chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Malaise
Clinical narrative: So reactive and this is kicking my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included shingles (had a mild first outbreak 15 to 20 years back). Previously administered products included covid shot (dose received on an unknown date and reacting with each covid shot) and bivalent vaccine (dose received on an unknown date and reacting with the bi-valent one).   On 14-MAR-2023, the patient received Shingles vaccine and Flu vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine and Flu vaccine, the patient experienced malaise (Verbatim: So reactive and this is kicking my butt). The outcome of the malaise was not resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine and Flu vaccine.     It was unknown if the company considered the malaise to be related to Shingles vaccine and Flu vaccine.   Additional Information: GSK Receipt date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a mild first outbreak 15 to 20 years back.  The patient went to the doctor and now it was time for the new vaccine of two shots 2 to 6 months apart. after reacting with each covid shot and the bi-valent one, went to then get a flu shot and yesterday his/her first of the newer shingles one.  The patient having reactions the past couple years helps me cope. The patient so reactive and this one we kicking his/ her butt. still at 70, very happy to have done it. Too many stories about shingles that were awful. patient read and read and read science and testimonials.  The patient was glad he/she did. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot hurts like hail; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot hurts like hail). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient received shingles shot hurts like hail The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body pain; Headache; Fever; Chills; Mild nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included pain (patient had severe pain from other medical conditions).  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Body pain), headache (Verbatim: Headache), fever (Verbatim: Fever), chills (Verbatim: Chills) and nausea (Verbatim: Mild nausea). The patient was treated with paracetamol (Tylenol) and mylanta (nos) (Mylanta). The outcome of the general body pain and headache were resolved and the outcome of the fever, chills and nausea were not reported.  It was unknown if the reporter considered the general body pain, headache, fever, chills and nausea to be related to Shingles vaccine.  It was unknown if the company considered the general body pain, headache, fever, chills and nausea to be related to Shingles vaccine.  Additional Information: GSK receipt date 31-MAR-2023 This case was reported by the patient via interactive digital media.  He/She was under the weather for a few days and had body pain, headaches.  The reporter stated that, he/she would rather be uncomfortable for a few days, than have shingles.  He/she had experienced more severe pain from other medical conditions and would get the 2nd shot in 4 months.  The reporter had stated that, yes, as a matter of fact he/she did get fever and chills and mild nausea and had taken some Tylenol and Mylanta. The reporter had asked that, just do it and get it behind you.  Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Tiny soreness at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Tiny soreness at injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050560   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient got both shots and had absolutely no side effects at all, may be some tiny soreness at injection site, perfectly fine. The patient would be 70 this year, and had chicken pox as a child. The follow-up could not be possible as no contact details were available. Note: As in narrative it was not clear after which dose event occur hence only one case retain without dose number.; Sender's Comments:  US-GSK-US2023AMR050560:Same patient (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms last two days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms last two days). The outcome of the influenza-like symptoms was resolved (duration 2 days).   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got the booster, and flu like systems last two days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050636   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient haven't gotten shingles yet but had the vaccines last fall. The patient first shot was a bitch, more painful than any flu shot. Must have had the consistency of maple syrup. The booster not nearly as bad, but the condition was worse, her/his sister had it a couple of times. The follow-up could not be possible as no contact details were available. For tolerance to the Flu shot case refer FR2023007617.; Sender's Comments:  US-GSK-US2023AMR050636:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st in 2019, never got the 2nd; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st in 2019, never got the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-APR-2023 The patient never got the second Shingles shot. The patient asked what to do now? Till the time of reporting, the patient did not receive 2nd dose of Shingles shot, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is so sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-MAR-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm is so sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient interactive digital media. The patient got the Shingles shot one day before reporting. The patient's arm was so sore but it was worth it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Feel like flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: Feel like flu). The outcome of the influenza like illness was resolved (duration 3 days).   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the second dose of Shingles vaccine really made him or her feel like flu for three days. The patient stated that he or she was glad as he or she was now safe though. Follow-up would not possible as no contact details were available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Shingrix administered; 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 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 74FB9, expiry date 17-MAR-2023) for prophylaxis.   On 22-MAR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 22-MAR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Shingrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 27-MAR-2023 The reporter consented to follow up.  The patient was administered with an expired Shingrix vaccine inadvertently, which led to expired vaccine used. This case was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023046091:Same reporter US-GSK-US2023046092:Same reporter
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This non-serious case was reported by a physician via call center representative and described the occurrence of allergic reaction in a female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Menveo (had a dose in 2017 and tolerated it).   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced allergic reaction (Verbatim: Allergic reaction). The outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Havrix.     It was unknown if the company considered the allergic reaction to be related to Havrix.   Linked case(s) involving the same patient:  US2023AMR046638   Additional Information: GSK receipt date: 27-MAR-2023 The reporter was an allergist. The reporter reported that a patient who had an allergic reaction to Havrix in 2020 and was due for a Menveo booster in 2023.  The reporter enquired about any contraindication to having Menveo because of the reaction to Havrix, similar components and the ingredients of each vaccine. The follow up would not be possible as no contact details were provided. This case was linked with US2023AMR046638 reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR046638:Same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Incomplete course of vaccination, Injection site pain, Pyrexia
Clinical narrative: 1st dose in 2019, never completed the series; Pain at the injection site; Chills; Fever; bad headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30-OCT-2019, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 30-OCT-2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site), chills (Verbatim: Chills), fever (Verbatim: Fever) and headache (Verbatim: bad headaches). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, never completed the series). On 31-OCT-2019, the outcome of the injection site pain, chills, fever and headache were resolved (duration 1 day). The outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, chills, fever and headache to be related to Shingrix.   Additional Information: GSK receipt date: 28-Mar-2023  This case was self-reported by the patient. The patient started with bad headaches on day of vaccination, and then the following day had fever, chills and pain at the injection site.  The next day, all the symptoms were disappeared.  The patient never completed the vaccination series. Details were reported for 1st dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 2-yerar-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 28-MAR-2023, the patient received Kinrix. On 28-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 2-yerar-old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Mar-2023  The reporter was the patient. The medical assistant called to inquire what to look for with this patient. The medical assistant reported they inadvertently administered a Kinrix (prefilled) dose to a 2-year-old patient on the day of reporting.  The healthcare professional mentioned administered in their facility a few minutes ago. The reporter did not consent to follow up. The 2 year old patient inadvertently received Kinrix (prefilled) dose which led to inappropriate age at vaccine administration.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Diagnosed with shingles; Red itchy bumps on back; Red itchy bumps on back; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2023, the patient received the 1st dose of Shingrix (left arm). In FEB-2023, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Diagnosed with shingles), itchy rash (Verbatim: Red itchy bumps on back) and papular rash (Verbatim: Red itchy bumps on back). The outcome of the shingles, itchy rash and papular rash were not resolved.   It was unknown if the reporter considered the shingles, itchy rash and papular rash to be related to Shingrix.     It was unknown if the company considered the shingles, itchy rash and papular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The reporter was the patient. The patient reported that she got her first dose of Shingrix vaccine and that about 3 days later she got some red, itchy bumps on the left side of her back.  She went to the physician and it was diagnosed as Shingles.   The bumps were still present.   She did not have any further information about the vaccine. The reporter did not consented to followup.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Ocular discomfort
Clinical narrative: Pressure behind right eye; Right eye swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensation of pressure in eye in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 2nd dose of Shingrix. On 06-MAR-2023, 3 days after receiving Shingrix, the patient experienced sensation of pressure in eye (Verbatim: Pressure behind right eye) and eye swelling (Verbatim: Right eye swelling). The outcome of the sensation of pressure in eye and eye swelling were not resolved.   It was unknown if the reporter considered the sensation of pressure in eye and eye swelling to be related to Shingrix.     It was unknown if the company considered the sensation of pressure in eye and eye swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The reporter was the patient who received his second dose of Shingrix and stated that he experienced pressure behind his right eye and swelling of his right eye.  Symptoms had not resolved, and he had been going to an ophthalmologist. The reporter did not consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vx not  mixed with conjugate; Vx not  mixed with conjugate; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a child female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vx not  mixed with conjugate) and inappropriate dose of vaccine administered (Verbatim: Vx not  mixed with conjugate). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-MAR-2023 The Nurse practitioner (NP) reported a dose of Menveo was administered to a patient after it was mixed with something other than the liquid conjugate portion of Menveo. The reporter consented to follow up via email or mail - address and email provided were in HCP details. The patient received Menveo after it was mixed with something other than the liquid conjugate portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2 YO received Kinrix; Kinrix dose was this patient's fourth DTaP dose and third IPV dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included DTap (last DTap dose 1 year ago) and IPV (IPV dose was 2 years ago).   On 28-MAR-2023, the patient received Kinrix. On 28-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 YO received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix dose was this patient's fourth DTaP dose and third IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 29-MAR-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up, though did not wish to provide last name and did not have an email address to provide. The reporter consented to follow up. The patient received a dose of Kinrix as fourth DTaP dose and third IPV dose at inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-JUN-2022, the patient received the 1st dose of Shingrix. On 01-DEC-2022, 169 days after receiving Shingrix, the patient experienced shingles (Verbatim: developed shingles). The outcome of the shingles was resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 29-Mar-2023 The reporter reported that the patient received dose of Shingrix, and developed shingles.  The reporter said Shingles was still present but nearing the end in the patient.  The reporter did not have the lot number/ expiration date information for the Shingrix dose.  At the time of reporting, a second dose was not administered.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023047399:Same reporter/different patient
Sex: U
Vaccine: MENB
Symptoms: Product prescribing error
Clinical narrative: Bexsero prescribed to a 61-year-old; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug prescribing error in a 61-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug prescribing error (Verbatim: Bexsero prescribed to a 61-year-old). The outcome of the drug prescribing 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: 30-Mar-2023 The sales representative reported on behalf of a nurse.  This was reported to first line specialist, no further details was provided, second line specialist forwarding details to safety per case notes. Callback attempt was made to nurse but she did not answer.  No further details were available. A patient without a spleen was prescribed Bexsero, which led to drug prescribing error.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Tremor
Clinical narrative: Not received the 2nd dose; Uncontrollable shaken; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tremor in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In FEB-2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor (Verbatim: Uncontrollable shaken). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Not received the 2nd dose). The outcome of the tremor was resolved (duration 1 hr) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the tremor to be related to Shingrix.     It was unknown if the company considered the tremor to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAR-2023 and 31-MAR-2023 The reporter states that the patient visited pharmacy today (day of reporting) and reported that after he received Shingrix vaccine and had uncontrollable shaken. HCP (healthcare professional) reported that patient had not received the 2nd dose until additional information was gathered due to initial AE (adverse events) reaction of uncontrollable shaking, pharmacist did not provide any information for the patient's reaction augmented. The reporter did not consent to follow-up.  Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was identified as duplicate of US2023048514. Case US2023048514 was deleted, and all the future correspondence will be added in the present case which stands as case of record for this subject.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Given Vx exposed for 1 week at 78°F; This non-serious case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a elderly 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 incorrect storage of drug (Verbatim: Given Vx exposed for 1 week at 78°F). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Mar-2023 The patient's daughter reported that the patient was given the Shingrix vaccination after the medication set out on a countertop for 1 week in a house that was 78 degree fahrenheit.   The reporter stated that the patient lives in an independent care setting with nursing services provided once weekly.   The reporter stated that the Shingrix was delivered to the home in a cold pack.   The patient removed the medication from the cold pack and set it on the countertop.   A nurse practitioner came to the home one week later and administered the vaccine (product storage error).   No further information was available. The phone number belongs to the reporter, as she did not want to give her phone number out of fear that GlaxoSmithKline may try to call the patient, report was made, was not on the call at the time.  The reporter did not want to give her address. The reporter consented to follow-up. The consent was asked but the reporter did not have the information for the physician. The patient received a dose of Shingrix after temperature exposure, which led to incorrect storage of drug.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Chest pain, Pain, Rash pruritic
Clinical narrative: Looks like chicken pox; Very itchy scabs on arms; Sores on arms; Chest and back burn sensation; Back pain; Chest pain/ Chest burning; Pain sensation; Very itchy rash on arms; This non-serious case was reported by a other health professional via call center representative and described the occurrence of chickenpox in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.  On 07-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than a month after receiving Shingrix, the patient experienced chickenpox (Verbatim: Looks like chicken pox), scab (Verbatim: Very itchy scabs on arms), ulcer of upper extremity (Verbatim: Sores on arms), burning sensation (Verbatim: Chest and back burn sensation), back pain (Verbatim: Back pain), chest pain (Verbatim: Chest pain/ Chest burning), pain (Verbatim: Pain sensation) and itchy rash (Verbatim: Very itchy rash on arms). The outcome of the chickenpox, back pain and chest pain were not reported and the outcome of the scab, ulcer of upper extremity, burning sensation, pain and itchy rash were unknown.  It was unknown if the reporter considered the chickenpox, scab, ulcer of upper extremity, burning sensation, back pain, chest pain, pain and itchy rash to be related to Shingrix.  It was unknown if the company considered the chickenpox, scab, ulcer of upper extremity, burning sensation, back pain, chest pain, pain and itchy rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 31-MAR-2023 The reporter was a Medical Assistant. The patient was not immunocompromised. He had reached to the Healthcare Professional (HCP) office the morning of the reporting and reported very itchy rash scabs, sores, on arms, chest and back burn and it pain sensation.  The HCP stated that, this had looked like kind of chicken pox. The reporter had consented to follow-up via email.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Skin ulcer, Varicella
Clinical narrative: Looks like chicken pox; Very itchy scabs on arms; Sores on arms; Chest and back burn sensation; Back pain; Chest pain/ Chest burning; Pain sensation; Very itchy rash on arms; This non-serious case was reported by a other health professional via call center representative and described the occurrence of chickenpox in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.  On 07-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than a month after receiving Shingrix, the patient experienced chickenpox (Verbatim: Looks like chicken pox), scab (Verbatim: Very itchy scabs on arms), ulcer of upper extremity (Verbatim: Sores on arms), burning sensation (Verbatim: Chest and back burn sensation), back pain (Verbatim: Back pain), chest pain (Verbatim: Chest pain/ Chest burning), pain (Verbatim: Pain sensation) and itchy rash (Verbatim: Very itchy rash on arms). The outcome of the chickenpox, back pain and chest pain were not reported and the outcome of the scab, ulcer of upper extremity, burning sensation, pain and itchy rash were unknown.  It was unknown if the reporter considered the chickenpox, scab, ulcer of upper extremity, burning sensation, back pain, chest pain, pain and itchy rash to be related to Shingrix.  It was unknown if the company considered the chickenpox, scab, ulcer of upper extremity, burning sensation, back pain, chest pain, pain and itchy rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 31-MAR-2023 The reporter was a Medical Assistant. The patient was not immunocompromised. He had reached to the Healthcare Professional (HCP) office the morning of the reporting and reported very itchy rash scabs, sores, on arms, chest and back burn and it pain sensation.  The HCP stated that, this had looked like kind of chicken pox. The reporter had consented to follow-up via email.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pediarix given instead of Infanrix; This is extra, 5th dose of HEP B; 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 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number GT39Z, expiry date 03-DEC-2024) for prophylaxis.   Previously administered products included Hepatitis B (received 4 doses of Hepatitis B on an unknown date) and IPV vaccine (received 3 doses IPV vaccine on an unknown date).   On 31-MAR-2023, the patient received Pediarix. On 31-MAR-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix given instead of Infanrix) and extra dose administered (Verbatim: This is extra, 5th dose of HEP B). The outcome of the wrong vaccine administered and extra dose administered 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: 31-Mar-2023  CMA stated that patient received dose of Pediarix instead of Infanrix.  The patient received 4 Hepatitis B and 3 Polios, so this was extra (4th dose of IPV and 5th dose of Hepatitis B).  This was supposed to be the patient's 4th dose of Infanrix.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient received dose of Pediarix instead of Infanrix, which led to wrong vaccine administered, extra dose administered for the hepatitis B component.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: When attempting to withdraw and the suspension leaked; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique 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 inappropriate reconstitution technique (Verbatim: When attempting to withdraw and the suspension leaked). The outcome of the inappropriate reconstitution technique was unknown.   Additional Information: GSK Receipt Date: 31-MAR-2023 HCP (healthcare professional) stated that no air was injected into the Shingrix adjuvant suspension vial while attempted to withdraw but the suspension leaked only onto the countertop, not on her hands, which led to Inappropriate reconstitution technique. HCP stated that she believes that the needle was not securely fastened to the syringe.  The reporter consented to follow up.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 30-year-old male patient who received HBV (Engerix B pediatric) (batch number 97KT7, expiry date 15-MAR-2024) for prophylaxis.   On 30-SEP-2022, the patient received the 2nd dose of Engerix B pediatric. On 30-SEP-2022, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to an adult) and adult use of a child product (Verbatim: Pediatric dose given to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt date: 31-MAR-2023 The pharmacist reported that, an adult patient that was supposed to receive the 2nd dose of Engerix-B was administered a pediatric dose which led to underdose and adult use of a child product. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 0.25
Sex: F
Vaccine: RV1
Symptoms: Product preparation issue, Underdose
Clinical narrative: He did not shake the diluent very well prior to transferring diluent into the vial/still some white substance left on the side of the syringe; Some white substance left on the side of the syringe; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate reconstitution technique in a 3-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 47Y9A, expiry date 17-FEB-2025) for prophylaxis.  On 01-FEB-2023, the patient received the 1st dose of Rotarix lyophilized formulation. On 01-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate reconstitution technique (Verbatim: He did not shake the diluent very well prior to transferring diluent into the vial/still some white substance left on the side of the syringe) and underdose (Verbatim: Some white substance left on the side of the syringe). The outcome of the inappropriate reconstitution technique and underdose 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: 31-MAR-2023 Physician stated that, he had administered a dose of Rotarix to an infant patient, and at the time of reporting, he was questioning about the efficacy of this dose. He stated that, he did not shake the diluent very well prior to transferring diluent into the vial and so there was still some white substance left on the side of the syringe.  He saw the patient again on 31 March 2023 and had administered a properly reconstituted second dose.  The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up. At the time of reporting, the physician did not had shaken the diluent very well prior to transferring diluent into the vial, which had led to Inappropriate reconstitution technique and underdose.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, No adverse event, Regurgitation
Clinical narrative: Dose spit out by the patient; Dose spit out by the patient; This non-serious case was reported by a physician via sales rep and described the occurrence of regurgitation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 31-MAR-2023, the patient received Rotarix lyophilized formulation (oral). On 31-MAR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Dose spit out by the patient) and accidental underdose (Verbatim: Dose spit out by the patient). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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:31-MAR-2023 The sales representative submitted for possible dose of Rotarix that was spit out by the patient, which led to accidental underdose.  No additional adverse event details were available. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose administered to pediatric patient; 13yo received adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Havrix 1440 adult. On 29-MAR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Adult dose administered to pediatric patient) and adult product administered to child (Verbatim: 13yo received adult dose). The outcome of the overdose and adult product administered to child 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: 31-MAR-2023 The reporter was a medical assistant. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The pediatric patient was accidentally administered with Havrix 1440 adult vaccine, which led to accidental overdose and adult product administered to child. The case is linked with case US2023048545, reported by same reporter.; Sender's Comments:  US-GSK-US2023048545:Same report/other patient
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Death
Clinical narrative: DIED; SEVERE MEDICAL ISSUES; This spontaneous report received from a consumer via social media (RA) concerned multiple (unspecified numbers) patients of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced severe medical issues. On an unspecified date, the patients died from an unknown cause of death. It was unspecified if an autopsy was performed. It was reported as "I have friends-family members died and have severe medical issues from this Vaccine" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe medical issues was not reported. This report was serious (Death).; Sender's Comments: V0: 20230412578- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Muscle spasms
Clinical narrative: CRAMPS IN LEGS AND TOE / CRAMPS EVERY NOW AND AGAIN EVERYWHERE; SEVERE ABDOMEN / STOMACH CRAMPS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 230 pounds, and height was 73 inches. The patient's concurrent conditions included: grass molds allergy (grass molds in the springtime some allergy symptoms. fall is worse with taking meds), alcohol use (0.5 in a week), and non-smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient never had cramps issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 16:51 for covid-19 prophylaxis. Age at time of vaccination 54 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced cramps in legs and toe / cramps every now and again everywhere, and severe abdomen / stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramps in legs and toe / cramps every now and again everywhere, and severe abdomen / stomach cramps. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23).    No concomitant information was reported. No treatment information was provided.