chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Vaccination site reaction
Clinical narrative: Patient had a major site reaction following injection, affeting large part of the arm; This spontaneous report aws received from a reporter of unknown credentials and refers to a 48-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided).  On an unknown date the patient experienced vaccination site reaction. The patient said she is highly susceptible to such reactions, as well as various illnesses. The outcome of vaccination site reaction was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events was not applicable.   The reporter considered vaccination site reaction to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered after the TE.; No reported adverse reactions; This spontaneous report was received from a medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions  and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #w039294, expiration date: 11-DEC-2024, administered for prophylaxis (strength, dose description, vaccination scheme, anatomical location, and route of administration were not provided) following a temperature excursion (Improper storage of product in use). No reported adverse reactions.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2310USA000653: US-009507513-2310USA000492:
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; wrong dose was administered to the patient; This non-serious case was reported by a pharmacist and described the occurrence of underdose in a 18-year-old patient who received HBV (Engerix B) for prophylaxis.   In AUG-2023, the patient received Engerix B (unknown arm) 10 ug. In AUG-2023, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: wrong dose was administered to the patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 This was subsequent dose.  The pharmacist reported that the wrong dose was administered to the patient. The patient was supposed to get 3 doses of Hepatitis B vaccine. They were using an alternative dosing schedule because the patient was from a part of country with a high level of circulating Hepatitis B disease and intended to travel.  There was 20mcg given at first dose, but the next dose was only 10 mcg, which led to adult use of a child product and underdose. No harm to the patient, just reported since it did not follow the recommended dosing schedule.
Sex: U
Vaccine: COVID19, FLUX, RVX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; little tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis and INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received RSV vaccine, COVID VACCINE and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving RSV vaccine and an unknown time after receiving INFLUENZA VACCINE, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: little tired).  The outcome of the pain in arm and tiredness were not reported.   It was unknown if the reporter considered the pain in arm and tiredness to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and tiredness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 24-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she took Covid, Flu and RSV at the same time and just had a sore arm and a little tired. It was unknown if the reporter considered the pain in arm and tiredness to be related to COVID-19 VACCINE and INFLUENZA VACCINE. The follow up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Asthenia, Cardiac disorder, Heart rate increased, Illness
Clinical narrative: have been sick; now I am very weak; my heart is acting up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 19-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: have been sick), weakness (Verbatim: now I am very weak) and heart rate increased (Verbatim: my heart is acting up).  The outcome of the sickness was not reported and the outcome of the weakness and heart rate increased were not resolved.   It was unknown if the reporter considered the sickness, weakness and heart rate increased to be related to RSV vaccine.     It was unknown if the company considered the sickness, weakness and heart rate increased to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-SEP-2023 This case was reported the patient via interactive digital media. The patient got last Tuesday and had been sick since got the shot and now was very weak and heart was acting up .  The patient was thinking of going to emergency room.  If anyone else had issues then the patient would like you to hear. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no adverse event; Medical assistant calls to report AE.  GARDASIL 9 given during a temperature excursion.  No further AE.  No PQC.  GARDASIL 9 was evaluated as supported see TE case.  TEs were on Aug 2, 2023 and Aug 4, 2023.  Called in on 9/6/2023.  AE cases0; This spontaneous report was received from a clinical medical assistant (CMA) regarding a patient of unspecified age or gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported.   On 02-AUG-2023 and 04-AUG-2023, it was evaluated that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Lot #w026152 and expiration date: 29-JAN-2025) underwent temperature excursion (Product temperature excursion issue and Product storage error). Then, on 05-SEP-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) once for prophylaxis (Lot #w026152 and expiration date: 29-JAN-2025) administered for prophylaxis (dose description, and route of administration were not provided). There were no further adverse events regarding this administration.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP calling to get T/E evaluation for GARDASIL 9. GARDASIL 9 was transferred in a cooler with ice packs without a data logger from one facility to another. Gardasil 9 was administered while it had a T/E. T/E could not be evaluated. HCP did not h; This spontaneous report was received from a nurse referring to a patient of unknown age ad gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 07-SEP-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 957404, expiration date 05-OCT-2025 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was transferred in a cooler with ice packs without a data logger from one facility to another.  Lot number 957404 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered after the TE.; No reported adverse reactions; This spontaneous report was received from a medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #w039294, expiration date: 11-DEC-2024, administered for prophylaxis (strength, vaccination scheme, anatomical location,  and route of administration were not provided) following a temperature excursion (Improper storage of product in use).  No reported adverse reactions.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2310USA000671:
Sex: U
Vaccine: RVX
Symptoms: Illness, Mobility decreased
Clinical narrative: very sick; couldn't move for several days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Covid 19 vaccine (received on an unknown date).   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: very sick) and mobility decreased (Verbatim: couldn't move for several days).  The outcome of the sickness and mobility decreased were resolved.   It was unknown if the reporter considered the sickness and mobility decreased to be related to RSV vaccine.     It was unknown if the company considered the sickness and mobility decreased to be related to RSV vaccine.   Additional Information: GSK receipt date: 24-SEP-2023 The case was received from the patient interactive digital media. The patient got his/her shot and was very sick and could not move for several days. The patient stated that would never get it again, his/her COVID shots were a breeze. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fall, Gait disturbance, Movement disorder
Clinical narrative: Difficulty lifting my legs and hips; Difficulty to walk; fell trying to walk up a curb; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of movement disorder 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 movement disorder (Verbatim: Difficulty lifting my legs and hips), walking difficulty (Verbatim: Difficulty to walk) and unable to walk (Verbatim: fell trying to walk up a curb).  The outcome of the movement disorder, walking difficulty and unable to walk were not reported.   It was unknown if the reporter considered the movement disorder, walking difficulty and unable to walk to be related to Arexvy.     It was unknown if the company considered the movement disorder, walking difficulty and unable to walk to be related to Arexvy.   Additional Information: GSK Receipt date: 25-SEP-2023 This case was reported by patient via (Open field AE monitoring) interactive digital media. Follow up was not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of shingrix beyond the 6 month of 1st dose; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown).   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 drug dose administration interval too long (Verbatim: 2nd dose of shingrix beyond the 6 month of 1st dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The healthcare professional reported receiving the 2nd dose of Shingrix beyond the 6 month after first dose recommended schedule. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule(Drug dose administration interval too long) plus 7 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: very painful rash all over the body; This non-serious case was reported by a physician via sales rep and described the occurrence of painful rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, 2 days after receiving Shingrix, the patient experienced painful rash (Verbatim: very painful rash all over the body).  In JUL-2023, the outcome of the painful rash was resolved (duration 8 weeks).   The reporter considered the painful rash to be related to Shingrix.     The company considered the painful rash to be related to Shingrix.   Additional Information: GSK receipt date: 26-Sep-2023 The patient received Shingrix dose 1 at the pharmacy and got a very painful rash all over the body 2-3 days after the injection.  This lasted for several weeks and probably resolved 8 weeks after dose 1. The physician did believe that the adverse event  was related to the Shingrix vaccine. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a female 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 fatigue (Verbatim: fatigue).  The outcome of the fatigue was not reported.   It was unknown if the reporter considered the fatigue to be related to Arexvy.     It was unknown if the company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt date: 26-SEP-2023 A nurse reported that the patient was recommended to get Arexvy by her pulmonologist and got the vaccine but reported fatigue to her primary care provider. No additional details are available related to the time the vaccine was given to the time the patient asked about fatigue. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: RVX
Symptoms: Discomfort
Clinical narrative: Discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort 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 discomfort (Verbatim: Discomfort). The outcome of the discomfort was not reported.   It was unknown if the reporter considered the discomfort to be related to RSV vaccine.     It was unknown if the company considered the discomfort to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient reported after the shot effects of shot were almost as bad as the shingles shot. Th effects were not pleasant, but patient rather put up with some discomfort and then ended up in hospital. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: DTAPHEPBIP, VARZOS
Symptoms: Pain, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: sore arms; body aches; 58 year old male was given PEDIARIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concurrent medical conditions included stem cell transplant.   On 19-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) and the 1st dose of Pediarix (intramuscular, unknown arm). On 19-SEP-2023, less than a day after receiving Shingrix and Pediarix, the patient experienced pain in arm (Verbatim: sore arms), general body pain (Verbatim: body aches) and inappropriate age at vaccine administration (Verbatim: 58 year old male was given PEDIARIX).  The outcome of the pain in arm and general body pain were resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix, Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm and general body pain to be related to Shingrix, Pediarix and Pediarix 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: 25-SEP-2023 The patient was self reported. The patient had undergone stem-cell transplant, rendering all past immunizations useless.  He had begun the revaccination process. He reports that on 19th September 2023 he had his first series of injections, receiving 5 injections total, 3 in one arm and 2 in the other.  He noted that he was given Pediarix as one of the vaccines and was calling the GRC to find out if it was appropriate to receive at his age.  Referred him to his HCP for clarification and he also mentioned that Shingrix was one of the vaccines given.  He reports body aches, and sore arms.  58 year old patient received Pediarix vaccine which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number OS444, expiry date 16-SEP-2023) for prophylaxis.   On 16-SEP-2023, the patient received Infanrix. On 16-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose).  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: 25-SEP-2023 The nurse reported that a patient received a dose of an expired Infanrix, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an eighteen month old male child was vaccinated with KINRIX; 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 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 20-JUL-2023, the patient received Kinrix (left thigh) .5 mg. On 20-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an eighteen month old male child was vaccinated with KINRIX).  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: 25-SEP-2023 A reporter reported that an eighteen month old child was vaccinated with Kinrix which led to inappropriate age at vaccine administration. The reporter Consented to follow up.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: a patient that was intended to receive an HPV vaccine received Boostrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 39-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594) for prophylaxis.   On 22-SEP-2023, the patient received Boostrix. On 22-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: a patient that was intended to receive an HPV vaccine received Boostrix instead).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 25-SEP-2023 A nurse called to inform that, a patient that was intended to receive an HPV vaccine received Boostrix instead, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter.                                                                The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: a patient that was intended to receive an HPV vaccine received Boostrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 45-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594) for prophylaxis.   On 22-SEP-2023, the patient received Boostrix. On 22-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: a patient that was intended to receive an HPV vaccine received Boostrix instead).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The nurse reported the patient who was intended to receive the HPV vaccine received Boostrix vaccine which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache
Clinical narrative: felt fatigued; developed a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-SEP-2023 13:30, the patient received Arexvy. On 22-SEP-2023 11:00, 9 hrs 30 min after receiving Arexvy, the patient experienced fatigue (Verbatim: felt fatigued) and headache (Verbatim: developed a headache).  The patient was treated with paracetamol (Acetaminophen). On 24-SEP-2023, the outcome of the fatigue and headache were resolved (duration 1 day 13 hrs).   It was unknown if the reporter considered the fatigue and headache to be related to Arexvy.     It was unknown if the company considered the fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-SEP-2023 The patient received the Arexvy vaccine and on same evening had fatigue and developed headache. The patient took acetaminophen and rest OTC (over the counter) drugs. By Sunday morning symptoms of patient resolved and she felt great. The reporter did not consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix was administered on September 23rd 2023 and had expired on September 22nd; 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 44-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 23-SEP-2023, the patient received Twinrix. On 23-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix was administered on September 23rd 2023 and had expired on September 22nd). 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: 25-SEP-2023 The reporter was a pharmacy technician. The reporter wanted to know was the dose valid. The vaccine administration facility was the same as primary reporter. The pharmacist reported the administration of expired Twinrix vaccine to patient, which led to expired vaccine used. The reporter did not consent to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2 month old baby was administered Kinrix; Received kinrix first dose in DTAP AND IPV series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 20-SEP-2023, the patient received Kinrix. On 20-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 month old baby was administered Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Received kinrix first dose in DTAP AND IPV series).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter was a medical assistant. The reporter reported that the 2 month old baby patient was administered Kinrix vacine.  The reporter stated that it was supposed to be the first dose in DTAP AND IPV series, which led to Inappropriate schedule of vaccine administered. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: non-immunocompromised patients received their 2nd shingrix dose at 1 month, rather than 2 months; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: non-immunocompromised patients received their 2nd shingrix dose at 1 month, rather than 2 months).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 25-SEP-2023 The health care professional reported that some of our non-immunocompromised patients received their 2nd shingrix dose at 1 month, rather than 2 months.  He/she understand the shortest interval could be 4 weeks for certain populations. For the ones not in that population. The reporter wanted to know do we need to repeat a second dose and should we check a titer at some point. Are there any considerations that we have to tell the patient. The patient received 2nd dose of Shingrix shorter than the recommended interval, which led to shortening of vaccinations schedule. The reporter consented to follow up.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 1 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.; 21 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old male patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 25-SEP-2023, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 25-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 1 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.) and adult use of a child product (Verbatim: 21 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter was a nurse practitioner reported that 21 year old patient came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired Boostrix dose to a patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On 25-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired Boostrix dose 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: 25-SEP-2023 The reporter reported that the patient received Boostrix vaccine which was already expired, which led to expired vaccine used. The reporter asked if the patient had to be re vaccinated. The reporter consented to follow up.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix expired on Sept 16, 2023 and was administered today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received the 4th dose of Infanrix. On 25-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix expired on Sept 16, 2023 and was administered today).  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: 25-SEP-2023 Registered nurse stated that Infanrix expired on 16-SEP-2023 and was administered today, which led to expired vaccine used. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Healthcare professional did not provide initials.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site rash, Rash, Vaccination failure
Clinical narrative: rash at the injection site; red patch on my face; rash on the right side of the chest; he got shingles; he got shingles/vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number YC56Y7) for prophylaxis.   The patient's past medical history included shingles (had episode of shingles 20 years ago on the right side of his chest). Concomitant products included valaciclovir (Valacyclovir).   On 03-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 22-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 24-SEP-2023, 52 days after receiving Shingrix and 186 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: he got shingles/vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he got shingles). On an unknown date, the patient experienced injection site rash (Verbatim: rash at the injection site), skin red (Verbatim: red patch on my face) and rash (Verbatim: rash on the right side of the chest).  The outcome of the vaccination failure, injection site rash, shingles and rash were unknown and the outcome of the skin red was not resolved.   It was unknown if the reporter considered the vaccination failure, injection site rash, shingles, skin red and rash to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, injection site rash, shingles, skin red and rash to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 27-Sept-2023 The patient reported he got his 1st and 2nd dose of Shingrix at his physician's office and developed a rash on the right side of the chest.   The patient reported that it was a pretty good size rash at the injection site and it was from 1/2 to 3/4 wide and about 4 inches long and described like a band. The patient also got shingles and red patch on his face. The patient was prescribed Valacyclovir and steroid, but patient reported that he only took the Valacyclovir and not the steroid. Not all information was available. The patient's address was requested but patient forgot to provide.  Agent attempted to contact for full address information, but patient was not available. Only email information and zip code were provided.  The Vaccine Administration Facility was the same as Primary Reporter. The patient provided consent to follow up with him and with his PCP. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced shingles in September 2023; experienced shingles in September 2021; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (first outbreak of shingles was 2003) and shingles (had a history of recurrent shingles). Previously administered products included Zostavax (vaccinated with Zostavax in 2013) and Shingrix (received Shingrix in December 2016).   In APR-2018, the patient received the 1st dose of Shingrix. In SEP-2021, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: experienced shingles in September 2021). In SEP-2023, the patient experienced shingles (Verbatim: experienced shingles in September 2023).  The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles was not resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles and shingles to be related to Shingrix.     It was unknown if the company considered the shingles and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-Sept-2023 The patient stated that she was vaccinated with the first dose of Shingrix in December 2016 and the Shingrix was not approved for use in this country until 2017.   Patient was made aware, but stated that was what her records show and she was 1 and 1/2 years late with the second dose of Shingrix because it was not available. The patient received a dose of Shingrix and had experienced shingles in September 2021 and September 2023. For the current episode of shingles, the patient was on day 14 of Valtrex in which she had been taking 1000mg daily. It was unclear how the VALTREX was prescribed to the patient. The reporter consented to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye paraesthesia, Headache, Herpes zoster, Hordeolum, Hyperaesthesia
Clinical narrative: shingles rash/Suspected vaccination failure; shingles rash; itchy scalp; tingling around left eye; sensitivity of nerves on forehead; tingling around left eye socket; swollen left eye/eye was closed shut; Sty; headache; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 524S7, expiry date 12-FEB-2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19-JAN-2019, the patient received the 2nd dose of Shingrix. On 30-SEP-2018, the patient received the 1st dose of Shingrix. On 10-AUG-2023, 1664 days after receiving Shingrix and 1775 days after receiving Shingrix, the patient experienced eye swelling (Verbatim: swollen left eye/eye was closed shut). In AUG-2023, the patient experienced stye (Verbatim: Sty) and headache (Verbatim: headache). On an unknown date, the patient experienced vaccination failure (Verbatim: shingles rash/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles rash), itchy scalp (Verbatim: itchy scalp), eye paresthesia (Verbatim: tingling around left eye), hyperesthesia (Verbatim: sensitivity of nerves on forehead) and tingling (Verbatim: tingling around left eye socket).The patient was treated with valaciclovir hydrochloride (Valtrex), prednisone, ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)) and antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the vaccination failure was unknown and the outcome of the shingles, stye, headache and eye swelling were resolved and the outcome of the itchy scalp, eye paresthesia, hyperesthesia and tingling were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, stye, headache, itchy scalp, eye paresthesia, hyperesthesia, eye swelling and tingling to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, stye, headache, itchy scalp, eye paresthesia, hyperesthesia, eye swelling and tingling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient stated that she received Shingrix.  She stated that she experienced a swollen left eye and her eye doctor gave her eye drops and diagnosed her with a sty. A few days after that she started getting headaches and by 13th August 2023 her eye was closed shut. She went to emergency room. The healthcare professional prescribed antibiotics, Valtrex, Prednisone and eye drops.  She stated that she was down for a week and a half. Her symptoms had since resolved except she has itchy scalp, tingling around left eye socket and sensitivity of nerves on forehead.  She still used eye drops and Valtrex. ER (emergency visit) required. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Swelling of eyelid, Vaccination failure
Clinical narrative: shingles rash/Suspected vaccination failure; shingles rash; itchy scalp; tingling around left eye; sensitivity of nerves on forehead; tingling around left eye socket; swollen left eye/eye was closed shut; Sty; headache; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 524S7, expiry date 12-FEB-2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19-JAN-2019, the patient received the 2nd dose of Shingrix. On 30-SEP-2018, the patient received the 1st dose of Shingrix. On 10-AUG-2023, 1664 days after receiving Shingrix and 1775 days after receiving Shingrix, the patient experienced eye swelling (Verbatim: swollen left eye/eye was closed shut). In AUG-2023, the patient experienced stye (Verbatim: Sty) and headache (Verbatim: headache). On an unknown date, the patient experienced vaccination failure (Verbatim: shingles rash/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles rash), itchy scalp (Verbatim: itchy scalp), eye paresthesia (Verbatim: tingling around left eye), hyperesthesia (Verbatim: sensitivity of nerves on forehead) and tingling (Verbatim: tingling around left eye socket).The patient was treated with valaciclovir hydrochloride (Valtrex), prednisone, ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)) and antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the vaccination failure was unknown and the outcome of the shingles, stye, headache and eye swelling were resolved and the outcome of the itchy scalp, eye paresthesia, hyperesthesia and tingling were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, stye, headache, itchy scalp, eye paresthesia, hyperesthesia, eye swelling and tingling to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, stye, headache, itchy scalp, eye paresthesia, hyperesthesia, eye swelling and tingling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient stated that she received Shingrix.  She stated that she experienced a swollen left eye and her eye doctor gave her eye drops and diagnosed her with a sty. A few days after that she started getting headaches and by 13th August 2023 her eye was closed shut. She went to emergency room. The healthcare professional prescribed antibiotics, Valtrex, Prednisone and eye drops.  She stated that she was down for a week and a half. Her symptoms had since resolved except she has itchy scalp, tingling around left eye socket and sensitivity of nerves on forehead.  She still used eye drops and Valtrex. ER (emergency visit) required. The reporter did not consent to follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: a patient received a dose of Boostrix that had already expired on 24/Sep/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received Boostrix. On 27-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: a patient received a dose of Boostrix that had already expired on 24/Sep/2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 A nurse called to inform that earlier that day, a patient received a dose of Boostrix that had already expired on 24th September 2023, which led to expired vaccine used. The reporter did not consent to follow-up. This case had been linked with US2023133458, reported by same reporter.; Sender's Comments:  US-GSK-US2023133458:Same reporter 2nd patient
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: LPN mixed menveo with sterile water; LPN mixed menveo with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) for prophylaxis.   On 25-SEP-2023, the patient received Menveo. On 25-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: LPN mixed menveo with sterile water) and inappropriate dose of vaccine administered (Verbatim: LPN mixed menveo with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 27 Sep 2023 Nurse reported an LPN mixed menveo with sterile water and gave to patient instead of mixing the gray cap diluent.  The reporter asked if the patient need another injection and how long would she have to wait? The reporter did not consent to follow-up. The nurse mixed menveo with sterile water and gave to patient instead of mixing the gray cap diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.