chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Post herpetic neuralgia, Therapeutic response unexpected, Vaccination failure
Clinical narrative: Re-emergence of PHN/suspected vaccination failure; Re-emergence of PHN; burning sensation on his back; No longer experienced post-herpetic neuralgia; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles around 2010). Previously administered products included Acyclovir (had PHN 8 years before receiving the first dose of the Shingrix vaccine). Concurrent medical conditions included benign prostatic hypertrophy. Concomitant products included tamsulosin.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Re-emergence of PHN/suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: Re-emergence of PHN), burning sensation (Verbatim: burning sensation on his back) and unexpected therapeutic effect (Verbatim: No longer experienced post-herpetic neuralgia). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and unexpected therapeutic effect were unknown and the outcome of the post herpetic neuralgia was not resolved and the outcome of the burning sensation was not reported.   It was unknown if the reporter considered the vaccination failure, post herpetic neuralgia and burning sensation to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, post herpetic neuralgia and burning sensation to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was the patient. The patient stated that he received the full vaccination with Shingrix in 2018.  The day after receiving the first dose of Shingrix, the patient no longer experienced post-herpetic neuralgia. The patient stopped taking Acyclovir (which was prescribed for his PHN) once the PHN resolved.  The patient now reported that he was experiencing PHN again in his back.  The patient had restarted taking Acyclovir. He had no rash but just a burning sensation on his back. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming post herpetic neuralgia were unknown at the time of reporting.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: NONE
Age: 37.0
Sex: M
Vaccine: TD, TYP
Symptoms: Diarrhoea, Dizziness, Laboratory test normal, Nausea, Pain
Clinical narrative: Patient experienced low grade fever of 101 F, nausea and diarrhea x 3 episodes, general feeling of moderate body aches, lightheadedness. Patient reported to local hospital ER (non-descript from patient) for care 03AUG2023 @ 05:00PM. Patient reports Treatment with moltrin and tylenol then, discharged at 02:00 AM 04AUG2023. He was given instructions to follow up with health provider. He followed up with Medical Clinic, vitals wnl and had 3  episodes of diarrhea since awaking at 07:00 AM 04AUG2023 and reports a 5/10 generalized pain throughout body. Patient discharged with no restricitions and counseled to return as needed if symptoms start to worsen again.
Age: 37.0
Sex: M
Vaccine: TD, TYP
Symptoms: Pyrexia
Clinical narrative: Patient experienced low grade fever of 101 F, nausea and diarrhea x 3 episodes, general feeling of moderate body aches, lightheadedness. Patient reported to local hospital ER (non-descript from patient) for care 03AUG2023 @ 05:00PM. Patient reports Treatment with moltrin and tylenol then, discharged at 02:00 AM 04AUG2023. He was given instructions to follow up with health provider. He followed up with Medical Clinic, vitals wnl and had 3  episodes of diarrhea since awaking at 07:00 AM 04AUG2023 and reports a 5/10 generalized pain throughout body. Patient discharged with no restricitions and counseled to return as needed if symptoms start to worsen again.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: NONE
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: NONE
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient received 5-11yo bivalent vaccine when the patient was 15yo.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NONE
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: hives/all over rash
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received bivalent vaccine for 12y and older. Patient was Age 7 at the time of vaccination error.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received bivalent vaccine for 12 years and older. Patient was 8 years at the time of vaccination.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, Incorrect dose administered
Clinical narrative: Nurse saw 10mcg and not the 0.2ml, pt received the Moderna 6yr-11y vaccine the volume in the syringe was equal to 0.1ml per the nurse.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Skin reaction, Vision blurred
Clinical narrative: 2x4 oval on arm, blurry vision, double vision
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 40.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 7/2023.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: CSF protein increased, CSF test, General physical health deterioration, Immunoglobulin therapy, Magnetic resonance imaging
Clinical narrative: acute progressive lower extremity weakness, beginning on 7/25.  Worsened and seen in a different ED, on 7/30.  Observed overnight and family felt patient was better.  DCd on 7/31, but progressively got worse.  Seen again on ED 8/2 and transferred to our care for inpatient visit.  Patient is on day 3/5 IVIG treatment today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Muscular weakness, White matter lesion
Clinical narrative: acute progressive lower extremity weakness, beginning on 7/25.  Worsened and seen in a different ED, on 7/30.  Observed overnight and family felt patient was better.  DCd on 7/31, but progressively got worse.  Seen again on ED 8/2 and transferred to our care for inpatient visit.  Patient is on day 3/5 IVIG treatment today.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have any adverse effects; medication was expired but patient experienced no side effects.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration error- dose administered past its beyond use date.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration error- dose administered past its beyond use date.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: Vaccine error. Pt was administered Dose 2 of Tdap when first Tdap vaccination had already been received on 11/30/2021. Medical assistant notified physician and parent right away. Documentation completed.
Age: 91.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration error- dose administered past its beyond use date.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration error- dose administered past its beyond use date.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Abdominal pain upper, Chest pain, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain and redness over left deltoid occurring hours following vaccination and persists for eight days following vaccination. Pain in anterior chest near clavicle.  Upset stomach one day following vaccination resolved,  Headache following vaccination, headache off and on since vaccination.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration error- dose administered past beyond use date.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered a pediatric dose of Engerix; Inappropriate schedule of vaccine; Drug dose administration interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 32-year-old male patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   Previously administered products included hep b (adolescent doses of a Merck's Hep B in 1 in 2002) and hep b (adolescent doses of a Merck's Hep B in 2 in 2003).   On 21-JUL-2023, the patient received Engerix B pediatric (right deltoid). On 21-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Inadvertently administered a pediatric dose of Engerix), inappropriate age at vaccine administration (Verbatim: Inappropriate schedule of vaccine) and drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the accidental underdose, inappropriate age at vaccine administration and drug dose administration interval too long were unknown.   Additional Information: Receipt Date: 26-JUL-2023 The patient received 2 adolescent doses of a Merck's Hep B in 1 in 2002 and 1 in 2003 The health care professional (HCP) mentioned this would be an attempt as the patient's second dose of the series and the first dose was administered back. Expert noted that may be a potential of a third dose of Hep B for the patient. An adult patient was inadvertently administered a pediatric dose of Engerix, which led to accidental underdose and inappropriate age at vaccine administration. The administration of Engerix B 2nd dose after schedule which led to lengthening of vaccination schedule. The HCP did not consent to follow up.
Age: 0.58
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: 2nd dose received at 4 month age and 3rd dose at 7 month age; 1st dose pediarix and 2nd dose pentacel 3rd dose pediarix 4th pentacel; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included PENTACEL for prophylaxis and PENTACEL for prophylaxis.   Previously administered products included Pediarix  (1st dose received at the age of 2 months).   On an unknown date, the patient received the 3rd dose of Pediarix, the 4th dose of PENTACEL and the 2nd dose of PENTACEL. On an unknown date, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received at 4 month age and 3rd dose at 7 month age) and interchange of vaccine products (Verbatim: 1st dose pediarix and 2nd dose pentacel 3rd dose pediarix 4th pentacel). The outcome of the drug dose administration interval too long and interchange of vaccine products were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 26-JUL-2023 The reporter was the medical assistant. The reporter reported that the patient received first dose and third dose of DTaP vaccine was Pediarix at the age of 2nd and 7th month. The reporter stated that the patient received 2nd and 4th dose of DTaP vaccine was pentacle at the age of 4th and 9th month. The patient received 5th dose of DTaP at the age of19 months of unknown brand name. The 5th DTaP dose was administered then because the 4th dose of DTaP the Pentacel vaccine was early and needed to be repeated.  Boostrix was intended to be administered as a catch-up 5th dose. The patient received 3rd dose of Pediarix late than recommended time frame, which led to lengthening of vaccination schedule. The patient was administered with Pediarix vaccine after Pentacel, which led to interchange of vaccine products.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Insomnia, Myalgia, Pyrexia
Clinical narrative: was in bed all day; fever; fatigue; muscle aches; sleeplessness; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, 5 hrs after receiving Shingrix, the patient experienced sleeplessness (Verbatim: sleeplessness). On 28-JUL-2023, the patient experienced fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle aches) and fever (Verbatim: fever). On 30-JUL-2023, the patient experienced bedridden (Verbatim: was in bed all day). The outcome of the sleeplessness, fatigue, muscle pain, bedridden and fever were resolved.   It was unknown if the reporter considered the sleeplessness, fatigue, muscle pain, bedridden and fever to be related to Shingrix.     It was unknown if the company considered the sleeplessness, fatigue, muscle pain, bedridden and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2023 The reporter stated patient had administered the first dose of Shingrix and had reactions about 5 hours after vaccination. She was then bed ridden all the day. She was recovered from all the symptoms she had. She wanted to know if she administer the 2nd dose of shingrix will it give her the same reactions or not. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain in the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JUL-2023, the patient received the 1st dose of Shingrix. On 27-JUL-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in the 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 Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2023 The patient had a mild reaction to the first dose with pain in the injection site since administration. The reporter did not consented to follow up. This is 1 of 2 linked report, reported by same reporter for his wife.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: first dose with pain in the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: first dose with pain in the injection site). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt date: 31-JUL-2023 The reporter was the patient's husband who states his wife had a mild reaction to the first dose with pain in the injection site since administration. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023104111:Same reporter
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Product Use; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 30-JUL-2023, the patient received Havrix. On 30-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Product Use). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-JUL-2023 The pharmacist reported the patient was administered a dose of Havrix, which had an expiration date of 17 June 2023, which led to expired vaccine used. The pharmacist was unsure which dose number this was in the series.  At the time of reporting, the dose was not repeated. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: having left arm pain; cant move her left arm; arm barely able to function; Upset; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2M3K) for prophylaxis.   On 27-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 27-JUL-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: having left arm pain), injected limb mobility decreased (Verbatim: cant move her left arm), activities of daily living impaired (Verbatim: arm barely able to function) and emotional distress (Verbatim: Upset). The outcome of the pain in arm, injected limb mobility decreased and activities of daily living impaired were not resolved and the outcome of the emotional distress was not reported.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, activities of daily living impaired and emotional distress to be related to Shingrix.     It was unknown if the company considered the pain in arm, injected limb mobility decreased, activities of daily living impaired and emotional distress to be related to Shingrix.   Additional Information: GSK receipt date: 31-Jul-2023 The patient stated that she had a dose of Shingrix vaccine and was upset stating she was having left arm pain, could not move her left arm and just barely able to function.  The patient stated these details started the day of receiving her Shingrix vaccine.  The patient did not specify whether or not these events had resolved.  The patient questioned that what can be done to help her and repeatedly asked how she could help her so, gave medical disclaimer.  Referred to health care professional and spoken as per package insert and content.  Provided medical information phone number for health care professional reference.  Offered after call survey.  The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: an adult patient was given a pediatric dose of Engerix-B; an adult patient was given 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 42-year-old male patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 05-APR-2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: an adult patient was given a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: an adult patient was given a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 01-AUG-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional was not sure of patient exact age and did not have initials at time of call. The reporter consented to follow up.  The reporter reported that an adult patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid component of menveo; received only the liquid component of menveo; 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 adolescent male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA791A, expiry date 31-JAN-2024) 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: received only the liquid component of menveo) and inappropriate dose of vaccine administered (Verbatim: received only the liquid component of menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 1-Aug-2023 The reporter consented to follow-up. The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: she experienced heart palpitations; This non-serious case was reported by a consumer via call center representative and described the occurrence of palpitation in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 28-JUL-2023, 4 hrs after receiving Shingrix, the patient experienced palpitation (Verbatim: she experienced heart palpitations). The outcome of the palpitation was not resolved.   It was unknown if the reporter considered the palpitation to be related to Shingrix.     It was unknown if the company considered the palpitation to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 The reporter was the husband of the patient. The reporter stated that his wife received second dose of Shingrix vaccine and that evening she experienced heart palpitations. The reporter mentioned that the palpitations were not constant but they have not gone away either. The patient would go to see the doctor tomorrow. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd December 2019) and Shingrix (received 2nd dose on 10th February 2020).   On 01-AUG-2023, the patient received the 3rd dose of Shingrix. On 01-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose today). The outcome of the extra dose administered was unknown.   Additional Information: Receipt date: 01-Aug-2023 Nurse practitioner stated a patient came in to get her 2nd dose of Shingrix on the day of reporting, stating that she had only 1 dose previously. After the vaccine was administered, it was discovered that she had received 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Decreased appetite, Headache, Myalgia
Clinical narrative: He experienced an achy arm where the shot was administered; Fever; Muscle soreness; Headache; no appetite; congestion; generalized weakness; necessitating him staying in bed; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of asthenia (1st dose received in November 2022, for tolerance of 1st dose,refer case US2023101959).   In JAN-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: He experienced an achy arm where the shot was administered), fever (Verbatim: Fever), muscle soreness (Verbatim: Muscle soreness), headache (Verbatim: Headache), appetite absent (Verbatim: no appetite), nasal congestion (Verbatim: congestion), weakness generalized (Verbatim: generalized weakness) and bedridden (Verbatim: necessitating him staying in bed). Rechallenge with Shingrix was positive. The outcome of the pain in arm, fever, muscle soreness, headache, appetite absent, nasal congestion, weakness generalized and bedridden were resolved.   It was unknown if the reporter considered the pain in arm, fever, muscle soreness, headache, appetite absent, nasal congestion, weakness generalized and bedridden to be related to Shingrix.   It was unknown if the company considered the pain in arm, fever, muscle soreness, headache, appetite absent, nasal congestion, weakness generalized and bedridden to be related to Shingrix.   Linked case(s) involving the same patient:US2023101959   Additional Information: GSK receipt date: 25-JUL-2023 The reporter calling in response to a message on social media, where he had shared his adverse event experience following both of his Shingrix vaccinations. The patient experienced an achy arm where the shot was administered, along with fever, muscle soreness, headache, no appetite, congestion and generalized weakness necessitating him staying in bed. The patient experienced all of the same symptoms but for a shorter length of time as compared to 1st dose (length of time not specified). This case was linked to the case US2023101963, reported for wife's patient.; Sender's Comments:  US-GSK-US2023101959:Same patient US-GSK-US2023101963:Different patient, same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: He experienced an achy arm where the shot was administered; Fever; Muscle soreness; Headache; no appetite; congestion; generalized weakness; necessitating him staying in bed; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of asthenia (1st dose received in November 2022, for tolerance of 1st dose,refer case US2023101959).   In JAN-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: He experienced an achy arm where the shot was administered), fever (Verbatim: Fever), muscle soreness (Verbatim: Muscle soreness), headache (Verbatim: Headache), appetite absent (Verbatim: no appetite), nasal congestion (Verbatim: congestion), weakness generalized (Verbatim: generalized weakness) and bedridden (Verbatim: necessitating him staying in bed). Rechallenge with Shingrix was positive. The outcome of the pain in arm, fever, muscle soreness, headache, appetite absent, nasal congestion, weakness generalized and bedridden were resolved.   It was unknown if the reporter considered the pain in arm, fever, muscle soreness, headache, appetite absent, nasal congestion, weakness generalized and bedridden to be related to Shingrix.   It was unknown if the company considered the pain in arm, fever, muscle soreness, headache, appetite absent, nasal congestion, weakness generalized and bedridden to be related to Shingrix.   Linked case(s) involving the same patient:US2023101959   Additional Information: GSK receipt date: 25-JUL-2023 The reporter calling in response to a message on social media, where he had shared his adverse event experience following both of his Shingrix vaccinations. The patient experienced an achy arm where the shot was administered, along with fever, muscle soreness, headache, no appetite, congestion and generalized weakness necessitating him staying in bed. The patient experienced all of the same symptoms but for a shorter length of time as compared to 1st dose (length of time not specified). This case was linked to the case US2023101963, reported for wife's patient.; Sender's Comments:  US-GSK-US2023101959:Same patient US-GSK-US2023101963:Different patient, same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17-JAN-2023) for prophylaxis.   On 01-AUG-2023, the patient received Kinrix. On 01-AUG-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 02-AUG-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient was administered an expired dose of Kinrix, which led to expired vaccine used.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered the Shingrix Diluent only without the Lyophilized powder; inadvertently administered the Shingrix Diluent only without the Lyophilized powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 42KG3, expiry date 15-AUG-2025) for prophylaxis.   On 01-AUG-2023, the patient received the 1st dose of Shingrix. On 01-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Shingrix Diluent only without the Lyophilized powder) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Shingrix Diluent only without the Lyophilized powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 02-AUG-2023 The pharmacist  called to inquire that if any information available? What to look for? The reporter did not consent to follow-up. The patient was inadvertently administered the Shingrix diluent only without the lyophilized powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: mild reaction at the site of injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: mild reaction at the site of injection). The outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     It was unknown if the company considered the injection site reaction to be related to Shingrix.   Additional Information: GSK Receipt date: 02-AUG-2023 The reporter reported about herself she had her first Shingrix vaccination on 21 July 2023 and experienced mild reaction at the site of injection. No further information was known. For tolerance refer case US2023105234, reported by same reporter The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023105234:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received only the menA component of Menveo reconstituted; patient received only the menA component of Menveo reconstituted; 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received only the menA component of Menveo reconstituted) and inappropriate dose of vaccine administered (Verbatim: patient received only the menA component of Menveo reconstituted). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-AUG-2023 The reporter consented to follow up. The reporter reported that a patient received only the menA component of Menveo reconstituted with a saline solution, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: menopause for 1.5 years, 2-3 days later started her period; This spontaneous case was reported by a physician and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (menopause for 1.5 years, 2-3 days later started her period) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Menopause.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (menopause for 1.5 years, 2-3 days later started her period) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (menopause for 1.5 years, 2-3 days later started her period) outcome was unknown.        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 reported. Patient has been in menopause for 1.5 years, 2-3 days post-vaccination  had her period Treatment medication was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Upon internal review on 04-Aug-2023, significant corrections performed to update event. On 03-Jun-2021: Follow up received on 03-Jun-2021,no new information was added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood creatinine, Disease recurrence, Glomerulonephritis minimal lesion, Urine protein/creatinine ratio
Clinical narrative: Recurrent Minimal Change Disease; Disease recurrence; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE     The patient's past medical history included Minimal change disease (MCD diagnosed in the past, and one episode of relapsed minimal change disease following COVID-19 infection) and COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) and DISEASE RECURRENCE (Disease recurrence) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2022, Biopsy kidney: consistent with recurrent MCD. On an unknown date, Blood creatinine: 1.03. On an unknown date, Urine protein/creatinine ratio: 9.04.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) and DISEASE RECURRENCE (Disease recurrence) to be related.    Concomitant and treatment medications were not reported.  This study identified eight patients with renal biopsy proven renal diseases due to COVID infection from the end of 2020 to the middle of 2022.   After Moderna COVID-19 vaccine, he developed nephrotic range proteinuria  Patient developed one episode of relapsed MCD after his COVID infection, followed by another episode of relapsed MCD, which was triggered by COVID-19 vaccination.  Biopsy type was reported as native.  Company Comment: This literature-non-study case concerns a 73-year-old male patient, with relevant medical history of minimal change disease (MCD) in the past and one episode of relapsed MCD following COVID-19 infection, who experienced the unexpected and serious (due to medically significant) event of Glomerulonephritis minimal lesion (reported as recurrent minimal change disease), which occurred within 2 weeks after mRNA-1273 vaccine, administered as third booster within COVID-19 vaccination schedule. After 2 weeks of vaccination, patient developed nephrotic range proteinuria. Diagnostic tests revealed blood creatinine of 1.03 and urine protein/creatinine ratio of 9.04. Renal biopsy confirmed diagnosis of relapsed MCD. No information disclosed about clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, COVID-19
Clinical narrative: afib; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (afib) and COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (afib) had not resolved and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient also received the Moderna COVID-19 Vaccine. It was reported that patient had been to the hospital 4 times with COVID-19 and afib in the past 8 weeks. No diagnosis of myocarditis or pericarditis. Hospital kept changing medications. No information on treatment. Company comment: This spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced Serious, unexpected (due to Hospitalization, Medically Significant criteria) AESI of atrial fibrillation and serious (hospitalization criteria) unexpected event of COVID-19. A dose of mRNA-1273 Vaccine was administered as fifth dose in COVID 19 vaccination series. Previous vaccinations were not reported. The patient assisted to the hospital 4 times in 8 weeks due to the events. Medication was indicated (details not provided). At the time of the latest report, atrial fibrillation had not resolved; and the outcome of COVID-19 was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an elderly male patient 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.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was over 65 years old. Patient stated the event happened about a month after receiving the vaccine, it was not an immediate side effect and now he's fine and happy. No treatment information was reported.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Atrial fibrillation, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: afib; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, ATRIAL FIBRILLATION (afib), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Reporter stated that her husband has AFib and he was on a blood thinner. Reporter also stated she read something about being on a blood thinner. when she was speaking about receiving the Moderna COVID19 vaccine.  Company comment- This is a spontaneous case concerning a 74-year-old male patient with no medical history reported, who experienced the serious (medically significant) unexpected AESI atrial fibrillation. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as a booster dose of COVID-19 vaccination schedule, was administered. Onset date of the event and vaccination date were not provided hence latency cannot be assessed. Patient also received a dose of TOZINAMERAN vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products). Reporter stated that patient had atrial fibrillation and he was on a blood thinner. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact