chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: I accidentally put it in an open freezer (no cover, broken) with 4 other vaccines for 3 hours; This non-serious case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: I accidentally put it in an open freezer (no cover, broken) with 4 other vaccines for 3 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-JUN-2024 This case was reported by patient itself. The patient purchased a Shingrix vaccine and accidentally put it in an open freezer (no cover, broken) with 4 other vaccines for 3 hours, which led to incorrect storage of drug. The patient asking question, was it still effective? Or should buy a new vaccine?
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: I'm weak today; legs feel really heavy; arm has been red; swollen arm; sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2024, the patient received the 2nd dose of Shingrix. On 10-JUN-2024, less than a week after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: arm has been red), swelling arm (Verbatim: swollen arm) and pain in arm (Verbatim: sore arm). On 14-JUN-2024, the patient experienced weakness (Verbatim: I'm weak today) and heaviness in leg (Verbatim: legs feel really heavy). The outcome of the weakness and heaviness in leg were not resolved and the outcome of the erythema of extremities, swelling arm and pain in arm were not reported.   It was unknown if the reporter considered the weakness, heaviness in leg, erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     It was unknown if the company considered the weakness, heaviness in leg, erythema of extremities, swelling arm and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2024 The patient self-reported this case for himself/herself. The patient took the Shingrix vaccine 5 days ago from the reporting and he/she was weak and legs feel really heavy on the day of reporting. The patient reported that on Monday arm had red and swollen and sore but this was new on the day of reporting. It was suggested to the patient that talk with doctor about the weakness, just in case it was not related to the vaccine. The patient had not talked to physician till the time of reporting.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEPA, HEPAB, HIBV, MENB, MNQ, RSV
Symptoms: Product storage error
Clinical narrative: temperature excursion of several vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, RSVPreF3 adjuvanted (Arexvy) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HAB (Twinrix) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient did not receive Menveo, Bexsero, Arexvy, Infanrix, Pediarix, Kinrix, Havrix, Twinrix and Hiberix. On 10-JUN-2024, an unknown time after receiving Menveo, Bexsero, Arexvy, Infanrix, Pediarix, Kinrix, Havrix, Twinrix and Hiberix, the patient experienced intercepted product storage error (Verbatim: temperature excursion of several vaccines). The outcome of the intercepted product storage error 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: 11-JUN-2024  A reporter reported to have a temperature excursion of several vaccines (Shingrix, Boostrix, Menveo 1 vial, Bexsero, Arexvy, Infanrix, Pediarix, Kinrix, Havrix, Twinrix and Hiberix), she said that the vaccines were between 34.4 to 34.6 degree Fahrenheit, from 07:41 pm to 08:41 pm of 10 June 2024 which led to Intercepted product storage error. This is 1 of 4 linked report, reported by same reporter.; Sender's Comments:  US-GSKCCFUS-Case-02031575_AE-112671: US-GSK-US2024072703:Same reporter US-GSK-US2024072700:Same reporter US-GSK-US2024072705:Same patient/Different suspect.
Sex: U
Vaccine: HIBV
Symptoms: Product complaint, Skin laceration, Syringe issue
Clinical narrative: hard plastic piece broke out and cut the person in the hand; syringe broke off; Product Complaint; This non-serious case was reported by a consumer via call center representative and described the occurrence of laceration of hand in a patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced laceration of hand (Verbatim: hard plastic piece broke out and cut the person in the hand), syringe broken (Verbatim: syringe broke off) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the laceration of hand was not reported and the outcome of the syringe broken and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of hand to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the laceration of hand to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.   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: 04-APR-2024 Pediatric immunization specialist from GlaxoSmithKline called to report that when a Hiberix vaccine was given the hard plastic piece broke out and cut the person in the hand which led to syringe broken and pharmaceutical product complaint. She did not have any information on the patient or the vaccine. The reporter is a GlaxoSmithKline Pediatric Immunization Specialist calling on behalf of a Physician's office Vaccine Coordinator who stated that an administrator in the office was administering a dose of Hiberix with the prefilled diluent, and a piece of the syringe broke off of the syringe that one uses to hold the syringe when pushing the plunger to administer the dose at the base of the syringe. The reporter stated that the Physician's office is not asking for replacement, as they administered the dose correctly, and the patient was fine. The suspect product was administered. The defect was discovered during administration. No demographics were provided for the administrator. The patient/child did receive the dose of Hiberix and was fine. No date was provided for this adverse event. No Lot/Expiry/NDC was provided.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injury associated with device, Syringe issue
Clinical narrative: landed on the ground with the needle still in the patient; Product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a female patient who received DTPa-HBV-IPV (Pediarix) (batch number 77j49, expiry date 09-FEB-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced accidental needle stick (Verbatim: landed on the ground with the needle still in the patient) and pharmaceutical product complaint (Verbatim: landed on the ground with the needle still in the patient). The outcome of the accidental needle stick was not reported and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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: 08-APR-2024 The Healthcare professional (HCP) stated that she was administering Pediarix to a patient. The HCP secured the plunger and primed the syringe. When she inserted the needle into the injection site and began to apply pressure to inject the medication the plunger fell out and landed on the ground with the needle still in the patient. When the reporter was questioned that what part of plunger was loose, the reporter stated ROD. The reporter stated that the defect was possibly related to the plunger rod or plunger stopper. The reporter stated that the plunger fall out completely during administration. The reporter confirmed that all operations were performed appropriately before defect was discovered. The pre-filled syringe was inverted (upside down) to prime the syringe. The reporter stated that the vaccine was not administered using this pre-filled syringe. Patient was vaccinated using another pre-filled syringe of Pediarix. The HCP preparing/administering vaccine was a experienced user. The component impacted was Plunger of pre-filled syringe of Pediarix. The suspect product was available.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Dtap to a 5 year-old patient; Boostrix instead of Dtap to a 5 year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number NL475, expiry date 08-AUG-2026) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Dtap to a 5 year-old patient) and inappropriate age at vaccine administration (Verbatim: Boostrix instead of Dtap to a 5 year-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 11-JUN-2024 The health care professional reported that the patient received Boostrix instead of Dtap to a 5 year-old patient, which led to wrong vaccine administered. The reporter was asked for guidance on this situation.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Administration at the incorrect age; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a child male patient who received DTPa-IPV (Kinrix) (batch number 34MS9, expiry date 13-FEB-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Administration at the incorrect age) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were 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: 14-JUN-2024 The nurse contacted GSK to report that they had been administering Kinrix as the first dose in the DTap-IPV vaccination series for children and wanted to know if what they were doing was correct, which led to inappropriate age at vaccine administration and inappropriate schedule at vaccine administration. They also stated during the phone call that some of the children were three to seven years of age but did not give specific information for any of the children. They mentioned that groups of male children received the dose and this case was filed for that collective group. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up. The case was linked with US2024066324, by same reporter.; Sender's Comments:  US-GSK-US2024066324:Same reporter
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Anisomastia, Breast swelling, Malaise, Mammogram normal, Ultrasound scan normal
Clinical narrative: she feels lousy; Breast softer/ Lop Sided; her left breast swelled up; This non-serious case was reported by a consumer via call center representative and described the occurrence of breast swelling in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 29-DEC-2023, the patient received Arexvy (left arm). On 30-DEC-2023, 1 days after receiving Arexvy, the patient experienced breast swelling (Verbatim: her left breast swelled up). On an unknown date, the patient experienced feeling bad (Verbatim: she feels lousy) and breast asymmetry (Verbatim: Breast softer/ Lop Sided). The outcome of the breast swelling, feeling bad and breast asymmetry were not resolved.   It was unknown if the reporter considered the breast swelling, feeling bad and breast asymmetry to be related to Arexvy.     It was unknown if the company considered the breast swelling, feeling bad and breast asymmetry to be related to Arexvy.   Additional Information: GSK receipt date: 17-JUN-2024 The reporter was a female patient that received the Arexvy vaccine and her left breast swelled up.  The patient also reported the left breast was softer than the right breast. The patient did go to two different Physicians and had a mammogram and a sonogram done with both, and neither physician could find anything there and they did not know why the patient was experiencing this adverse reaction.  The swelling and softness was still there today (on the day of reporting).  The patient said she felt lousy, because she could not close the top of her normal size 12 as a result of the lop sided size of her left breast. They have reported all that was provided about this adverse event. Consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: 4th dose; 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number K72R2, expiry date 24-JAN-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number KK3JM, expiry date 25-SEP-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10-JUL-2021, lot number and expiration date: unknown) and Shingrix (2nd dose received on 22-OCT-2021, lot number and expiration date: unknown).   On 16-MAR-2024, the patient received the 4th dose of Shingrix. On 22-OCT-2022, the patient received the 3rd dose of Shingrix. On 22-OCT-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose). On 16-MAR-2024, the patient experienced extra dose administered (Verbatim: 4th dose). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 17-JUN-2024 The patient already received four Shingrix doses and want to receive a 5th dose at the time of reporting. The patient received third and fourth dose of Shingrix, which led extra dose administered. The reporter mentioned he was not comfortable giving it, and there was no prescription from a physician for any additional doses, but patients just want to get a booster to be protected. The patient was not immunocompromised. The reporter consented to follow up. This case was linked with US2024075167 for same reporter.; Sender's Comments:  US-GSK-US2024075167:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: pediatric patient is overdue for the 3rd dose of Engerix-B, it's been 9 months since the last shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an specified number of patients who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (on an unknown date received 1st dose) and Engerix b (on an unknown date received 2nd dose).   On an unknown date, the patients did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: pediatric patient is overdue for the 3rd dose of Engerix-B, it's been 9 months since the last shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 12-JUN-2024  A pharmacist reported that a two patient was overdue for the 3rd dose of Engerix-B, it's been 9 months since the last shot. Till the time of reporting the patient had not received the second dose of Engerix B, which led to incomplete course of vaccination. The case US2024075151 was identified as duplicate of case US2024075146. All future correspondence would be added in case US2024075146, which stands as case of record for this patient and the case US2024075151 would be deleted.
Age: 1.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired Hiberix dose to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-month-old female patient who received Hib (Hiberix) (batch number EX777, expiry date 15-JUN-2024) for prophylaxis.   On 17-JUN-2024, the patient received the 1st dose of Hiberix. On 17-JUN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired Hiberix dose to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-JUN-2024 The nurse explained that they accidentally administered an expired Hiberix dose to a patient, which led to expired vaccine used. The reporter explained that this was the first Haemophilus influenzae type b vaccine for the patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: I was diagnosed with pericarditis and still having symptoms until now it's extremely painful to walk or sit; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PERICARDITIS (I was diagnosed with pericarditis and still having symptoms until now it's extremely painful to walk or sit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (I was diagnosed with pericarditis and still having symptoms until now it's extremely painful to walk or sit) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (I was diagnosed with pericarditis and still having symptoms until now it's extremely painful to walk or sit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications provided by the reporter.  Patient experienced pain in upper body and which was extreme, and patient used to lie in bed all the time.  It was reported that patient was struggled with adverse reaction from the Moderna COVID vaccine for more than 3 years.  No treatment medications provided by the reporter.  Company Comment:  This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) expected event of pericarditis. The event occurred on an unknown date after a dose of Moderna COVID-19 Vaccine (mRNA-1273). Dose number, date for vaccination and onset date were not provided, hence, latency could not be estimated. The patient reported that pain, which was extreme in the upper body, led the patient to stay in bed all time. The outcome of the event was reported not recovered. The benefit-risk relationship of Moderna COVID-19 Vaccine (mRNA-1273) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2024: Upon internal review on 21-Jun-2024, significant correction was performed to update suspect product coding from Spikevax NOS to Moderna COVID-19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Adrenergic syndrome, Loss of personal independence in daily activities, Tinnitus, Vestibular disorder
Clinical narrative: persistent tinnitus; residual vestibular dysfunction symptoms; severely impacting their daily activities; sympathetic hyperadrenergic symptoms; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (persistent tinnitus), VESTIBULAR DISORDER (residual vestibular dysfunction symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (severely impacting their daily activities) and ADRENERGIC SYNDROME (sympathetic hyperadrenergic symptoms) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (persistent tinnitus), VESTIBULAR DISORDER (residual vestibular dysfunction symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (severely impacting their daily activities) and ADRENERGIC SYNDROME (sympathetic hyperadrenergic symptoms). At the time of the report, TINNITUS (persistent tinnitus), VESTIBULAR DISORDER (residual vestibular dysfunction symptoms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (severely impacting their daily activities) and ADRENERGIC SYNDROME (sympathetic hyperadrenergic symptoms) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient has received the booster vaccine.  Patient could barely stand or do much of anything. Patient was profoundly affected by the effects. No treatment information was reported.
Age: 69.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid 20x150 mg &10 x 100 mg treatment received from 05Jun2024 to 10Jun2024, lot number 00069-5321-30).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 09Jun2024 to 13Jun2024.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "tobacco smoking" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of covid-19 and included treatment with PAXLOVID from 11Jun2024 to 16Jun2024.
Age: 37.0
Sex: F
Vaccine: 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 Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: CVS88600) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Pollen" (unspecified if ongoing); "dust" (unspecified if ongoing); "pets" (unspecified if ongoing); "mold" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN; LEXAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; N-ACETYLCYSTEINE; LIFE EXTENSION CLEARLY EPA/DHA FISH OIL; HYALURONIC ACID; RITUAL ESSENTIAL FOR WOMEN POSTNATAL. Past drug history included: Covid-19 vaccine for COVID-19 immunization, notes: DOSE 1; MANUFACTURER UNKNOWN; Covid-19 vaccine for COVID-19 immunization, notes: DOSE 2; MANUFACTURER UNKNOWN; Covid-19 vaccine for COVID-19 immunization, notes: DOSE 3, (BOOSTER); MANUFACTURER UNKNOWN; Covid-19 vaccine for COVID-19 immunization, notes: DOSE 4, (BOOSTER); MANUFACTURER UNKNOWN; Covid-19 vaccine for COVID-19 immunization, notes: DOSE 5, (BOOSTER); MANUFACTURER UNKNOWN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Return of symptoms and positive test after improvement of symptoms and testing negative.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "possible Afib" (unspecified if ongoing); "Drug allergy: Dilodad" (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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received COVID-19 Vaccine as "dose 2" on 11May2020 03:00 PM (as reported) and Pfizer / BioNTech vaccine as "dose 2" (as reported). Patient took Tylenol on 11Jun2024 to 15Jun2024, Paxlovid from 15Jun2024 to 19Jun2024.; Sender's Comments: A causal relationship to the suspect drug BNT162b2 (BNT162B2 NOS) cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: on behalf of a patient who was administered a dose of acthib that was reconstituted with sterile diluent instead of the saline that the vaccine comes with no reported adverse event; Initial information received on 18-Jun-2024 regarding an unsolicited valid non-serious case received from an other health professional. This case was a courtesy case received from  MERCK.  This case involves an unknown age and unknown gender patient where patient who was administered a dose of HIB (PRP/T) Vaccine [ACT-HIB] that was reconstituted with sterile diluent instead of the saline that the vaccine comes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot- UJ992AA and expiration date- 28-Feb-2025) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (product preparation error) (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.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion/Max/Low Temperature reached: 1.0 C or 34.3 F for less than an hour with no reported adverse event; vaccines were administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to 2024SA174753 (Master case)  This case involves a 11 years old female patient and it was reported Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] underwent temperature excursion/max/low temperature reached: 1.0 C or 34.3 F for less than an hour with no reported adverse event and vaccines were 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.  Concomitant medications included HPV vaccine VLP RL1 4V (YEAST) (Gardasil) for Immunisation; and Diphtheria vaccine Toxoid, Pertussis vaccine Acellular 5-Component, Tetanus vaccine toxoid (ADACEL) for Immunisation.  On 05-Jun-2024, the patient received 0.5 ml dose (frequency: once; strength: standard) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7945BB and expiry: 30-Mar-2026 via intramuscular route in the right arm for immunization.  On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine underwent temperature excursion/max/low temperature reached: 1.0 C or 34.3 F for less than an hour with no reported adverse event (product storage error) (unknown latency).  On 05-Jun-2024 the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine post excursion with no reported adverse event (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.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product container issue
Clinical narrative: ipol was soaked with the medication. there are no ice packs or anything the box vial was broken with no reported adverse event; Initial information received on 12-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient and reporter reported ipol was soaked with the medication. there were no ice packs or anything the box vial was broken with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-jun-2024, suspect IPV (VERO) Suspension for injection lot W1C741M expiry date- 17-Nov-2025 via unknown route in unknown administration site for immunization (strength, dose unknown) was soaked with the medication. there were no ice packs or anything the box vial was broken with no reported adverse (accidental exposure to product) (latency same day).  Reportedly, It came in a bigger box and when they took the smaller box inside, it was soaked with the medication. There were no ice packs or anything. When her co-worker opened the box, the glass/ vial was broken. She said that they never had an issue before.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient came in for the first dose, but missed their second dose, dose is a week late with no reported adverse event; Initial information received on 12-Jun-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender of patient who received Rabies (HDC) Vaccine [Imovax Rabies] came in for the first dose, but missed their second dose, dose is a week late 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 an unknown date, the patient received a dose 2 of suspect Rabies (HDC) Vaccine  (Powder and solvent for suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for pre-exposure (Immunization) and patient came in for the first dose, but missed their second dose, dose is a week late with no reported adverse event (inappropriate schedule of product administration) (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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered ipol that had expired previously with no reported adverse event; Initial information received on 12-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered IPV (VERO) [Ipol] that had expired previously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Jun-2024, the patient received suspect IPV (VERO) Suspension for injection expiry date- 01-Jun-2024 via unknown route in unknown administration site for immunization (strength, dose, batch number unknown), administered ipol that had expired previously with no reported adverse event (expired product administered) (latency same day). Information on batch number 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 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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB lyophilized vaccine was diluted with a Merck diluent accidentally, and it was given to a patient with no reported adverse event; Initial information received on 12-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] lyophilized which was diluted with a merck diluent accidentally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included pneumococcal vaccine for Immunisation.  On 11-Jun-2024, the patient received a standard dose of 0.5 ml total of suspect HIB (PRP/T) Vaccine lyophilized Powder and solvent for solution for injection (lot UJ975AC, Expiry: 31-Oct-2014) via unknown route in unknown administration site as Immunization which was diluted with a merck diluent accidentally with no reported adverse event (product preparation error) (latency: same day).   Reportedly, Treatment: No and no emergency room visit.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ipol was administered to a patient with no reported adverse event; Initial information received on 12-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age/gender patient who received expired IPV (VERO) [IPOL] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose of suspect IPV (VERO), Suspension for injection (dose, strength, lot and expiry date: unknown) (expired product administered) (latency same day) via unknown route in unknown administration site for prophylactic vaccination (immunization).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 5-month-old that received their PENTACEL dose too early described as the dose was due 6-weeks after getting the dose on 01May2024, but the consumer got the dose not on 15Jun2024 but on 08Jun2024 with no reported ae; Initial information received on 17-Jun-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old female patient who received her diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] dose too early described as the dose was due 6-weeks after getting the dose on 01-May-2024, but the consumer got the dose not on 15-Jun-2024 but on 08- Jun-2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) for and pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) both for Prophylactic vaccination.  On 01-May-2024, the patient received dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Powder and suspension for suspension for injection) (with an unknown lot number, dose, expiry date); then On 08-Jun-2024, the patient received the same vaccine (lot: UK015AA; expiry date: 31-May-2025; strength: standard; frequency: once) (dose 2 (0.5 ml)) too early described as the dose was due 6-weeks after getting the 1st dose, but the consumer got the dose not on 15-Jun-2024 (inappropriate schedule of product administration) (latency: same day) via unknown route in the left thigh for Immunization.  It was reported, "that they spoke with manufacturer and gave the dose at the original scheduled interval 1-week later"  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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no patients reported any adverse issues or side effects from the administrations; HCP calling back to provide patient information for Administered TE's that were previously reported on 5/28/2024; This spontaneous report was received from a Nurse and refers to an 1-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 26-MAY-2024, varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X023718, expiration date: 26-SEP-2025, and Lot # X026790, expiration date: 14-NOV-2025 (Both captured in MARRS case #2405USA009119), and Lot # X025342, expiration date: 12-MAY-2025 and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, Lot #: Y004543 expiration date: 19-AUG-2025 (captured in MARRS case # 2406USA005530) and Lot: Y002100 expiration date: 09-JUL-2025  (captured in MARRS case #2406USA005531 and 2406USA005535) underwent a temperature excursion (TE) at 0.1 C for a time frame of 4 hours and 30 minutes and 0 seconds.   On 28-MAY-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, Lot # X025342 (Lot # X025342 is an invalid for varicella virus vaccine live), expiration date reported as: 12-MAY-2025, (strength, exact dose and route of administration were not provided) administered for prophylaxis in combination with sterile diluent (exact dose, lot #, expiration date and route of administration were not provided). The patient was vaccinated prior to realizing the product had undergone a TE (Product storage error). There was not previous TE reported. The reporter state that no patient reported any adverse issues or side effects from the administration. No other information was able to be obtain during the call. No additional adverse event and no product quality complaint reported. No other information provided.  This is one of several reports that were received from the same reporter.; Sender's Comments:  US-009507513-2406USA005531:Original Case : 2405USA009119 US-009507513-2405USA009119:Original Case : 2405USA009119 US-009507513-2406USA005530:Original Case : 2405USA009119 US-009507513-2406USA005535:Original Case : 2405USA009119