chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 11th 2022 planning to receive second on Jun 29th 2022; 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 HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. 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. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 11th 2022 planning to receive second on Jun 29th 2022; 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 HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. 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. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 11th 2022 planning to receive second on Jun 29th 2022; 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 HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. 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. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Rash, Swelling face
Clinical narrative: rash; swelling of her face; given 3 doses of a Shingles vaccine; This case was reported by a pharmacist and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknwon date) and Shingles vaccine (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced rash, facial swelling and extra dose administered. On an unknown date, the outcome of the rash, facial swelling and extra dose administered were unknown.   It was unknown if the reporter considered the rash and facial swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments:  The patient was inadvertently given 3 doses of a Shingles vaccine and within days, developed a rash and swelling of her face. The reporter asked about data or studies on the effects of 3 doses of the vaccine and potential side effects of this. Additional Supportive Information: The patient received 3 doses of a Shingles vaccine, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: could not get dose two within six months from dose one due to the pandemic; This case was reported by a other health professional via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 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 social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The pharmacy operations manager reported that a couple years ago (as reported) the patient could not get second dose of Shingrix within six months from dose one and could not get the vaccine due to COVID. The reporter clarified that it was not due to a COVID infection but due to the pandemic restrictions. The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2022093601 and US2022093603, reported by same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093601:Same reporter. US-GLAXOSMITHKLINE-US2022093603:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Both doses 2 years ago, developed shingles last month/Suspected vaccination failure; Developed shingles last month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received the Shingrix vaccine (both doses) about 2 years ago and developed shingles last month. The patient asked if she/he need to repeat the vaccine series? Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine and has shingles right now/suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: This case was reported by a patient's wife via interactive digital media. The patient had vaccine and had shingles right now.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, have shingles again/suspected vaccination failure; 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.   The patient's past medical history included shingles (had shingles face for 5 weeks and that was horrible).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles on face for 5 weeks and that was horrible. The patient got the vaccine but the patient had shingles again on the back of both hands. The patient praise the Lord this time it was not nearly as severe. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Relative took the vaccine and experienced a sore arm for a week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The reporter was patient's relative. This reporter had questions about possible side effects and if it was appropriate to get the Shingrix vaccine after already taken the Zostavax. The reporter stated that the patient took the vaccine and experienced a sore arm for a week. The reporter ended the call precipitously due to an incoming call and agent was unable to provide any information. The reporter did not wish to provide demographic information and did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: since shingrix, has had 4 outbreaks of shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 2nd dose of Shingrix .5 ml. On 11th July 2020, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: The patient self-reported this case. The patient stated that since she had gotten her Shingrix vaccine, she had about 4 outbreaks of shingles. The patient's outbreaks lasted about 10 days to 2 weeks. The patient did not currently had shingles.  The patient did not have any further information about the lot number and expiration date of vaccine. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Caller is the patient stating that since she has gotten her shingrix vaccine, she has had about 4 outbreaks of shingles.  She states that her outbreaks last about 10 days to 2 weeks. She doesn't currently have shingles.  She doesn't have any further information about the vaccine; i.e. lot # or expiration. Did not consent to follow-up. Call Notes:No HCP for follow up
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose, Device leakage, No adverse event, Underdose
Clinical narrative: medication leaked out, received maybe 0.1 ml; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult male patient who received Herpes zoster (Shingrix) (batch number 4XA55, expiry date 13th July 2023) 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 accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: The reporter reported that, while administering the Shingrix vaccine, most of the medication leaked out.  The patient might be received 0.1 ml of the Shingrix.  No reactions were reported. The reporter consented to follow up via email. Additional Supportive Information: While administering the Shingrix vaccine, most of the medication leaked out and the patient received might be 0.1 ml of the Shingrix, which led to accidental underdose.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAB (Twinrix) (batch number 9RT94, expiry date 24th May 2022) 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.   On 13th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Twinrix and Twinrix 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: 14-JUN-2022 Reporter's Comments: The nurse reported that a dose of Twinrix was given to the patient and it was already expired.  The health care professional (HCP) reported that patient born in 1964, with full DOB (date of birth was unavailable). Adverse event contains all reported information by HCP.  The HCP gave consent for safety team to follow up. The reporter consented to follow up. Additional Supportive Information: The use of Twinrix dose which was already expired on 24th May 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was given the vaccine subcutaneously instead of intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 14-Jun-2022 Reporter's Comments: The reporter stated that a patient was given Shingrix vaccine subcutaneously instead of intramuscularly. Additional Supportive Information: The reporter stated that a patient was given Shingrix vaccine subcutaneously instead of intramuscularly, which led to Intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, Underdose, Wrong technique in product usage process
Clinical narrative: Vaccine was administered using a 1cm needle, and some of it leaked out.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix. On 13th June 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comment: The reporter stated that, he was administering Shingrix a day before the date of reporting using a 1cm needle, and some of it leaked out. The reporter declined to provide date of birth of patient.  The reporter consented to follow up via postal. Additional Supportive Information: The reporter was administering Shingrix a day before the date of reporting using a 1cm needle, and some of it leaked out, which led to incomplete dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 12/18/2018, not able to come for 2nd dose; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 18th December 2018, received 1st dose).   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: 14-JUN-2022 Reporter's Comments: The patient was not able to come for second dose. The chat ended by healthcare professional before follow up consent obtained. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; chills; tired; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disorder. Concomitant products included cardiovascular system drugs (Heart Medication).   On 14th June 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 14th June 2022, less than a day after receiving Shingrix, the patient experienced chills and tiredness. On 15th June 2022, the patient experienced headache. The patient was treated with acetylsalicylic acid (Aspirin). On 15th June 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills, tiredness and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: The case was reported by the patient. He received his Shingrix dose the day before reporting. The day before reporting, he had chills and was tired. On the time of reporting, 1 day after receiving Shingrix, he had a headache that he treated with two Aspirin.  He had nothing else to report.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix. On 13th June 2022, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: This case was self reported by patient. The patient received first dose of Shingrix at noon and in evening the patient developed a headache which had not resolved till the time of reporting.  The reporter provided medical advise disclaimer and referred to HCP (health care professional).  The reporter provided information per PI (package insert) on adverse reactions. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received the 1st dose of Havrix, the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022093645   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The reporter stated that, on 29th March 2022 a female patient was administered the Havrix and Infanrix vaccine after a temperature excursion. The anatomical location was left arm for Havrix and Infanrix. The reporter give consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter US-GLAXOSMITHKLINE-US2022093638:Same reporter US-GLAXOSMITHKLINE-US2022093640:Same reporter US-GLAXOSMITHKLINE-US2022093642:Same reporter US-GLAXOSMITHKLINE-US2022093644:Same reporter US-GLAXOSMITHKLINE-US2022093646:Same reporter US-GLAXOSMITHKLINE-US2022093648:Same reporter US-GLAXOSMITHKLINE-US2022093647:Same reporter.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old male patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received the 2nd dose of Havrix, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Havrix in left arm and Infanrix in right arm after a temperature excursion. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Havrix and Infanrix after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter. US-GLAXOSMITHKLINE-US2022093646:Same patient - FU1 US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: administered havrix after a temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Havrix vaccine after a temperature excursion in right arm. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Havrix vaccine after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same patient, same reporter, different product US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: Administered Havrix and Infanrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 6-year-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Havrix and Infanrix. On an unknown date, the patient started Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Havrix in right arm and Infanrix in left arm after a temperature excursion. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Havrix and Infanrix after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 10 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter. FU1 deleted.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Administered Infanrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Infanrix vaccine after a temperature excursion in left arm. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Infanrix vaccine after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: administered infanrix after a temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.    Additional Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Infanrix vaccine after a temperature excursion in right arm. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Infanrix vaccine after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093640:Same patient, same reporter, different product US-GLAXOSMITHKLINE-US2022093600:Same reporter US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a dose with just adjuvant; received a dose with just adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The reporter was purchasing officer for pharmacy which covers multiple long term care sites. He reported that a few days ago the patient at a facility received a dose of SHINGRIX with just the adjuvant (missing antigen). Patient initials not provided. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of SHINGRIX with just the adjuvant (missing antigen) which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This case has been linked with the case US2022094104 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094104:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a dose with just adjuvant; received a dose with just adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The reporter was purchasing officer for pharmacy which covers multiple long term care sites. He reported that a few days ago patient at a facility received a dose of SHINGRIX with just the adjuvant (missing antigen). Patient initials not provided. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of SHINGRIX with just the adjuvant (missing antigen) which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This case has been linked with the case US2022094101 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094101:Same reporter
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the liquid vial of Menveo only; received the liquid vial of Menveo 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 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA673A, expiry date 30th June 2023) for prophylaxis.   On 16th June 2022, the patient received Menveo. On 16th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022  Reporter's comments: The medical assistant reported that, the patient received dose of Menveo liquid vial only without reconstitution with lyophilized MenA powder.  The reporter consented to follow up. Additional Supportive Information: The patient received dose of Menveo liquid vial only without reconstitution with lyophilized MenA powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments: Medical assistant reported that a patient received the liquid vial of Menveo only (without reconstitution with lyophilized MenA powder) on 16-Jun-2022.  ~~~~~~~Consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Disturbance in attention, Dizziness, Feeling drunk
Clinical narrative: GOT COVID-19; FELT DRUNK; HARD TO CONCENTRATE; DIZZY/LIGHT HEADED; 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 pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2022 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2022, the patient experienced got covid-19, felt drunk, hard to concentrate, and dizzy/light headed. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid-19, felt drunk, hard to concentrate and dizzy/light headed was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000235409. The suspected product quality complaint has been confirmed to be voided (did not meet criteria) based on the evaluation/investigation performed.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; REBOUND OF COVID AFTER 14 DAYS OF LAST INFECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma ((from adolescence to young adult) occasional issues with coughing when sick), and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported,1 total administered on 20-DEC-2021 14:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-May-2022, the patient received paxlovid for treatment of Covid-19 that was last administered on 16-MAY-2022. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. On 04-JUN-2022 at 15:00 hours the patient experienced rebound of covid after 14 days of last infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, was recovering from rebound of covid after 14 days of last infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000235961.; Sender's Comments: V0. 20220630163-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (also a physician) via other manufacturer Pfizer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (not specified) and other pre-existing medical conditions included: The patient had no known allergy. The patient is also a HCP (health care professional). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient additionally received two doses (dose number 1 and 2) (booster) of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid 19 infection (Dose number in series 2). The patient additionally received non company suspect Paxlovid (form of admin not reported, oral, batch number were not reported and expiry: unknown) dose was not reported, administered on 17-MAY-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 22-MAY-2022.  On 29-MAY-2022, the patient experienced rebound covid infection (suspected covid-19 infection) five days after completion of paxlovid (Dose number in series 2), thus patient had suspected clinical vaccination failure (Dose number in series 1). The patient was recovering from rebound covid infection. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was treatment discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220632682- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (also a physician) via other manufacturer Pfizer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (not specified) and other pre-existing medical conditions included: The patient had no known allergy. The patient is also a HCP (health care professional). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient additionally received two doses (dose number 1 and 2) (booster) of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid 19 infection (Dose number in series 2). The patient additionally received non company suspect Paxlovid (form of admin not reported, oral, batch number were not reported and expiry: unknown) dose was not reported, administered on 17-MAY-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 22-MAY-2022.  On 29-MAY-2022, the patient experienced rebound covid infection (suspected covid-19 infection) five days after completion of paxlovid (Dose number in series 2), thus patient had suspected clinical vaccination failure (Dose number in series 1). The patient was recovering from rebound covid infection. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was treatment discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220632682- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.