chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain
Clinical narrative: I experienced that Shingles about 6 years go/I dealt with this shingles for a few days; It was unbearably painful/it was very uncomfortable and excruciating pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123678   Additional Information: GSK receipt date: 22-AUG-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received first dose of shingle vaccine 6 years ago and experienced pain and shingles. The patient also sated that shingles was for few days and it was very uncomfortable and excruciating pain. The patient thought initially not going to recovered but that was recovered. Additional Supportive information: For tolerance of 2nd dose of Shingles vaccine, refer case US2022AMR123678.; Sender's Comments:  US-GSK-US2022AMR123678:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: sore arms where got the shot.; 1st dose about 6 years ago; headache for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (For tolerance of 1st dose, refer case US2022AMR123664).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a month after receiving Shingles vaccine, the patient experienced injection site pain, headache and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR123664   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just had his/her 2nd shingles vaccine a few days ago and the side effects of getting it was not also comfortable.  The patient had a headache for about 3 days and sore arms where he/she got the shot. Additional Supportive Information: The patient received the 2nd dose of shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR123664:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Dr said it was shingles; lower back had five hundred blisters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and blisters. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the shingles and blisters were recovered/resolved.   It was unknown if the reporter considered the shingles and blisters to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022.  Reporter's Comments:  This case was reported by patient via interactive digital media. The patient got the shot then about two weeks later his/her lower back had five hundred blisters. The patient went to the doctor, he said it was shingles. He gave patient a couple of shots and some pills and patient got over it in a couple of days. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: sore arm; upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles twice.).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and upset stomach. On an unknown date, the outcome of the pain in arm and upset stomach were recovered/resolved.   It was unknown if the reporter considered the pain in arm and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: This case was received from Consumer via interactive digital media. The patient had shingles twice and it was no joke.  The first time was awful and the second not as bad and the patient was much younger. The older now and did not want it again so the patient just had the fist of two shots and had a sore arm and upset stomach for a couple of days but still better then shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitus, had it before but not as bad as this; This case was reported by a consumer via interactive digital media and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included tinnitus.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   The reporter considered the tinnitus to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: This case was reported by consumer (patient) via interactive digital media. The Shingle shot triggered patient's tinnitus the day after the first dose. The patient checked with a doctor for ears last week from reporting.  The patient had tinnitus before but not as bad as this was.  The ear doctor just wrote a paper regarding Covid could cause shingles.  The patient did think the shingles shot triggered tinnitus like 1000 bees in head. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on abdomen; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-AUG-2022.  Reporter's Comments: The patient self-reported this case. The patient got first Shingles vaccine and had developed a rash on his/her abdomen. The patient was asking that was this a possible side effect. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: first shot did hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR122410   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The first shot was regular one that did hurt patient. The reporter called pharmacy in their area and asked them what would be the cost if the age was under 60. Additional Supportive Information: For tolerance to the 2nd dose refer US2022AMR122410.; Sender's Comments:  US-GSK-US2022AMR122410:same report, other dose
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: am felt going to fall off; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-AUG- 2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received shingle vaccine and stated arm felt like it was going to fall off for a couple days. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Fever; Chills; Headache; Body aches during the night; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pyrexia (received 1st dose on an unknown date and had fever, refer case US2022AMR094576).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a month after receiving Shingles vaccine, the patient experienced influenza-like symptoms, fever, chills, headache and general body pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, headache and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, headache and general body pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR094576   Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient just got his/her second.  Both times the patient had flu like symptoms, fever, chills, headache, body aches during the night. The patient stated that but worth it if the vaccine helps. The patient got the vaccine because if reading all these comments. The patient was sorry everyone was going through the effects of shingles. The patient stated god bless. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094576:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Malaise, Nervousness
Clinical narrative: flu symptoms/ those symptoms; nervous; felt so sick; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced nervous and feeling unwell. On 19th August 2022, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms and nervous were unknown and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the flu symptoms, nervous and feeling unwell to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the first shot two days ago and had flu symptoms one day before reporting date. Less than a week after the vaccination, the patient felt so sick and was nervous about getting the next one but he/she really did not want shingles. The patient asked that there was anything that he/she can do to felt better for the second shot. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm just hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the 2nd dose one day before the reporting date and his/her arm just hurts this time. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: terrible pain; having clothes touch me is excruciating; 1st shot, shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than 5 months after receiving Shingles vaccine, the patient experienced shingles and touch sensitivity increased. On an unknown date, the patient experienced pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was unknown and the outcome of the pain and touch sensitivity increased were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and touch sensitivity increased to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the 1st of 2 shots in April and came down with shingles last week. The patient was in terrible pain, they gave him anti viral drug. They said hopefully between getting 1 shot and medications the patient had a mild case. The patient could not believe this was mild. The patient stated that just having clothes touch him/her was excruciating. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm  extremely sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient just got his/her first shot a week ago and his/her arm was extremely sore, but nowhere as bad as having shingles, from what the patient read. Additional supportive information: The follow-up could not be possible as no contact details were available.
Age: 16.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Accidental overdose, Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 2 doses of Boostrix administered; Adult Engerix B instead of Pediatric dose; Adult Engerix B instead of Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number yr7aa, expiry date 4th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 20th August 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 17th July 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 17th July 2022, not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device and unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On 20th August 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comments: This case was reported by the pharmacist. The patient was administrated with 2 doses of Boostrix. No adverse event was reported. The 1st dose of Boostrix was given on 20th July 2022 having Lot/batch number 997k, expiration 7th April 2024. The patient received a dose of Adult Engerix B instead of the appropriate pediatric dose according to the age. The reporter consented to follow up and then in later report did not consent to follow-up. Additional Supportive Information: The patient received a dose of Adult Engerix B instead of the appropriate pediatric dose, which led to accidental overdose, adult use of a child product. The patient had received 2 doses of Boostrix, which led to extra dose administered. This case was linked to US2022122099 for Same reporter.; Sender's Comments:  US-GSK-US2022122102:Same reporter US-GSK-US2022122099:Same reporter US-GSK-US2022122099:Same reporter
Age: 82.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: shingles on RIGHT side; backache; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) unknown for shingles.   On 5th August 2022, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2022, the patient started Valtrex at an unknown dose and frequency. On 14th August 2022, 9 days after receiving Shingrix and not applicable after starting Valtrex, the patient experienced shingles and back pain. The action taken with Valtrex was unknown. On an unknown date, the outcome of the shingles and back pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and back pain to be related to Shingrix. It was unknown if the reporter considered the back pain to be related to Valtrex.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: The reporter was the patient. The patient reports he received his first Shingrix vaccine in the left arm. On 14th August 2022 patient started getting a backache which had not resolved. On 18th August 2022, patient had a shingles on his right side. The patient went to the urgent care and the doctor placed him on Valtrex on 19th August 2022. The patient pain had gotten worse since starting the Valtrex.  The patient would contact his HCP (health care professional) to see if he should continue taking Valtrex. The reporter did not consent to follow up.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received a dose of Bexsero instead of the intended hepatitis B; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th August 2022, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 24-Aug-2022 Reporter's comment: The patient received Bexsero vaccine in left deltoid. The GlaxoSmithKline field representative reported that an office manager reported to them that the patient received a dose of Bexsero instead of the intended hepatitis B. The consent to follow-up was granted. Additional Supportive Information: The patient received Bexsero instead of the intended hepatitis B, which led to wrong vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: patient was administrated with a pediatric dose of Engerix-b; Adult patient received Engerix B pediatric; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult male patient who received HBV (Engerix B pediatric) (batch number lm992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, 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: 24-AUG-2022 Reporter's Comments: The registered nurse stated that an adult patient was administrated with a pediatric dose of Engerix-b with no adverse event was reported.  The nurse was asked about should she gave another pediatric dose and what was the recommendation. The patient's identifiers not provided The reporter consented to follow up.  Additional Supportive Information: The adult patient received Engerix B pediatric, which led to adult use of a child product and underdose.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: 46 year male patient received the havrix pediatric dose inadvertently on 24-August-2022; 46 year male patient received the havrix pediatric dose inadvertently on 24-August-2022; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 46-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 24th August 2022, the patient received the 1st dose of Havrix 720. On 24th August 2022, unknown after receiving Havrix 720, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK receipt date: 25-AUG-2022 Reporter's comment: The pharmacist reported that a 46 year old patient had received the Havrix pediatric dose inadvertently on 24th August 2022. The reporter had consent to follow-up. Additional supportive information: The adult patient received the Havrix pediatric dose inadvertently, which led to adult use of a child product and accidental underdose.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: received an extra dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (1st original dose received in March 2022).   In August 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. In August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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-AUG-2022 Reporter's Comments: The medical assistant reported that the patient received an extra dose of Kinrix. The reporter consent to follow up via email. Additional supportive information: The patient received 2nd dose, which led to extra dose administered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third Shingrix dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number H49MA, expiry date 29th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose was received in January 2022) and Shingrix (2nd dose was received in April 2022).   On 24th August 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 24th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.      Additional Information: GSK Receipt Date: 25-Aug-2022:  Reporter's comments: The reporter was the HCP (paramedic/office manager). The Healthcare professional reported that patient received first and second dose of Shingrix. The patient mistakenly received a third dose of Shingrix. The Healthcare professional had nothing else to report. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up. Additional Supportive Information: The patient was mistakenly administered a third dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: feverpatient received an expired dose of Havrix today (August 25, 2022).; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:25-AUG-2022 Reporters comment: Physician Assistant (HCP)stated that a patient received an expired dose of Havrix on 25th Aug 2022 HCP opted out of providing additional patient information. The reporter did not give consent to follow-up. Additional Supportive information: The patient received an expired dose of Havrix , which led to expired vaccine used.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received a 10 days expired dose; This 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 female patient who received HBV (Engerix B) (batch number KQO79, expiry date 12th August 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The reporter reported that, a patient received a 10 days expired dose of Engerix-B. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Engerix-B, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: Administered SQ instead of IM; Injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2022, the patient received Shingrix (subcutaneous). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site reaction. On 24th August 2022, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The pharmacist who works at the same hospital reported a nurse received a Shingrix at her physician 's office that was administered subcutaneous instead of intramuscular. The healthcare professional called in to get efficacy data for a subcutaneous Shingrix dose, at the end of the call she mentioned in passing that the patient had an injection site reaction. The reporter gave consent to follow up via email. Additional Supportive Information: Shingrix administered subcutaneous instead of intramuscular which led to intramuscular formulation administered by other route.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of HAVRIX administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The reporter reported that the patient received an expired dose of Havrix 1440 (Hepatitis A) vaccine. The reporter stated that the vaccine administration facility was the same as primary reporter. Additional supportive information: The patient received a Havrix 1440 which was already expired, which led to expired vaccine used.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 2 y/o; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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-AUG-2022 Reporter's comment: The nurse reported that the two-year-old patient received a dose of Kinrix. The reporter consented to follow up. Additional Supportive Information: The 2 years old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix adult administered to a 2 y/o; Havrix adult administered to a 2 y/o; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included HAVRIX PEDIATRIC (1st dose received on 25th February 2022).   On 25th August 2022, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-Aug-2022 Reporters comments: The medical assistant reported that the patient was inadvertently administered an adult dose of Havrix. The reporter did not consent to follow-up. Additional Supportive Information: The child patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The registered nurse called to report that patient received an expired Havrix vaccine which was expired on 9th August 2022. No more patient´s details provided. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old female patient who received HBV (Engerix B) (batch number LG5RN, expiry date 20th August 2022) for prophylaxis.   On 25th August 2022, the patient received the 3rd dose of Engerix B. On 25th August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 25-AUG-2022 Reporter's comment: Medical Assistant(MA) reported that the patient was administered a dose of Engerix-B on 25th August 2022 which had an expiration date of 20th August 2022. At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Engerix-B which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: 8 patients got vx reconstituted w/wrong adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 26-Aug-2022 Reporter's comment: The GlaxoSmithKline representative reported that a wrong solution used adverse event for Shingrix with limited information. The reporter reported that the office manager at one of his accounts stated that the Shingrix vaccine was reconstituted with the wrong adjuvant. He stated that instead of using the adjuvant that comes with Shingrix, an adjuvant specified for the Merck MMR vaccine was used to reconstitute the Shingrix antigen.   The reporter stated that office manager indicated that this event happened for 8 patients.   The reporter had no further information regarding patient demographics or the vaccine itself. No follow-up was requested. The reporter did not consent to follow-up. Additional supportive information: The patient received Shingrix vaccine which was reconstituted with wrong solution, which led to wrong solution used in drug reconstitution. This case was for 2 of 8 patients.; Sender's Comments:  US-GSK-US2022AMR124633:Same reporter. US-GSK-US2022AMR124632:Same reporter. US-GSK-US2022AMR124631:Same reporter. US-GSK-US2022AMR124630:Same reporter. US-GSK-US2022AMR124629:Same reporter. US-GSK-US2022AMR124634:Same reporter. US-GSK-US2022124281:Same reporter.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Nausea
Clinical narrative: Malaise; Nausea; This case was reported by a nurse via call center representative and described the occurrence of malaise in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31st August 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo. In August 2022, less than 2 weeks after receiving Menveo, the patient experienced malaise and nausea. On an unknown date, the outcome of the malaise and nausea were unknown.   It was unknown if the reporter considered the malaise and nausea to be related to Menveo.     Additional Information: GSK Receipt Date: 26-Aug-2022:  Reporter's comments: The nurse practitioner called to inquire about any additional information on reactions. The nurse practitioner reported the patient received Menveo of certain lot number.  The patient experienced malaise and nausea. The nurse practitioner stated read the adverse event section in the product PI (package insert) but wanted additional information on reactions. The reporter did not consent to follow up. Additional Supportive Information: This case had been linked with US2022124288, reported by same reporter.; Sender's Comments:  US-GSK-US2022124288:Same reporter.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Overdose
Clinical narrative: received Pediarix and Infanrix on 25Aug2022; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 26-AUG-2022.  Reporter's Comments: An health care professional (HCP) reported that a patient received Pediarix and Infanrix (double dose of DTaP) on the same day.  The health care professional (HP) did not have the patient's date of birth (DOB) or the lot/exp dates at the time of report. The consent to follow up was granted. Additional Supportive Information: As patient had Pediarix and Infanrix having same antigen on the same day, which led to overdose of DTPa component.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Given expired dosage; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAB (Twinrix adult) (batch number X239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Twinrix adult (intramuscular) 1 ml and Twinrix Pre-Filled Syringe Device. On 26th August 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The caller was a pharmacist stated that a patient was given an expired dosage of Twinrix on 26th August 2022 on right arm which was expired on 7th August 2022. The reporter did not consented to follow-up.  No HCP for follow up. Additional Supportive Information: The patient received expired dose of Twinrix adult, which led to expired vaccine used.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant; received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingrix. On 22nd August 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter reported that, a patient received only the adjuvant (AS01B) portion of Shingrix without reconstituting in the right deltoid. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received only the adjuvant (AS01B) portion of Shingrix without reconstituting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.