chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever; Chills/had a lot of chils; Nauseated; Wiped out; Felt like had Covid-19, patient caught Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Felt like had Covid-19, patient caught Covid-19), PYREXIA (Fever), CHILLS (Chills/had a lot of chils), NAUSEA (Nauseated) and FATIGUE (Wiped out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M1A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced COVID-19 (Felt like had Covid-19, patient caught Covid-19). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills/had a lot of chils), NAUSEA (Nauseated) and FATIGUE (Wiped out). At the time of the report, COVID-19 (Felt like had Covid-19, patient caught Covid-19), PYREXIA (Fever), CHILLS (Chills/had a lot of chils), NAUSEA (Nauseated) and FATIGUE (Wiped out) outcome was unknown.            The patient caught Covid-19 on 29-JUL-2022. Patient could not taste anything. No treatment medications were reported.   This case was linked to MOD-2022-666023, MOD-2022-666026 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Atrial fibrillation, Pain in extremity
Clinical narrative: sore arm for about 24 hours then went away. Then patient's heart went into A-fib per patient
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Mouth ulceration, Nausea, Pain, Pyrexia
Clinical narrative: mouth ulcers--several small ulcers on inside of bottom lip, duration 3+ days fever, chills, aches, nausea--duration 8 hours
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: PT PREVIOUSLY HAD VACCINE ADMINISTERED AT ANOTHER CLINIC AND DATA WAS NOT INPUTTED INTO OUR SYSTEM WHICH SHOWED THAT THE PT WAS DUE FOR THE VACCINE
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Needle issue, Syringe issue
Clinical narrative: While administering vaccination, the needle popped off of the syringe barrel (wasn't screwed on tight) and the vaccine shot out of the barrel. It is unknown the dose the patient actually received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided; Office manager reports that MMR II was administered to three patients after the product's expiration date.Office manager confirms the product was stored appropriately prior to administration and had no temperature excursions.; This spontaneous report has been received from an office manager concerning to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant medications were not provided.  On 07-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, at a dose of 0.5 milliter(ml), (strength, vaccination scheme frequency, route and anatomical location were not provided; lot number T029549 that was verified to be a valid lot number with an expiration date reported as 01-SEP-2022, but upon internal validation established as 10-SEP-2022) (expired product administered) for prophylaxis.  By the reporting time, the caller confirmed that the product was stored appropriately prior to administration and had no temperature excursions.  No additional adverse event (AE) information provided(no adverse event).  This is one of two reports received from  the same reporter.; Sender's Comments:  US-009507513-2210USA010287:AE report #: 02276203 US-009507513-2210USA010314:AE report #: 02276158
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; HCP states that ROTATEQ was administered to a patient after temperature excursions.; This spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-OCT-2022, the patient was vaccinated orally with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # W002561, expiration date 07-OCT-2023 (dose was not provided) administered as prophylaxis (Product storage error).   The improperly stored vaccine underwent a temperature excursion for 1 hour at 9.13 degree Celsius and for 37 hours at a minimum of -8.45 degree Celsius without previous excursions. No additional adverse events were reported (No adverse event).
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reports that lot expired on 10/12/22 and was administered to patient on 10/24/22.; This spontaneous report has been received from a pharmacist concerning to a currently 2-month-old female patient. The patient's medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.  On 24-OCT-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, by defaulted oral route of administration, at a dose of 2 milliliter(ml) once (strength and vaccination frequency were not provided; lot number 1742415 that was verified to be valid lot number with an expiration date reported as and established as 12-OCT-2022) (expired product administered) for prophylaxis.  No additional adverse events was reported (AE's)(no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; ROTATEQ was administered to a patient after temperature excursions.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  lot #W002561, expiration date: 07-OCT-2023, taken orally (strength and dosage regimen were not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 9.13 degrees Celsius (C) for 1 hour, and at minimum of -8.45 degrees Celsius (C) for 37 hours and 15 minutes, without previous excursions. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got all the shots but still got shingles after/suspected vaccination failure; Still 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: 25-OCT-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reporter stated that got all the shots but I still got my first case of shingles after.  The patient also reported that had all my Covid shots but got Covid twice. The follow up would not possible, as no contact, details were available. Additional Supportive Information: As per source document the patient vaccination schedule was not confirm hence single shingles vaccine was captured. As per narrative due to insuffient information for start date for Covid hence which were captured in narrative.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nasopharyngitis, Pain, Pruritus, Vaccination failure
Clinical narrative: Got vaccinated and got them/Suspected vaccination failure; Hit me on face, went up to head; It's painful; Cold fever; Head itching a night; 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), shingles, pain, pyrexial cold and pruritus. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the vaccination failure, pain, pyrexial cold and pruritus were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pyrexial cold and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine. The patient stated that he/she after received Shingles vaccine he/she experienced Shingles hit on his/her right side of the face and it was went up to his/her head. The patient was went to the doctor, and the doctor prescribed some pills to him/her and patient took it pills in every 5 minutes. The shingles was went away but it was painful, the patient got cold fever and itch on his/her head at the night. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles vaccine and still got shingles/suspected vaccination failure; huge bout of shingles/could´t have worse; 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.     Linked case(s) involving the same patient:  US2022AMR004113   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and still got a huge bout of shingles. The patient knew that same with a few other people and no, his/her could not had worse without the shot. The case was linked with case US2022AMR156040, reported by same reporter for different patients. 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.; Sender's Comments:  US-GSK-US2022AMR156040:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/other people had the shingles vaccine and still got shingles; huge bout of shingles/other people had the shingles vaccine and still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter knew that few other people got the vaccine and still had shingles. The case was linked with case US2022AMR156026, reported by same reporter for himself/herself. 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.; Sender's Comments:  US-GSK-US2022AMR156026:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: none of them actually prevent getting the disease/ hospitalized after second dose; Suspected vaccination failure/ none of them actually prevent getting the disease/ hospitalized after second dose; 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 (serious criteria hospitalization). 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 and Shingles vaccine.     Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that new mRNA jabs had a whole list of adverse side effects. The three people whom reporter knew where hospitalized after receiving their second dose of Shingles jabs. The reporter reported that none of them actually prevent getting the disease. The reporter also mentioned that Flu vaccine was still only 40 to 60 percent effective. This was 1 of 3 linked cases reported by same reporter for different patients. 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-US2022AMR156126:Same reporter US-GSK-US2022AMR156127:Same reporter US-GSK-US2022AMR156128:Same reporter (case deleted, case created in error) US-GSK-US2022AMR156129:Same reporter (case deleted, case created in error)
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: none of them actually prevent getting the disease/ hospitalized after second dose; Suspected vaccination failure/ none of them actually prevent getting the disease/ hospitalized after second dose; 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 (serious criteria hospitalization). 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 and Shingles vaccine.     Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that new mRNA jabs had a whole list of adverse side effects. The three people whom reporter knew where hospitalized after receiving their second dose of Shingles jabs. The reporter reported that none of them actually prevent getting the disease. The reporter also mentioned that Flu vaccine was still only 40 to 60 percent effective. This was 1 of 3 linked cases reported by same reporter for different patients. 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-US2022AMR156120:Same reporter US-GSK-US2022AMR156127:Same reporter US-GSK-US2022AMR156128:Same reporter (Case deleted, case created in error) US-GSK-US2022AMR156129:Same reporter (Case deleted, case created in error)
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: none of them actually prevent getting the disease/ hospitalized after second dose; Suspected vaccination failure/ none of them actually prevent getting the disease/ hospitalized after second dose; 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 (serious criteria hospitalization). 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 and Shingles vaccine.     Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that new mRNA jabs had a whole list of adverse side effects. The three people whom reporter knew where hospitalized after receiving their second dose of Shingles jabs. The reporter reported that none of them actually prevent getting the disease. The reporter also mentioned that Flu vaccine was still only 40 to 60 percent effective. This was 1 of 3 linked cases reported by same reporter for different patients. 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-US2022AMR156120:Same reporter US-GSK-US2022AMR156126:Same reporter US-GSK-US2022AMR156128:Same reporter (Case deleted, case created in error) US-GSK-US2022AMR156129:Same reporter (Case deleted, case created in error)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shots didn't stop mine nope/suspected vaccination failure; didn't stop mine; 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: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that shots did not stop his/her, nope. 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: got the vaccine years ago, got Shingles this summer/suspected vaccination failure; Shingles / not bad; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)) and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got got the vaccine for Shingles 3 or 4 years ago, but he/she got a case of the shingles this summer (2022).  The patient stated that it was not a bad case and his/her physician cured them quickly with antibiotics and a pharma (Rx) cream. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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. Time to onset was captured as more than 2 years as shingles was occurred this summer (in 2022) after 3 or 4 years.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: They got this shot and got shingles/suspected vaccination failure; shingles/ got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: 28-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter stated that everyone he/she knew got this shot and got shingles. The reporter mentioned another hoax in his/her opinion and had been convinced to be an antivaxxer. 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: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Red spot where shot was given; Red spot at shoulder; Warm; Painful spot; Arm hurts off and on; Shoulder painful; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Shingrix (intramuscular). In October 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, erythema, skin warm, pain, pain in arm and shoulder pain. On an unknown date, the outcome of the injection site erythema, erythema, skin warm and pain were recovering/resolving and the outcome of the pain in arm and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema, skin warm, pain, pain in arm and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-Oct-2022 and 24-Oct-2022 Reporter's comment: The patient received first dose of Shingrix on left deltoid The patient had a red spot where the shot was given (in the deltoid) and a red spot an inch above (at the shoulder) that were painful and warm. The patient's spots were finally starting to lighten up and arm only hurts off and on. The patient also experienced shoulder sore and painful. The patient was not having decreased mobility of the injected arm. The patient did not have the lot number however that information should be on record at vaccine administered at pharmacy. The reporter gave Medical doctor contact to contact her primary care physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Red spot where shot was given; Red spot at shoulder; Warm; Painful spot; Arm hurts off and on; Shoulder painful; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Shingrix (intramuscular). In October 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, erythema, skin warm, pain, pain in arm and shoulder pain. On an unknown date, the outcome of the injection site erythema, erythema, skin warm and pain were recovering/resolving and the outcome of the pain in arm and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema, skin warm, pain, pain in arm and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-Oct-2022 and 24-Oct-2022 Reporter's comment: The patient received first dose of Shingrix on left deltoid The patient had a red spot where the shot was given (in the deltoid) and a red spot an inch above (at the shoulder) that were painful and warm. The patient's spots were finally starting to lighten up and arm only hurts off and on. The patient also experienced shoulder sore and painful. The patient was not having decreased mobility of the injected arm. The patient did not have the lot number however that information should be on record at vaccine administered at pharmacy. The reporter gave Medical doctor contact to contact her primary care physician.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever worst than Covid Vaccine; 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.   Previously administered products included Covid vaccine with an associated reaction of pyrexia.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   The reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient too had fever from this vaccine, it was worse than the covid vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: burning sensation on skins and body; painful sensation on skins/Painful and annoying; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation 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 burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were not recovered/not resolved.   It was unknown if the reporter considered the burning sensation and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced burning sensation on skins on body and would not go away.  The patient experienced very painful and annoying. The patient was asking how long this would last. The patient did not want to take second vaccine.  The patient did not have rush just awful painful sensations on skins. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: It was red; It was warm; Got shingles shot, it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On 19th October 2022, the patient experienced erythema and skin warm. On an unknown date, the outcome of the pain, erythema and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her shingles shot this past Monday. It hurt for a few days, then 3 days ago it was red and warm. On day of reporting (morning) the patient woke up and it hurts again.  The patient asked should be worried. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm hurt all the way to elbow; arm hurt all the way to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and pain in elbow. On an unknown date, the outcome of the pain in arm and pain in elbow were unknown.   It was unknown if the reporter considered the pain in arm and pain in elbow to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient asked was it a side effect after the shingle shot for arm to hurt all the way to elbow. Additional supportive information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: GAVE KINRIX FOR THE 3 RD DOSE OF DTAP; This case was reported by a nurse via sales rep and described the occurrence of inappropriate schedule of vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comments: Nurse gave a dose of kinrix for the 3rd dose of dtap. Additional supportive information: The patient received kinrix as the 3rd dose of dtap, which led to inappropriate schedule of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered before the 2-6 month period; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: Inquiry came in via chat. On 3rd October 2022, the patient received first dose of Shingrix. The pharmacist had a question on the administration of the Shingrix vaccine. The second dose was administered before the 2 and 6 month period that would the patient have to retake the second dose. The reporter did not consent to follow-up.  User ended chat before providing any details. Additional supportive information: The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two doses of Shingrix, 20 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received two doses of Shingrix vaccine about 20 days apart. The reporter wanted to remain anonymous and had not provided details to provide about this adverse event. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix early than recommended time frame, which led to shortening of vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Late for the 3rd dose, not administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 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 on 2015) and Twinrix (2nd dose received on 2015).   On an unknown date, the patient did not receive 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: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter was a healthcare professional. The reporter reported that the patient was late for the 3rd dose. The reporter stated that there was no adverse event reported. The reporter reported that the patient identifiers, lot number, expiration date and vaccination date was not provided. No vaccination date provided for the third dose as it was not administered. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Suicidal ideation, Vomiting
Clinical narrative: Suicidal thoughts; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of suicidal ideation in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced suicidal ideation (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the suicidal ideation and vomiting were recovered/resolved.   It was unknown if the reporter considered the suicidal ideation and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The reporter was the patient. The patient reported that she received Shingrix vaccine and 1 day after received Shingrix vaccine, she experienced vomiting which was lasted for 2 days, following this she experienced suicidal thoughts which was lasted for one day. The patient was called to suicide hot line for the help. The patient stated that she would not receive the second dose. The reporter did not recall the date of vaccination and unsure of the site of administration, but she believed that it was in the left arm. The reporter did consent to follow up with HCP.
Age: 0.42
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FluLaval administered to a 5 months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3K75S, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra 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-Oct-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a Flulaval vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old female patient who received HBV (Engerix B) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th October 2022, unknown after receiving Engerix B and Engerix B 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: 26-Oct-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B on the day of reporting, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Hasn't yet received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose intramuscularly in 2018 ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix (intramuscular). 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: 27-Oct-2022 Reporter's comment: The patient mentioned she has not yet second dose. The reason for delay was unknown. Nothing else was reported. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccine administered after it expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 27th October 2022, the patient received Havrix. On 27th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 and 28-Oct-2022 Reporter's comment: The reporter asked that what was the expected results of this and did the vaccine need to be administered again to complete series or possible side effects or risks. Unable to reach health care professional for further information. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Pain, Paralysis, Wheelchair user
Clinical narrative: Guillain-Barré Syndrome, nearly killed her; paralyzed, in a wheel chair; paralyzed, in a wheel chair; Pain; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included pneumonia (pneumonia at 2 weeks old), difficulty breathing (breathing problems (colds, bronchitis, pneumonia) when she was in her late 20's), cold, bronchitis, numbness of lower extremities and passive smoking (never smoked (inhaled second hand smoke as a child)). Previously administered products included Brovana (Brovana (arformoterol)-was using this product for a few years but it started to wear off after about 2 hours also was hospitalized due to it causing her legs/feet numb). Concurrent medical conditions included drug allergy (Allergic to propellant in Proventil - was in hospital for 2 weeks) and allergic asthma (allergy related asthma).   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant and life threatening), paralysis (serious criteria GSK medically significant), wheelchair user and pain. The patient was treated with morphine. On an unknown date, the outcome of the guillain barre syndrome, paralysis, wheelchair user and pain were recovered/resolved.   The reporter considered the guillain barre syndrome, paralysis, wheelchair user and pain to be related to Influenza vaccine.  Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter was the patient.  She did not want to provide her street address nor did she want to answer any further questions as she did not want a report to be filed.  The reporter was calling to ask questions about Trelegy.  She had not started using Trelegy yet but was given samples.  She was asking if it was okay to use ipratropium bromide 0.2 percent nebulizer solution prior to inhaling Trelegy During the call, she mentioned many of her medical conditions (present and past) and indicated that in 2005 she developed GBS (Guillain-Barre Syndrome) due to receiving a flu shot. The patient received flu shot in 2005. She did not remember the name of the specific flu shot she had received.  She said that the GBS nearly killed her and that it took her 2 years to get over it from the day of reporting. She said that, she was paralyzed and in a wheel chair and was taking mega doses of morphine for the pain. On 27th October 2022, used Albuterol nebulizing solution 0.083 percent and had it make her feel shaky for 2-3 hours. The reporter did not want to answer any further questions and did not want a report to be filed.