chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them 3 times since my vac.shot/Suspected vaccination failure; had them 3 times since my vac.shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them 3 times since the vaccine shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had them after Shingles shot/Suspected vaccination failure; Had them after Shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles prior to the vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them twice. The patient had second time after shingles shot. No near as severe as the first time. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Skin lesion
Clinical narrative: Rash, red, raised w/ small lesions; Back is quite itchy; small lesions; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced red rash, pruritus and skin lesion. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the red rash, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the red rash, pruritus and skin lesion to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the shingles vaccine and about a week later he/she developed a rash (red,raised with small lesions).  The right side of back in a strip quite itchy.  The patient applied Hydrocortisone cream which helped some.  The reporter wanted to know could you get the virus 7-8 days later. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made me sicker than a dog.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR131430   Additional Information: GSK receipt date: 11-SEP-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient he/she received the one set of shots shingle vaccine and experienced sickness  The patient also stated that he/she sicker than a dog and he/she hope and pray they were much more affective than the phony Covid shots that did not worked for anyone.; Sender's Comments:  US-GSK-US2022AMR131430:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: been more than 4Yr  since 1st shot, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that it had been more than 4 years since patient had the first Shingrix shot and due to the second shot being unavailable and then forgetting about it. The patient had not received the second shot yet.  The patient wanted to know could he/she got the second shot at this time or did needed to started over again. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on stomach and back; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 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: 13-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had his/her first shingles shot and had a rash on my stomach and back. The patient wanted to know was that serious. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shot, a week later had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: This case was reported by the patient's friend via interactive digital media. The patient received dose of Shingles vaccine and a week later patient had severe case of shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles right after they got the shot; 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, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter know patient that received Shingles vaccine and right after experienced Shingles. Additional supportive information: This case had been linked with US2022AMR132557 and US2022AMR132560 reported by same. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR132560:Same reporter US-GSK-US2022AMR132557:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Discomfort, Headache, Nasal discomfort
Clinical narrative: Slight headache; nose issues; cough; chest hurting; feels heavy a little; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received Shingrix 50 ug. In September 2022, less than a week after receiving Shingrix, the patient experienced headache, nasal discomfort, cough, chest pain and sensation of heaviness. On an unknown date, the outcome of the headache, nasal discomfort, cough, chest pain and sensation of heaviness were not recovered/not resolved.   It was unknown if the reporter considered the headache, nasal discomfort, cough, chest pain and sensation of heaviness to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022  Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had Shingrix shot yesterday (before reporting). The patient was experiencing slight headache, nose issues, cough and chest hurting, feels heavy a little. The patient asked was this common or could it be side effects. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt for few days; 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.   The patient's past medical history included stress (few years back for being out of work) and rash (went from the spine and wrapped under the armpit and stopped at the nipple). Concurrent medical conditions included nerve damage and pruritus.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year 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.     Additional Information: GSK Receipt Date: 13-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had permanent nerve damage so the nipple always had a slight itchiness.  The patient did not find it too terrible, just had to wear long sleeve shirt till the rash was gone.  The patient got the vaccine recently and that actually had an hurt for a few days.  The patient could only wait now to see if it worked. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pain
Clinical narrative: painful it was; 1st dose received in jan 2022, missed my 2nd shot appointment scheduled for Feb 15 2022; got an attack / painful it was; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had).   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. In March 2022, between 1 and 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Sep-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient missed his/her 2nd shot appointment which was scheduled for 15th February 2022 and got an attack in March 2022.  Though painful it was not as bad a case as he/she recall from his/her mother when she had it.  The patient question was whether he/she should start over. Additional Supportive Information: Less than 9 months after vaccination the patient had pain. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site pain
Clinical narrative: injection site pain; shoulder pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd September 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, shoulder pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The reporter was the patient. The patient received her second dose of Shingrix on 2nd September 2022. That day she experienced pain at the injection site and shoulder. She also had flu-like symptoms. She had nothing else to report. She declined to provide HCP information as she did not see her doctor. The reporter was consented to follow up. Additional Supportive Information: This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022131429:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date February 2022) 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.   In July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In July 2022, unknown after receiving Bexsero and Bexsero 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: 12-SEP-2022 Reporter's Comments: The nurse reported that a patient administered Bexsero which was expired onFebruary 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral
Clinical narrative: Arm edema; This case was reported by a pharmacist via call center representative and described the occurrence of edema arms in a 64-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced edema arms. On an unknown date, the outcome of the edema arms was unknown.   It was unknown if the reporter considered the edema arms to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The pharmacist reported that the patient received Flu vaccinations in the past (manufacturer was unknown) and developed arm edema. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Worse arm  pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case-US2022AMR131928).   On 12th September 2022, the patient received the 2nd dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. 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 Shingrix.     Linked case(s) involving the same patient:  US2022AMR131928   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The patient reported that today on the day of reporting the patient received  second dose of Shingrix vaccine. The patient again had worse arm pain. The reporter did not consent to follow up. The patient does not wish to provide demographic or HCP information.; Sender's Comments:  US-GSK-US2022AMR131928:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after Shingrix 1st dose; This case was reported by a physician via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The reporter stated that a patient developed shingles after the first dose of Shingrix. The reporter give consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Muscle pain in shoulder/ pain; Weakness in shoulder; Unable to raise arm above head; This case was reported by a consumer via call center representative and described the occurrence of localized muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced localized muscle pain, localized muscle weakness and mobility decreased. On an unknown date, the outcome of the localized muscle pain, localized muscle weakness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the localized muscle pain, localized muscle weakness and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced muscle pain and weakness in her shoulder that resolved in about 6 days.  The reporter also stated that she started a home improvement project this week and found that the pain and weakness had returned and she was unable to raise her arm above her head. The patient was given medical disclaimer. Referred to Professional. Spoke per PI (package insert) and content. The reporter consented to follow-up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: Active shingles while Shingrix administration; This case was reported by a nurse via call center representative and described the occurrence of off label use in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (On 11th September 2022 patient had Shingles).   On 12th September 2022, the patient received Shingrix. On 12th September 2022, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Shingrix vaccine on 12th September 2022 and at that time patient had Shingles on 11th September 2022. The reporter lot number and expiration was not provided. The reporter did consent to follow up. Additional supportive information: The reporter reported that the patient received Shingrix vaccine while having active shingles, which led to off label use.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 12/2021, but he has not received the second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 13-SEP--2022 Reporters comment:  The reporter reported that her husband (the patients) received the first dose of Shingrix but yet did not received the second dose The reporter did not consent to follow-up. No additional information was provided by the reporter. Additional Supportive information: The patient received the first dose of Shingrix but did not receive the second dose, which led to incomplete course of vaccination
Sex: U
Vaccine: TDAP
Symptoms: Overdose
Clinical narrative: receiving 2 Boostrix on 13sep2022; This case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 13th September 2022, the patient received Boostrix. On 13th September 2022, unknown after receiving Boostrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.      Additional Information: GSK receipt date: 13-SEP-2022 Reporters comment:  The reporter reported that patient received the 2 doses of Boostrix on September 13, 2022. The reporter consent to follow-up. The reporter did not have any patient demographics or lot, at time of call. Additional Supportive information: Till the time of reporting, the patient received two doses of boostrix on same day which led to overdose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Trigeminal neuralgia
Clinical narrative: trigeminal neuralgia pain returned; 1st dose Jan2021, 2nd  Feb2022; This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included trigeminal neuralgia (trigeminal neuralgia, that she suffered with for years, was completely pain free). Previously administered products included Shingrix (received 0.5 ml 1st dose on 1st January 2021 into unknown arm).   On 1st February 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th September 2022, the patient experienced trigeminal neuralgia. On an unknown date, the outcome of the trigeminal neuralgia was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the trigeminal neuralgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The case was reported by the patient. The patient received second dose of Shingrix (Inappropriate schedule of vaccine) and the patient had trigeminal neuralgia, that patient suffered with for years, was completely pain free until today (the day of reporting) and pain returned.  The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric Engerix b administered to adult; Pediatric Engerix b instead adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 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: 13-SEP-2022 Reporter's Comment: The reporter reported a patient were administrated with the pediatric dose of Engerix B instead of the adult dose.  No adverse event was reported. No patient's identifiers were provided No lot number and expiration date were provided. The reporter consented to follow up. Additional Supportive Information: The reporter reported a patient were administrated with the pediatric dose of Engerix B instead of the adult dose, which led to underdose and adult use of a child product. The case had been linked to US2022AMR132515, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR132515:Same reporter
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: pediarix expired and was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Pediarix and Pediarix 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: 13-SEP-2022 Reporter's Comments: The health care professional reported that expired dose of Pediarix was administered to a patient on 13th September 2022. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Pediarix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after 2nd dose /Suspected vaccination failure; possible episode of shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 14th September 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: The Sales rep had submitted a medical information request on behalf of a healthcare provider, which contains a potential adverse event related to a possible episode of shingles after the 2nd dose of Shingrix. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Due to discrepancy in source document outcome date 14th September 2022 was captured.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her second dose of Twinrix 3 months after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22nd September 2023) 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.   Previously administered products included Twinrix (1st dose received 3 months before 2nd dose).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: 14-Sep-2022 Reporter's comment: The pharmacist reported a patient received her second dose of Twinrix 3 months after dose 1. The consent to follow up was granted. There was no date of administration available for dose 1 and 2. Additional Supportive information: The patient received 2nd dose longer than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Caller reports she gave a patient the adjuvant ONLY of the Shingrix vaccine; Caller reports she gave a patient the adjuvant ONLY of the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 5th October 2023) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 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: 14-Sep-2022 Reporter's comment: The caller was the pharmacist to report a Shingrix vaccine adverse event.  The patient received Shingrix vaccine in left arm. The caller reported that she gave a patient the adjuvant only of the Shingrix vaccine (Inappropriate Reconstitution Technique).  The call was transferred to medical information for further instructions. The caller would call the patient with follow-up steps after talking to medical information. The consent to follow up was granted. Additional Supportive Information: The caller reported that she gave a patient the adjuvant only of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient get dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix pediatric) (batch number yr532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving Havrix pediatric 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: 14-Sept-2022 Reporter's comment: The office manager had a question around Havrix Pediatric vaccine.  The reporter  had a pediatric patient get the booster dose of Havrix pediatric dose on day of reporting and after noticed that the product had expired on 9th September 2022. Agency inquiry was did they need to call the patient back in to redo the booster dose and how long do they need to wait if so. Patient's date of birth and initials unavailable at this time. The reporter will be out of the office from tomorrow until next Tuesday.  The reporter consented to follow-up via email. Additional supportive information: The patient had received an expired dose of Havrix pediatric vaccine, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient got an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number abxb39aa, expiry date 31st July 2022) 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 September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving Bexsero and Bexsero 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: 15-SEP-2022 Reporter's comment: The nurse reported that the patient was administrated Bexsero which was expired on July 2022. No adverse event was reported. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 54 yo patient received a pediatric 10 mcg dose; 54 yo patient received a pediatric 10 mcg dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old male patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 8th September 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: 15-SEP-2022 Reporter's comment: The reporter reported that, a patient received a pediatric 10 mcg dose of Engerix-B prefilled syringe.  The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received a pediatric 10 mcg dose of Engerix-B prefilled syringe, which led to underdose and adult use of a child product.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Kinrix administered subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old male 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 16th September 2022, the patient received Kinrix (subcutaneous) and Kinrix Pre-Filled Syringe Device. On 16th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment:No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received Kinrix subcutaneously, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 12Feb2021, 2nd dose not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose pre-covid on 12th February 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The reporter reported that 1 dose of Shingrix pre-covid and reported asked that did they need to start over or was one more shot sufficient. The reporter consented to follow-up via postal. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received Engerix-B pediatric (0.5 ml); Adult received Engerix-B pediatric (0.5 ml); This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 62-year-old male patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   On 16th September 2022, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 16th September 2022, unknown after receiving Engerix B pediatric, 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.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received pediatric dose of Engerix B which led to underdose and adult use of a child.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Headache
Clinical narrative: NOT FEELING LIKE MYSELF; BACK ACHES; CONSTANT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced not feeling like myself, back aches, and constant headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling like myself, constant headache and back aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220938910.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was reported that "we had a very good friend taken the JnJ shot. Now he's dead from it". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220933313- covid-19 vaccine ad26. cov2. s- death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Hyperhidrosis, Hypoaesthesia
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2022 for covid-19 prophylaxis. No concomitant medications were reported. On 2022, the patient experienced tingling of both arms from the elbow until the hands and in both legs from knees until the feet, and numbness of both arms from the elbow until the hands and in both legs from knees until the feet. On 30-AUG-2022, the patient experienced lot of runny nose, sweating, dry cough, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lot of runny nose, sweating, weakness, and tiredness on SEP-2022, and had not recovered from dry cough, tingling of both arms from the elbow until the hands and in both legs from knees until the feet, and numbness of both arms from the elbow until the hands and in both legs from knees until the feet. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rhinorrhoea
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2022 for covid-19 prophylaxis. No concomitant medications were reported. On 2022, the patient experienced tingling of both arms from the elbow until the hands and in both legs from knees until the feet, and numbness of both arms from the elbow until the hands and in both legs from knees until the feet. On 30-AUG-2022, the patient experienced lot of runny nose, sweating, dry cough, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lot of runny nose, sweating, weakness, and tiredness on SEP-2022, and had not recovered from dry cough, tingling of both arms from the elbow until the hands and in both legs from knees until the feet, and numbness of both arms from the elbow until the hands and in both legs from knees until the feet. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: DOWN THE DAY AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced down the day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down the day after vaccination was not reported. This report was non-serious.