chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 24-DEC-2024 The two patient developed guillain barre syndrome after their second dose of Shingrix. This case was linked with case US2024AMR163730 reported by the same reporter, for different patient.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2024AMR163730:Same reporter
Sex: U
Vaccine: RVX
Symptoms: Tinnitus
Clinical narrative: Annoying sound; This non-serious case was reported by a consumer and described the occurrence of ear discomfort in a 45-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ear discomfort (Verbatim: Annoying sound). The outcome of the ear discomfort was not resolved.   It was unknown if the reporter considered the ear discomfort to be related to RSV vaccine.     It was unknown if the company considered the ear discomfort to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient had annoying sound after RSV vaccine. The symptoms were not treated.
Sex: U
Vaccine: RVX
Symptoms: Irritability
Clinical narrative: Annoyance; This non-serious case was reported by a consumer and described the occurrence of feeling irritated in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced feeling irritated (Verbatim: Annoyance). The outcome of the feeling irritated was resolving.   It was unknown if the reporter considered the feeling irritated to be related to RSV vaccine.     It was unknown if the company considered the feeling irritated to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient experienced annoyance.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: HCP reported that the patient has not received the second or third doses of the ENGERIX-B since October; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in a adult patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in October 2024).   On an unknown date, the patient did not received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: HCP reported that the patient has not received the second or third doses of the ENGERIX-B since October). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2024 The reporter called to report an adverse event regarding the Engerix-B vaccine.  The reporter stated that an adult patient had received the Engerix- B vaccine in October.  The reporter reported that the patient had not received the second or third doses of the Engerix-B since October. The reporter stated that the patient was going to receive the second and third doses of the Recombivax HB vaccine in order to complete the vaccination series.  No additional adverse event or product quality complain was reported. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B , which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose at least 14 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-DEC-2024 The pharmacist reported that he/she had a patient who received the 1st dose of the Shingrix, more than a year ago. The reporter knew it was a 2 dose series, did they need to repeat the whole series again. The healthcare professional did not have any patient data nor vaccine information. The pharmacist also mentioned that the 1st dose was administer at least 14 months ago, but no more than 2 years, however, she did not share any specific date. The pharmacist mentioned that she estimated that the patient was 70 years old, but never confirmed the date of birth.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: expired dose administered; 2nd dose received late; 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 9-year-old female patient who received HAV (Havrix) (batch number 2X2EJ, expiry date 14-OCT-2024) and (batch number ZJ3G3) for prophylaxis.   Previously administered products included Hepatitis A (received 1st dose on 08th September 2021).   On 10-DEC-2024, the patient received the 2nd dose of Havrix. On 10-DEC-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired dose administered) and drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the expired vaccine used and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-DEC-2024 The clinical supervisor explained that an expired dose of Havrix was administered to a patient which led to, expired vaccine used. The patient got a first dose of Hepatitis A (unknown brand name) vaccine back on 08th September 2021, but caller did not have expiration date for the first vaccine. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccinations schedule
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received an extra dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in March 2024). Concurrent medical conditions included psoriasis and hypertension.   In DEC-2024, the patient received the 2nd dose of Arexvy. In DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received an extra dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 16-DEC-2024 and 17-DEC-2024 The patient was given two doses of the Arexvy vaccine, which led to extra dose administered.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: on same visit the patient received 2 doses of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 06-DEC-2024, the patient received Menveo and Menveo. On 06-DEC-2024, an unknown time after receiving Menveo and Menveo, the patient experienced overdose (Verbatim: on same visit the patient received 2 doses of Menveo). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 09-DEC-2024 The physician's assistant reported that he/she had a patient that got the same vaccine twice and according to reporter, on the same visit, that was done as the patient received one dose of Bexsero and two doses of Menveo, which led to overdose. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Experienced rash; Experienced hives; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced rash (Verbatim: Experienced rash) and hives (Verbatim: Experienced hives). The outcome of the rash and hives were resolved.   It was unknown if the reporter considered the rash and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the rash and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient was allergic to egg and approximately 20 years ago they got a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (unknown brand name) and experienced rash and hives, that was currently solved. The reporter did not have a specific date of administration, lot number or expiration date for the vaccine, and they did not know if it was the first and only dose of a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: an expired dose of Priorix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-month-old male patient who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis.   On 11-DEC-2024, the patient received Priorix. On 11-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: an expired dose of Priorix was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-DEC-2024 The nurse reported that an expired dose of Priorix was administered to a patient which led to, expired vaccine used. The nurse that administered the vaccine observed the expiration date on the diluent instead of the expiration on the lyophilized or box. The reporter reported an expired dose of the vaccine was given, did not mentioned anything about it being only the diluent. The vaccine administration facility was the same as primary reporter.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depression, Injury, Pain, Sudden death, Surgery
Clinical narrative: Online report of sudden death for mid 50's male EUA countermeasure recipient. Victim was a musician. A copy of vax card after DOSE1 was obtained. Based on the victims extensive international travel I believe he received the 2nd inoculation. DOSE#1 Date 03/10/21 LOT#EN6207. Victim was under the care of Acupuncture around 12/12/23. On 09/10/24 his social media post indicate he received a surgical procedure. It seems victim had some type of injury that caused chronic pain that required pain killers and acupuncture or chiropractic care. Victim also posted about 3-month depression in December 2023. Victim consumed alcohol, seemed to be high BMI and physically active based on online photos.
Age: 28.0
Sex: U
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: a consumer received one dose of a varicella vaccine on 1/19/1996. The consumer has not received a 2nd dose at this time.; no adverse event; This spontaneous report was received from a registered pharmacist referring to a 29 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 19-JAN-1996, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, dose number, route, lot#, expiration date and anatomical location were not provided) for prophylaxis.      The patient had not received a second dose at this time (incomplete course of vaccination). The patient was planning to receive another dose of varicella virus vaccine live (oka/merck)(VARIVAX) on 02-JAN-2025 (also reported as: "today".  No adverse event reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker, and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the vaccine pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot#y002643 has been verified to be a valid lot number, expiration date: 04-OCT-2026) had a temperature excursion of 46.6F for 1 hour 55 minutes. There was no previous temperature excursion.   On 31-DEC-2024, the patient was vaccinated with above pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (1 dose) for prophylaxis (strength, and route of administration were not provided) (product storage error). No additional adverse event (no adverse event) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported ROTATEQ administered after temperature excursion. Temperature 55.9F; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-JAN-2025, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 0.5 milliliter, administered orally, lot # 2003166, expiration date 06-SEP-2025. Improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) experienced excursion with temperature reported as 55.9 degrees Fahrenheit for 4 hours (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On 31-DEC-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered as the first dose for prophylaxis (lot number reported as Y002643, which has been verified as valid, expiration date reported and validated as 04-OCT-2026) (strength, dose, route of administration, and anatomical site of injection were not provided).  The administered dose was exposed to a temperature excursion of 46.6 Fahrenheit degrees (F) for 1 hour and 55 minutes. There was no previous excursion. No additional adverse events were reported. No further information provided.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On 30-DEC-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered as the first dose for prophylaxis (lot number reported as Y002643, which has been verified as valid, expiration date reported and validated as 04-OCT-2026) (strength, dose, route of administration, and anatomical site of injection were not provided).  The administered dose was exposed to a temperature excursion of 46.6 Fahrenheit degrees (F) for 1 hour and 55 minutes (Product storage error). There was no previous excursion. No additional adverse events were reported. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; reported that a dose of PROQUAD was administered to a patient on 12/2/2024 and another dose of PROQUAD (Same Lot Number) was administered to the patient on 12/10/2024; This spontaneous report has been received from Other Health Professional regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 02-DEC-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, then on 10-DEC-2024, the patient received the second dose (Extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), both doses administered as prophylaxism lot number Y010306 which was determined to be valid, with an expiration date on 01-DEC-2025 (doses, routes of administration, and anatomical sites of injection were not reported).  No additional adverse events were reported in the patient.
Sex: M
Vaccine: RVX
Symptoms: Tinnitus
Clinical narrative: Triggers tinnitus; This non-serious case was reported by a consumer and described the occurrence of tinnitus in a 67-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tinnitus (Verbatim: Triggers tinnitus). The outcome of the tinnitus was not resolved.   It was unknown if the reporter considered the tinnitus to be related to RSV vaccine.     It was unknown if the company considered the tinnitus to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-DEC-2024 The patient self-reported this case. The patient received RSV vaccine and stated that vaccine triggered tinnitus and was impossible to avoid except by never watching TV and the symptoms were not treated
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Antigen was not reconstituted with adjuvant; Antigen was not reconstituted with adjuvant; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication 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 preparation of medication (Verbatim: Antigen was not reconstituted with adjuvant) and inappropriate dose of vaccine administered (Verbatim: Antigen was not reconstituted with adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-DEC-2024 The pharmacist reported the patient had Shingrix vaccine and for antigen was not reconstituted with adjuvant, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 shingles (Verbatim: Shingles). The outcome of the shingles was resolved (duration 1 week).   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: 09-DEC-2024 This case was reported by a patient via interactive digital media. Reporter indicated it was so horrible. Reporter had it 3 times but only with pain, no rash. The pain was horrible. Reporter got vaccinated with 1 dose because the reaction was horrible also for a week. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Very sick; Shingrix shot kicked to butt; Felt bad; This non-serious case was reported by a physician via market research programs and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Very sick), feeling unwell (Verbatim: Shingrix shot kicked to butt) and feeling bad (Verbatim: Felt bad). The outcome of the sickness was resolved and the outcome of the feeling unwell and feeling bad were not reported.   The reporter considered the sickness to be related to Shingrix. It was unknown if the reporter considered the feeling unwell and feeling bad to be related to Shingrix.     The company considered the sickness to be related to Shingrix. It was unknown if the company considered the feeling unwell and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2024  The reporter reported that pretty early when Shingrix came out, the patient jumped on it and got it in the next week in the morning huddle where the plan out the day, he said by the way know the literature as chances of bad reaction was 2 percent with Shingrix. The reporter said he took Shingrix shot last week and it kicked to butt, very sick felt so badly so missed work and did not go to work the next day.
Sex: U
Vaccine: RVX
Symptoms: Cough
Clinical narrative: coughing their hearts out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: coughing their hearts out). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to RSV vaccine.     It was unknown if the company considered the cough to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 This case was reported by a patient via interactive digital media. Consumer reported that he/she had met a lot of older people coughing their hearts out, after taking the RSV vaccine. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   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: 12-DEC-2024 The patient had developed shingles about one week after taking a dose of Shingrix (the reporter believed that it was first of two dose series). No other patient information was provided at the time of discussion.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis.   On 08-DEC-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-DEC-2024 The pharmacist called to report while administering the second dose of Shingrix to a patient the vaccine dripped out of the collar of the syringe resulting in an incomplete dose. The Vaccine Administration Facility is the same as Primary Reporter. The reporter reported that no product quality complaint involved in this case since Shingrix was packed without syringes or needles.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Congestion; Muscle aches; chills; cough; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of nasal congestion in a adult 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, 2 days after receiving Shingrix, the patient experienced nasal congestion (Verbatim: Congestion), muscle pain (Verbatim: Muscle aches), chills (Verbatim: chills), cough (Verbatim: cough) and fever (Verbatim: fever). The outcome of the nasal congestion, muscle pain, chills, cough and fever were unknown.   It was unknown if the reporter considered the nasal congestion, muscle pain, chills, cough and fever to be related to Shingrix.     It was unknown if the company considered the nasal congestion, muscle pain, chills, cough and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient self-reported this case for herself. Customer (patient) reported that 2 days after she received the first Shingrix dose she started to experience cough, fever, chills, muscle aches, congestion.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product use in unapproved indication, Skin lesion
Clinical narrative: shingles; received a 2nd dose on 11/7/2024 after first daose administered in mar 2024; shingles in March of 2024 and was vaccinated shortly thereafter, while the existing lesions were still active; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-NOV-2024, the patient received the 2nd dose of Shingrix. On 01-MAR-2024, the patient received the 1st dose of Shingrix. On 01-MAR-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: shingles in March of 2024 and was vaccinated shortly thereafter, while the existing lesions were still active). On 07-NOV-2024, the patient experienced drug dose administration interval too long (Verbatim: received a 2nd dose on 11/7/2024 after first daose administered in mar 2024). On 27-NOV-2024, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles, drug dose administration interval too long and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-DEC-2024 The consumer reports that she experienced shingles in March of 2024 and was vaccinated shortly thereafter, while the existing lesions were still active, which led drug use for unapproved indication. The patient received 2nd dose of Shingrix and experienced full blown shingles just three weeks after that shot. The patient received 2nd dose at longer time than recommended, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Pediarix instead of Kinrix; inappropriate schedule of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   On 15-NOV-2024, the patient received Pediarix. On an unknown date, the patient did not receive Kinrix. On 15-NOV-2024, immediately after receiving Pediarix and not applicable after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Pediarix instead of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: inappropriate schedule of vaccine administered). The outcome of the wrong vaccine administered 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:09-DEC-2024 Nurse reported that a 4-year-old female patient received Pediarix instead of Kinrix which led to wrong vaccine administered and inappropriate schedule of vaccine administered. Considering this last Pediarix shot, patient had 5 Dtaps, 3 IPV doses and 3 hep B doses.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Local reaction
Clinical narrative: localized reaction in arm; administered the Shingrix Vaccine  Subcutaneously instead of intramuscular; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number KB2YT, expiry date 29-OCT-2026) for prophylaxis.   On 04-DEC-2024, the patient received the 1st dose of Shingrix (subcutaneous, left arm). On 04-DEC-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered the Shingrix Vaccine  Subcutaneously instead of intramuscular). On an unknown date, the patient experienced local reaction (Verbatim: LOCALIZED REACTION IN LEFT ARM). The outcome of the intramuscular formulation administered by other route and local reaction were unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.     It was unknown if the company considered the local reaction to be related to Shingrix.   Additional Information: GSK receipt date: 09-DEC-2024 The reporter reported that patient had administered the Shingrix Vaccine Subcutaneously instead of Intramuscularly which lead to intramuscular formulation administered by other route. The patient had a localized reaction, but physician wanted to double check, as there any information to pass along to the patient about whether or not patient would need to re-do the vaccine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: think it was subcutaneous vaccine but it was given intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: think it was subcutaneous vaccine but it was given intramuscularly). The outcome of the subcutaneous injection formulation administered by other route 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: 10-DEC-2024 Pharmacist reported the Priorix was subcutaneous vaccine but given intramuscularly, which led subcutaneous injection formulation administered by other route. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient received Priorix after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received MMR (Priorix) (batch number 9594A, expiry date 01-DEC-2024) for prophylaxis.   On 10-DEC-2024, the patient received Priorix. On 10-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient received Priorix after the expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-DEC-2024 The nurse reported that the patient received Priorix after the expiration which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not receive 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 30th September 2024 with batch number: H7RF2 and expiry date: 17 January 2026).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not receive 2nd dose yet). The outcome of the incomplete course of vaccination 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: 12-DEC-2024 The reporter reported that the patient received 1st dose of Twinrix on 30th September 2024. The reporter reported that it was supposed to be a 3 doses series, at zero-month, 1 month and 6 months the reporter had question if the 2nd dose was not given in 1 month, what was the protocol. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 4-month patient instead of a 4-year old patient; patient was intended to receive Pediarix; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 06-DEC-2024, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 06-DEC-2024, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4-month patient instead of a 4-year old patient) and wrong vaccine administered (Verbatim: patient was intended to receive Pediarix). The outcome of the inappropriate age at vaccine administration and wrong 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: 12-DEC-2024 The reporter reported that a dose of Kinrix was administered to a 4-month patient instead of a 4-year-old patient which led to, inappropriate age at vaccine administration. The reporter reported that the patient was intended to receive Pediarix which led to, wrong vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 82.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Burning sensation, Injection site pain, Paraesthesia
Clinical narrative: burning sensation; left side of his body had a tingling sensation; injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   Previously administered products included Shingrix (Patient received first dose on an unknown date).   On 08-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) and COVID-19 vaccine (left arm). On 12-OCT-2024, 4 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation) and tingling sensation (Verbatim: left side of his body had a tingling sensation). In OCT-2024, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the injection site pain was unknown and the outcome of the burning sensation and tingling sensation were not resolved.   It was unknown if the reporter considered the injection site pain, burning sensation and tingling sensation to be related to Shingrix.     It was unknown if the company considered the injection site pain, burning sensation and tingling sensation to be related to Shingrix.   Additional Information: GSK Receipt Date:12-DEC-2024 Patient reported a reaction after receiving his second Shingrix vaccine and Covid-19 vaccine at the same time in the same arm. He reported that 2 days later he had injection site pain.  Also reported that 2 days later the left side of his body had a tingling sensation the tingling was on the left side of the face, neck arm and thigh.  Patient reported the tingling on the left arm was the most bothersome and there was a burning sensation on the left thigh. The doctor was just watching it to see if it goes away, no medications were prescribed.  The doctor informed the patient that it was a reaction to the Shingrix vaccine, not the Covid-19 vaccine.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old female received Havrix adult vaccine; 11 year old female received Havrix adult vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 11-year-old female patient who received HAV (Havrix 1440 adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis.   On 12-DEC-2024, the patient received the 1st dose of Havrix 1440 adult (left deltoid). On 12-DEC-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: 11 year old female received Havrix adult vaccine) and overdose (Verbatim: 11 year old female received Havrix adult vaccine). The outcome of the adult product administered to child and overdose 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: 12-DEC-2024 The health care professional reported that an 11 year old female received Havrix-adult vaccine today on 12th December 2024 which led to adult product administration to child and overdose. She stated it was given in left deltoid.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Engerix-B 20mcg on 16-AUG-2023 and were asking how to proceed with schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix b adulto (received first dose on 16-AUG-2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: received first dose of Engerix-B 20mcg on 16-AUG-2023 and were asking how to proceed with schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the patient received their first dose of Engerix-B adult and were asking how to proceed with schedule. Till the time of reporting, the patient did not receive 2nd dose of Engerix B adult, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19-2
Symptoms: Balance disorder, Fall, Headache, Limb injury, Multi-organ disorder
Clinical narrative: My balance and equilibrium etc was affected by COVID-19 Virus; My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc; Headaches that are a 10+; fell in my bed room; injured my right leg; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell in my bed room), LIMB INJURY (injured my right leg), BALANCE DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus), MULTI-ORGAN DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc) and HEADACHE (Headaches that are a 10+) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In December 2024, the patient experienced FALL (fell in my bed room) and LIMB INJURY (injured my right leg). On an unknown date, the patient experienced BALANCE DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus), MULTI-ORGAN DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc) and HEADACHE (Headaches that are a 10+). At the time of the report, FALL (fell in my bed room), LIMB INJURY (injured my right leg), BALANCE DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus) and MULTI-ORGAN DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc) outcome was unknown and HEADACHE (Headaches that are a 10+) had resolved.            On 14-Jan-2021, the patient received first dose of Moderna COVID-19 Vaccine.  On 12-Feb-2021, received second dose of Moderna COVID-19 Vaccine (Lot: 006M20A).  Concomitant medication was not reported.  It was reported that patient was over 92 years old now, fell in bedroom 11 days ago and injured right leg severely. Patient balance equilibrium etc. was affected by the covid-19 virus, as well as all of vital organs etc. Headache that was a 10+ and last for several days and nights and required two ice packs 24/7 until finally dissipate. It was mentioned that patient has more than a dozen symptoms from covid-19 infection that deal with daily.   Treatment medication was not reported.   This case was linked to MOD-2024-776499 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Headache
Clinical narrative: PRESENTED TO ER WITH HEADACHE, NAUSEA, VOMITING. FOUND TO HAVE MENINGITIS AND SPINAL HEMORRAHGE
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Magnetic resonance imaging spinal abnormal, Meningitis, Nausea, Spinal cord haemorrhage, Vomiting
Clinical narrative: PRESENTED TO ER WITH HEADACHE, NAUSEA, VOMITING. FOUND TO HAVE MENINGITIS AND SPINAL HEMORRAHGE
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Patient is feeling consistent pain, weakness, and restricted movement in the left arm since the vaccination. Patient went to her dr who is referring her to an orthopedic specialist
Age: 0.17
Sex: F
Vaccine: HEPA, PNC20, RV5
Symptoms: Wrong product administered
Clinical narrative: Havrix was ordered and administered in lieu of Vaxelis.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: 32 WEEKS GESTATION received MMR vaccine
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: sore arm and neck still on 1/6/25 from this
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Brain fog, Dizziness, Fall, Head injury, Headache
Clinical narrative: On January 7;  while walking dog, I started getting dizzy reached out and grabbed nearby fence and blacked out -- fell to ground hit and back of head.  Husband was with me and he woke me up and we came home.  Put ice on head to reduce swelling on bump.  I was foggy and had a slight headache.     January 8, I still have a headache and foggy and waiting for doctor to recommend course of action
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Loss of consciousness
Clinical narrative: On January 7;  while walking dog, I started getting dizzy reached out and grabbed nearby fence and blacked out -- fell to ground hit and back of head.  Husband was with me and he woke me up and we came home.  Put ice on head to reduce swelling on bump.  I was foggy and had a slight headache.     January 8, I still have a headache and foggy and waiting for doctor to recommend course of action
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar 20 twice. Secon vaccine was not needed