chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No symptomatic AEs reported; A pregnant patient was administered GARDASIL 9 inadvertently; This spontaneous prospective pregnancy report has been received from a nurse concerning a pregnant female patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patient became pregnant (last menstrual period (LMP), estimated date of conception (EDC) and estimated due date (EDD) were not reported and could not be calculated). On 13-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (lot # U024832, has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine [yeast] [GARDASIL 9], expiration date not reported, but upon internal validation established as 09-DEC-2023) for prophylaxis (Exposure during pregnancy). The pregnancy outcome was pending and the fetal outcome was unknown.  No adverse event was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received both doses and still get shingles/Suspected vaccination failure; Get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine (dose received on unknown date years before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient received the original shingles vaccine years ago from date of reporting, then two years ago. The patient received both the doses of Shingrix and still got shingles.  The patient wanted to ask that, was there anything that he/she could do perhaps booster. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as permission denied.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots, 3 years later has shingles; Shingles a bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that his/her sister had the shots and 3 years later had shingles a bad case. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had my shingles shot, but still had suffered it/Suspected vaccination failure; Still had suffered it for 3 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had shingles shot, but still had suffered shingles it for 3 months.  The doctor said if patient hadn't vaccinated for shingles he/her would have it worse. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as contact details not provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: had two shots, now had a terrible case of the virus/ Suspected vaccination failure; Terrible case of the virus, from the middle of his back to the middle of his front; Big blisters; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and blisters. On an unknown date, the outcome of the vaccination failure, herpes zoster and blisters were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and blisters to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: This case was received from patient's wife via interactive digital media. The reporter reported that the patient had two shots and now had a terrible case of the virus from the middle of his back to the middle of his front and had big blisters. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Third dose of Bexsero; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in 2020) and Bexsero (2nd dose received in March 2022).   On 22nd August 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: The patient received third dose of Bexsero vaccine. The reporter consented to follow-up. Additional Supportive Information:  The patient received third dose of Bexsero vaccine, which led to Extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash; This case was reported by a physician via interactive digital media and described the occurrence of skin rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced skin rash. On an unknown date, the outcome of the skin rash was unknown.   It was unknown if the reporter considered the skin rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: This case was reported via interactive digital media. The reporter stated that, had a patient called with skin rash 2 days after taking Shingrix. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Herpes simplex outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had herpes simplex at the time of reporting. The patent wanted to ask that can Shingrix cause herpes simplex outbreaks. The follow up would not be possible as contact details were not provided.; Sender's Comments:  US-GSK-US2022AMR123057:Same reporter - deleted
Age: 60.0
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Body temperature increased, Fluid retention, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: soreness in left arm; flu-like sx's; mild temp; headaches; gained 8 lbs of presumed water weight; enlarged lymph nodes; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   On 17th August 2022, the patient received Shingrix. On an unknown date, the patient received Influenza vaccine and COVID 19 BOOSTER. In August 2022, less than a week after receiving Shingrix and not applicable after receiving Influenza vaccine, the patient experienced pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes to be related to Influenza vaccine.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix into left arm and co-administered with Flu vaccine and Covid Booster (Pfizer) into right arm and patient experienced soreness in left arm, flu-like sx's, mild temperature, headaches, gained 8 Pound-Mass of presumed water weight and enlarged lymph nodes. The symptoms were gone by 36 hours (mid day Friday) post vaccination. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, fever, headache, fluid retention and enlargement of lymph nodes to be related to COVID 19 Booster.
Age: 60.0
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in left arm; flu-like sx's; mild temp; headaches; gained 8 lbs of presumed water weight; enlarged lymph nodes; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   On 17th August 2022, the patient received Shingrix. On an unknown date, the patient received Influenza vaccine and COVID 19 BOOSTER. In August 2022, less than a week after receiving Shingrix and not applicable after receiving Influenza vaccine, the patient experienced pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, body temperature increased, headache, fluid retention and enlargement of lymph nodes to be related to Influenza vaccine.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix into left arm and co-administered with Flu vaccine and Covid Booster (Pfizer) into right arm and patient experienced soreness in left arm, flu-like sx's, mild temperature, headaches, gained 8 Pound-Mass of presumed water weight and enlarged lymph nodes. The symptoms were gone by 36 hours (mid day Friday) post vaccination. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, fever, headache, fluid retention and enlargement of lymph nodes to be related to COVID 19 Booster.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Dec2020, 2nd dose Aug2022; This case was reported by a consumer via interactive digital media 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 (1st dose received in December 2020).   On 22nd August 2022, the patient received the 2nd dose of Shingrix. On 22nd August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 23-AUG-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient had a 2nd Shingrix vaccine one day before reporting.  The patient had no immune problems. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore spot on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123588   Additional Information: GSK Receipt Date: 23-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first dose and was fine, just had a sore spot on his/her arm. Additional Supportive Information: Follow-up would not be possible, as no contact details were available. For tolerance to the 2nd dose refer case US2022AMR123588.; Sender's Comments:  US-GSK-US2022AMR123588:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Limb discomfort
Clinical narrative: Arm now feeling normal, had almost every side affect; Arm now has a nice bruise; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and refer case US2022AMR123583).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort and contusion. On an unknown date, the outcome of the arm discomfort and contusion were recovered/resolved.   It was unknown if the reporter considered the arm discomfort and contusion to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123583   Additional Information: GSK Receipt Date: 23-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received 2nd shot and had almost every side effect listed for 4 days.  The patient's arm was just now feeling normal but had a nice bruise. The patient was still okay with decision to get the vaccine though because the patient was hoping it would prevent from getting a bad case of shingles. Additional Supportive Information: Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR123583:Same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness at the injection site; heat at the injection site; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2022, the patient received the 2nd dose of Shingrix. On 19th August 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The consumer was the reporter and the patient. Consumer stated she received her 2nd Shingrix vaccination in the arm and experienced redness, heat, and swelling at the injection site. The reporter stated that all symptoms was not resolved as of 23th August 2022.  Consumer Inquiring if this was an expected side effect and should she notify her rheumatologist. Spoke from content and package insert. The reporter was provided HCP referral.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: made me feel a little icky; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. Patient had 2 shingles shots within the past year and the second one made patient feel a little icky, but it sure beats getting shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Received shot, how long before I feel better; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-AUG-2022 Reporter's comments: This case was reported from the patient via interactive digital media. It was reported that patient received the Shingles shot and patient enquired how long it would take before patient feels better. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: doses apart, two years eight months; This case was reported by a consumer via interactive digital media 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 (1st dose received two years eight months ago).   On 23rd August 2022, the patient received the 2nd dose of Shingrix. On 23rd August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient put off getting the second dose but received a second dose a day before reporting.  The doses were so far apart two years eight months so patient wanted to know he/she need to get another shot. The follow-up could not be possible as no contact details were available. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced rash from Shingrix. Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 17 year old female received an adult 20 mcg dose; 17 year old female received an adult 20 mcg dose; This case was reported by a physician via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 10th August 2022, the patient received the 1st dose of Engerix B adult 20 mcg/mg. On 10th August 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The physician reported that an adult 20 mcg dose of Engerix B was given to the 17 years old patient. No symptoms were reported. The health care professional did not have the lot/expiry date of the vaccine. The reporter consented to follow up. Additional supportive information: The use of an adult dose of Engerix B to 17 years old patient, which led to overdose and adult product administered to child.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent component; Administered only the diluent component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7BC47, expiry date 9th June 2023) for prophylaxis.   On 18th August 2022, the patient received Shingrix. On 18th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: The medical assistant reported that administering only the Shingrix diluent component to a patient one day before the reporting, without the lyophilized component. No additional details were provided. The reporter did not gave consent to follow up. Additional Supportive Information: The patient received only the Shingrix diluent component to without the lyophilized component in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The pharmacist stated that the patient never received the second dose. The reporter did not consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Menactra on 08Oct2021 and Menveo on 18Aug2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva675a, expiry date 31st March 2023) for prophylaxis.   Previously administered products included Menactra (received on 8th October 2021).   On 19th August 2022, the patient received Menveo. On 19th August 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2022.  Reporter's Comments: Medical assistance reported that a patient who was vaccinated with Menactra received additional dose of Menveo on the day of reporting.  No adverse event was reported The consent to follow up was granted. Additional Supportive Information: As per schedule only single dose should have been administered, patient had received Menveo post Menactra, which led to extra dose administered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Administered vx reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA701A, expiry date February 2023) for prophylaxis.   On 18th August 2022, the patient received the 1st dose of Menveo. On 18th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The health care professional reported that menveo was reconstituted with sterile water and administered to a patient. The reporter consented to follow up. Additional Supportive Information: The patients received Menveo vaccines reconstituted with sterile water which led to wrong solution used in drug reconstitution.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Hypersomnia, Incomplete course of vaccination, Rash, Rash macular
Clinical narrative: slept for days; fatigued; red and black spots on right side body; red and black spots on right side body; dose 1 back in 2017, refusing to get dose #2; bumps on left side of face; This case was reported by a consumer via call center representative and described the occurrence of sleep excessive in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the patient received 1st dose of Shingrix. In February 2022, not applicable after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced papular rash. On an unknown date, the patient experienced sleep excessive, fatigue, red spotty rash, skin discoloration and incomplete course of vaccination. On an unknown date, the outcome of the sleep excessive, fatigue, red spotty rash, skin discoloration and papular rash were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sleep excessive, fatigue, red spotty rash, skin discoloration and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The patient reported that she received Shingrix dose back in 2017.  She stated that minutes after she went home and slept for days after the vaccine. She was fatigued.  She did not remember the exact date but afterwards she noticed red and black spots on right side body.   She stated that 6 months ago of reporting date she experienced bumps on left side of face.  She was refusing to get dose 2. Additional Supportive Information: The patient was refusing to get dose 2 which led to incomplete course of vaccination. In 2017, the patient experienced sleep excessive, fatigue and incomplete course of vaccination. Time to onset for event sleep excessive and fatigue were several minutes with respect to 1st dose of Shingrix. Time to onset for events red spotty rash, skin discoloration and incomplete course of vaccination was unknown with respect to 1st dose of Shingrix. In 2022, the event papular rash was recovered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, Skin discolouration
Clinical narrative: slept for days; fatigued; red and black spots on right side body; red and black spots on right side body; dose 1 back in 2017, refusing to get dose #2; bumps on left side of face; This case was reported by a consumer via call center representative and described the occurrence of sleep excessive in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the patient received 1st dose of Shingrix. In February 2022, not applicable after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced papular rash. On an unknown date, the patient experienced sleep excessive, fatigue, red spotty rash, skin discoloration and incomplete course of vaccination. On an unknown date, the outcome of the sleep excessive, fatigue, red spotty rash, skin discoloration and papular rash were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sleep excessive, fatigue, red spotty rash, skin discoloration and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The patient reported that she received Shingrix dose back in 2017.  She stated that minutes after she went home and slept for days after the vaccine. She was fatigued.  She did not remember the exact date but afterwards she noticed red and black spots on right side body.   She stated that 6 months ago of reporting date she experienced bumps on left side of face.  She was refusing to get dose 2. Additional Supportive Information: The patient was refusing to get dose 2 which led to incomplete course of vaccination. In 2017, the patient experienced sleep excessive, fatigue and incomplete course of vaccination. Time to onset for event sleep excessive and fatigue were several minutes with respect to 1st dose of Shingrix. Time to onset for events red spotty rash, skin discoloration and incomplete course of vaccination was unknown with respect to 1st dose of Shingrix. In 2022, the event papular rash was recovered. The reporter consented to follow up.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old was administrated with Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. In November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comments: Nurse reported that a 6-month female patient was administrated with Kinrix. No adverse event was reported. The vaccination occurred on another facility. The Healthcare Professional (HCP) wanted to be contacted by phone. The expiration date was not provided. The reporter consented to follow-up. Additional supportive information: The patient was administered Kinrix while she was 6-month old which had led to inappropriate age at vaccine administration.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose April of 2019, second dose on 19Aug2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2019).   On 19th August 2022, the patient received the 2nd dose of Shingrix. On 19th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The pharmacist had a patient who had first dose of Shingrix in April 2019 and was given a second dose on 19th August 2022.  The reporter did not ask about follow up but email was above. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with sterile diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA702A, expiry date 28th February 2023) for prophylaxis.   On 20th August 2022, the patient received Menveo. On 20th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The pharmacist reported that the patient received a dose of Menveo and dose was reconstituted with a sterile diluent instead of the supplied CYW-135 diluent.  At the time of reporting, the dose had not been repeated.  The reporter gave permission for follow up but did not wish to share last name. The reporter consented to follow up. Additional supportive information: The patient received a dose of Menveo and dose were reconstituted with a sterile diluent instead of the supplied CYW-135 diluent, which led to wrong solution used in drug reconstitution.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the diluent portion of the Menveo; Patient received only the diluent portion of the Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   On 20th August 2022, the patient received Menveo. On 20th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:22-AUG-2022 Reporters comment: The patient received only the diluent portion of the Menveo. No reactions reported.  Call Notes:Follow up email The reporter given consent to follow-up. Additional Supportive information: Till the time of reporting the patient received only the diluent portion of the Menveo which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: While waiting for 2nd dose, contracted COVID; incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: Pharmacist reported that a patient received her first dose of Shingrix 2 years ago. While the patient was waiting for the 2nd dose, she contracted COVID and forgot about getting the 2nd dose. The reporter did not have any details of when the patient had COVID and was unable to provide a lot number and expiration date for the 1st vaccine. The reporter consented to follow-up via postal. Additional Supportive Information: Till the time of reporting the patient did not received the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rrash at the site of injection; Rash at right side of neck; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The reporter was a physician. The GSK representative was reporting on behalf of Healthcare professional(HCP). The patient received dose of Shingrix on her left arm a week ago and rash had appeared at the site of the injection as well as on the right side of her neck. The reporter consented to follow up.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Given the CWY component without A portion; Given the CWY component without A portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22nd August 2022, the patient received Menveo. On 22nd August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022.  Reporter's Comments: The pharmacist reported that a patient was given just the Menveo CWY component only without combining it with the menA portion. The reporter declined to provide lot no/expiry date. The reporter declined to store her contact information in our database but consented to follow-up. The reported contact info emailed. Additional Supportive Information: The patient received only Menveo CWY component only without combining with the menA portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 19th August 2022, the patient received Havrix. On 19th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The pharmacist reported that a patient was administered a dose of Havrix that had expired on 18th June 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 72t95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The reporter reported that, a patient was administered an expired dose of Havrix. The reporter declined to provide more information due to not having the patient's permission. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstitution with regular diluent; Menveo reconstitution with regular diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The health care professional reported that the patient received a dose of Menveo vaccine reconstituted with regular diluent and not the one provided by GlaxoSmithKline. The reporter did not consent to follow up. Additional supportive information: The health care professional reported that the patient received a dose of Menveo vaccine reconstituted with regular diluent and not the one provided by GlaxoSmithKline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.