chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RV1
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: in process of administering Rotarix when she took off the cap; a drop squirted in her eye; This non-serious case was reported by a nurse via sales rep and described the occurrence of occupational exposure while administering product in a 21-year-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced occupational exposure while administering product (Verbatim: in process of administering Rotarix when she took off the cap) and exposure via eye contact (Verbatim: a drop squirted in her eye). The outcome of the occupational exposure while administering product and exposure via eye contact 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: 26-MAY-2023. Medical Assistant was in process of administering Rotarix. When she took off the cap, a drop squirted in her eye. She went home and rinse her eye and notified office manager. A portion of the Rotarix dose leaked on the pharmacist eye, which led to exposure via eye contact and occupational exposure while administering product. The reporter agrees to follow up from GlaxoSmithKline.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Feel really badly; Significant arm pain; Difficulty lifting arm; Fever; Fatigue; This non-serious case was reported by a consumer and described the occurrence of feeling bad in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feel really badly), pain in arm (Verbatim: Significant arm pain), mobility decreased (Verbatim: Difficulty lifting arm), fever (Verbatim: Fever) and fatigue (Verbatim: Fatigue). The outcome of the feeling bad, pain in arm, mobility decreased, fever and fatigue were resolved (duration 1 day).   It was unknown if the reporter considered the feeling bad, pain in arm, mobility decreased, fever and fatigue to be related to Shingrix.     It was unknown if the company considered the feeling bad, pain in arm, mobility decreased, fever and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023 The patient received 2nd dose of Shingrix and had fever, fatigue, significant arm pain and difficulty lifting arm for a day or so but made her feel really badly. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: The first vaccine made me sick for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Covid vaccine (On an unknown date patient received covid vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: The first vaccine made me sick for 2 days). The outcome of the sickness was resolved (duration 2 days).   The reporter considered the sickness to be possibly related to Shingrix.     The company considered the sickness to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023. This case was reported by a consumer via interactive digital media It was reported the patient got shingles. The patient received covid vaccine. It was reported patient cannot say that patient was even aware that it was a threat before got it. The patient received Shingrix and vaccine made sick for 2 days, the patient not used to this. The reporter thought that the event might had been related to product/device.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: he had a negative reaction to Shingrix1st shot/he had a flu-like reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza like illness (Verbatim: he had a negative reaction to Shingrix1st shot/he had a flu-like reaction). The outcome of the influenza like illness was resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingrix.     It was unknown if the company considered the influenza like illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2023 and 01-JUN-2023 The reporter was the patient who had stated that, he had got the 1st shot 4 years ago.  No second shot received. The reporter had asked if he should get a new series.  He was advised he would receive a letter from safety. He stated that the reason he did not received Shingrix second shot was that he had a negative reaction to Shingrix first shot.  He indicated that he had a flu-like reaction. (The event was resolved).  No further details were provided. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: incomplete course of vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th March 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-May-2023 The case was received from the patient via interactive digital media. The patient asked that he or she would have to start over on the two shot's or just need to get the second shot. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive the second shot of Shingrix, which led to incomplete course of  vaccination.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Injection site pain, Muscular weakness, Somnolence
Clinical narrative: weakness in both legs; Fatigue; 3 to 4 naps per day; barely able to walk; experiencing pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix. In MAY-2023, 2 days after receiving Shingrix, the patient experienced lower extremities weakness of (Verbatim: weakness in both legs), fatigue (Verbatim: Fatigue), sleepiness (Verbatim: 3 to 4 naps per day) and walking difficulty (Verbatim: barely able to walk). On 16-MAY-2023, the patient experienced injection site pain (Verbatim: experiencing pain at the injection site). The outcome of the injection site pain was resolved (duration 1 day) and the outcome of the lower extremities weakness of, fatigue, sleepiness and walking difficulty were not resolved.   It was unknown if the reporter considered the injection site pain, lower extremities weakness of, fatigue, sleepiness and walking difficulty to be related to Shingrix.     It was unknown if the company considered the injection site pain, lower extremities weakness of, fatigue, sleepiness and walking difficulty to be related to Shingrix.   Additional Information: GSK receipt date:26-MAY-2023 The reporter reported after receiving first dose of Shingrix at pharmacy she experienced pain at the injection site, fatigue, and weakness in both legs.She reported experiencing pain at the injection site, immediately which resolved the next day.  She reported onset of leg weakness and fatigue two to three days after receipt of Shingrix dose. She reported being so fatigued she took 3 to 4 naps per day. Prior to receiving Shingrix,she reported taking no naps or only one per day. She reported leg weakness in both legs, so she was barely able to walk.  She reported fatigue and leg weakness were ongoing. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Recurring shingles every 6 weeks for 3 episodes so far; Circumstance or information capable of leading to medication error; considering giving a third dose; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 29-JUN-2022, the patient received the 2nd dose of Shingrix. On 29-APR-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recurring shingles every 6 weeks for 3 episodes so far), circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and extra dose administered (Verbatim: considering giving a third dose). The outcome of the vaccination failure, circumstance or information capable of leading to medication error and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 and 30-MAY-2023 The pharmacist was considering giving a third dose to the patient and called to ask for the information and explained wanted to review as the patient who was fully vaccinated with recurring shingles every 6 weeks for 3 episodes so far. The patient received 1st and 2nd dose of Shingrix on April 29, 2022 and June 29, 2022 respectively. The pharmacist was considering giving a third dose to the patient, which led to extra dose administered and circumstance or information capable of leading to medication error. 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 The consent for follow up was not asked.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: the injected arm swelled; the injected arm swelled and it hurt really bad; shingles on leg; it has come back and it is painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (vaccinated with live Shingles vaccine (Zostavax) 7 to 8 years ago from reporting).   In FEB-2023, the patient received the 1st dose of Shingrix (unknown arm). On 24-MAY-2023, between 2 and 4 months after receiving Shingrix, the patient experienced pain (Verbatim: it has come back and it is painful). On an unknown date, the patient experienced swelling arm (Verbatim: the injected arm swelled), pain in arm (Verbatim: the injected arm swelled and it hurt really bad) and shingles (Verbatim: shingles on leg). The patient was treated with medication unknown (Cream (Medication Unknown)). The outcome of the swelling arm and pain in arm were resolved and the outcome of the shingles and pain were not resolved.   The reporter considered the swelling arm and pain in arm to be related to Shingrix. It was unknown if the reporter considered the shingles and pain to be related to Shingrix.     The company considered the swelling arm and pain in arm to be related to Shingrix. It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The case was self-reported by the patient. The patient received first dose of Shingrix about 3 months ago from reporting and reported that the injected arm swelled, and it hurt really bad. Two or three weeks later, the patient broke out in shingles on her leg. The patient went to the doctor, and he said it looks like shingles and he prescribed a cream, and it cleared up.  The patient stated that her doctor did not want her to get Shingrix second shot. Now, she was experiencing a similar situation with her other leg. The patient had it on other leg and it had come back, and it was painful.  The patient had not yet seen a doctor about this because it only began 2 days ago. Therefore, she did not know for sure it was shingles again. But she said it covers a big portion of her leg and she was using an unspecified cream and she was going to get Benadryl if it itches. No further information was collected due to a poor phone connection.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not yet received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2018).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not yet received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received her first dose of Shingrix about 4 years ago and never got a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received her first dose of Shingrix about 4 years ago and never got a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 The pharmacy technician reported that a patient never got a second dose. The reporter did not ask about follow-up - pharmacy address is above in HCP details. 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, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: accidentally received a 3rd dose on 5/27/2023; both doses of Shingrix in 2020 (1st-1/8/2020 and 2nd-8/14/2020); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2020).   On 27-MAY-2023, the patient received the 3rd dose of Shingrix. On 14-AUG-2020, the patient received the 2nd dose of Shingrix. On 14-AUG-2020, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: both doses of Shingrix in 2020 (1st-1/8/2020 and 2nd-8/14/2020)). On 27-MAY-2023, the patient experienced extra dose administered (Verbatim: accidentally received a 3rd dose on 5/27/2023). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 The health care professional (HCP) declined to provide patient demographics. She also did not had the lot number for the 2nd dose of Shingrix (which was a late dose).  The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via mail. The patient accidentally received a 3rd dose of Shingrix, which led to extra dose administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received their first dose of Twinrix standard schedule in MAY-2022. The second dose was given on 27-MAY-2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   Previously administered products included Twinrix (1st dose received in May 2022).   On 27-MAY-2023, the patient received the 2nd dose of Twinrix. On 27-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received their first dose of Twinrix standard schedule in MAY-2022. The second dose was given on 27-MAY-2023.). 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: 31-MAY-2023 The reporter declined to provide initials.  The reporter did not consent to follow-up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   On 31-MAY-2023, the patient received Havrix. On 31-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 31-May-2023 The healthcare professional called to inform that earlier that day, a patient received an expired dose of Havrix, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Twinrix dose and Hep-A series completed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2023) for prophylaxis.   Previously administered products included Hepatitis A vaccine (completed Hepatitis A series on an unknown date).   On 30-MAY-2023, the patient received Twinrix. On 30-MAY-2023, an unknown time after receiving Twinrix, the patient experienced extra dose administered (Verbatim: Twinrix dose and Hep-A series completed). 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: 31-May-2023 The patient received a dose of Twinrix after receiving the complete dose of Hepatitis A years ago (extra dose for Hepatitis-A), which led to extra dose administered.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed; a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed) and inappropriate dose of vaccine administered (Verbatim: a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-May-2023 A physician wished to know how to proceed. Information about the event, vaccine and patient were disclosed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient was accidentally given only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema
Clinical narrative: redness at injection site and a red spot further down the left arm; She also mentions being fatigued for a few days, starting the day after vaccine, but has since subsided.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 26-MAY-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site and a red spot further down the left arm) and fatigue (Verbatim: She also mentions being fatigued for a few days, starting the day after vaccine, but has since subsided.). The outcome of the injection site erythema was not resolved and the outcome of the fatigue was resolved.   It was unknown if the reporter considered the injection site erythema and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site erythema and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient reported that she received dose 1 Shingrix. The patient stated that the next day she noticed redness at injection site and a red spot further down the left arm which was not resolved yet at the time of reporting. The patient also mentioned being fatigued for a few days, started the day after vaccine, but had since subsided.  The patient was referred to Health care professional. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed 2nd dose within 6 month window; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female 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 received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed 2nd dose within 6 month window). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter reported that the patient missed to receive her second dose of Shingrix vaccine. The reporter did not had expiration date and lot number. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Diarrhoea, Dysphonia, Influenza like illness
Clinical narrative: cough; voice changes - hoarseness; nausea; diarrhea; flu-like symptoms; shivering; injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix. On 25-MAY-2023, 30 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site soreness), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), influenza-like symptoms (Verbatim: flu-like symptoms) and shivering (Verbatim: shivering). On 28-MAY-2023, the patient experienced cough (Verbatim: cough) and hoarseness (Verbatim: voice changes - hoarseness). The outcome of the injection site pain was resolved and the outcome of the cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering were not resolved.   It was unknown if the reporter considered the injection site pain, cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering to be related to Shingrix.     It was unknown if the company considered the injection site pain, cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient self-reported this case. The patient called to ask about Shingrix side effects.   The patient began experiencing shivering, flu-like symptoms, diarrhea, nausea and soreness at injection site one-half hour after her shot.   All symptoms remained with patient except injection site soreness, which resolved after a couple of days. About 4 days ago from reporting, the patient began having voice changes and cough.  She did not provide consent to contact her health care professional, as she would prefer to have a conversation with her health care professional first. The reporter did not consent to follow-up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: cough; voice changes - hoarseness; nausea; diarrhea; flu-like symptoms; shivering; injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix. On 25-MAY-2023, 30 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site soreness), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), influenza-like symptoms (Verbatim: flu-like symptoms) and shivering (Verbatim: shivering). On 28-MAY-2023, the patient experienced cough (Verbatim: cough) and hoarseness (Verbatim: voice changes - hoarseness). The outcome of the injection site pain was resolved and the outcome of the cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering were not resolved.   It was unknown if the reporter considered the injection site pain, cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering to be related to Shingrix.     It was unknown if the company considered the injection site pain, cough, hoarseness, nausea, diarrhea, influenza-like symptoms and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient self-reported this case. The patient called to ask about Shingrix side effects.   The patient began experiencing shivering, flu-like symptoms, diarrhea, nausea and soreness at injection site one-half hour after her shot.   All symptoms remained with patient except injection site soreness, which resolved after a couple of days. About 4 days ago from reporting, the patient began having voice changes and cough.  She did not provide consent to contact her health care professional, as she would prefer to have a conversation with her health care professional first. The reporter did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 20 months male baby was administered Boostrix instead of Infarix; 20 months male baby was administered Boostrix instead of Infarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 01-JUN-2023, the patient received Boostrix (left thigh). On 01-JUN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 20 months male baby was administered Boostrix instead of Infarix) and inappropriate age at vaccine administration (Verbatim: 20 months male baby was administered Boostrix instead of Infarix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was the medical assistant who stated that the vaccine was administered in left thigh at the medical office.  The reporter consented to follow up. On the day of reporting, a 20 months patient was administered Boostrix instead of Infarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site infection, Product administered at inappropriate site
Clinical narrative: patient had developed an infection in his lower arm  where it was given and required antibiotics; incorrect vaccination site that was well below the deltoid muscle; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site infection (Verbatim: patient had developed an infection in his lower arm  where it was given and required antibiotics) and vaccine administered at inappropriate site (Verbatim: incorrect vaccination site that was well below the deltoid muscle). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the injection site infection was not reported and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site infection to be related to Shingrix.     It was unknown if the company considered the injection site infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter reported that the patient was concerned that the Shingrix might not be effective due to inappropriate vaccine administration. The reporter consented to follow up. The Shingrix injection was given below the deltoid muscle, which led to vaccine administered at inappropriate site. This case was identified as duplicate of US2023077761. Case US2023077761 was deleted, and all the future correspondence will be added in the present case US2023AMR077452 which stands as a case of record for this subject.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 31-MAY-2023, the patient received Boostrix. On 31-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: (Possible) administration of extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: (Possible) administration of extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 01-JUN-2023 The reporter enquired that were there additional side effects, if the patient accidentally took three doses of Shingrix vaccine. Medical Information (MI) did not speak with the health care provider, so requested to follow up with the sales representative for more information.  The patient received 3rd dose of Shingrix (possible), which led to extra dose administered.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The administration of Kinrix to a 31 months old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 31-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: The administration of Kinrix to a 31 months old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was a medical assistant. The reporter wanted to know the information about the administration of Kinrix vaccine to the 31 month old patient. The reporter did consent to follow up. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose given/9 month old patient accidentally received a 4th dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   Previously administered products included Infanrix (received three doses of Infanrix on an unknown date).   On an unknown date, the patient received the 4th dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too short (Verbatim: Extra dose given/9 month old patient accidentally received a 4th dose of Infanrix ). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-June-2023 A nurse wished to know if there was any information that could be given.  The partial information about the  patient, vaccine and event were given. The reporter consented to follow-up. The patient received 4th dose of Infanrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Pediarix Expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Pediarix. On 01-JUN-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix Expired dose administration). 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: 02-JUN-2023 The reporter was a clinic manager. The reporter asked for information about the administration of an expired Pediarix dose to patient. The reporter asked how to proceed with this patient.  The reporter consented to follow up. The patient received an expired dose of Pediarix, which led to expired vaccine used.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Havrix. On 01-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Havrix). 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: 02-JUN-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient was administered an expired dose of Havrix, which led to expired vaccine used. The case had been linked to US2023078480, reported by the same reporter, for a different patient.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Havrix. On 01-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 02-JUN-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient was administered an expired dose of Havrix, which led to expired vaccine used. The case had been linked to US2023078479, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023078479:Same reporter, different patients
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received Hib (Hiberix) (batch number EK5Y2, expiry date 25-MAY-2023) for prophylaxis.   On 02-JUN-2023, the patient received the 3rd dose of Hiberix. On 02-JUN-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter was a medical assistant. The reporter wished to know how to proceed.  The information about patient, vaccine and event was provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient accidentally received an expired dose of Hiberix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose between 12 or 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter was pharmacist student. The reporter was looking for recommendation on timing for Shingrix late second dose.  No further details on this case were available during the call. The reporter personal information on Medical Information database was declined. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 02-JUN-2023, the patient received Kinrix. On 02-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Kinrix). 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: 02-JUN-2023 The reporter consented to follow up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY; This spontaneous report received from a patient via a company representative via concerned a patient of unspecified age, sex, race and ethnicity. 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, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 31-MAY-2023, the patient was diagnosed with bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230606764- Bell's palsy. The event has an unknown/unclear temporal relationship, and is labeled. There are no other factors more likely to be associated with the event than the vaccine. Therefore, this event is considered consistent with vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruising of arm; This non-serious case was reported by a consumer and described the occurrence of bruising of arm in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bruising of arm (Verbatim: Bruising of arm). The outcome of the bruising of arm was not resolved.   It was unknown if the reporter considered the bruising of arm to be related to Shingles vaccine.     It was unknown if the company considered the bruising of arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was a caregiver. At the time of reporting, the symptoms were not treated. The reporter did not give consent to contact.