chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Even with the vaccines, I still have flare ups/Suspected vaccination failure; Still have flare ups (shingles); 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: 12-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that even with the vaccines, the patient still had flare ups. The reporter denied to follow-up. 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.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Was patient pregnant while using the product - Yes; This prospective pregnancy case was reported by a consumer via patient support programs and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 953Y2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th April 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 5th April 2022. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-NOV-2022 Reporter's comment: This case was reported by a consumer via (McKesson) patient support programs.  The reporter stated that patient received vaccine when the patient was pregnant. The reporter also confirmed that vaccine was not expired.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on my back, is it a mild case of shingles?; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-Nov-2022 Reporter's Comments: The patient self-reported this case. The patient had a rash on his/her back one week after receiving first dose of Shingrix.  The patient wants to know could this be a side effect, was it a mild case of shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash on my back; is a mild case ofshingles?; 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 the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient reporter that he/she had a rash on his/her back one week after receiving first dose of Shingrix.  The reporter asked could this be a side effect. The reporter asked as it was a mild case of shingles. Additional Supportive Information: Follow up would not possible, as no contact details were available.
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Bedridden, Fatigue, Loss of personal independence in daily activities, Nausea, Urticaria
Clinical narrative: Welt on arm; Nausea; vomiting; Fatigue.; Normal activity affected; In bed for 4-5 days. Normal activity affected.; This case was reported by a nurse via sales rep and described the occurrence of welts in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   Concurrent medical conditions included immunocompromised (immunocompromised due to medication).   On an unknown date, the patient received the 2nd dose of Shingrix and PREVNAR 20. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired. On an unknown date, the outcome of the welts, nausea, vomiting, fatigue and activities of daily living impaired were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK receipt date: 08-Nov-2022 Reporter's comment: The patient received Shingrix co-administered with Prevnar 20. 4 hours after Prevnar 20 the symptoms began, the patient had welt on arm. Nausea and vomiting. In bed for 4 to 5 days. Normal activity affected.  The patient experienced fatigue. Patient was immunocompromised due to medication on two biologics. Less than a week, after Shingrix and Prevnar 20 the patient was bedridden and activities of daily living impaired. It was unknown if the reporter considered the welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired to be related to Prevenar 20.
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Vomiting
Clinical narrative: Welt on arm; Nausea; vomiting; Fatigue.; Normal activity affected; In bed for 4-5 days. Normal activity affected.; This case was reported by a nurse via sales rep and described the occurrence of welts in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   Concurrent medical conditions included immunocompromised (immunocompromised due to medication).   On an unknown date, the patient received the 2nd dose of Shingrix and PREVNAR 20. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired. On an unknown date, the outcome of the welts, nausea, vomiting, fatigue and activities of daily living impaired were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK receipt date: 08-Nov-2022 Reporter's comment: The patient received Shingrix co-administered with Prevnar 20. 4 hours after Prevnar 20 the symptoms began, the patient had welt on arm. Nausea and vomiting. In bed for 4 to 5 days. Normal activity affected.  The patient experienced fatigue. Patient was immunocompromised due to medication on two biologics. Less than a week, after Shingrix and Prevnar 20 the patient was bedridden and activities of daily living impaired. It was unknown if the reporter considered the welts, nausea, vomiting, bedridden, fatigue and activities of daily living impaired to be related to Prevenar 20.
Sex: U
Vaccine: VARZOS
Symptoms: Ear discomfort, Insomnia, Tinnitus
Clinical narrative: strong ringing, thought was having high blood pressure.; haven't been able to sleep.; ears bordering; This case was reported by a consumer and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st October 2022, the patient received Shingles vaccine. In October 2022, several days after receiving Shingles vaccine, the patient experienced ear discomfort. On 30th October 2022, the patient experienced ringing in ears and sleeplessness. On an unknown date, the outcome of the ringing in ears, ear discomfort and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears, ear discomfort and sleeplessness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 08-Nov-2022 Reporter's comment:  The patient received the Shingle vaccine. After couple of days, the patient felt ears bordering. On Sunday, the patient ears were ringing so strong that patient thought having a high blood pressure. The patient's ears did not stop ringing up to the point so was unable to sleep.  After 9 days, the patient experienced ringing in ears and sleeplessness. The patient did not know what else to do and was asking for advice.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only given the liquid portion; Only given the liquid portion; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate preparation of medication 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 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: 08 NOV 2022 Reporter's Comment: This case was reported via interactive digital media. The reporter had Shingrix at office, then was realized that patient was only given the liquid portion of vaccine. The reporter wanted to know that could they give the correct dose now or if there was something, they need to do different. Additional supportive information: The patient received only liquid portion of vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm still hurting; 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.   In October 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that his/her arm was still hurting after getting the shot almost 2 and one half weeks ago from the date of reporting. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: feeling feverish; chills; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th November 2022, the patient received the 2nd dose of Shingles vaccine. On 9th November 2022, 12 hrs after receiving Shingles vaccine, the patient experienced fever, chills and muscle pain. On an unknown date, the outcome of the fever, chills and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and muscle pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 09-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received second dose of Shingles vaccine this morning (reporting day) was feeling feverish, chills and muscle aches. The patient was asking was this normal 12 hours later and how long would it last. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included chronic uti, foot fracture and clot blood (renal blood clot). Concurrent medical conditions included hypertension, endocrine disorder, renal cell carcinoma and penicillin allergy. Concomitant products included lenvatinib mesilate (Lenvima), amlodipine, levothyroxine, hydrocortisone, pembrolizumab (Keytruda), ciprofloxacin (Cipro), sulfamethoxazole + trimethoprim (Bactrim), hydrocodone bitartrate + paracetamol (Norco), paracetamol (Tylenol Es) and apixaban (Eliquis).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comments:  The patient received Flu vaccine and she got sick. No other information was provided. Additional Supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product dose omission issue
Clinical narrative: I forgot to get my 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in mid April 2022).   On an unknown date, the patient received 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: 10 NOV 2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received 1st dose of Shingrix in mid April. The patient reported that forgotten to take 2nd dose of vaccine at 6th months. It had been 7 months since 1st Shingrix dose, the reporter asked it was ok to get second dose now or it was problematic to have the 2nd dose now Additional supportive information: Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had experienced headache since his/her shingles injection 3 days ago from the day of reporting. The reporter wanted to know if it was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Feeling of body temperature change, Hyperhidrosis, Rash vesicular
Clinical narrative: shingles like rashes; shaking; sweating; felt hot and cold; diarrhea; loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash vesicular (Received 1st dose on October 2020 for tolerance of 1st dose, refer case US2022166275).   On an unknown date, the patient received the 2nd dose of Shingrix. On 9th November 2022, less than 2 years after receiving Shingrix, the patient experienced tremor, sweating, feeling hot and cold, diarrhea and appetite lost. On an unknown date, the patient experienced vesicular rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved and the outcome of the tremor, sweating, feeling hot and cold, diarrhea and appetite lost were unknown.   It was unknown if the reporter considered the vesicular rash, tremor, sweating, feeling hot and cold, diarrhea and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022166275   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, after receiving Shingrix, he had continued outbreaks of the same shingles like rashes.  The reporter stated that, the day before reporting, he was shaking, sweating, felt hot and cold, had diarrhea and a loss of appetite.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022166275:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: shingles like rashes; shaking; sweating; felt hot and cold; diarrhea; loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash vesicular (Received 1st dose on October 2020 for tolerance of 1st dose, refer case US2022166275).   On an unknown date, the patient received the 2nd dose of Shingrix. On 9th November 2022, less than 2 years after receiving Shingrix, the patient experienced tremor, sweating, feeling hot and cold, diarrhea and appetite lost. On an unknown date, the patient experienced vesicular rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved and the outcome of the tremor, sweating, feeling hot and cold, diarrhea and appetite lost were unknown.   It was unknown if the reporter considered the vesicular rash, tremor, sweating, feeling hot and cold, diarrhea and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022166275   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, after receiving Shingrix, he had continued outbreaks of the same shingles like rashes.  The reporter stated that, the day before reporting, he was shaking, sweating, felt hot and cold, had diarrhea and a loss of appetite.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022166275:Same reporter
Sex: M
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: has only had one DTaP dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 6-year-old male patient who received DTPa (DTaP vaccine) for an unknown indication.   Previously administered products included DTaP  (received only one DTaP dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, 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: 8-Nov-2022 Reporter's comment: The registered nurse reported that the patient come in their clinic on the day of reporting and want to administer Kinrix on the day of reporting. The reporter did not know what DTaP, the child had received, so unknown DTaP as first dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of DTaP, which led to incomplete course of vaccination.
Sex: U
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Bexsero as 1st dose and Trumenba as 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In November 2022, the patient received TRUMENBA. In November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 8-Nov-2022 Reporter's comment: The nurse called in and reported that the patient received first dose of Bexsero and last weekend received a dose of Trumenba in another pharmacy. The reporter consented to follow-up. Additional supportive information: The patient received Bexsero dose and then Trumenba, which led to interchange of vaccine products.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the previous dose was 4 years prior.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received the previous dose of Twinrix 4 years prior at the time of reporting).   On an unknown date, the patient did not receive Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The reporter called in to inquire about the vaccination schedule of Twinrix, as the patient that, wished to receive the vaccine had gotten the previous dose 4 years prior at the time of reporting.  The reporter did not have information other than the patient's date of birth and gender. The Vaccine Administration Facility was the same as Primary Reporter. The VAERS details were updated for the previously administered Twinrix dose. The reporter asked to be contacted through e-mail. Additional Supportive Information: Till the time of reporting, the patient did not completed the Twinrix vaccine immunization, which led to incomplete course of vaccination. As it was not clear which dose was pending, therefore in worst approach case was kept valid with incomplete course of vaccination considering the Twinrix vaccine immunization was pending and meanwhile follow-up request was raised for the same.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Epigastric discomfort, Injection site pain, Paraesthesia, Pigmentation disorder
Clinical narrative: Minimal pain and soreness at the injection site; 10-12 inch rectangle area on stomach is tingly; 10-12 inch rectangle area on stomach is sensitive; small pink spot on the inside of her left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st November 2022, 1 days after receiving Shingrix, the patient experienced spot pigmented. On 2nd November 2022, the patient experienced tingling and irritable stomach. In 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the spot pigmented, tingling and irritable stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, spot pigmented, tingling and irritable stomach to be related to Shingrix.     Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was patient. The patient received the first dose of shingrix in left arm and experienced minimal pain and soreness at the injection site,small pink spot on the inside of her left arm,10 to12 inch rectangle area of her upper left side of her stomach was tingly and sensitive that was felt 2 days. The patient reported that the rectangle area had no rash or discoloration. patient wants to know if this was from the shingrix vaccine and what should she do. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Administered to about 100 patients after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients 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, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The medical assistant reported that Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix and Pediarix were exposed to 31.00 degree Fahrenheit for 1 minute, not specifying when the excursion took place.  The vaccine were then applied to an approximate 100 patients.  No patients identifiers, vaccination date, lot number or expiration dates were provided at the moment.  The Vaccine Administration Facility waas the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patients received Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix and Pediarix after temperature excursion, which led to incorrect storage of drug.
Age: 85.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 85-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th November 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: 8-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. This is report for 1 of 2 linked patients reported by same reporter. Suspect was coded as per narrative information.; Sender's Comments:  US-GSK-US2022163638:Same reporter
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th November 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: 8-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. This is report for 2 of 2 linked patients reported by same reporter. Suspect was coded as per narrative information.; Sender's Comments:  US-GSK-US2022163637:Same reporter
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Axillary mass, Cardiac discomfort, Cardiac disorder, Diarrhoea, Hypertension
Clinical narrative: Not feeling well; large lump under armpit; injection site was sore; High blood pressure 160/100; I feel pressure on my heart"; I hve an itchy hand; diarrhea; She states she had to take 2 days off from work; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) (batch number 437BK, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. In November 2022, several hours after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced feeling unwell, axillary lump, injection site pain, blood pressure high, heart pressure sensation of, itching both hands, diarrhea and activities of daily living impaired. On an unknown date, the outcome of the feeling unwell and activities of daily living impaired were unknown and the outcome of the axillary lump, injection site pain and diarrhea were recovered/resolved and the outcome of the blood pressure high, heart pressure sensation of and itching both hands were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, axillary lump, injection site pain, blood pressure high, heart pressure sensation of, itching both hands, diarrhea and activities of daily living impaired to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was the patient.  The patient received the flulaval vaccine and after an hours she experienced feeling unwell, injection site was sore, her blood pressure was high 160/100,cardiac disorder, axillary lump, itchy hand, diarrhea and had to take 2 days off from work. The reporter did not consent to follow-up. Note-clarification was raised but as per narrartive outcoem captured as recovering
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Malaise, Pruritus
Clinical narrative: Not feeling well; large lump under armpit; injection site was sore; High blood pressure 160/100; I feel pressure on my heart"; I hve an itchy hand; diarrhea; She states she had to take 2 days off from work; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) (batch number 437BK, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. In November 2022, several hours after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced feeling unwell, axillary lump, injection site pain, blood pressure high, heart pressure sensation of, itching both hands, diarrhea and activities of daily living impaired. On an unknown date, the outcome of the feeling unwell and activities of daily living impaired were unknown and the outcome of the axillary lump, injection site pain and diarrhea were recovered/resolved and the outcome of the blood pressure high, heart pressure sensation of and itching both hands were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, axillary lump, injection site pain, blood pressure high, heart pressure sensation of, itching both hands, diarrhea and activities of daily living impaired to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was the patient.  The patient received the flulaval vaccine and after an hours she experienced feeling unwell, injection site was sore, her blood pressure was high 160/100,cardiac disorder, axillary lump, itchy hand, diarrhea and had to take 2 days off from work. The reporter did not consent to follow-up. Note-clarification was raised but as per narrartive outcoem captured as recovering
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received Bexsero expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) 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.   On 26th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th August 2022, unknown after receiving Bexsero and Bexsero 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: 09-Nov-2022 Reporter's comment: On 11th November 2022, the vaccine coordinator reported that on 26th August 2022 the patient received Bexsero expired dose.  The consent to follow-up was granted. The follow-up was accepted by email. The patient´s details were not available at the moment of the call. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluent only used; received diluent only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022, the patient received Shingrix. On 8th November 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: 09-NOV-2022 Reporter's Comment: The reporter reported that, a patient received a dose of the Shingrix diluent only.  No symptoms were reported. The reporter consented to follow up. The reporter did not have any patient details or lot/expiry at the time of report. Additional Supportive Information: The reporter reported that, a patient received a dose of the Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site pain, Tenderness
Clinical narrative: Soreness at injection site; Tenderness by the wrist; Redness by the wrist; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, wrist pain and erythema of extremities. On an unknown date, the outcome of the injection site pain, wrist pain and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site pain, wrist pain and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date:09-NOV-2022 Reporter's Comment: The case was reported by the patient. The reporter did not wish to provide further demographics or information. The patient received his Shingrix.  He experienced soreness at the injections site and redness and tenderness by the wrist on the same arm as the injection. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received HBV (Engerix B adult) (batch number 4F472, expiry date 6th November 2022) for prophylaxis.   On 8th November 2022, the patient received Engerix B adult. On 8th November 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: The reporter reported that, a patient was administered an expired dose of Engerix-B. The reporter did not have any of the patient information at the time of reporting, just that it was an adult. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that, a patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No DCA BOT sheet attached, manual checked performed, no duplicate found- ; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th November 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: 09-NOV-2022 Reporters comment: The pharmacist reported that the patient received the expired dose of Havrix vaccine. The reporter did not consent to follow-up. HCP declined giving contact information. Additional Supportive information: The patient received the expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the initial dose of Twinrix and received the 2nd dose 1 month later and now wants to complete the series with a dose of Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received In April 2022) and Twinrix (2nd dose received  in May 2022).   On an unknown date, the patient did not received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK receipt date: 09-NOV-2022 Reporters comment:  The patient received the initial dose of twinrix and received the 2nd dose 1 month later and now wants to completed the series with a dose of Engerix. Health care professional  did not have the exact dates of dose 1 and 2 dose, and belived it was April/May. The dose of Engerix  was not yet administered at the time of this report The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 3rd dose of twinrix, which led to incomplete course of vaccination.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix adult administered to 18 months-old; Havrix adult administered to 18 months-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old patient who received HAV (Havrix adult) (batch number W006214, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix 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: 08-NOV-2022 Reporter's Comment: The registered nurse reporter that the pediatric patient received Havrix adult dose. The reporter had no patient or product other than lot number (which was not registering as a lot number in database). The reporter reported that it was unknown Havrix was solution or PFS. The reporter consented to follow up. Additional Supportive Information: The pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Paraesthesia
Clinical narrative: intermittent paresthesia of upper, lower extremities, and scalp; severe headache; This case was reported by a physician via call center representative and described the occurrence of paresthesia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In November 2022, 1 week after receiving Shingrix, the patient experienced paresthesia and headache. On an unknown date, the outcome of the paresthesia and headache were not recovered/not resolved.   It was unknown if the reporter considered the paresthesia and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter who was reporting on behalf of a patient.  He stated that, the patient received her Shingrix, approximately two and a half weeks ago, giving no specific date, the patient started to present paresthesia in upper and lower extremities as well on the scalp..  She also experienced a severe headache.  Information for the patient was given, no specific information about the vaccine. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The case US2022166269 was identified as duplicate of US2022166279. The case US2022166279 would be voided, and all the future correspondence would be added in this case US2022166269 which stands as a case of record for this patient.