chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: swollen arm  on the arm where she has received flu shots, flu shot every Oct; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Flu vaccine.     Linked case(s) involving the same patient: US2016018882, US2022AMR097788, US2022AMR097791, US2022AMR097795   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received Flu vaccine in the past into unknown arm and had swollen arm. The patient had a Flu shot every October of each year. The patient did not know the manufacturing company of these Flu shots, but she experienced a swollen arm after each dose. The reporter did not consent to follow up. For tolerance to the other suspects refer case US2016018882, US2022AMR097788, US2022AMR097791 and US2022AMR097795. This case is linked to the case US2022096943 and US2022AMR097632, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2016018882:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097788:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097791:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097795:Same patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the first dose of Shingrix in 2018 and did not receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a unk patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 2018 prior before reporting).   On an unknown date patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On 23rd June 2022, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date :23rd June 2022 Reporters comment: The reporter did not consent for follow-up and did not provide adverse event details by the health care professional. The health care professional does not consent to follow up by safety team. Adverse event contained all information provided by the reporter. Additional Supportive information: The patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's comments:  The patient received an expired dose of Kinrix, the vaccine expired on 4th June 2022. No symptoms reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received expired Kinrix, which led to expired vaccine used.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on March 2019 and 2nd dose administered on 04-JUN-22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of shingrix received on March 2019).   On 4th June 2022, the patient received the 2nd dose of Shingrix. On 4th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK receipt date:23rd June 2022 Reporters comment: The reporter consent for follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest pain, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Muscle pain at right arm and in the center of chest; chest pain; pain in the RIGHT arm; Blood pressure was 161/120.; Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 14th June 2022, the patient experienced muscle pain, chest pain, pain in arm and increased blood pressure. On 16th June 2022, the outcome of the muscle pain, chest pain, pain in arm and increased blood pressure were recovered/resolved. On 18th June 2022, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the muscle pain, chest pain, pain in arm and increased blood pressure to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's comment: The patient self reported this case. The patient received dose of Shingrix vaccine into left arm and a couple hours later he had soreness at the injection site. The patient stated that on next day after vaccination his right arm had muscle pain and so did the center of his chest. The patient also reported his blood pressure was 161/120.  The pain in the right arm, chest and elevated blood pressure continued into the next day (15th June 2022).  The patient experienced muscle pain, chest pain, pain in arm and increased blood pressure events one day after the vaccination. The patient's HCP (Health Care Professional) had told him if he ever had elevated blood pressure to take an extra Clonidine tablet. The patient said all symptoms (right arm pain, chest pain and elevated blood pressure) resolved completely by 16th June 2022. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: Inadvertently put in the freezer. It has not been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: Pharmacy intern reported that the Shingrix was inadvertently put in the freezer. It had not been administered. The reporter did not consent to follow-up. Additional supportive information: The Shingrix vaccine was inadvertently put in the freezer. It had not been administered, which led to intercepted product storage error.
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9-year-old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The nurse reported that on 8Jun2022, a 9-year-old patient received Kinrix. The reporter gave consent to follow up. Additional Supportive Information: a 9-year-old patient received Kinrix which lead to Inappropriate age at vaccine administration.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received dose of that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 22nd June 2022, the patient received Engerix B. On 22nd June 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The nurse reported that a dose of Engerix B was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Engerix B dose which was already expired on 6th April 2022, which led to expired vaccine used.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: received a Twinrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 58-year-old male patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) 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 Engerix B (received 1st dose 22nd March 2022, batc number 9AX5P and expiry date 23rd November 2023).   On 21st June 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 21st June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong 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: 24-JUN-2022 Reporter's Comments: After receiving 1st dose of Engerix B, three months latre did not receive another dose of Engerix B but received Twinrix. The reporter did not consent to follow up. Additional Supportive Information: After receiving 1st dose of Engerix B, the patient received Twinrix vaccine, which led to wrong vaccine administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: She began to notice blurred vision; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2022, the patient received the 1st dose of Shingrix. On 23rd June 2022, 1 days after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was not recovered/not resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, she received Shingrix and the following day after the vaccination she began to experience blurred vision.  The reporter reported that symptoms was not resolved yet. The reporter was provided medical advise disclaimer and referred to healthcare professional. The reporter did not consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (penicillin, aminoglycosides, sulfonamides, ) and drug allergy (dextromethorphan, codeine, morphine).   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Tdap Vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The patient had an anaphylactic reaction to an unknown Tdap vaccine in the past. The reporter did not gave consent to follow-up.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient has received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HBV (Engerix B) (batch number 9KG74, expiry date 9th May 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 24th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 24th June 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: 24-JUN-2022 Reporter's Comments: The office manager reported that a dose of Engerix B was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Engerix B dose which was already expired on 9th May 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Outbreak of herpes simplex; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex type i (the patient had a history of herpes simplex type 1).   On 23rd June 2022, the patient received the 1st dose of Shingrix. In June 2022, several hours after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-Jun-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, a few hours after receiving a Shingrix, she experienced outbreak of herpes simplex. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: burning sensation on the bottom of her foot; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 10th June 2022, 4 days after receiving Shingrix, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The patient received the Shingrix vaccine and she began to experience a burning sensation on the bottom of her foot.  The reporter gave consent to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: 4th dose Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3TS, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 3 doses on an unknown date).   On 22nd June 2022, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments:  The reporter was medical assistant at health care professional office who called in to report that a patient received a 4th dose of Pediarix. The patient had already received his 3 doses and completed the series but accidentally received a 4th dose. Initials of patient unavailable during call. The vaccine administration facility was the same as primary reporter The reporter consented to follow up. Additional Supportive Information: The patient received a 4th dose of Pediarix, which led to extra dose administered.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered a dose of Shingrix that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 24th May 2022, the patient received Shingrix. On 24th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 50 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 1 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097903:Same Reporter, patient 2 US-GLAXOSMITHKLINE-US2022097904:Same Reporter, patient 3 US-GLAXOSMITHKLINE-US2022097905:Same Reporter, patient 4 US-GLAXOSMITHKLINE-US2022097908:Same Reporter, patient 5 US-GLAXOSMITHKLINE-US2022097904:Same Reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administered a dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 31st May 2022, the patient received Shingrix. On 31st May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 50 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 2 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097898:Same Reporter US-GLAXOSMITHKLINE-US2022097904:Same Reporter US-GLAXOSMITHKLINE-US2022097905:Same Reporter US-GLAXOSMITHKLINE-US2022097908:Same Reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient was administered with a dose that was expired.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 10th June 2022, the patient received Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 60 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 3 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097903:Same Reporter US-GLAXOSMITHKLINE-US2022097905:Same Reporter US-GLAXOSMITHKLINE-US2022097908:Same Reporter US-GLAXOSMITHKLINE-US2022097898:Same Reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 16th June 2022, the patient received Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 59 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 4 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097903:Same Reporter US-GLAXOSMITHKLINE-US2022097904:Same Reporter US-GLAXOSMITHKLINE-US2022097898:Same Reporter US-GLAXOSMITHKLINE-US2022097908:Same Reporter
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered a dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 16th June 2022, the patient received Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-JUN-2022 Reporter's comment: The patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used. This was 1 of the 5 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097905:Same Reporter US-GLAXOSMITHKLINE-US2022097904:Same Reporter US-GLAXOSMITHKLINE-US2022097898:Same Reporter, patient 5 US-GLAXOSMITHKLINE-US2022097903:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 4XA55, expiry date 13th July 2023) for prophylaxis.   On 16th June 2022, the patient received the 1st dose of Shingrix. On 20th June 2022, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Jun-2022 Reporters comment: The patient received a dose of shingrix and experienced shingles outbreak. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rash pruritic
Clinical narrative: band, 3 inches in width, of little bumps on her left arm that were itchy; pain on her left arm; could not lift her arm without having pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2022, the patient received the 1st dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced mobility decreased. On 20th June 2022, the patient experienced pain in arm. On 23rd June 2022, the patient experienced itchy rash. On an unknown date, the outcome of the pain in arm and itchy rash were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and itchy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUN-2022  Reporter's Comments: The patient received Shingrix and experienced pain on left arm on the day she received vaccine. The patient could not lift her arm without having pain for the next three days.  The pharmacist reported that three days after patient noticed a band, three inches in width, of little bumps on left arm that were itchy.  The pharmacist would like to know if the patient should get the second dose.  The reporter provided medical disclaimer and referred to health care professional.  The pharmacist did not want to provide any patient contact or demographic information.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received only first dose 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: No lot or expiration date were available. The reporter consented to follow-up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an 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 HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 27th June 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: 27-JUN-2022 Reporter's comment: HCP (Health Care Professional) reported that the patient received an expired Havrix. No reactions were reported. The reporter consented to follow-up by email. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose early 2020, has not received dose 2; This case was reported by a pharmacist 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 1st dose in early 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JUNE-2022 The reporter stated that patient had not received dose two. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. This was one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193859:Same reporter US-GLAXOSMITHKLINE-US2020193848:Same reporter US-GLAXOSMITHKLINE-US2019058222:Same reporter
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11-year-old patient received a dose; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-JUNE-2022 Reporter's comment: Medical doctor reported that a 11 year old patient received Kinrix. Consented to follow up. Additional supportive information: 11 years old patient received Kinrix, which led to inappropriate age at vaccine administration
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st dose 9 months ago and still didn´t received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 9 months ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-Jun-2022 The reporter stated that patient received their only one dose of Shingrix 9 months ago and still did not receive the 2nd dose. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: An expired dose was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th June 2022, the patient received Havrix. On 28th June 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: 28-JUN-2022 Reporter's comments:  The reporter reported that the patient received expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was expired on 24th May 2022, which led to expired vaccine used.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received 2nd dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 27th June 2022, the patient received the 2nd dose of Havrix. On 27th June 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: Receipt Date: 28-JUN-2022 Reporter's comments:  The reporter reported that the patient received expired dose of Havrix on 27th June 2022. At time of reporting, dose was not repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was expired on 18th June 2022, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received adjuvant only; received adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number DA32Z, expiry date 30th May 2023) for prophylaxis.   On 22nd June 2022, the patient received Shingrix (intramuscular). On 22nd June 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: 28-JUN-2022 Reporter's comment: Pharmacy Technician reported that a the patient from a care facility received the adjuvant only of the shingrix vaccine into the left deltoid, without it being mixed with the antigen powder. The nurse form the care facility also participated in the call to provide further information. The reporter consented to follow-up. Additional Supportive Information: The patient received only the adjuvant of shingrix vaccine, without it being mixed with the antigen powder, which led Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose on 2019, Only first was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (first dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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: 28-JUN-2022 Reporter's Comment: The patient was late for the second dose of Engerix-B. No adverse event was reported. No patient's identifiers were provided. No lot number and expiration date was provided. No vaccination date was provided. The Vaccine Administration Facility was the same as Primary Reporter. The VAERS details for first dose was reported. The reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: How to proceed with 2nd dose, 1st dose back on 8/6/2019; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The case was reported by a nurse. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired about how to proceed with second dose of Shingrix. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The reporter did not consent to follow up.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered 1st dose 29Jun2022, dose had an expiration date of 18Jun2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 29th June 2022, the patient received the 1st dose of Havrix. On 29th June 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: 29-JUN-2022 Reporter's comment: The nurse reported that the patient received an expired Havrix dose. At the time of reporting, the dose was not repeated. The Vaccine Administration Facility was same as Primary Reporter The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2.5 years before, not received dose two; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022  Reporter's comment: The physician reported a patient received first dose of Shingrix two and a half years before this report and had not received dose two. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2022099884, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099884:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Bexsero second dose 2 years apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in July 2019).   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: Health care professional (HCP) wanted to see how to proceed with the second dose because GlaxoSmithKline studies were developed upto 6 month apart but not with 2 years apart. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Bexsero, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Neoplasm malignant
Clinical narrative: CURRENT CANCER; NOT FEELING WELL IN GENERAL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: radiation, and chemotherapy, and concurrent conditions included: colon cancer (from 5 years ago), non alcoholic, and smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s  (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 04ZAZ1A expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient was not feeling well in general and was in bed for 2 days post initial vaccine. On 30-APR-2021, the patient experienced current cancer (swollen lymph node shortly after the first dose) (Dose number in series 1).  The lung doctor found swollen lymph node growing on the artery connecting the heart to the lungs right side in APR-2021. He had undergone radiation and chemotherapy for this. It was inoperable because of current position of lymph node. Doctors found it strange to get two types of cancer like the patient had back to back. Currently under the care of the Oncologists at the local Cancer Centre in his city. Patient now worried that the vaccine was linked to current swollen lymph node and current cancer. The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total administered on 23-NOV-2021 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling well in general, and had not recovered from current cancer. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220647124-COVID-19 VACCINE AD26.COV2.S- Current Cancer. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.