chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other issues or concerns noted; a 3 year old female patient was accidently administered GARDASIL 9; This spontaneous report was received from an office manager (reported also as customer) and refers to a 3-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-MAR-2022, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No other issues or concerns were noted (no adverse event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: she received either GARDASIL or GARDASIL 9 about 15 years ago, she passed out.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant medications, drugs and allergies were not provided.  On an unknown date in 2007 (reported as about 15 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, lot # and expiration dates were not reported) for prophylaxis. On unspecified date in 2007, the patient experienced loss of consciousness for a few seconds., but ^^came to pretty quickly.^^The outcome of loss of consciousness was unknown. Action taken was reported as not applicable.  Upon internal review, the event of loss of consciousness was considered to be medically significant.  The causal relationship between the event and study therapies was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Patient got shingles 1 month aher first dose; I have a patient due for their second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. One month after receiving 1st dose of Shingrix, the patient got shingles, which was totally resolved at the time of reporting. The patient was due for 2nd dose and did not receive 2nd dose of Shingrix till the time of reporting, which led to incomplete vaccination schedule. The reporter asked if  the patient could take a 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This case was reported by a consumer via interactive digital media and described the occurrence of chills 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 chills and fever. On an unknown date, the outcome of the chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter asked what he/she could take for chills, fever from Shingrix shot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had both shingles shots. At the time of reporting, he/she was suffering with shingles. The patient stated that it was milder than if he/she had not been vaccinated probably. The patient further stated the vaccine did not prevent getting this virus. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 2019, still need 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter wanted to know do he/she have to start over and still need second dose. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: first shot in 2019, Covid happened could not get back to Doctor; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot in October 2019).   On an unknown date, the patient received 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 details were reported as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received first dose and then Covid happened and the patient could not get back to doctor until 2022. The patient had received another dose of Shingrix in January (year unspecified), it was more than 6 months between the 2 shots. The patient asked should he/she take a 3rd dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness bilateral
Clinical narrative: considerable hearing loss in both ears; This case was reported by a consumer via interactive digital media and described the occurrence of hearing loss bilateral in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss bilateral to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient recently got Shingrix vaccine and had considerable hearing loss in both ears. The reported wanted to know if it was temporary. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First shingles shot 2019, second in 2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shot of Shingles vaccine in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient was reporter's brother. The age at vaccination was not reported. The patient had his second Shingles shot in 2022 later than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked should the patient take a 3rd dose of Shingles vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on my thigh; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. In January 2022, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient developed rash on his/her thigh 2 days after a dose of Shingrix vaccine and that was in January and rash had still not gone away. The patient asked that what could he/she put on it that would help him/her. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: develop Shingles after vaccination/ suspected vaccination failure; shingles; severe pain; rash; This case was reported by a physician via sales rep and described the occurrence of suspected 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. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix vaccine and had shingles. The reporter stated that the vaccine was working and doing its job, however, when a patient, develop shingles in rare instance after vaccination, it takes a very long time and many different tests to determine that the issue was shingles because there was no rash that occurs right away like it typically did for shingles diagnosis. The patient had severe pain and many tests for months before the rash finally occurred and then were diagnosed with Shingles, at this point it was too late to treat. The reporter stated that the Shingles vaccine in cases where there was an outbreak in a patient after vaccination, prolongs diagnosis of actual Shingles. This case was considered as suspected vaccination failure since the details regarding time to onset for shingles was not provided. The reporter did not consent to follow up. This case was linked with case US2022AMR048866, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR048866:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st dose 2 yrs ago, never got 2nd because of COVID; This case was reported by a consumer 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 2 years ago).   On an unknown date, the patient received 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 details were reported as follows: The patient self reported this case. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix 2 years ago and never got 2nd dose because of COVID pandemic.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's husband. The age at vaccination was not reported The patient experienced a sore and swollen arm  at injection site after receiving a dose of Shingrix vaccine couple years ago. The reporter did not consent to follow-up. This case has been linked with case US2022046177, reported by same reporter. Note: Conservatively coded injection site events. Clarification had been raised.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046177:same reporter
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received a 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 46-year-old male patient who received HAV (Havrix 1440) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Havrix 1440 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 details reported were as follows: Medical assistant reported that, the patient received a havrix expired dose, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received her first dose on february 2020-had not received 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 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details reported were as follows: The age at vaccination was not applicable for this report. The patient received her  first Shingrix vaccine and had not received the second dose till the date of reporting, which led to incomplete course of vaccination. The reporter was looking for guidance regarding second dose. The reporter did not have any further information regarding the first vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient may have received dose after the expiration date of 31Jan2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd February 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 details reported were as follows: The registered nurse (RN) reported that, the patient might had received Kinrix after the expiration date of 31st January 2022., which led to expired vaccine used. The reporter consented to follow up via email. The Vaccine Administration Facility is the same as Primary Reporter. This case has been linked to US2022046885, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046885:Same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: administered a 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7p2y3, expiry date 8th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 14th February 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 were received as follows: The medical assistant reported that one of their patient was administered a 4th dose of Hepatitis B in the form of Pediarix in her right thigh, which led to extra dose administered for hepatitis B. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st February 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 details reported were as follows: The medical assistant reported about the administration of expired Kinrix to the patient, which led to expired vaccine used. Therefore a repeat dose of Kinrix was administered on 15th March 2022 (Lot number H9FM5 and Expiry date 7th May 2023). The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: Practice Manager called in to inquire if they should revaccinate the patient who they inadvertently administered an expired Bexsero dose, which led to expired vaccine used. The reporter declined follow-up.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Patient received 3rd dose of Rotarix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2FM7, expiry date 4th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st and 2nd dose on an unspecified date).   In December 2021, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. In December 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 details reported were as follows: Registered Nurse reported that, the patient received 3rd dose of Rotarix, which led to extra dose administered. They noticed this situation at the facilitie on 7th March 2021 and got in contact with baby's mother who stated that the baby did not present any adverse events and was ok. The health care professional (HCP) got in contact with the CDC (Center for Disease Control) who provided information and explained that importance was in the interval between doses than the number of doses. The reporter consented to follow up.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Administered an adult with pediatric dose; Administered an adult with pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 39-year-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 1st March 2022, the patient received the 2nd dose of Engerix B pediatric. On 1st March 2022, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details reported were as follows: The reporter accidentally administered an adult with a pediatric dose of Engerix-B for their 2nd dose, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sept2021 and 2nd dose Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in September 2021).   In January 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Twinrix and Twinrix 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 details reported were as follows: The patient was late for her 2nd dose of Twinrix. First dose was received in September 2021 and second dose was received in January 2022, which led to lengthening of vaccination schedule. The reporter consented to follow up. No additional information available from RPH since she did not have their profiles available. This case had been linked to US2022047723, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047723:Same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received Boostrix and Menveo twice; Boostrix on 5/12/2021 and 3/16/2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number gc5ng, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number amva640z, expiry date 30th November 2022) for prophylaxis.   Previously administered products included Menveo (received on 12th May 2021) and Boostrix (received on 12th May 2021).   On 16th March 2022, the patient received Boostrix (intramuscular) .5 ml, Boostrix Pre-Filled Syringe Device and Menveo (intramuscular) .5 ml. On 16th March 2022, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced extra dose administered and drug dose administration interval too short. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose of Menveo on 12th May 2021, 0.5 ml, batch number:amva435a, expiry date : 31st March 2022,  intramuscularly in left arm and 1st dose of Boostrix 12th May 2021, 0.5 ml batch number: 33at7, expiry date: 7th November 2022, intramuscularly in right arm. It was stated that, the patient accidently received his Boostrix and Menveo vaccine twice, which led to extra dose administered.   The patient received Boostrix in right arm and menveo in left arm. The patient received boostrix earlier than recommended which led to shortening of vaccination schedule. The patient had no symptoms related to this adverse event.   The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2020. Late 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (received 1st dose on 23rd December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose and no reactions reported. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. Note: It was unknown if the patient received 2nd dose or not, so the case was conservatively kept valid for incomplete course of vaccination and query was raised.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles. In 1 to 3  dermatome on left shoulder and back side; This case was reported by a physician via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2022, the patient received the 1st dose of Shingrix. On 12th March 2022, less than a day 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 details were provided as follows: The patient received Shingrix and developed shingles the same evening.  It started in 1 dermatome to 3 dermatome and location on left shoulder and back side. The reporter consented to follow up by email.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult patient received Infanrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 60-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that, an adult patient received Infanrix instead of Tdap booster dose, which led to inappropriate age at vaccine administration.  The reporter stated that it was not done at her location. Lot and expiration date not available to share. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 8/13/2019, second on 11/11/2021; 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 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 45N3Y, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th August 2019).   On 11th November 2021, the patient received the 2nd dose of Shingrix. On 11th November 2021, 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 details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.  The reported did not had any more information regarding 1 dose lot number. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received HAV (Havrix adult) (batch number B4JL4, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th March 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 16th March 2022, unknown after receiving Havrix adult 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 details were provided as follows: The reporter did not had demographic details from patient. Registered pharmacist reported that an adult patient received an expired dose of Havrix, which led to expired vaccine used. The reporter also reported that it was an adult dose. The reporter accidentally forgot to ask for follow-up. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose years ago, 2nd dose wasn´t administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. Till the time of reporting the patient had not received their 2nd dose, which led to incomplete course of vaccination. The pharmacist reported that a patient being vaccinated with first dose of Shingrix two years ago from the day of reporting and the 2nd dose was never administered. The pharmacist did not had more information regarding 1st dose. The patient received the 1st dose and then moved to another city. The reporter consented to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose 2 of SHINGRIX 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 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 7th August 2019).   On 11th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th September 2021, 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 details were provided as follows: The reporter stated that she was calling from a pharmacy on behalf of a patient. The patient received 2nd dose of Shingrix 2 years apart, which led to lengthening of vaccination schedule. Limited information was available on reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient 1st dose on june 2019, second dose on january 2021.; This case was reported by a physician 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 received on an unknown date in June 2019, Lot number: 2yn4s).   In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, 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 details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule.  The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Pollakiuria
Clinical narrative: Fatigued; Short of breath, felt worse through the night; Got up 8 to 10 times in the night to urinate; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2022, the patient received Shingrix. On 16th March 2022, less than a day after receiving Shingrix, the patient experienced fatigue, shortness of breath and increased urinary frequency. On an unknown date, the outcome of the fatigue and shortness of breath were not recovered/not resolved and the outcome of the increased urinary frequency was unknown.   It was unknown if the reporter considered the fatigue, shortness of breath and increased urinary frequency to be related to Shingrix.  Additional details were reported as follows: The case was self reported by the patient. The reporter stated that he received a dose of the Shingrix vaccine a day before reporting.  The reporter stated that during evening (on the day of vaccination) he had felt fatigued and short of breath (adverse event) and felt worse through the night.  The reporter stated that he got up 8 to 10 times during the night to urinate (adverse event). The reporter inquired if these side effects were normal. The reporter prematurely disconnected call. No additional details were provided by the reporter. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The pharmacist reported use of Shingrix dose to a patient and the vaccine was already expired on 17th October 2021, which led to expired vaccine used. The reporter consented to follow up via email.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the adjuvant; Patient received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   On 16th March 2022, the patient received Shingrix. On 16th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The Medical assistant reported that the patient received only the adjuvant of Shingrix, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness bilateral
Clinical narrative: Hearing loss in both ears; This case was reported by a consumer via call center representative and described the occurrence of hearing loss bilateral in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2022, the patient received the 1st dose of Shingrix. On 12th March 2022, less than a day after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss bilateral to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received  dose of Shingrix in left arm 5 days ago from the date of reporting and since receiving the vaccine, she had experienced hearing loss in both ears. The patient was inquiring if this was a potential side effect of receiving the vaccine.  Spoke as per package insert content, provided medical advice disclaimer, referred to health care professional and offered number to medical informer for health care professional to call. The patient provided permission to contact healthcare professional. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: SWELLING ON THE SIDE OF FACE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: bell's palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced swelling on the side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling on the side of face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, COVID-19, Colitis, Feeding disorder, Inappropriate schedule of product administration
Clinical narrative: UNABLE TO EAT; LOST WEIGHT; HAIR LOSS; COLITIS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; COVID-19; This spontaneous report received from a patient concerned a 7 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-MAR-2021, and dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced unable to eat, lost weight, hair loss, colitis, off label use, and inappropriate schedule of vaccine administered. Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19, and the outcome of unable to eat, lost weight, hair loss, colitis, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220336953.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Weight, Weight decreased
Clinical narrative: UNABLE TO EAT; LOST WEIGHT; HAIR LOSS; COLITIS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; COVID-19; This spontaneous report received from a patient concerned a 7 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-MAR-2021, and dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced unable to eat, lost weight, hair loss, colitis, off label use, and inappropriate schedule of vaccine administered. Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19, and the outcome of unable to eat, lost weight, hair loss, colitis, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220336953.