved.   This is one of two reports from the same reporter.  ; Sender's Comments:  US-009507513-2307USA011441:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no side effects; VAQTA was administered after it experienced a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, administered for prophylaxis (lot #1971534, expiration date: 06-OCT-2024; strength, and route of administration were not provided) after the vaccine experienced a temperature excursion at 50 F for 1 hour 40 min (product storage error). There was no previous temperature excursion. No side effects were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no side effects; GARDASIL 9 was administered after it experienced a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (lot #W028573, expiration date: 06-JAN-2025; strength, and route of administration were not provided) after the vaccine experienced a temperature excursion at 50 F for 1 hour 40 min (product storage error). There was no previous temperature excursion. No side effects were reported.  This is one of several reports received from the same reporter.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a TE with PROQUAD; was administered outside of the indicated age range in the PI.; This spontaneous report was received from an office manager referring to a 18-year-old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       From 19-AUG-2022, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status recombinant Human albumin (rHA) lot # U039261 with expiration date 09-JUN-2023 underwent temperature excursion and was administered to the patient on 05-JAN-20213 at a dose of 0.5 mL for prophylaxis (strength, dose , route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. The temperature of exposure and the duration time of the temperature excursion were not reported.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Dysstasia, Limb discomfort, Pain in extremity
Clinical narrative: Vaccine name is in my records from the clinic, I don't the name with me, sorry. After I received the vaccine I went home and noticed my let arm was sore and heavy. The next day early in the morning I felt a strong pain on my right leg in the area below my butt sheek next to my hip. It was hard to get up to walk. So, I rested and used some Ice/Heat on the area. Today is Thursday I am still in pain, will be going to the ER tomorrow.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Influenza like illness, Pain
Clinical narrative: Patient complained of severe body aches; joint pains; flu-like symptoms; arthritis; Condition aggravated; This non-serious case was reported by a physician via sales rep and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 27-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Patient complained of severe body aches), joint pain (Verbatim: joint pains), influenza-like symptoms (Verbatim: flu-like symptoms), arthritis (Verbatim: arthritis) and condition aggravated (Verbatim: Condition aggravated). The outcome of the general body pain, influenza-like symptoms, arthritis and condition aggravated were not reported and the outcome of the joint pain was not resolved.   It was unknown if the reporter considered the general body pain, joint pain, influenza-like symptoms, arthritis and condition aggravated to be related to Shingrix.     It was unknown if the company considered the general body pain, joint pain, influenza-like symptoms, arthritis and condition aggravated to be related to Shingrix.   Additional Information: GSK Receipt date: 25-JUL-2023 The physician reported that a patient received only one shot of vaccine and no 2nd dose given. Patient complained of severe body aches, joint pains, flu-like symptoms that persisted for weeks to months per patient reporting.  Patient was afraid that the second dose of shingrix might "accelerate" her arthritis as her symptoms got worse after the first dose. Patient still had joint pains. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore arm for 3 days at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Sore arm for 3 days at the injection site). The outcome of the injection site pain was resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUL-2023 The case was received via interactive digital media. The reporter stated sore arm at the injection site for 3 days with no side effects.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE; Caller reported an AE for MMRII. The caller said an expired dose was administered on 7/28/2023 to a patient. Confirmed no other AE occurred and the product did not have any temperature excursions prior to administration. AE letter sent to provided. N; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 28-JUL-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) (lot # U022318, expiration date 15-JUL-2023; strength, frequency, and route were not reported) for prophylaxis. Confirmed no other adverse event (AE) occurred and the product did not have any temperature excursions prior to administration.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunodeficiency, Invasive lobular breast carcinoma
Clinical narrative: Immunocompromised; lobular carcinoma/breast cancer; This spontaneous case was reported by a patient and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) and INVASIVE LOBULAR BREAST CARCINOMA (lobular carcinoma/breast cancer) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received 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 IMMUNODEFICIENCY (Immunocompromised) (seriousness criteria medically significant and life threatening) and INVASIVE LOBULAR BREAST CARCINOMA (lobular carcinoma/breast cancer) (seriousness criteria medically significant and life threatening). At the time of the report, IMMUNODEFICIENCY (Immunocompromised) and INVASIVE LOBULAR BREAST CARCINOMA (lobular carcinoma/breast cancer) 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.   No concomitant medication was reported.  Patient reported the vaccination provider said that they should receive one more. Patient talked to pharmacist who stated they would not give another vaccine. No treatment information was reported.  Company comment- This spontaneous case concerns an elderly patient of unknown gender with no medical history reported, who experienced the unexpected serious (life threatening and medically significant) events immunodeficiency and invasive lobular breast carcinoma. Two doses of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine were administered. Latency unknown as the onset date of the events and vaccination dates were not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received expired first dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired first dose) and NO ADVERSE EVENT (No adverse event) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received expired first dose).    No concomitant medication was reported.  It was unknown when the vial was initially stored in refrigerator. It was unknown the vial undergo temperature excursions.  Expiration date was reported as 12-MAR-2023. No treatment information was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Major depression, Peroneal nerve palsy
Clinical narrative: Foot drop no treatment disappeared after 1 year Diagnosed with major depressive disorder treatment ongoing
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Bacteraemia, Sepsis
Clinical narrative: hospitalization - acute resp failure, sepsis secondary to bacteremia
Sex: M
Vaccine: COVID19
Symptoms: Myocardial injury
Clinical narrative: severe damage to his heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the parent.  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INJURY (death) with onset 17Feb2022, outcome "fatal", described as "severe damage to his heart". On 17Feb2022, reporter's son passed away in his sleep after receiving the 2nd dose of Covid vaccine, the vaccine did severe damage to his heart, he was forced to take the vaccine to keep his job. The patient date of death was 17Feb2022. Reported cause of death: "severe damage to his heart". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: severe damage to his heart
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details provided.; HCP called to report that a dose of PROQUAD was administered to a patient after a TE.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 08-JUN-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route and anatomical location of administration were not reported), in combination with a sterile diluent. The administered dose underwent a temperature excursion via data logger of 12.8 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported (product storage error).   No additional adverse effect was reported.   This case was determined to be non-valid due to the lack patient's identifiers.  This is one of three reports from the same reporter.  Follow-up information was received from the nurse on 25-JUL-2023.  The report concerns to a 4-year-old female patient.  The vaccine was administered subcutaneosly in the left thigh.   It was reported that on 22-MAY-2023, the vaccine freezer was open to allow for scraping ice from sides. The door was left open too long, temperature excursion occurred and was inaccurately reported to manufacturer. The temperature excursion did not occur as a result of a reading from a Data Logger (previously reported that temperature excursion was via Data Logger, conflicting information). The vaccine was administered by a heathcare professional and according to the instruction leaflet and it was not available for return/evaluation. On 11-JUL-2023, the vaccine was properly reported to manufacturer and seemed safe for use. The patient did not experience medical adverse events as a result of temperature excursion. The vaccine was no  longer in stock.; Sender's Comments:  US-009507513-2307USA002368: US-009507513-2307USA002433: US-009507513-2308USA001000:
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No event/No adverse effects; Indicate at which point in the process the medication error occurred? Storage in clinical practice/Temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a nurse, referring to a 11-year-old female patient. The patient's pertinent medical histories, drug reactions/allergies and concomitant medications were not reported.  On 14-JUN-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W011455, expiration date: 11-DEC-2024, administered for prophylaxis (strength and route of administration were not provided) that was improperly stored (product storage error). No additional adverse event was reported (no adverse event). ; Sender's Comments:  US-009507513-2306USA013096:
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No event/No adverse effects; Indicate at which point in the process the medication error occurred? Storage in clinical practice/Temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a nurse, referring to a 11-year-old female patient. The patient's pertinent medical histories, drug reactions/allergies and concomitant medications were not reported.  On 14-JUN-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W011455, expiration date: 11-DEC-2024, administered for prophylaxis (strength and route of administration were not provided) that was improperly stored (product storage error). No additional adverse event was reported (no adverse event). ; Sender's Comments:  US-009507513-2306USA013096:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report as received from a consumer referred to a patient of unknown age and gender.   On 22-JUN-2023, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (lot # 1968385, expiration date 22-MAY-2024), orally for prophylaxis (strength, frequency, and dose# were not provided) (improper storage of product in use). The vaccine underwent multiple temperature excursions since 20-JUN-2023 until 05-JUL-2023. There were no previous temperature excursions reported. No product quality complain (PQC) reported.  This is one of several cases received from the same reporter (cross-referenced with US-009507513-2307USA009292 and US-009507513-2307USA009675).; Sender's Comments:  US-009507513-2307USA009292: US-009507513-2307USA009675:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient's temperature was 99.9F; Patient has a loss of appetite; The lesion is warm and tender; The lesion is warm and tender; The patient has a large red lesion on the right thigh at the site of the injection; This spontaneous report has been received from a physician concerning a 4-year-old female patient.      The patient's concurrent conditions, medical history, concomitant therapies, and allergy/drug reactions were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccination scheme, dose/route/frequency of administration, lot number, and expiration date were not reported), as immunization against measles, mumps, rubella and varicella.  Over the past week (approximately on 18-JUL-2023), the patient started to experience adverse effects as a large red lesion on the right thigh at the site of the injection (injection site erythema). The patient's lesion was 7 cm in diameter, a bright red circle and it has been getting bigger over the past week (18-JUL-2023). Also, the patient had a loss of appetite (decreased appetite) and had no other systemic symptoms. The physician reported that the lesion was warm (injection site warmth) and tender (injection site pain). The physician also reported that the patient's temperature was 99.9-degree Fahrenheit (body temperature abnormal). It was reported that medical attention was sought for the patient. The outcome of the events was not reported.  The physician did not report a causality assessment between the events of injection site erythema, body temperature abnormal, injection site warmth, injection site pain, and decreased appetite and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune hepatitis
Clinical narrative: autoimmune hepatitis; This serious case was reported by a consumer via sales rep and described the occurrence of autoimmune hepatitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced autoimmune hepatitis (Verbatim: autoimmune hepatitis) (serious criteria GSK medically significant). The outcome of the autoimmune hepatitis was not reported.   It was unknown if the reporter considered the autoimmune hepatitis to be related to Shingrix.     It was unknown if the company considered the autoimmune hepatitis to be related to Shingrix.   Additional Information: GSK Receipt date: 30-JUL-2023 The reporter self-reported that she been diagnosed with autoimmune hepatitis after first dose of Shingrix and she did not receive second dose of Shingrix.  The reporter agreed to follow up from GSK.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scab, Vaccination failure
Clinical narrative: had the worst case of shingles ever/suspected vaccination failure; had the worst case of shingles ever; Pain; Scab; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the worst case of shingles ever/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the worst case of shingles ever), scab (Verbatim: Scab) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the scab was resolved (duration 21 days).   It was unknown if the reporter considered the vaccination failure, shingles, scab and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, scab and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-JUL-2023 This case was reported by patient via interactive digital media. The reporter reported that his/her mother got the vaccination and had the worst case of shingles ever. 21 days to scab over and ended up in ER twice because the pain was unbearable. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, both ears. Noticed symptom within 2-3 weeks of vaccine. Symptom has continued since then without abatement. Symptom was new/not experienced with any prior migraines or illnesses.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure
Clinical narrative: CHRONIC RESPIRATORY FAILURE
Age: 44.0
Sex: M
Vaccine: ANTH, UNK, UNK
Symptoms: Formication, Injection site paraesthesia, Paraesthesia
Clinical narrative: Right arm has near continuous tingling and crawling of my skin from injection site down to finger tips
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY
Age: 56.0
Sex: M
Vaccine: HEPA, MNQ, SMALLMNK
Symptoms: Dizziness, Malaise
Clinical narrative: Client came in and requested the 3 vaccines we were providing at the outreach: Menveo (MenACWY), Havrix (Hepatitis A), and Jynneos (MPox). After receiving the 3 vaccines, client went to the front waiting room and notified one of the staff that he was feeling lightheaded, dizzy, and unwell. Client was brought to an exam room, was laid down, assessed by staff, and provided an electrolyte beverage. Client notified staff that he had not eaten that day yet, and had taken a 5mg Valium before coming to the vaccination event. EMS was called and showed up to assess the client. After assessment, the client ended up being transported via EMS to hospital. Client was vaccinated at approximately 12:30pm. Client notified staff he was feeling unwell around 12:35pm. EMS was called at 1:23pm. EMS showed up at 1:30pm. Client's emergency contact was notified by staff at 1:41pm.
Age: 63.0
Sex: F
Vaccine: COVID19-2, PNC20, TDAP, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt was given an extra dose of Shingrix unknowingly,  they had previously received 2 doses of Shingrix, a few years ago.  symptoms or events unknown
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid Breakthrough Infection
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Client came in with siblings to get back to school immunizations with grandma. Grandma brought all 3 sibling backs, another nurse was in the room with me helping with vaccines.  Clients sister, who is 16 was suppose to get Bexsero not the 11 year old client. 11 year old client jumped on the bed,   Client was asked name and DOB, grandma confirmed. When nurse called for client, client jumped on the bed and nurse asked name again, client and grandma confirmed named (although, it was the wrong name) and nurse gave bexsero to wrong client. Client and grandma was notified that Bexsero was given to wrong client.  Clients grandma stated, they were not paying attention when nurse asked what the clients name was, and that its okay she received the Bexsero immunization early. Educated client that although she received the vaccine early, it is safe for ages 10 and up who are in the high risk or traveling. Educated client and grandma an adverse reactions to watch for. Client had no reactions to the vaccination during visit. A follow up will be made with the client. Dr. was notified about medication Error.