chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2-shot vaccine and shingles/suspected vaccination failure; Very bad shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 56-year-old female 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's sister) currently have had very bad shingles and both of them had the updated 2 shot vaccine. The reporter stated that but it was still a good idea to get the vaccine, as it apparently did work for most people, just not for everyone. The case was linked with case US2022AMR125478, reported by same reporter for different patient. 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. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR125478:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/got shingles AFTER getting a shot; shingles/ got shingles after getting a shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles after getting the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The patient got the vaccine and still got shingles.  The patient was still dealing with them, the patient had them for 5 months now. The patient stated that hope you feel better soon. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: It's painful but no worse than other pain I already have; Suspected vaccination failure/I had the vaccine and I have shingles now; I have shingles now; 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.   Concurrent medical conditions included pain (have had other pain).   On an unknown date, the patient received Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and have had shingles right now. The patient stated that they were painful but no worse than other pain that he/she already had. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the vaccine, then got the worst case of shingles; Got the worst case of shingles imaginable; This case was reported by a consumer via interactive digital media and described the occurrence of 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: This case was received from the patient's children via interactive digital media. The patient never had shingles, she got the vaccine and then got the worst case of shingles imaginable. The reporter said that stay away from the vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles from the shot/Suspected vaccination failure; I got 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 (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 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: 22-Aug-2022 Reporter's comment: This case was received from the patient via interactive digital media. The patient got shingles from the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had both shingle shots and got the shingles; shingles/Got shingles just over it; 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.   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) 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 and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: This case was received from the patient via  interactive digital media. The patient had both shingles shots and got the shingles just got over them. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/got both shots and got shingles 4 months later; shingles/got both shots and got shingles 4 months later; 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.   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, 4 months after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got both shots and got shingles 4 months later and lasted 8 weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had them 4 times even I had shot; I had them 4 times; 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 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: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them 4 times even though, he/she had the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: mild tension in the muscles / muscle stiffness; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced muscle stiffness. On an unknown date, the outcome of the muscle stiffness was unknown.   It was unknown if the reporter considered the muscle stiffness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022123179   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The reporter was the patient. After receiving Shingrix vaccine the patient experienced mild tension in the muscle or muscle stiffness. The reporter did not consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022123179, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022123179:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Aug-2022 Reporters comments: The patient self-reported this case via interactive digital media. The patient received shingles vaccine and still got shingles. The doctor said the patient must've had a mild dose, 2 years prior to being vaccinated, declined receiving another dose. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Felt sick, 3 days out; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, 1 day after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine and following day patient felt sick but 3 days out and all good. The patient was glad that he/she got it. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: body aches; chilling; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (On an unknown date patient received the 1st dose of shingles vaccine refer case.US2022AMR125278).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than 3 weeks after receiving Shingles vaccine, the patient experienced general body pain and chills. On an unknown date, the outcome of the general body pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and chills to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was sucked with both shingles shots but it was better than getting the shingles. The patient just had body aches and chilling. The patient stated that, he/she would get it if others could. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR125278:same patient, other dose US-GSK-US2022AMR117863:tag at post
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got the 2 dose vaccine and became quite ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Aug-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the 2 dose vaccine and became quite ill with the second shot.  The patient know it was not as bad as getting shingles, so he/she was glad and had got it.  But the patient would advise scheduling the second dose on a day they were free the next day.  It lasted about 24 hours. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm is a little sore; Felt a little achy this morning; 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.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   On 20th August 2022, the patient received the 2nd dose of Shingles vaccine. On 21st August 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm and generalized aching. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the generalized aching was unknown.   It was unknown if the reporter considered the pain in arm and generalized aching to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient got his/her vaccine yesterday. The patient experienced little sore arm and felt a achy this morning.  The patient did not had any reaction for the first one. They were not 100% effective but patient thought was  91% effective. The patient was glad that he/she now had both. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: get shingles; Rash; Second dose later than 2-6 month; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced shingles, rash and drug dose administration interval too long. On an unknown date, the outcome of the shingles, rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The pharmacist reported that sometimes the patients received their second dose later than the recommended 2-6 month time frame. The reporter indicated there were patients who broke out in shingles rash a few months after the second dose, in patients who received second dose per recommended schedule, as well as the patients who received second dose late. The pharmacist did not had any patient specific information at time of reporting, just stated that it had happened to several patients. The reporter consent to follow up. The case was linked with case US2022123774, reported by same reporter. Additional Supportive Information: The patients received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022123774:Same reporter
Age: 17.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Extra dose administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 2 doses of Boostrix administered; Adult Engerix B instead of Pediatric dose; Adult Engerix B instead of Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number yr7aa, expiry date 4th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 20th August 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 20th July 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 20th July 2022, not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device and unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On 20th August 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, overdose and adult product administered to child 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: 22-AUG-2022 Reporter's Comments: The pharmacist reported that the patient was administrated with 2 doses of Boostrix.  The pharmacist reported that the patient received a dose of Adult Engerix B instead of the appropriate Pediatric dose according to the age.  The Vaccine Administration Facility is the same as Primary Reporter. No adverse event was reported. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administrated with 2 doses of Boostrix which led to Extra dose administered. The patient received a dose of Adult Engerix B instead of the appropriate Pediatric dose according to the age which led to overdose and adult product administered to child. This case was identified as duplicate of case US2022122103. The case US2022122103 was merged to this case as FU1, and deleted from system. This case was linked with case US2022122101 reported by same reporter.; Sender's Comments:  US-GSK-US2022122102:Same reporter US-GSK-US2022122101:Same reporter
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Inappropriate schedule of product administration, Lethargy, Myalgia
Clinical narrative: first dose 15-AUG-2022, second 22-AUG-2022; Every muscle in his body aches; He has  pain; feels foggy; lethargic; feels a little hot, fever; Headache; Sinus Pressure; feels a little hot; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 15-Aug-2022 Batch-ASKU).   On 22nd August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced myalgia, pain, foggy feeling in head, lethargy, fever, headache, sinus pressure and skin warm. On 22nd August 2022, the patient experienced drug dose administration interval too short. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the myalgia, lethargy, headache and skin warm were not recovered/not resolved and the outcome of the pain, foggy feeling in head, fever and sinus pressure were recovering/resolving and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the myalgia, pain, foggy feeling in head, lethargy, fever, headache, sinus pressure and skin warm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR123585   Additional Information: GSK receipt date: 24-AUG-2022 Reporters comment: The patient received both doses at the same HCP site. The patient received the second dose and he stated that the side effects devastated to him Every muscle in his body aches, he has pain, feels foggy/lethargic, had a fever, headache, and sinus pressure. He sated he felt a little better today than yesterday, but he still felt a little hot, has a headache, and feels lethargic. He took 2 Advil, to alleviate his symptoms, but it has not helped. Reporter requested to end call before this writer was able to ask for consent to contact HCP or further information. The reporter consented to follow up. Additional Supportive information: The patient received second dose earlier than the recommended interval, which led to Drug dose administration interval too short; Sender's Comments:  US-GSK-US2022AMR123585:Same patient
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paranasal sinus discomfort, Pyrexia, Skin warm
Clinical narrative: first dose 15-AUG-2022, second 22-AUG-2022; Every muscle in his body aches; He has  pain; feels foggy; lethargic; feels a little hot, fever; Headache; Sinus Pressure; feels a little hot; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 15-Aug-2022 Batch-ASKU).   On 22nd August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced myalgia, pain, foggy feeling in head, lethargy, fever, headache, sinus pressure and skin warm. On 22nd August 2022, the patient experienced drug dose administration interval too short. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the myalgia, lethargy, headache and skin warm were not recovered/not resolved and the outcome of the pain, foggy feeling in head, fever and sinus pressure were recovering/resolving and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the myalgia, pain, foggy feeling in head, lethargy, fever, headache, sinus pressure and skin warm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR123585   Additional Information: GSK receipt date: 24-AUG-2022 Reporters comment: The patient received both doses at the same HCP site. The patient received the second dose and he stated that the side effects devastated to him Every muscle in his body aches, he has pain, feels foggy/lethargic, had a fever, headache, and sinus pressure. He sated he felt a little better today than yesterday, but he still felt a little hot, has a headache, and feels lethargic. He took 2 Advil, to alleviate his symptoms, but it has not helped. Reporter requested to end call before this writer was able to ask for consent to contact HCP or further information. The reporter consented to follow up. Additional Supportive information: The patient received second dose earlier than the recommended interval, which led to Drug dose administration interval too short; Sender's Comments:  US-GSK-US2022AMR123585:Same patient
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received the pediatric dose of engerix-b; Adult received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HBV (Engerix B 10 mcg) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   On 24th August 2022, the patient received the 2nd dose of Engerix B 10 mcg. On 24th August 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received the pediatric dose of Engerix-B in the right deltoid. The reporter consented to follow up. Additional supportive information: The adult patient was administered a pediatric dose of Engerix-B, which led to adult use of a child product and underdose.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on RIGHT side of face between ear and chin; This case was reported by a consumer via call center representative and described the occurrence of localized rash in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient first had a case of shingles, in 1995).   On 10th August 2022, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2022, 15 days after receiving Shingrix, the patient experienced localized rash. On an unknown date, the outcome of the localized rash was not recovered/not resolved.   It was unknown if the reporter considered the localized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022.  Reporter's Comments:   The caller was the patient. The patient reported he received his Shingrix vaccine in the left deltoid.  On the morning of the reporting day, patient had reported that, on 25th August 2022 he noticed a half-dollar size rash on the right side of his face between his ear and chin.  The patient was not sure if this was shingles or not.  He had an appointment with his doctor on the day of the reporting.  The patient mentioned when he first had a case of shingles, in 1995, the shingles was on the right side of his face in the same spot.  The patient would call back if it was shingles (he had this case number).  The follow up would not be possible as did not give permission to contact health care professional (HCP). Did not consent to follow-up. Caller does not give permission to contact HCP.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 18jun2018, 2nd 24aug2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 9CR2S, expiry date 24th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th June 2018).   On 24th August 2022, the patient received the 2nd dose of Shingrix. On 24th 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: 25-AUG-2022 Reporter's Comments: The nurse reported that the patient received first dose of Shingrix series on 18th June 2018, and did not receive second dose until 24th August 2022. The reporter did not have lot number/expiration date information for the first dose. Additional Supportive Information: The patient received 2nd dose Shingrix late, more than recommended interval which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 YO patient received infanrix vaccine inadvertently; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Infanrix and Infanrix 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: 26-Aug-2022 Reporter's comment: The nurse reported that the 12 year old patient received the Infanrix vaccine in left deltoid inadvertently. The consent to follow-up was granted. Additional Supportive Information: The patient received the dose of Infanrix at the age of 12 years, which led to inappropriate age at vaccine administration. Note: Dose number was not captured in the product field. As per the structural field mentioned in the source document, it was not confirmed, clarification had been raised.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: experienced general localized reactions like warm and tender to touch, redness; experienced general localized reactions like warm and tender to touch, redness; experienced general localized reactions like warm and tender to touch, redness; This case was reported by a nurse via call center representative and described the occurrence of localized feeling of warmth in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31st August 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. In August 2022, less than a week after receiving Menveo, the patient experienced localized feeling of warmth, tenderness and localized erythema. On an unknown date, the outcome of the localized feeling of warmth, tenderness and localized erythema were unknown.   It was unknown if the reporter considered the localized feeling of warmth, tenderness and localized erythema to be related to Menveo.     Additional Information: GSK receipt date: 26-AUG-2022 Reporter's Comments: Nurse Practitioner called to inquire any additional information on reactions.  The patient experienced general localized reactions like warm and tender to touch, redness.  Nurse stated read the adverse event section in the product (package insert) PI but wanted additional information on reactions.  The reporter did not consent to follow-up. The case US2022124287 was linked by same reporter.; Sender's Comments:  US-GSK-US2022124287:Same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   On 25th August 2022, the patient received Menveo. On 25th August 2022, 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: 29-AUG-2022 Reporter's Comments: The nurse reported that a staff member most likely administered a dose of Menveo powder after reconstituting it with a non-GlaxoSmithKline diluent. They had a leftover diluent. It was unknown which patient out of a group of five patients it was.  All five patients were 11 years of age.  The reporter consented to follow up by email. Additional supportive information: The nurse reported that the patient received a dose of Menveo powder after reconstituting it with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Kinrix and Kinrix 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: 29-AUG-2022 Reporter's Comment:  The reporter stated that the Kinrix was administered on 29AUG2022 and expired on 26AUG2022. No reactions reported. The reporter gave consent to follow up. Additional Supportive Information: The patient received expire Kinrix dose, which led to expired vaccine used.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 29th August 2022, the patient received Boostrix. On 29th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's comment: Nurse reported a patient received a dose of Boostrix that had expired on 27th August 2022. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Boostrix which was already expired, which led to expired vaccine used.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Kinrix and Kinrix 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: 29-AUG-2022 Reporter's Comment:  The nurse reported that a patient received an expired dose of Kinrix on 29Aug2022. The vaccine expired on 26Aug2022. No symptoms reported. The reporter gave consent to follow up. Additional Supportive Information: The patient received expire dose, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Hepatic enzyme, Hepatic enzyme increased, Nausea
Clinical narrative: LIVER ENZYMES ELEVATED; NAUSEA; VOMITING; HEADACHES; This spontaneous report received from consumer via other manufacturer Novavax concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total (first dose) administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced nausea, vomiting, headaches, she could not keep fluids down. She went to the ER the next day and was hospitalized (date unspecified). They looked at her liver enzymes because they were elevated (liver enzymes elevated) and they kept her overnight. They took her blood and gave her fluids. The next day (date unspecified), she was discharged and followed by her medical team.The number of days of hospitalization was reported as 1.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, headaches and liver enzymes elevated was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220859708-Covid-19 vaccine ad26.cov2.s- liver enzymes elevated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220859708- Covid-19 vaccine ad26.cov2.s- nausea, vomiting, headaches .This event(s) is labeled per RSI and is therefore considered potentially related
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: LIVER ENZYMES ELEVATED; NAUSEA; VOMITING; HEADACHES; This spontaneous report received from consumer via other manufacturer Novavax concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total (first dose) administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced nausea, vomiting, headaches, she could not keep fluids down. She went to the ER the next day and was hospitalized (date unspecified). They looked at her liver enzymes because they were elevated (liver enzymes elevated) and they kept her overnight. They took her blood and gave her fluids. The next day (date unspecified), she was discharged and followed by her medical team.The number of days of hospitalization was reported as 1.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, headaches and liver enzymes elevated was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220859708-Covid-19 vaccine ad26.cov2.s- liver enzymes elevated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220859708- Covid-19 vaccine ad26.cov2.s- nausea, vomiting, headaches .This event(s) is labeled per RSI and is therefore considered potentially related
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Aneurysm, Ankle operation, Cerebrovascular accident, Joint swelling, Knee operation
Clinical narrative: STROKE; BACK OPERATION; ANKLE OPERATION; KNEE OPERATION; ANEURYSM; HAND SWELLING; JOINT SWELLING OF HAND; This spontaneous report received from a patient concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 59 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drug included: upadacitinib (form of admin unknown, oral, batch number and expiry was not reported) dose and frequency and therapy dates were not reported, ongoing treatment for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced stroke, back operation, ankle operation, knee operation, aneurysm, left hand shaking, hand swelling, and joint swelling of hand (Knuckle swelling). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient was recovering from stroke, and aneurysm, had not recovered from hand swelling, and joint swelling of hand, and the outcome of back operation, ankle operation and knee operation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220860405- covid-19 vaccine ad26.cov2.s -Stroke, Back operation, Ankle operation, Knee operation, aneurysm. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.