chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE; HCP called to report that a dose of expired PNEUMOVAX 23 was inadvertently administered to a patient.; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 03-OCT-2023 (reported also as yesterday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (ml) series, expiration date a few days before the end in September 2023, administered for prophylaxis (dose number, lot number, vaccination scheme, frequency and route of administration were not provided), the expired dose did not suffer any temperature excursion, the healthcare provider (HCP) could not confirm the exact date of expiration or the lot number for the product(expired product administered).   No additional adverse event (AE).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reported MMRII was administered after temperature excursion.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-SEP-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) injection, one dose (valid lot number W021191 [expiration date 29-MAR-2024]) (dose, dose number, frequency, vaccination scheme, route of administration, and anatomical location were not provided) after a temperature excursion of 8.9 degrees Celsius (C) with a time frame of 12 hours 20 minutes and 0 seconds on 14-AUG-2023 and 9.4 degrees C with a time frame of 8 hours 20 minutes and 0 seconds on 28-AUG-2023 (product storage error). No previous temperature excursion.   No additional adverse event (AE).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant reported VAQTA was administered after temperature excursion. See full details below. The operator of the device was a healthcare provider. HCP provided lot number that did not appear to be similar to other Merck vaccine lot numbers;; This spontaneous report was received from a medical assistant, regarding an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 18-SEP-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (route and dosage information were unknown; lot number reported as Y3ME2 expiration date: 23-FEB-2025) for prophylaxis. It was reported that the administered dose had suffered a temperature excursion (incorrect product storage).  On 14-AUG-2023, the dose was stored at a temperature of 8.9 degrees Celsius with a time frame of 12 hours 20 minutes and 0 seconds. On 28-AUG-2023 it was stored at a temperature of 9.4 degrees Celsius with a time frame of 8 hours, 20 minutes and 0 seconds.  There was no previous temperature excursion.  No adverse events were reported.   Lot number Y3ME2 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; ROTATEQ  was administered after temperature excursion.; This spontaneous report was received from medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-AUG-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, first dose, lot #1968393, expiration date: 24-MAY-2024, administered orally for prophylaxis (strength was not provided) following a temperature excursion of 8.9 degree Celsius (C) for 12 hours 20 minutes o seconds and 9.4 C for 8 hours 20 minutes and 0 seconds, it was stated that no previous temperature excision occurred. No additional adverse event was reported.
Sex: U
Vaccine: RVX
Symptoms: Erythema
Clinical narrative: Had horrible reaction/still red; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: Had horrible reaction/still red).  The outcome of the erythema was not resolved.   It was unknown if the reporter considered the erythema to be related to RSV vaccine.     It was unknown if the company considered the erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2023 This case was reported by a patient via interactive digital media. The patient had a horrible reaction from that shot it lasted for over a month still red. Follow-up was not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Arthropathy, Cough, Feeling abnormal, Headache, Injection site pain
Clinical narrative: injection site pain; headache; coughing; body aches; joint issue; Feel terrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain), headache (Verbatim: headache), cough (Verbatim: coughing), general body pain (Verbatim: body aches), joint disorder (Verbatim: joint issue) and feeling bad (Verbatim: Feel terrible).The outcome of the injection site pain, headache, cough, general body pain, joint disorder and feeling bad were not reported.   It was unknown if the reporter considered the injection site pain, headache, cough, general body pain, joint disorder and feeling bad to be related to Arexvy.     It was unknown if the company considered the injection site pain, headache, cough, general body pain, joint disorder and feeling bad to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had all the side effects listed, he/she had joint issue, body aches, headache and injection site pain. The reporter stated that he/she also had some coughing.  The patient felt terrible. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Pain
Clinical narrative: injection site pain; headache; coughing; body aches; joint issue; Feel terrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain), headache (Verbatim: headache), cough (Verbatim: coughing), general body pain (Verbatim: body aches), joint disorder (Verbatim: joint issue) and feeling bad (Verbatim: Feel terrible).The outcome of the injection site pain, headache, cough, general body pain, joint disorder and feeling bad were not reported.   It was unknown if the reporter considered the injection site pain, headache, cough, general body pain, joint disorder and feeling bad to be related to Arexvy.     It was unknown if the company considered the injection site pain, headache, cough, general body pain, joint disorder and feeling bad to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had all the side effects listed, he/she had joint issue, body aches, headache and injection site pain. The reporter stated that he/she also had some coughing.  The patient felt terrible. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Injection site pain is continuing at 48 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain is continuing at 48 hours).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt date: 26-SEP-2023 This case was reported via (Open field AE monitoring) interactive digital media. The reporter reported that all the side effect was about for 36 hours. The Injection site pain was continuing at 48 hours. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site; swelling at the injection site; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 week after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness and swelling at the injection site) and injection site swelling (Verbatim: swelling at the injection site).  The outcome of the injection site erythema and injection site swelling were not reported.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Arexvy.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 It was reported that patient had redness and swelling at the injection site, the size of a silver dollar a week after the injection.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was administered the un-reconstituted Menveo suspension; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered the un-reconstituted Menveo suspension) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 The provider reported that a patient was administered the un-reconstituted Menveo suspension, due to human error, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Sex: U
Vaccine: PNC20, RVX
Symptoms: Pain in extremity
Clinical narrative: Pain on my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   On an unknown date, the patient received RSV vaccine and PREVNAR 20. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Pain on my arm). The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via (social media) interactive digital media. The patient reported that he or she received RSV vaccine along with the new Prevenar20 and experienced pain on his or her arm for one day and had no other side effects. It was unknown if the reporter considered the pain in arm to be related to Prevenar20. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Illness
Clinical narrative: I was really sick for 2 days after taking it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: I was really sick for 2 days after taking it).  The outcome of the sickness was resolved (duration 2 days).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 28-SEP-2023 This case was reported the patient via interactive digital media. The patient reported that the shot was not for everyone as an adult.  The patient was really sick for 2 days after taking the vaccine. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: RVX, RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   In SEP-2023, the patient received RSV vaccine, FLU VACCINE (NAME UNKNOWN) and COVID 19 VACCINE. On an unknown date, less than 2 weeks after receiving RSV vaccine and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced pain in arm (Verbatim: Sore arms). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 27-SEP-2023 The case was received from the patient interactive digital media. The patient got RSV, Covid and Flu shots last week and had no symptoms except slight sore arm. In SEP-2023, less than 2 weeks after receiving Covid 19 and Flu vaccines, the patient experienced pain in arm. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR135367, reported by same reporter (Husband's case).; Sender's Comments:  US-GSK-US2023AMR135367:Patient husband/same reporter
Sex: M
Vaccine: RVX, RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis and INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   In SEP-2023, the patient received RSV vaccine, COVID 19 VACCINE and FLU VACCINE (NAME UNKNOWN). In SEP-2023, less than 2 weeks after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arms).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 27-SEP-2023 The case was received from the patient's wife interactive digital media. The patient got RSV , Covid and Flu shots last week and had no symptoms except slight sore arm. In SEP-2023, less than 2 weeks after receiving Covid 19 and Flu vaccines, the patient experienced pain in arm. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR135357, reported by same reporter (Wife's case).; Sender's Comments:  US-GSK-US2023AMR135357:Patient wife case/same reporter
Age: 62.0
Sex: F
Vaccine: FLUX, RSV
Symptoms: Oral mucosal blistering, Oral mucosal scab, Pyrexia
Clinical narrative: Fever in mouth; Scabs; Blisters in mouth; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 07-SEP-2023, the patient received Arexvy and INFLUENZA VACCINE. On 08-SEP-2023, 1 days after receiving Arexvy and INFLUENZA VACCINE, the patient experienced fever (Verbatim: Fever in mouth) and blistering of mouth (Verbatim: Blisters in mouth). In SEP-2023, the patient experienced oral mucosal scab (Verbatim: Scabs).  The outcome of the fever and oral mucosal scab were not reported and the outcome of the blistering of mouth was resolving (duration 4 days).   It was unknown if the reporter considered the fever, blistering of mouth and oral mucosal scab to be related to Arexvy.     It was unknown if the company considered the fever, blistering of mouth and oral mucosal scab to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 It was reported that patient experienced fever and blisters in mouth that started the day after receiving Arexvy and Flu vaccine which was persistent for 4 days and turned to scabs by day 7. The physician saw patient and had reported through VAERS. Flu vaccine was giving by providers office and Arexvy was given by across the street.  Information was provided when contacted the pharmacy. It was unknown if the reporter considered the fever, blistering of mouth and oral mucosal scab to be related to Influenza vaccine.
Sex: U
Vaccine: RVX
Symptoms: Headache, Pain
Clinical narrative: Aches; headaches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: Aches) and headache (Verbatim: headaches).The outcome of the pain and headache were resolved.   It was unknown if the reporter considered the pain and headache to be related to RSV vaccine.   It was unknown if the company considered the pain and headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that RSV shot put him/her down for 2 and half days. The patient experienced aches and headaches but now just fine. The reporter stated that he/she would do it again to not get the SRV. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick).The outcome of the sickness was resolved (duration 7 days).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.   It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and was very sick for seven days.  The patient thought that he/she was doing better now.  The patient would be afraid to recommend it but he/she guessed getting RSV would be worse. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Urticaria
Clinical narrative: hives; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   In SEP-2023, the patient received RSV vaccine and INFLUENZA VACCINE. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced hives (Verbatim: hives).The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to RSV vaccine.   It was unknown if the company considered the hives to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got RSV or flu vaccine 3 weeks ago and still had hives. The patient never had them before. It was unknown if the reporter considered the hives to be related to Flu vaccine. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.  It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got his/her RSV shot and only a slight sore arm for a day. The patient felt great no after affects.  The reporter stated that better the shot than getting the virus. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Pyrexia
Clinical narrative: Chills; Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Shingrix. On 27-SEP-2023, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills) and fever (Verbatim: Fever).The outcome of the chills and fever were resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.     It was unknown if the company considered the chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that Shingrix was a 2-part vaccination.  The patient had part 1 and the day before reporting he was down with chills and fever all day. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Fatigue, Pain
Clinical narrative: Tired; Achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tiredness (Verbatim: Tired) and pain (Verbatim: Achy). The outcome of the tiredness and pain were resolved (duration 1 day).   It was unknown if the reporter considered the tiredness and pain to be related to RSV vaccine.     It was unknown if the company considered the tiredness and pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received RSV vaccine and experienced tired and achy for a day so receive it now. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: soreness in the arm; day I felt not so good/feel a bit off; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm) and COVID VACCINE (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: soreness in the arm) and feeling unwell (Verbatim: day I felt not so good/feel a bit off).  The outcome of the pain in arm was not resolved and the outcome of the feeling unwell was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 27-SEP-2023 This case was reported by consumer via (Facebook) interactive digital media. The reporter reported that he or she did not think that we could generalized these vaccination shots. The reporter never had a bad reaction but sometimes some soreness in the arm until his or her last shot last year which was the covid shot and one arm and Shingles in the other. The reporter reported that for one day he or she felt not so good but after that he or she was fine. Reporter asked question that which injection made him or her felt a bit off, who knowns. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Covid vaccine.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Nasopharyngitis
Clinical narrative: Bad cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received RSV vaccine and INFLUENZA VACCINE. On an unknown date, several days after receiving RSV vaccine, the patient experienced cold (Verbatim: Bad cold).  The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to RSV vaccine.     It was unknown if the company considered the cold to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received RSV vaccine and flu vaccine and few days after experienced bad cold. It was unknown if the reporter considered the cold to be related to Influenza vaccine. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Product supply issue
Clinical narrative: Post herpetic neuralgia; alleviate the pain; Nerve damage; Shingles; Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia), pain (Verbatim: alleviate the pain), nerve damage (Verbatim: Nerve damage), shingles (Verbatim: Shingles) and product supply issue (Verbatim: Inappropriate schedule of vaccine).The outcome of the post herpetic neuralgia, pain and shingles were not reported and the outcome of the nerve damage was not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the post herpetic neuralgia, pain, nerve damage and shingles to be related to Shingrix.     It was unknown if the company considered the post herpetic neuralgia, pain, nerve damage and shingles to be related to Shingrix.   Additional Information: The age at vaccination was not applicable for this report.  The age group was not reported but it was selected as adult as per vaccine indication. The patient inquired about the inability for him to obtain the second vaccine of Shingrix in the allotted time frame secondary to lack of availability in his area.  The six month window of time had come and gone.  He was provided with the CDC guidance statement that he did not have to re-start the series but felt that was not appropriate guidance when it comes to the efficacy of the series.  He was on a waiting list but the longer time went by, he was losing interest and was probably not going to get the second vaccine. The patient was unhappy with the CDC guidance after the 6 month window and felt that there was a schedule of time it should be adhered to.  The patient provided limited information and declined to provide demographics.  Unable to obtain the physician's name and phone number secondary to call flow.   Follow-up information received on 27-Sep-2023. The reporter wanted to know if you had Post Herpetic Neuralgia (PCN) if he should still get the Shingrix shot. The reporter wanted to know would it help protect from getting Shingles again. The reporter wanted to know would it help alleviate the pain and current damage to the nerves on the one side of the head from the PCN. Summary of changes: product details, event details and narrative details were updated.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1 year patient received kinrix; Extra hep-b that came from the 3rd Pediarix administration; 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 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17-FEB-2024) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 24th March 2022) and Pediarix (1st dose received on 1st June 2022). Concomitant products included PEDIARIX.   On 11-OCT-2022, the patient received the 3rd dose of Pediarix. On 20-JUL-2023, the patient received the 4th dose of Kinrix. On 11-OCT-2022, an unknown time after receiving Pediarix and not applicable after receiving Kinrix, the patient experienced extra dose administered (Verbatim: Extra hep-b that came from the 3rd Pediarix administration). On 20-JUL-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: 1 year patient received kinrix).  The outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-SEP-2023 The patient received 3rd dose of Pediarix, which led to extra dose administered for hepatitis B antigen. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient inadvertently received an expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-month-old female patient who received DTPa (Infanrix) (batch number AK443, expiry date 16-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Infanrix. On 25-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient inadvertently received an expired dose of Infanrix).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient inadvertently received an expired dose of Infanrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a consumer 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 27 February 2023 batch number XG7RF expiry date 21 MAY 2024 on Left arm).   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 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter reported that she was more than 6 months after her first dose and had not received her second dose of Shingrix. The reporter consented 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: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of Infanrix; 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 2-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Infanrix. On 25-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient received expired dose of Infanrix).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2023 The medical assistant reported on that a patient received a dose of Infanrix that had expired which led to expired vaccine used. The reporter enquired should the patient be re vaccinated. The reporter did not consent to follow up.  The vaccine administration facility is the same as primary reporter.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: inadvertently given a dose of Boostrix after it was involved in a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 27-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently given a dose of Boostrix after it was involved in a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient was inadvertently given a dose of Boostrix after it was involved in a temperature excursion that rendered the product unstable, which led to incorrect storage of drug The reporter consented to follow up. The case is linked with US2023132547, by same reporter; Sender's Comments:  US-GSK-US2023132547:Same reporter
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: inadvertently given a dose of Boostrix after it was involved in a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 53-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 22-JAN-2026) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently given a dose of Boostrix after it was involved in a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient was inadvertently given a dose of Boostrix after it was involved in a temperature excursion that rendered the product unstable, which led to incorrect storage of drug. The reporter consented to follow up. The case is linked with US2023132545, by same reporter; Sender's Comments:  US-GSK-US2023132545:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: patient was inadvertently given a dose of Havrix after it was involved in a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 25-SEP-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: patient was inadvertently given a dose of Havrix after it was involved in a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient was inadvertently given a dose of Havrix after it was involved in a temperature excursion that rendered the product unstable, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Myofascial spasm, Rash
Clinical narrative: shingles rash from breast to armpit around to back in a line on right side; muscle knot in back; shingles rash/ rash; 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.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles rash from breast to armpit around to back in a line on right side), myofascial spasm (Verbatim: muscle knot in back) and rash (Verbatim: shingles rash/ rash).  The outcome of the shingles, myofascial spasm and rash were resolved.   It was unknown if the reporter considered the shingles, myofascial spasm and rash to be related to Shingrix.     It was unknown if the company considered the shingles, myofascial spasm and rash to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient self-reported this case. The reporter stated that she received Shingrix dose 1 about a year ago from reporting and within 3 days, she experienced shingles rash from breast to armpit around to back in a line on right side.  The patient stated the rash went away within a week-10 days and the muscle knot took about a month to resolve.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Expired product administered, Myalgia, Piloerection
Clinical narrative: hair on his arms were standing on its end; both arms (from his biceps to his hands) felt like they were on fire; felt like they were on fire; lot number provided is expired. Patient may have also received expired vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of piloerection in a male patient who received Herpes zoster (Shingrix) (batch number 4h9g2, expiry date 25-SEP-2021) for prophylaxis.   In SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced piloerection (Verbatim: hair on his arms were standing on its end), burning sensation (Verbatim: both arms (from his biceps to his hands) felt like they were on fire), muscle burning sensation (Verbatim: felt like they were on fire) and expired vaccine used (Verbatim: lot number provided is expired. Patient may have also received expired vaccine).  The outcome of the piloerection and muscle burning sensation were not reported and the outcome of the burning sensation and expired vaccine used were unknown.   It was unknown if the reporter considered the piloerection, burning sensation and muscle burning sensation to be related to Shingrix.     It was unknown if the company considered the piloerection, burning sensation and muscle burning sensation to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient was self-reported. The patient who received his first dose of Shingrix 2 weeks ago and he stated that a few days after the dose, both arms (from his biceps to his hands) felt like they were on fire.  He also stated that the hair on his arms were standing on its end.  The lot number provided was expired and the patient might had also received expired vaccine based on the lot number which led to expired vaccine used. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient received Twinrix first dose expired vaccine; 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 41-year-old male patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Twinrix. On 26-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient received Twinrix first dose expired vaccine).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-SEP-2023 The Immunization technician reported that an patient received Twinrix 1st dose expired vaccine, which led to expired vaccine used. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm hurt; arm swelled up; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-SEP-2023, the patient received Shingrix. On 18-SEP-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm hurt) and swelling arm (Verbatim: arm swelled up).  The outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.     It was unknown if the company considered the pain in arm and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The nurse practitioner reported that after administration of shingrix vaccine patients arm got hurted a lot and was swelled up. The reporter consented to follow up with healthcare profession on afternoon hours on voice mail box, if necessary, to collect additional details about AE. No additional details were provided on the afterhours voice mail box regarding adverse event.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo where the powder was reconstituted with another diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong diluent used in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA956A, expiry date 30-JUL-2024) for prophylaxis.   On 26-SEP-2023, the patient received the 2nd dose of Menveo. On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong diluent used (Verbatim: Menveo where the powder was reconstituted with another diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong diluent used and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-SEP-2023 The pharmacist reported the patient was given a dose of Menveo where the powder was reconstituted with another diluent other than what comes with Menveo, which led to wrong solution used and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 58 years old patient was administered Menveo 2 vial; 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 58-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 26-SEP-2023, the patient received Menveo. On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 58 years old patient was administered Menveo 2 vial).The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter stated that 58 year old patient was administered Menveo 2 vial the day before reporting as she was traveling to a high endemic area, which led to inappropriate age at vaccine administration. No lot/expiration date was available. The reporter consented to follow up.