chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RSV
Symptoms: Influenza like illness
Clinical narrative: reported "flu like" symptoms for 1 day after receiving shot; This non-serious case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced influenza-like symptoms (Verbatim: reported "flu like" symptoms for 1 day after receiving shot). The outcome of the influenza-like symptoms was resolved (duration 1 day).   It was unknown if the reporter considered the influenza-like symptoms to be related to Arexvy.     It was unknown if the company considered the influenza-like symptoms to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-NOV-2023 The pharmacist reported that the patient took Arevxy. The patient experience flu like symptoms for first day after receiving shot.   The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: COVID19, RSV
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; feeling sicker; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Arexvy and MODERNA COVID VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm) and feeling unwell (Verbatim: feeling sicker). The outcome of the pain in arm and feeling unwell were resolving.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Arexvy.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-NOV-2023 The pharmacist reported that when Arexvy was co-administered with Moderna Covid vaccine, patients were reporting sore arm and feeling sicker.  This was occurring with the patients that reported not usually having any reactions with vaccines.  However, patients usually felt better after a few days. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Moderna covid vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2 dose yet; This non-serious 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 31st March 2023).   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: not received 2 dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-NOV-2023 The patient reported that he/she had first dose of Shingrix on March 31st and missed the 2 to 6 month booster window. The enquired do he/she need to start over or  get the booster on day of reporting after 7 and half months since first one. 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: Injection site pain
Clinical narrative: stinging when the medication enters the muscle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stinging in an unspecified number of patients 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 stinging (Verbatim: stinging when the medication enters the muscle). The outcome of the stinging was not reported.   It was unknown if the reporter considered the stinging to be related to Shingrix.     It was unknown if the company considered the stinging to be related to Shingrix.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacist stated that some people have reported stinging when the medication enters the muscle, but not from the needle. He mentioned that he noticed it as well when he received his first dose of Shingrix. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.  No patient demographics just mentioned some patients.  This case is linked with US2023154447, same reporter.; Sender's Comments:  US-GSK-US2023154447:CASE FOR REPORTER/SAME PRODUCT/SAME EVENT
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dyspnoea, Immediate post-injection reaction, Incomplete course of vaccination, Injection site pain
Clinical narrative: Blisters; patient has not received the second dose of Shingrix; Burning at injection site; Sore torso (left side front and back); made it hard to take a deep breath; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site burning in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peanut allergy, sulfonamide allergy, allergic reaction to analgesics, penicillin allergy and allergy to antibiotic.   In APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In APR-2023, immediately after receiving Shingrix, the patient experienced injection site burning (Verbatim: Burning at injection site), pain (Verbatim: Sore torso (left side front and back)) and shortness of breath (Verbatim: made it hard to take a deep breath). On an unknown date, the patient experienced blister (Verbatim: Blisters) and incomplete course of vaccination (Verbatim: patient has not received the second dose of Shingrix). The outcome of the injection site burning and incomplete course of vaccination were unknown and the outcome of the pain, shortness of breath and blister were resolved.   It was unknown if the reporter considered the injection site burning, pain, shortness of breath and blister to be related to Shingrix.     It was unknown if the company considered the injection site burning, pain, shortness of breath and blister to be related to Shingrix.   Additional Information: GSK receipt date: 7-Nov-2023 The patient received a dose of  Shingrix in the upper left arm and experienced burning in the upper left arm while the vaccine was being injected.   By the end of the day, her torso (left side front and back) became sore, for which it made it hard to take a deep breath and this lasted for about three and one-half weeks.   Within a few days after receiving the vaccine, the patient experienced blisters on the left side of her back, which then started to drain after 3 weeks and continued to drain for a week and a half. The health care professional contact information was as complete as the consumer could provide. The reporter/patient gave consent to follow up with health care professional. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Blisters; patient has not received the second dose of Shingrix; Burning at injection site; Sore torso (left side front and back); made it hard to take a deep breath; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site burning in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peanut allergy, sulfonamide allergy, allergic reaction to analgesics, penicillin allergy and allergy to antibiotic.   In APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In APR-2023, immediately after receiving Shingrix, the patient experienced injection site burning (Verbatim: Burning at injection site), pain (Verbatim: Sore torso (left side front and back)) and shortness of breath (Verbatim: made it hard to take a deep breath). On an unknown date, the patient experienced blister (Verbatim: Blisters) and incomplete course of vaccination (Verbatim: patient has not received the second dose of Shingrix). The outcome of the injection site burning and incomplete course of vaccination were unknown and the outcome of the pain, shortness of breath and blister were resolved.   It was unknown if the reporter considered the injection site burning, pain, shortness of breath and blister to be related to Shingrix.     It was unknown if the company considered the injection site burning, pain, shortness of breath and blister to be related to Shingrix.   Additional Information: GSK receipt date: 7-Nov-2023 The patient received a dose of  Shingrix in the upper left arm and experienced burning in the upper left arm while the vaccine was being injected.   By the end of the day, her torso (left side front and back) became sore, for which it made it hard to take a deep breath and this lasted for about three and one-half weeks.   Within a few days after receiving the vaccine, the patient experienced blisters on the left side of her back, which then started to drain after 3 weeks and continued to drain for a week and a half. The health care professional contact information was as complete as the consumer could provide. The reporter/patient gave consent to follow up with health care professional. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Engerix-b Adult instead of Engerix-B Ped vaccine; Engerix-b Adult instead of Engerix-B Ped vaccine; Engerix-b Adult instead of Engerix-B Ped vaccine; Engerix-b Adult instead of Engerix-B Ped vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   On 07-NOV-2023, the patient received the 2nd dose of Engerix B adult. On 09-OCT-2023, the patient received the 1st dose of Engerix B adult. On 09-OCT-2023, not applicable after receiving Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engerix-b Adult instead of Engerix-B Ped vaccine) and overdose (Verbatim: Engerix-b Adult instead of Engerix-B Ped vaccine). On 07-NOV-2023, the patient experienced adult product administered to child (Verbatim: Engerix-b Adult instead of Engerix-B Ped vaccine) and overdose (Verbatim: Engerix-b Adult instead of Engerix-B Ped vaccine). The outcome of the adult product administered to child, overdose, adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-NOV-2023 The reporter was a medical assistant who stated about an 18 years old patient who received first and second doses of Engerix-b Adult instead of Engerix-B Pediatric vaccine.  According to the reporter the patient was doing fine, and the treating physician was aware. The reporter consented to follow up. The patient received a first and second doses of Engerix B adult instead of Engerix-B Pediatric vaccine, which led to the adult product administered to child and overdose.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nasal congestion, Oropharyngeal pain
Clinical narrative: pain at injection site/soreness; redness at injection site; swelling; nasal congestion; cough; tonsil pain/ sore throat; the male patient  should have been given the MCV4 vaccine (Wrong Vaccine Administered); This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis.   On 30-OCT-2023, the patient received Bexsero (intramuscular, left arm) .5 ml. On 30-OCT-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the male patient  should have been given the MCV4 vaccine (Wrong Vaccine Administered)). On an unknown date, the patient experienced injection site pain (Verbatim: pain at injection site/soreness), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling), nasal congestion (Verbatim: nasal congestion), cough (Verbatim: cough) and oropharyngeal pain (Verbatim: tonsil pain/ sore throat). The outcome of the injection site pain was not resolved and the outcome of the injection site erythema and injection site swelling were resolving and the outcome of the nasal congestion, cough and oropharyngeal pain were not reported and the outcome of the wrong vaccine administered was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nasal congestion, cough and oropharyngeal pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, nasal congestion, cough and oropharyngeal pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2023 The physician reports that the patient's mother states the patient experienced soreness, redness, swelling, and pain at injection site. The redness and swelling had improved, but pain was ongoing. The patient also had nasal congestion, cough, and tonsil pain or sore throat after receiving Bexsero. The patient was administered a Bexsero Vaccine instead of MCV4 vaccine, which led to wrong vaccine administered. No further details provided, but physician consents to follow up from safety.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: pain at injection site/soreness; redness at injection site; swelling; nasal congestion; cough; tonsil pain/ sore throat; the male patient  should have been given the MCV4 vaccine (Wrong Vaccine Administered); This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis.   On 30-OCT-2023, the patient received Bexsero (intramuscular, left arm) .5 ml. On 30-OCT-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the male patient  should have been given the MCV4 vaccine (Wrong Vaccine Administered)). On an unknown date, the patient experienced injection site pain (Verbatim: pain at injection site/soreness), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling), nasal congestion (Verbatim: nasal congestion), cough (Verbatim: cough) and oropharyngeal pain (Verbatim: tonsil pain/ sore throat). The outcome of the injection site pain was not resolved and the outcome of the injection site erythema and injection site swelling were resolving and the outcome of the nasal congestion, cough and oropharyngeal pain were not reported and the outcome of the wrong vaccine administered was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nasal congestion, cough and oropharyngeal pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, nasal congestion, cough and oropharyngeal pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2023 The physician reports that the patient's mother states the patient experienced soreness, redness, swelling, and pain at injection site. The redness and swelling had improved, but pain was ongoing. The patient also had nasal congestion, cough, and tonsil pain or sore throat after receiving Bexsero. The patient was administered a Bexsero Vaccine instead of MCV4 vaccine, which led to wrong vaccine administered. No further details provided, but physician consents to follow up from safety.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Product complaint
Clinical narrative: Pharmaceutical product complaint; sprayed back; product went on his face; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental occupational exposure to product in a adult male patient who received Herpes zoster (Shingrix) (batch number 74Z97, expiry date 21-NOV-2025) and (batch number 4JP7M, expiry date 21-NOV-2025) for prophylaxis. This case was associated with a product complaint.   On 07-NOV-2023, the patient received Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced accidental occupational exposure to product (Verbatim: sprayed back) and exposure via skin contact (Verbatim: product went on his face). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental occupational exposure to product, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 and 08-NOV-2023 Pharmacist stated that he was reconstituting a dose of Shingrix, the liquid product which also contained antigen sprayed back. The product went on his face and up his nose, the pharmacist washed his face and blew his nose and rinsed with water. Batch number of adjuvant was 74Z97 and antigen was 4JP7M. The reporter consented to follow up. The liquid product of Shingrix which also contained antigen sprayed back and the content came into contact with his face and nose, which led to accidental occupational exposure to product and exposure via skin contact. The Vaccine Administration Facility was the same as Primary Reporter. The reporter injected air from the syringe into the vial during preparation. Up to 0.5 ml air injected into adjuvant vial to draw it out. It was unknown if the leak coming from the stopper at the neck of the vial or from a needle puncture in the stopper. The vial rubber stopper/metallic skirt did not detach or become loose during handling or without any manipulation. The plastic flip-off or also the metallic skirt/ring of the vial before handling. There was no evidence of leakage in package or carton.
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient has a delayed 2nd dose of Twinrix; 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 72-year-old male patient who received HAB (Twinrix adult) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix adult (1st dose administered in March 2023).   On 07-NOV-2023, the patient received the 2nd dose of Twinrix adult. On 07-NOV-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: patient has a delayed 2nd dose of Twinrix). 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: 07-NOV-2023 The reporter was asking when the 3rd dose should be administered. The Pharmacist stated a patient has a delayed 2nd dose of Twinrix  administering today (on the day of reporting) after 1st dose administered which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: some people have reported stinging when the medication enters the muscle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stinging in a adult 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 stinging (Verbatim: some people have reported stinging when the medication enters the muscle). The outcome of the stinging was unknown.   It was unknown if the reporter considered the stinging to be related to Shingrix.     It was unknown if the company considered the stinging to be related to Shingrix.   Additional Information: GSK Receipt Date - 07-NOV-2023 The pharmacist reporter that for some people  of patient reported stinging at the time of medication enter the muscle , but not from needle  The reporter also stated that he as well noticed when he received first dose of shingrix. The reporter consent to follow up This case was linked with US2023AMR159370 as for the same reporter.; Sender's Comments:  US-GSK-US2023AMR159370:SOME PATIENT /SAME PRODUCT/SAME EVENT
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently received BOOSTRIX on November 7, 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-day-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7C75N, expiry date 06-DEC-2025) for prophylaxis.   On 07-NOV-2023, the patient received Boostrix. On 07-NOV-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently received BOOSTRIX on November 7, 2023). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter was a pharmacist.   The pharmacist reported that an infant inadvertently received Boostrix, which led to inappropriate age at vaccination.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NC4N, expiry date 08-OCT-2023) for prophylaxis.   On 07-NOV-2023, the patient received Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 08-NOV-2023 The pharmacist reported that a 75 year old male patient was administered an expired dose of Shingrix which led to expired vaccine used. At the time of reporting, repeat dose had not been administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case is linked with US2023154978, same reporter.; Sender's Comments:  US-GSK-US2023154978:Same reporter,2nd patient
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dysphagia, Fatigue, Malaise
Clinical narrative: Diarrhea; Vomiting; Raw in the mouth; Difficulty in swallowing; Muscle aches; Weakness; Tiredness/fatigue; Very ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), vomiting (Verbatim: Vomiting), raw mouth (Verbatim: Raw in the mouth), swallowing difficult (Verbatim: Difficulty in swallowing), muscle pain (Verbatim: Muscle aches), weakness (Verbatim: Weakness), tiredness (Verbatim: Tiredness/fatigue) and unwell (Verbatim: Very ill). The outcome of the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness and tiredness were unknown and the outcome of the unwell was not reported.   It was unknown if the reporter considered the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness, tiredness and unwell to be related to Shingrix.     It was unknown if the company considered the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness, tiredness and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date - 08-NOV-2023 The reporter was the friend of the patient. The reporter reported that the patient received 1st dose of shingrix vaccine 2 week ago . The reporter stated that patient experienced severe side effects and very ill.  The patient had diarrhea, vomiting, raw in the mouth and difficulty in swallowing and patient also had muscle aches and weakness and fatigue. The reporter stated that he or she did not know the date of vaccination, location of vaccination center or in which arm the vaccine was administered. The lot number and expiry date was not provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Stomatitis, Vomiting
Clinical narrative: Diarrhea; Vomiting; Raw in the mouth; Difficulty in swallowing; Muscle aches; Weakness; Tiredness/fatigue; Very ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), vomiting (Verbatim: Vomiting), raw mouth (Verbatim: Raw in the mouth), swallowing difficult (Verbatim: Difficulty in swallowing), muscle pain (Verbatim: Muscle aches), weakness (Verbatim: Weakness), tiredness (Verbatim: Tiredness/fatigue) and unwell (Verbatim: Very ill). The outcome of the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness and tiredness were unknown and the outcome of the unwell was not reported.   It was unknown if the reporter considered the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness, tiredness and unwell to be related to Shingrix.     It was unknown if the company considered the diarrhea, vomiting, raw mouth, swallowing difficult, muscle pain, weakness, tiredness and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date - 08-NOV-2023 The reporter was the friend of the patient. The reporter reported that the patient received 1st dose of shingrix vaccine 2 week ago . The reporter stated that patient experienced severe side effects and very ill.  The patient had diarrhea, vomiting, raw in the mouth and difficulty in swallowing and patient also had muscle aches and weakness and fatigue. The reporter stated that he or she did not know the date of vaccination, location of vaccination center or in which arm the vaccine was administered. The lot number and expiry date was not provided. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: being exposed to freezing temperatures; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 06-NOV-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: being exposed to freezing temperatures). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-NOV-2023 The reporter reported that a patient received a Flulaval QIV vaccine after being exposed to freezing temperatures, which led to incorrect storage of drug. Flulaval QIV Vaccines were exposed to a lowest temperature of 17F from 5th November 2023 to 7th November 2023. Vaccines were not frozen, they were all liquid. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: feeling achy; tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.     Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 07-NOV-2023, the patient received the 2nd dose of Shingrix (left arm) and INFLUENZA VACCINE (left deltoid). On 08-NOV-2023, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: feeling achy) and tiredness (Verbatim: tired). The outcome of the pain was not resolved and the outcome of the tiredness was not reported.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  It was unknown if the company considered the pain and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 8-NOV-2023 and 15-NOV-2023 The patient stated that he received Shingrix dose 2 and Flu shot (not sure which brand) in same (left) arm and woke up (next day) feeling achy and tired. On 08-NOV-2023, 1 days after receiving influenza vaccine, the patient experienced pain and tiredness.  It was unknown if the reporter considered the pain and tiredness to be related to influenza vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Patient received third dose of Shingrix; The patient received 1st and 2nd dose on same day; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 7cx23) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number fd47f) for prophylaxis and Herpes zoster (Shingrix) (batch number 7ta92) for prophylaxis.   On 08-NOV-2023, the patient received the 3rd dose of Shingrix. On 01-JAN-2023, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 01-JAN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix and Shingrix, the patient experienced overdose (Verbatim: The patient received 1st and 2nd dose on same day). On 08-NOV-2023, the patient experienced extra dose administered (Verbatim: Patient received third dose of Shingrix). The outcome of the overdose and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 08-Nov-2023 The reporter reported that the patient received first and second dose on same day, which led to overdose. The patient received third dose of Shingrix vaccine, which led to extra dose administered. The reporter asked information was available about the administration of a third dose of Shingrix in a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: A patient received her 3rd BEXSERO vaccination today (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 19-year-old female patient who received Men B NVS (Bexsero) (batch number 5yp3L, expiry date 31-JAN-2026) for prophylaxis.   On 08-NOV-2023, the patient received the 3rd dose of Bexsero (left deltoid). On 08-NOV-2023, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: A patient received her 3rd BEXSERO vaccination today (Extra Dose)). 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: 08-NOV-2023 The reporter stated that the patient received the 3rd Bexsero vaccination, which led to extra dose administered. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: gave an Engerix B Pediatric dose to a 59 year old female; gave an Engerix B Pediatric dose to a 59 year old female; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 59-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On 08-NOV-2023, the patient received Engerix B pediatric (intramuscular). On 08-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: gave an Engerix B Pediatric dose to a 59 year old female). On an unknown date, the patient experienced underdose (Verbatim: gave an Engerix B Pediatric dose to a 59 year old female). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 09-NOV-2023 The medical assistant reported that one of their staff gave Engerix B Pediatric dose to a 59 year old patient which led to underdose and adult use of a child product. The reporter consented to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-NOV-2023 A pharmacist reported that a patient received the first dose of Twinrix on August 14th 2023 and the patient attended the pharmacy on the day of reporting for the second dose. The reporter asked if they should resume the series or if they needed to start over the vaccination. The reporter did not provide information about first dose given. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient developed shingles.; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: patient developed shingles.). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date:09-NOV-2023 The reporter was the husband of the patient. The reporter reported that within 1 week after receiving the vaccine, the patient developed Shingles. Consent to follow up. This case has been linked to the case US2023155539 reported by the same reporter.; Sender's Comments:  US-GSK-US2023155539:2 of 2 report
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Overdose
Clinical narrative: patient received Pediarix and Engerix B at the same time.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old male patient who received HBV (Engerix B) (batch number 95D74, expiry date 28-FEB-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 09-NOV-2023, the patient received Engerix B and Pediarix. On 09-NOV-2023, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: patient received Pediarix and Engerix B at the same time.). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-NOV-2023 Nurse reported that on 09 November 2023 a patient received Pediarix and Engerix B at the same time which led to overdose for hepatitis b antigen.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: potentially receive a 3rd dose of Shingrix on that day; would potentially receive a 3rd dose of Shingrix on that day; 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) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 30th August 2019) and Shingrix (received 2nd dose of Shingrix on an unknown date).   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: potentially receive a 3rd dose of Shingrix on that day) and circumstance or information capable of leading to medication error (Verbatim: would potentially receive a 3rd dose of Shingrix on that day). The outcome of the extra dose administered and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK Receipt Date- 09-NOV-2023 The pharmacist reported that the patient would potentially receive the 3rd dose of Shingrix vaccine on that day which led to extra dose administered and circumstance or information capable of leading to medication error. The reporter denied to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine; developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine; developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number zm749, expiry date 30-AUG-2025) for prophylaxis.   On 06-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 06-NOV-2023, less than a day after receiving Shingrix, the patient experienced injection site warmth (Verbatim: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine), injection site erythema (Verbatim: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine) and injection site pain (Verbatim: developed soreness, tenderness, warm to touch and redness to his left arm where he got his vaccine). The outcome of the injection site warmth, injection site erythema and injection site pain were not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date - 09-NOV-2023 The patient is the reporter reported that he got first shingrix vaccine. The reported that at day one developed soreness, tenderness, warm to touch and redness at the injection site.  These have not resolved.  The reporter asked what he could for help.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.; Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-NOV-2023 Physician reported his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine, which led to wrong vaccine administration, which led to wrong vaccine administered.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: very red and swollen arm; itchy in her body; Red arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female 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 swelling arm (Verbatim: very red and swollen arm), generalized pruritus (Verbatim: itchy in her body) and erythema of extremities (Verbatim: Red arm). The outcome of the swelling arm, generalized pruritus and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm, generalized pruritus and erythema of extremities to be related to Shingrix.  It was unknown if the company considered the swelling arm, generalized pruritus and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-NOV-2023 The reporter stated that a person she did not know well, told her she received Shingrix dose a couple of months ago and had a horrible reaction, itchy in her body and a very red and swollen arm.  No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pateint received the second dose 09-NOV-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 60-year-old male patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis.   Previously administered products included Engerix b (received 1st dose of Engerix B on 16-MAR-2023.Batch number-NT9X3 and expiary date-09-SEP-2024).   On 09-NOV-2023, the patient received the 2nd dose of Engerix B. On 09-NOV-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Pateint received the second dose 09-NOV-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date:09-NOV-2023 A pharmacist called to ask for information regarding a patient who received the first dose of Engerix-B on Mar 16th 2023 and today received the second dose (Nov 9th 2023) which led to lengthening of the dose administration. The HCP ask for the recommended interval between the second and third dose. During the call permission to follow up was not requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix: Late 2nd dose; 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-NOV-2023 The patient was late for 2nd dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female 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 pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 09-NOV-2023 The reporter is the patient. The patient received shingrix 2 dose series. The reporter developed a sore arm after receiving the first dose. The reporter confirmed she received shingrix and not other vaccine for shingles but she did not recalled the dates. No other information was provided. Did not consented to follow-up.