chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Myalgia
Clinical narrative: Muscle ache; my heart rate is also elevated; my blood pressure is 143/69; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 67-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-MAY-2024, the patient received Shingles vaccine .5 ml. On 15-MAY-2024, 1 days after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: Muscle ache). In MAY-2024, the patient experienced heart rate increased (Verbatim: my heart rate is also elevated) and increased blood pressure (Verbatim: my blood pressure is 143/69). The outcome of the muscle pain and heart rate increased were not resolved and the outcome of the increased blood pressure was not reported.   It was unknown if the reporter considered the muscle pain, heart rate increased and increased blood pressure to be related to Shingles vaccine.     It was unknown if the company considered the muscle pain, heart rate increased and increased blood pressure to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2024 The patient self-reported this case. The heart rate was also elevated and was normally in the high fifties and it was now (during the reporting days) in the high eighties.  The patient also had his blood pressure which was 143/69 and it was normally in range of 114/60.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 4 doses of Shingrix/4th on 5/17/24; Patient received 4 doses of Shingrix/the third on 3/15/24; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number YL7LR, expiry date 15-MAY-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 23-FEB-2023) and Shingrix (received second dose on 24-APR-2023).   On 17-MAY-2024, the patient received the 4th dose of Shingrix (right deltoid). On 15-MAR-2024, the patient received the 3rd dose of Shingrix. On 15-MAR-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received 4 doses of Shingrix/the third on 3/15/24). On 17-MAY-2024, the patient experienced extra dose administered (Verbatim: Patient received 4 doses of Shingrix/4th on 5/17/24). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024  The patient accidentally received 4 doses of Shingrix.  The office was in transition to a new electronic medical record system and did not see that the patient had completed a 2 dose series of Shingrix in 2023.  It was unknown if the office had reached out to the patient to notify them and as of on 20-MAY-2024 (on the day of reporting) the patient had not reached out to the provider to seek medical information.  The patient received 4 dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: RVX
Symptoms: COVID-19
Clinical narrative: mild Covid; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included cold.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced covid-19 (Verbatim: mild Covid). The outcome of the covid-19 was not reported.   It was unknown if the reporter considered the covid-19 to be related to RSV vaccine.  It was unknown if the company considered the covid-19 to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2024 This case was reported by a patient via interactive digital media. The patient got the 3 vaccines and got very mild Covid, he/she did not even got fever. The reporter stated that when he/she got the cold it was very mild and went away very quickly.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Vaccine positive rechallenge
Clinical narrative: they have the same swelling; have the same red mark; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (received 1st dose on an unknown date and had swelling and a red mark, for tolerance to 1st dose, refer case US2024062288).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: they have the same swelling) and erythema (Verbatim: have the same red mark). Rechallenge with Shingrix was positive. The outcome of the swelling and erythema were resolved.   The reporter considered the swelling and erythema to be related to Shingrix.     The company considered the swelling and erythema to be related to Shingrix.   Linked case(s) involving the same patient:  US2024062288   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient self-reported this case. The patient had second shot of shingles for the opposite arm and had same swelling and a red mark.; Sender's Comments:  US-GSK-US2024062288:Same patient/ SECOND DOSE
Sex: U
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: Muscle pain). The outcome of the muscle pain was not resolved.   It was unknown if the reporter considered the muscle pain to be related to Arexvy.     It was unknown if the company considered the muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-MAY-2024 This case was reported by a patient via interactive digital media. The patient got the Arexvy vaccine and still have the muscle pain. The patient asked if this would go away or should he/she call the primary care physician (PCP). This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased
Clinical narrative: feels run down and has trouble getting out of bed; This non-serious case was reported by a physician via other manufacturer and described the occurrence of asthenia in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash (received 1st dose on an unknown date, refer case US2024AMR064487). Concurrent medical conditions included allergy to vaccine (sensitivity).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced asthenia (Verbatim: feels run down and has trouble getting out of bed). The outcome of the asthenia was unknown.   It was unknown if the reporter considered the asthenia to be related to Shingrix.  It was unknown if the company considered the asthenia to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR064487   Additional Information: GSK Receipt Date: 20-MAY-2024 The patient felt run down and had trouble getting out of bed when she had a vaccine. On 22-FEB-2024, the patient received the Tymlos and experienced dizziness, could only lay on the couch for four hours after the dose, headache, constipation, muscle weakness and low energy, felt run down and had trouble getting out of bed. This case had been link with US2024AMR064487, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR064487:same reporter, same patient
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: used a regular diluent, Specialist further clarified that the diluent used by the medical assistant was sterile water; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2024, the patient received the 1st dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: used a regular diluent, Specialist further clarified that the diluent used by the medical assistant was sterile water) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-MAY-2024 The reporter stated another medical assistant at the clinic administered Shingrix last week to a male patient for his first dose, but they used a regular diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The specialist further clarified that the diluent used by the medical assistant was sterile water. The patient's initials, date of birth, and exact date of administration were unknown to medical assistant.  She requested that any follow up from safety only go to the corporate office, which was the address that specialist has added to this case.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: gave an adolescent hepatitis A vaccine to a 50 years old; adolescent hepatitis A vaccine to a 50 years old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 50-year-old male patient who received HAV (Havrix Junior) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   In MAY-2024, the patient received the 1st dose of Havrix Junior. In MAY-2024, an unknown time after receiving Havrix Junior, the patient experienced underdose (Verbatim: gave an adolescent hepatitis A vaccine to a 50 years old) and adult use of a child product (Verbatim: adolescent hepatitis A vaccine to a 50 years old). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2024 The reporter reported that in last week they gave an adolescent hepatitis A vaccine to a 50 years old patient, which led to underdose and adult use of a child product. The reporter did not specify the date of the administered dose, she just stated that last week. The reporter consented to follow up
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 1 year old received a dose of Kinrix yesterday; received Kinrix on Rt.Vastus Lateralis; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 15-MAY-2024, the patient received Kinrix (intramuscular, rt. vastus lateralis). On 15-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 1 year old received a dose of Kinrix yesterday) and vaccine administered at inappropriate site (Verbatim: received Kinrix on Rt.Vastus Lateralis). The outcome of the inappropriate age at vaccine administration and vaccine administered at inappropriate site 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: 16-MAY-2024 The reporters were licensed practical nurse and mother of the patient reported that a 1 year old, patient was inadvertently administered a dose of Kinrix yesterday in error, which led to inappropriate age at vaccine administration. The patient received a dose Kinrix vaccine at rt. vastus lateralis, which led to vaccine administered at inappropriate site.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: records from pharmacy and health department shows patient had only one dose/ did not receive 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: records from pharmacy and health department shows patient had only one dose/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient self-reported this case. The patient reported that her husband had shingles from past 2 days (from the date of reporting) but did not receive the shingles vaccine. She thought she had both the dose of the Shingrix vaccine, but records from pharmacy and health department showed she had only one dose of Shingrix. The patient wanted to know was there any effect. She called pharmacy and did not get an answer and health department said she got only one. Also, patient wanted to know what if the health care provider had no records of it and if she gets another shot. Would that be ok. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to an incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, HEP, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: frozen vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Havrix, Infanrix, Engerix B, Boostrix and Bexsero. On an unknown date, an unknown time after receiving Havrix, Infanrix, Engerix B, Boostrix and Bexsero, the patient experienced incorrect storage of drug (Verbatim: frozen vaccine administered). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-MAY-2024 The Medical assistant reported that they had an issue back in the December 2023, one of fridges freeze, so they used the stability calculator to go through all of that, got rid of the ones were no longer stable however there were a couple that were used prior to finding out the temperature change. They need documentation as far as the risk of those and risk of revaccinated . The reporter did not know the names or anything there were 39 patients that were affected though, it was not all 5 of each for each one, some of them had only one some of them had couple depending on what they were needing. The temperature was minus o.5 degree Celsius for 3.5 hours. There was 39 patient received vaccines which was incorrectly stored, which led to incorrect storage of drug.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidentally gave a patient a pediatric dose of Engerix-B to an adult patient who needed an adult dose; accidentally gave a patient a pediatric dose of Engerix-B to an adult patient who needed an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) 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 accidental underdose (Verbatim: accidentally gave a patient a pediatric dose of Engerix-B to an adult patient who needed an adult dose) and adult use of a child product (Verbatim: accidentally gave a patient a pediatric dose of Engerix-B to an adult patient who needed an adult dose). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2024 and 17-MAY-2024 The nurse practitioner reported that he/she had accidentally gave a patient a pediatric dose of Engerix-B to an adult patient who needed an adult dose, which led to accidental underdose and adult use of a child product. Specialist attempted to call nurse practitioner back, but the call went to voicemail.  A message was left providing medical Information phone number and case number so nurse practitioner could follow up at her convenience.  For now specialist was submitting all details per voicemail left by nurse practitioner. It was unknown whether nurse practitioner gave permission for safety to follow up, and no further information were available at this time. No further details were provided.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a first dose of Hepatitis B vaccine on  March 7th 2024 and the second dose Engerix-B too soon on March 28th 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 3-week-old female patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE.   On 28-MAR-2024, the patient received the 2nd dose of Engerix B. On 28-MAR-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Patient received a first dose of Hepatitis B vaccine on  March 7th 2024 and the second dose Engerix-B too soon on March 28th 2024). The outcome of the drug dose administration interval too short 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: 17-MAY-2024 The reporter explained there was an incident where a 2 month old patient received a first dose of Hepatitis B vaccine (unknown brand) the day she born and the second dose (Engerix-B) too soon.
Sex: U
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Therapeutic response decreased, Underdose, Viral titre decreased
Clinical narrative: Patient got low hepatitis B titers; administered pediatric doses instead of adult doses; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 24-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for an unknown indication, HBV (Engerix B pediatric) for an unknown indication and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric, the 1st dose of Engerix B pediatric and Hepatitis B vaccine. On an unknown date, not applicable after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric and an unknown time after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased (Verbatim: Patient got low hepatitis B titers), adult use of a child product (Verbatim: administered pediatric doses instead of adult doses) and underdose (Verbatim: Underdose). The outcome of the therapeutic response decreased, adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-MAY-2024 A call from a pharmacist was received, during this interaction, the caller never mentioned the possibility of an adverse event.  Specialist contacted pharmacist the next day on May 17th, 2024, and he mentioned this time that a patient 24 years of age now, received hepatitis B vaccine as a child (in foreign country, no brand name of Hepatitis B vaccine provided). patient got low hepatitis B titers and was recommended to get revaccinated with Hepatitis B (Engerix B was utilized).
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Wrong product administered
Clinical narrative: Incomplete course of vaccination; Wrong vaccine administered; Inappropriate schedule of vaccine administered; 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.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Twinrix (Received 1st dose of Twinrix on 1st July 2023 with Batch number: 429JJ and Expiration date:1st April 2026) and Engerix b (Received Engerix B on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix and Engerix B. On an unknown date, an unknown time after receiving Twinrix and not applicable after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination), wrong vaccine administered (Verbatim: Wrong vaccine administered) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination, 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: 17-MAY-2024 The pharmacist reported that, the patient received 1st dose of Twinrix on 1st of July 2023. The pharmacist asked its been 10 months now (at the time of reporting) does the patient needs to restart series. After the initial conversation with the first agent, the healthcare professional did mention to the second agent that the series began with a monovalent dose of hepatitis B (Engerix-b) then the second dose was Twinrix and the following dose in the hepatitis B series was Engerix-B but a hepatitis A virus component vaccine had not been administered.  Till the time of reporting the patient did not received the 2nd dose of hepatitis A antigen which led to incomplete course of vaccination for hepatitis A antigen. The patient series began with a monovalent dose of hepatitis B (Engerix-b) then the second dose was Twinrix and the following dose in the hepatitis B series was Engerix-B, which led to wrong vaccine administered and inappropriate schedule of vaccine administered.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient got Shingrix, they never came back for the 2nd dose until now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in 2017).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: the patient got Shingrix, they never came back for the 2nd dose until now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2024 The pharmacist called and informed about a patient with an unclear vaccination history. The reporter asked for recommendations in patients who were not sure if they got one dose, they were not sure if they had the 2nd dose. According to reporter, this patient was not sure if back in 2017 they got the 1st dose of Shingrix or Zostavax. Also, if the patient got Shingrix, they never came back for the 2nd dose until the time of reporting. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 3rd dose was not administered 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 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix vaccine 10 years ago) and Twinrix (received second dose of Twinrix vaccine 10 years ago).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 3rd dose was not administered 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: 17-MAY-2024 The pharmacist reported that female patient received the first two doses of Twinrix vaccine 10 years ago. The pharmacist asked that they shoulder administer the 3rd dose (dose was not administered yet). Till the time of reporting the patient did not receive the 3rd dose of Twinrix vaccine, which led incomplete course of vaccination.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Kinrix to a 2 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Kinrix to a 2 year old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-MAY-2024 The pharmacist reported that the 2 year old patient had received Kinrix vaccine which led to, inappropriate age at vaccine administration. The reporter wanted to know do you had any data for that age group. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Headache; Dizziness; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on unknown date).   On 13-MAY-2024, the patient received the 2nd dose of Shingrix. In MAY-2024, less than a week after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and dizziness (Verbatim: Dizziness). The outcome of the headache and dizziness were unknown.   It was unknown if the reporter considered the headache and dizziness to be related to Shingrix.     It was unknown if the company considered the headache and dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 20-MAY-2024 Nurse reported that they had a patient who was in office who just received the second dose of Shingrix on the 13th of May, so 1 week ago from day of reporting. He was been experiencing headache and dizziness, and things. We were wondering if that was a common having symptoms after the 2nd dose not experienced after the first dose. The reporter did not provide batch number and expiration date due their system was not loading.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 35-year-old female patient who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis.   On 13-MAY-2024, the patient received the 1st dose of Priorix. On 13-MAY-2024, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   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: 21-MAY-2024 Pharmacist explained that 2 patients were inadvertently administered only with the diluent portion of Priorix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2024063698:Same reporter/Diffreent patient
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 42-year-old female patient who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis.   On 10-MAY-2024, the patient received the 1st dose of Priorix. On 10-MAY-2024, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   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: 21-MAY-2024 A pharmacist reported that a patient was inadvertently administered only with the diluent portion of Priorix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with case US2024063700 with same reporter.; Sender's Comments:  US-GSK-US2024063700:Same reporter/Diffreent patient
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; They recently had shingles; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) (batch number FA95N) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 3G33K) for prophylaxis.   On 07-MAY-2022, the patient received Shingrix. On 05-MAR-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: They recently had shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 21-MAY-2024 The reporter had a patient who received the 2 doses of Shingrix series in 2022 and recently had shingles.  The reporter asked if there ever any indication to repeat the 2 dose series or receive a booster. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consent to follow up by safety was not possible to obtain.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: warm to the touch; knot at the SHINGRIX injection site; It is sore; redness at Shingrix injection; had shivers the entire next day; felt feverish; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Pneumococcal vaccine.   On 17-MAY-2024, the patient received the 1st dose of Shingrix (intramuscular). On 18-MAY-2024, 1 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: warm to the touch), injection site nodule (Verbatim: knot at the SHINGRIX injection site), injection site pain (Verbatim: It is sore), injection site erythema (Verbatim: redness at Shingrix injection), shivering (Verbatim: had shivers the entire next day) and fever (Verbatim: felt feverish). On 19-MAY-2024, the outcome of the shivering and fever were resolved. The outcome of the injection site warmth, injection site nodule, injection site pain and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site warmth, injection site nodule, injection site pain, injection site erythema, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site nodule, injection site pain, injection site erythema, shivering and fever to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAY-2024 The patient was the reporter who states that she received her first Shingrix injection, along with a pneumococcal injection.   She reported that beginning the next day, she felt feverish, and had shivers the entire next day, then that resolved.   She also began noticing a knot at the Shingrix injection site that has grown to approximately 2"x2".   It was warm to the touch and sore.  It had not yet resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: warm to the touch; knot at the SHINGRIX injection site; It is sore; redness at Shingrix injection; had shivers the entire next day; felt feverish; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Pneumococcal vaccine.   On 17-MAY-2024, the patient received the 1st dose of Shingrix (intramuscular). On 18-MAY-2024, 1 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: warm to the touch), injection site nodule (Verbatim: knot at the SHINGRIX injection site), injection site pain (Verbatim: It is sore), injection site erythema (Verbatim: redness at Shingrix injection), shivering (Verbatim: had shivers the entire next day) and fever (Verbatim: felt feverish). On 19-MAY-2024, the outcome of the shivering and fever were resolved. The outcome of the injection site warmth, injection site nodule, injection site pain and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site warmth, injection site nodule, injection site pain, injection site erythema, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site nodule, injection site pain, injection site erythema, shivering and fever to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAY-2024 The patient was the reporter who states that she received her first Shingrix injection, along with a pneumococcal injection.   She reported that beginning the next day, she felt feverish, and had shivers the entire next day, then that resolved.   She also began noticing a knot at the Shingrix injection site that has grown to approximately 2"x2".   It was warm to the touch and sore.  It had not yet resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failuer; shingles outbreaks every 4-6 weeks; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old 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 (I had several times every 5 years or so).   In FEB-2023, the patient received the 2nd dose of Shingrix. In DEC-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failuer) (serious criteria GSK medically significant) and shingles (Verbatim: shingles outbreaks every 4-6 weeks). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 22-MAY-2024 The reporter was the patient.  The patient stated he has a history of shingles, had several times every 5 years or so.  The patient received both Shingles shots, and now (at the time of reporting) got shingles outbreaks every 4 to 6 weeks.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Consent to speak with pharmacy since they have his records.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: redness, itching, and a lump at the injection site of the right arm; redness, itching, and a lump at the injection site of the right arm; redness, itching, and a lump at the injection site of the right arm; This is a spontaneous report received from a Physician from a sales representative.  A 66-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15May2024 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Cardiomyopath" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Known allergy: Yes. Concomitant medication(s) included: PREGABALIN; ATORVASTATIN; JARDIANCE; VALSARTAN; SPIRONOLACTONE; VITAMIN D [VITAMIN D NOS]. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 17May2024, outcome "not recovered" and all described as "redness, itching, and a lump at the injection site of the right arm". Therapeutic measures were taken as a result of vaccination site mass, vaccination site erythema, vaccination site pruritus.  Additional information: The patient did not receive any other vaccines on the same date as the PREVNAR 20. It was reported that within 48 hours, patient experienced redness, itching, and a lump at the injection site of the right arm. The treatment received from the adverse events included antibiotic and steroid cream.  Causality for "redness, itching, and a lump at the injection site of the right arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administering one dose of ADACEL after the product experienced a delay in transit/product felt cold to the touch, with no reported adverse event; adacel vaccine that has experienced a delay in transit, with no reported adverse event; Initial information received on 21-May-2024 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 22 years old male patient who was administered with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] after the product experienced a delay in transit/product felt cold to the touch, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2024, the patient received a dose 2 of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 2CA56C1, expiry date: 12-May-2025) (strength: unknown) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 20-MAY-2024 the patient was administering one dose of adacel after the product experienced a delay in transit/product felt cold to the touch, with no reported adverse event (product storage error) and (poor quality product administered) (latency: same day) (lot 2CA56C1, expiry date: 12-May-2025) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. human error: yes  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Administered liquid (DTaP-IPV) component of PENTACEL without its powder (Hib) component to a patient with no reported AE; Initial information received on 21-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered liquid (dtap-ipv) component of pentacel without its powder (hib) component to a patient with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Oral 1v (Rotarix); Hepatitis B Vaccine Rhbsag (Yeast) (Engerix B); And Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Prophylactic vaccination.  On 25-Apr-2024, the patient received a dose 1 (0.5 ml) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection, expiry date-12-FEB-2025, lot UJ983AA via intramuscular route in the left vastus lateralis for immunization (strength unknown) liquid (dtap-ipv) component of pentacel without its powder (hib) component to a patient with no reported ae (single component of a two-component product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 21-May-2024 From other health care professional: Concomitant vaccination date were added. Text amended accordingly.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired mQUADRACEL was administered to a patient with no adverse event; Initial information received on 22-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 4 years old female patient who was administered expired diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-May-2024, the patient received 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Suspension for injection (lot number: C6002BA) (Expiry date: 18-May-2024) (Strength: standard) (Frequency: once) via intramuscular route in the thigh nos (not otherwise specified) for immunization.  On 21-May-2024, the patient was administered expired diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel] with no adverse event (expired product administered) (latency: same day).  Reportedly, Pharmacist said that after the vaccination, she gave the patient a Tylenol.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.