chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Caller reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information.          ?    Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report was received by customer refers to a patient of unknown age and gender.    The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U031056, expiration date: 16-JUN-2024, (, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  Administered dose of vaccine experienced the temperature excursion of - 40.0 degrees Fahrenheit for 70 hours and 5 minutes. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA008279
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AR reported; third dose of GARDASIL 9 on Nov 4, 2022; Nurse stated that patient received the first dose of GARDASIL 9 on Aug 5, 2019, second dose of GARDASIL 9 on Sep 23, 2022 and third dose of GARDASIL 9 on Nov 4, 2022. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from Other Health Professional and refers to a female of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-AUG-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 23-SEP-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, second dose, lot #T036444, expiration date: 09-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). On 04-NOV-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, third dose, lot #T039466, expiration date: 20-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided).  On unknown date, nurse stated that patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 05-AUG-2019, second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 23-SEP-2022 and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 04-NOV-2022 (Inappropriate schedule of vaccine administered). No further information provided. No additional AE reported. No PQC reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant calling to report PROQUAD administered to patient after TE occurred.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.       On 22-MAY-2023 the patient was vaccinated with wrongly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W032152 and expiration date 07-APR-2024  for prophylaxis (exact dose and route of administration were not provided) (product storage error and no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; Caller reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information.          ?    Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report has been received from an administrator, 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 09-MAR-2023, the patient was vaccinated with an improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: U031056, which was determined to be valid as syringe, with an expiration date on 16-JUN-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of -40 degrees Fahrenheit (F), for 70 hours and 5 minutes. No previous temperature excursion was reported. No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist reported that an expired PNEUMOVAX 23 was administered to a patient.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report has been received form a pharmacist, 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 24-MAY-2023, the patient was vaccinated with an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX23) injection, as prophylaxis (lot number: U022984, which was determined to be valid as syringe, with an expiration date on 29-JAN-2023) (strength, dose, scheme, route and anatomical location of administration were not reported).  No additional adverse event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Thrombosis
Clinical narrative: Covid shot reaction and blood cloths in the leg; Covid shot reaction and blood cloths in the leg; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-23-0138818-SR-01, US-AMGEN-USASL2023086947.  This serious solicited report (USASL2023086947) was reported on 18/MAY/2023 by a consumer from a commercial program and involves a 83 year old female patient who experienced COVID shot reaction and blood cloths in the leg [PT: thrombosis, PT: immunisation reaction] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided.The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient had (Corona virus disease 2019) Covid shot reaction, blood clots in the leg and hospitalized. No treatment information was received. The outcome of the events thrombosis, immunisation reaction were reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events thrombosis and immunisation reaction. The causal relationship between the events thrombosis, immunisation reaction and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. No further information has been requested.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Company comment: This individual case report does not change the safety profile of the product. Causality Assessment to Enbrel: Thrombosis leg, Vaccination adverse reaction are unrelated to etanercept.  Enbrel is under agreement.; Sender's Comments: Based on the temporal association, a causal relationship between the events thrombosis, and immunisation reaction and Covid-19 Vaccine cannot be excluded. The events are assessed as unrelated to suspect drug etanercept. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: VARZOS
Symptoms: Pulmonary embolism, Syncope
Clinical narrative: Syncope; Pulmonary embolism; This serious case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant) and pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria GSK medically significant). The outcome of the syncope and pulmonary embolism were not reported.   It was unknown if the reporter considered the syncope and pulmonary embolism to be related to Shingrix.     It was unknown if the company considered the syncope and pulmonary embolism to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2023 The physician mentioned she had seen a patient who recently received a 2nd dose of Shingrix and the next day the patient experienced syncope and subsequently had a pulmonary embolism. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Rash vesicular
Clinical narrative: Persistent shingles-like rash; Periodic fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult male 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 vesicular rash (Verbatim: Persistent shingles-like rash) and fatigue (Verbatim: Periodic fatigue). The outcome of the vesicular rash and fatigue were not resolved.   It was unknown if the reporter considered the vesicular rash and fatigue to be related to Shingrix.  It was unknown if the company considered the vesicular rash and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The case was reported by patient. The patient received vaccine and had a small, but persistent shingles-like rash, as well has periodic fatigue. The duration was 3 weeks and continue at the time of reporting.  The patient was specifically looking to find out if these symptoms tend to be worse with second shot. The reporter was requested for consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: stomach feels a little upset; arm was sore with a patchy area on it; arm was sore with a patchy area on it; Diarrhea; cramps; vomiting; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance of 1st dose refer case, US2023AMR074135).   On 15-MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, less than a week after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), cramp (Verbatim: cramps), vomiting (Verbatim: vomiting) and nausea (Verbatim: nausea). On 17-MAY-2023, the patient experienced pain in arm (Verbatim: arm was sore with a patchy area on it) and patchy rash (Verbatim: arm was sore with a patchy area on it). On 22-MAY-2023, the patient experienced upset stomach (Verbatim: stomach feels a little upset). Rechallenge with Shingrix was positive. The outcome of the diarrhea, cramp, vomiting, nausea and upset stomach were unknown and the outcome of the pain in arm and patchy rash were not reported.   It was unknown if the reporter considered the diarrhea, cramp, vomiting, nausea, upset stomach, pain in arm and patchy rash to be related to Shingrix.  It was unknown if the company considered the diarrhea, cramp, vomiting, nausea, upset stomach, pain in arm and patchy rash to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR074135   Additional Information: GSK Receipt Date: 22-MAY-2023 The case was reported by the patient. The patient stated that on Wednesday her arm was sore with a patchy area on it. Then on Friday night into Saturday morning, she reported having diarrhea, cramps, nausea and vomiting. At the time of reporting, she reported her stomach felt a little upset.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR074135:Original Case : US2023072482
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge, Vomiting
Clinical narrative: stomach feels a little upset; arm was sore with a patchy area on it; arm was sore with a patchy area on it; Diarrhea; cramps; vomiting; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance of 1st dose refer case, US2023AMR074135).   On 15-MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, less than a week after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), cramp (Verbatim: cramps), vomiting (Verbatim: vomiting) and nausea (Verbatim: nausea). On 17-MAY-2023, the patient experienced pain in arm (Verbatim: arm was sore with a patchy area on it) and patchy rash (Verbatim: arm was sore with a patchy area on it). On 22-MAY-2023, the patient experienced upset stomach (Verbatim: stomach feels a little upset). Rechallenge with Shingrix was positive. The outcome of the diarrhea, cramp, vomiting, nausea and upset stomach were unknown and the outcome of the pain in arm and patchy rash were not reported.   It was unknown if the reporter considered the diarrhea, cramp, vomiting, nausea, upset stomach, pain in arm and patchy rash to be related to Shingrix.  It was unknown if the company considered the diarrhea, cramp, vomiting, nausea, upset stomach, pain in arm and patchy rash to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR074135   Additional Information: GSK Receipt Date: 22-MAY-2023 The case was reported by the patient. The patient stated that on Wednesday her arm was sore with a patchy area on it. Then on Friday night into Saturday morning, she reported having diarrhea, cramps, nausea and vomiting. At the time of reporting, she reported her stomach felt a little upset.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR074135:Original Case : US2023072482
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Medication error
Clinical narrative: Circumstance or information capable of leading to medication error; patient might receive a possible third dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose in March 2022, batch number:DE9LR) and Shingrix (received 1st dose in September 2021 and batch number:C54P9).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and extra dose administered (Verbatim: patient might receive a possible third dose). The outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter reported that a patient might receive a possible third dose of Shingrix.  The partial information about patient, vaccine and event was given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter reported that a patient might receive a possible third dose of Shingrix, which led to extra dose administered and circumstance or information capable of leading to medication error .
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Priorix in the freezer and it was exposed to -22.4 F and it was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 16-MAY-2023, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Priorix in the freezer and it was exposed to -22.4 F and it was administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The reporter stated that they stored Priorix in the freezer and it was exposed to -22.4 degree F and it was administered to a patient, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Inflammation at the injection site; Pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (right arm). In APR-2023, less than a day after receiving Shingrix, the patient experienced injection site inflammation (Verbatim: Inflammation at the injection site) and injection site pain (Verbatim: Pain at the injection site). The outcome of the injection site inflammation and injection site pain were not resolved.   It was unknown if the reporter considered the injection site inflammation and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site inflammation and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date:23-MAY-2023 The reporter reported that she received first dose of Shingrix vaccine a month ago (date not provided) in her right arm and since that day she had been experiencing pain at the injection site and something she describe as inflammation at the injection site. Symptoms persist until the day of reporting.  Adverse Event had been filed. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: HIBV, UNK
Symptoms: Accidental overdose
Clinical narrative: third dose of Hiberix and accidentally received a dose of Vaxelis; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 6-month-old male patient who received Hib (Hiberix) (batch number 4SM94, expiry date 18-APR-2024) for prophylaxis.   Co-suspect products included VAXELIS VACCINE for prophylaxis.   On 22-MAY-2023, the patient received the 3rd dose of Hiberix (left thigh) .5 ml and VAXELIS VACCINE .5 ml. On 22-MAY-2023, an unknown time after receiving Hiberix, the patient experienced accidental overdose (Verbatim: third dose of Hiberix and accidentally received a dose of Vaxelis). The outcome of the accidental overdose was unknown.   Additional Information: GSK Receipt Date:23-MAY-2023 The reporter was the medical assistant of practice who states a male patient was given third dose of Hiberix and accidentally received a dose of Vaxelis (non GSK vaccine that contains Haemophilus b) the same day, which led to accidental overdose for Haemophilus b antigen. Adverse Event had been filed. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA771A, expiry date 31-OCT-2024) for prophylaxis.   On 17-MAY-2023, the patient received Menveo. On 17-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) 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: 23-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter called to inform that only the diluent portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult male 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 pain in arm (Verbatim: Pain in arm). The outcome of the pain in arm was resolved with sequelae.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 23-May-2023 The reporter was medical doctor who informed GlaxoSmithKline Sales rep that one of his patients in his 50's had been with sequelae after received Shingrix vaccine 8 months ago. No other information provided. This agent tried to contact reporter by phone unsuccessfully. Consented to follow up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Nurse practitioner reporting an expired dose of Menveo was administered on 05/16/2023. Dose expired on 04/30/2023.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Nurse practitioner reporting an expired dose of Menveo was administered on 05/16/2023. Dose expired on 04/30/2023.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter reported that an expired dose of Menveo was administered, which led to expired vaccine used.
Age: 93.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: he feels lethargic; pain at the injection site; This non-serious case was reported by a dentist via call center representative and described the occurrence of injection site pain in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (the patient received first dose on an unknown date and had no pain or other effects after first dose).   On 22-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 22-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site). On 23-MAY-2023, the patient experienced lethargy (Verbatim: he feels lethargic). The outcome of the injection site pain and lethargy were not resolved.   It was unknown if the reporter considered the injection site pain and lethargy to be related to Shingrix.     It was unknown if the company considered the injection site pain and lethargy to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter was the patient who was a dentist.  The patient received second dose of Shingrix and experienced pain at the injection site that continues today and one day after vaccination the patient felt lethargic. Nothing else was reported. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inadvertently given only the liquid portion of the Menveo vaccine; Inadvertently given only the liquid portion of the Menveo vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA911A, expiry date 28-FEB-2025) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertently given only the liquid portion of the Menveo vaccine) and inappropriate dose of vaccine administered (Verbatim: Inadvertently given only the liquid portion of the Menveo vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 The reporter declines to provide initials and date of birth on call, stating that she was not sure she can give those details.  The reporter did consent to follow up. The reporter gave by error Menveo liquid portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administration of Kinrix After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received the 1st dose of Kinrix. On 22-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Administration of Kinrix After the Expiration Date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 24-MAY-2023 The reporter was a medical assistant. The reporter reported that the patient received an expired Kinrix vaccine. The reporter did not consent to follow-up. The patient received an expired dose of Kinrix vaccine, which led to expired vaccine used.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo that was reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate; Menveo administered reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA926A, expiry date 31-MAY-2024) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo that was reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate) and inappropriate dose of vaccine administered (Verbatim: Menveo administered reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 The reporter reported that at the time of reporting the Menveo vaccine dose was not repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Coma, Dysgraphia, Dysstasia, Fall, Gait disturbance
Clinical narrative: was unable to get up; Gillian Barre Syndrome; Drug induce coma; fell out of her car; she has difficulty writing; she has difficulty walking; numbness in left hand, then numbness in left leg and back; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received on unknown date).  In DEC-2022, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced coma (Verbatim: Drug induce coma) (serious criteria hospitalization and GSK medically significant) and fall (Verbatim: fell out of her car) (serious criteria hospitalization). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: Gillian Barre Syndrome) (serious criteria hospitalization and GSK medically significant), difficulty in standing (Verbatim: was unable to get up) (serious criteria hospitalization), writing impaired (Verbatim: she has difficulty writing), walking difficulty (Verbatim: she has difficulty walking) and hypoesthesia (Verbatim: numbness in left hand, then numbness in left leg and back). The outcome of the guillain barre syndrome, writing impaired, walking difficulty and hypoesthesia were resolving and the outcome of the coma, fall and difficulty in standing were not reported.  It was unknown if the reporter considered the guillain barre syndrome, coma, fall, difficulty in standing, writing impaired, walking difficulty and hypoesthesia to be related to Shingrix.  It was unknown if the company considered the guillain barre syndrome, coma, fall, difficulty in standing, writing impaired, walking difficulty and hypoesthesia to be related to Shingrix.  Additional Information: GSK receipt date: 23-MAY-2023 The reporter was the patient who stated that, she received second shot of Shingrix vaccine late December 2022, previously had received first shot but does not remember the date. Then the reporter had developed numbness in left hand, then numbness in left leg and back. One-day reporter fell out of her car and was unable to get up. She was then transported to the hospital where she was in a drug induce coma, this event was in March.  Then reporter was diagnosed with Gillian Barre Syndrome. The reporter also stated that, she had difficulty writing and walking. Right now (at the time of reporting), reporter was in a rehab facility and was learning how to walk again, she was getting better. Reporter does not remember the exact dates for all the events reported in this case.  The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: was unable to get up; Gillian Barre Syndrome; Drug induce coma; fell out of her car; she has difficulty writing; she has difficulty walking; numbness in left hand, then numbness in left leg and back; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received on unknown date).  In DEC-2022, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced coma (Verbatim: Drug induce coma) (serious criteria hospitalization and GSK medically significant) and fall (Verbatim: fell out of her car) (serious criteria hospitalization). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: Gillian Barre Syndrome) (serious criteria hospitalization and GSK medically significant), difficulty in standing (Verbatim: was unable to get up) (serious criteria hospitalization), writing impaired (Verbatim: she has difficulty writing), walking difficulty (Verbatim: she has difficulty walking) and hypoesthesia (Verbatim: numbness in left hand, then numbness in left leg and back). The outcome of the guillain barre syndrome, writing impaired, walking difficulty and hypoesthesia were resolving and the outcome of the coma, fall and difficulty in standing were not reported.  It was unknown if the reporter considered the guillain barre syndrome, coma, fall, difficulty in standing, writing impaired, walking difficulty and hypoesthesia to be related to Shingrix.  It was unknown if the company considered the guillain barre syndrome, coma, fall, difficulty in standing, writing impaired, walking difficulty and hypoesthesia to be related to Shingrix.  Additional Information: GSK receipt date: 23-MAY-2023 The reporter was the patient who stated that, she received second shot of Shingrix vaccine late December 2022, previously had received first shot but does not remember the date. Then the reporter had developed numbness in left hand, then numbness in left leg and back. One-day reporter fell out of her car and was unable to get up. She was then transported to the hospital where she was in a drug induce coma, this event was in March.  Then reporter was diagnosed with Gillian Barre Syndrome. The reporter also stated that, she had difficulty writing and walking. Right now (at the time of reporting), reporter was in a rehab facility and was learning how to walk again, she was getting better. Reporter does not remember the exact dates for all the events reported in this case.  The reporter had consented to follow-up.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose of Engerix B; adult patient received a pediatric dose of Engerix B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 24-year-old female patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 17-MAY-2023, the patient received the 1st dose of Engerix B pediatric. On 17-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received a pediatric dose of Engerix B) and adult use of a child product (Verbatim: adult patient received a pediatric dose of Engerix B). The outcome of the underdose and adult use of a child product 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: 24-May-2023 The reporter was medical assistant. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. An adult patient received a dose of Engerix-B pediatric, which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Body Aches; Rigors/chills; This non-serious case was reported by a nurse via sales rep and described the occurrence of general body pain in a 52-year-old 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, 24 hrs after receiving Shingrix, the patient experienced general body pain (Verbatim: Body Aches) and chills (Verbatim: Rigors/chills). The outcome of the general body pain and chills were unknown.   It was unknown if the reporter considered the general body pain and chills to be related to Shingrix.     It was unknown if the company considered the general body pain and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 and 24-MAY-2023 The patient about received 1st dose of Shingrix at the physician's office, given by another nurse employee.  The nurse stated that the patient experienced chills, rigors, and body aches which started about 24 hours after the vaccination. The only time frame provided was around the holidays in early December 2022, and it was not certain if this was the 1st or 2nd dose.  There were no other patient demographics.  The location of administration was not known for either dose.  The reporter did not have the lot number or expiry information. The reporter did consent to follow up. For tolerance to the 2nd dose refer case US2023AMR074160.; Sender's Comments:  US-GSK-US2023AMR074160:same reporter
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received only first dose/Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received first dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received only first dose/Longer than Recommended Interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-May-2023 The pharmacist would like to know if the patient would have to restart the series. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain at the injection site; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old 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 injection site pain (Verbatim: Pain at the injection site) and fever (Verbatim: Fever). The outcome of the injection site pain and fever were not reported.   It was unknown if the reporter considered the injection site pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023074573   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter was the twin sister of the patient. The reporter reported that the patient received Shingrix vaccine and experienced pain at the injection site and experienced fever from the vaccine but unknown after which dose. This case had been linked with US2023074573 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023074573:Same patient, 2nd dose
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Heart rate, Heart rate increased, Malaise
Clinical narrative: Did not feel well; Heart rate increased; Rhabdomyolysis; Feeling almost Fainting after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), PRESYNCOPE (Feeling almost Fainting after first vaccine) and HEART RATE INCREASED (Heart rate increased). On 23-Apr-2021, the patient experienced MALAISE (Did not feel well). At the time of the report, RHABDOMYOLYSIS (Rhabdomyolysis), PRESYNCOPE (Feeling almost Fainting after first vaccine), MALAISE (Did not feel well) and HEART RATE INCREASED (Heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Heart rate: 150. On 23-Apr-2021, Blood test: Normal. On 23-Apr-2021, Electrocardiogram: Normal. On 23-Apr-2021, X-ray: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-243078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Upon internal review on 26-May-2023 significant corrections performed to upgrade the seriousness to Medically Significant for the event of Rhabdomyolysis; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Rhabdomyolysis, X-ray
Clinical narrative: Did not feel well; Heart rate increased; Rhabdomyolysis; Feeling almost Fainting after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), PRESYNCOPE (Feeling almost Fainting after first vaccine) and HEART RATE INCREASED (Heart rate increased). On 23-Apr-2021, the patient experienced MALAISE (Did not feel well). At the time of the report, RHABDOMYOLYSIS (Rhabdomyolysis), PRESYNCOPE (Feeling almost Fainting after first vaccine), MALAISE (Did not feel well) and HEART RATE INCREASED (Heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Heart rate: 150. On 23-Apr-2021, Blood test: Normal. On 23-Apr-2021, Electrocardiogram: Normal. On 23-Apr-2021, X-ray: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-243078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Upon internal review on 26-May-2023 significant corrections performed to upgrade the seriousness to Medically Significant for the event of Rhabdomyolysis; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 9th patient of 24 patients reported by the reporter.  Concomitant medications were not reported.  The vaccination clinic received incorrect guidance from the DOH in regards to the vaccination, who instructed to order and administer the vials with pink top to patients. This resulted in 24 patients being undervaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were aged between 6 months to 5 years. The patients were being contacted and revaccinated with the correct dose.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case