chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information provided.; Customer report that PROQUAD LOT U017137 expiration date 11/28/2022 was administered to a 4-year-old patient on 31-MAY-2022 after a temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 31-MAY-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot #: U017137, expiration date: 28-NOV-2022, administered subcutaneously at left leg (exact dose and strength was not provided) for prophylaxis. Temperature excursion information: due to loss of electrical power to freezer where vaccine was stored, temperature went out of suggested manufacturer range of -30 degree Celsius to -15 degree Celsius, with warmest reading of -3.6 degree Celsius for a duration of 40 minutes (reported also as: -14 degree Celsius up to -10 degree Celsius for 50 minutes; -10 degree Celsius up to 8 degree Celsius for 10 minutes). Temperature excursion occurred as a result of a reading from a digital data logger. The vaccine did not experience any prior temperature excursions. There was no additional adverse event reported  The event of improper storage of product in use was considered as an important medical event by a reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness, Death, Ear discomfort, Herpes zoster
Clinical narrative: hearing loss; ear discomfort; balance issues; herpes zoster; wrongful death; Information has been received from a lawyer, regarding a case in litigation concerning an approximately 59-year-old male patient (pt). Approximately on 19-NOV-2013, the pt was administered the dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a health care provider for the long-term prevention of shingles and zoster-related conditions, at county health department. Subsequently, on an unknown date, the pt was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, hearing loss , ear discomfort and balance issues. On 25-FEB-2019, the pt died. The cause of death was not reported. It was not reported whether an autopsy was performed or not. The reporter claimed damages as a result of wrongful death. The outcome of the events of herpes zoster, hearing loss, ear discomfort and balance issues was not provided. The lawyer considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling for TE evaluation on frozen products states products have been administered.     Names of vaccines involved (including lot/exp) PROQUAD   W004029   8/1/2023        ?    Temperature 6°F up to 14°F (8F) for 0 hours 18 minutes 0 second; No additional AE details; This spontaneous report has been received from a nurse, regarding a 4-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On unspecified date, the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) lot # W004029 experienced a temperature excursion of 6 grades fahrenheit (F) up to 14F (8F) for 0 hours 18 minutes 0 seconds, and another of 14 F up to 46 F (18.40F) for 0 hours 45 minutes 0 seconds. No additional temperature excursion. If a digital data logger was involved was not reported (product storage error) (product storage error).   Consequently, on unknown date, the patient was vaccinated the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD)  (lot number reported as W004029 confirmed as valid, expiration date reported and stablished as  02-AUG-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).; Sender's Comments:  US-009507513-2206USA002264: US-009507513-2206USA002231:
Sex: U
Vaccine: MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction to the PROQUAD; Information has been received from a nurse practitioner via company representative concerning a 4 years old patient of unknown gender. The patient had history of COVID infection 3 weeks prior to event. Information about concurrent condition and concomitant medication of the patient was unknown.    On an unknown date, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date in January 2021, the patient had an anaphylactic reaction to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Patient received epinephrine (EPI PEN) and was sent to the hospital. The outcome of anaphylactic reaction was recovered on an unknown date.  The event of anaphylactic reaction was considered to be related to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  Upon internal review, anaphylactic reaction to vaccine was determined to be medically significant.  This is one of two reports received from the same reporter (linked case # US-009507513-2206USA002513).; Sender's Comments:  US-009507513-2206USA002513:
Sex: U
Vaccine: MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction to the PROQUAD; Information has been received from a nurse practitioner concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history of the patient was unknown.   On an unknown date, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date in April 2022, the patient had an anaphylactic reaction to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Patient received diphenhydramine hydrochloride (BENADRYL) and was sent to the hospital. The outcome of anaphylactic reaction was recovered on an unknown date in 2022.  The event of anaphylactic reaction was considered to be related to the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  Upon internal review, anaphylactic reaction to vaccine was determined to be medically significant.   This is one of two reports received from the same reporter (linked case # US-009507513-2206USA002456).; Sender's Comments:  US-009507513-2206USA002456:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details.; Inbound all from HCP stating VARIVAX experienced a supported temp excursion and then was administered to patients. No additional AE details or PQC. Names of vaccines involved (including lot/exp) VARIVAX T031383 09/15/2022        ?    Te; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Concomitant medication included diluent. The patient's concurrent conditions, medical history, allergies and drug reactions were not reported.   On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot #T031383, expiration date: 15-SEP-2022 (strength, dose, dose number, route of administration was not provided) for prophylaxis. For varicella virus vaccine live (oka/merck) (VARIVAX), the temperature excursion was initially reported as 5.5 Fahrenheit degrees (F) for 10 minutes, however it was corrected (by the reporter) to temperature 9 F for 3 hours 50 minutes (product storage error). The previous temperature excursion was not reported. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Inbound all from HCP stating VARIVAX experienced a supported temp excursion and then was administered to patients.; This spontaneous report has been received from a medical assistant, concerning to a patient of unknown age and gender. They concomitant medications was sterile diluent (valid lot number U002746 with an expiration date on 25-JUN-2023).The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies,  were not provided.  On 03- JUN-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (valid lot number T031383 [expiration date 15-SEP-2022]) for prophylaxis, after a temperature excursion of 9 degrees Fahrenheit (F) for 3 hours (h), 50 minutes (min) (product storage error) (dose, vaccination scheme, dose number, frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.  No additional adverse events (AE) details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Sleep disorder, Vaccination failure
Clinical narrative: had shingles despite having the vaccine/suspected vaccination failure; shingles; still shooting pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with gabapentin and vicks vaporub nos (Vicks Vaporub). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles despite having the shingles vaccine.  The patient was on Gabapentin for a year but after that the doctor took him/her off despite still shooting pain.  The patient tried Vicks VapoRub and it had allowed him/her to sleep at night.  The patient did not know why he/she had shingles, despite having the vaccine.  It was been 2 years and still get shooting pain but he/she tried putting Vicks VapoRub on the area and it had really helped. The patient was not sure why, but after the doctor took him/her off Gabapentin and he/she had to try something so he/she could sleep through the night. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Husband had the 2 dose Vaccine 4 yrs ago and is suffering with shingles/ Suspected vaccination failure; Shingles on his face, head, and eyelid; 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.   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 Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: This case was reported by patient's wife via interactive digital media. The patient received 2 doses of Shingles vaccine 4 years ago from reporting and was experiencing shingles on his face, head and eyelid. The reporter questioned about the vaccine being good for 10 years. Additional Supportive Information: 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. The follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: how long can fever last after shingrix?; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media The reporter wanted to know about how long a fever could last after the Shingrix vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: MEN
Symptoms: Illness
Clinical narrative: got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 08-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had the Men B vaccine and still got sick. Additional Supportive Information: The follow-up would not be possible as no contact details were available
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of shingrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 15th May 2022) for prophylaxis.   On 9th June 2022, the patient received Shingrix. On 9th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Health care professional (HCP) reported an expired dose of Shingrix was administered to a patient.  The reporter consented to follow up. Additional supportive information: On 9th June 2022, patient received dose of Shingrix that was already got expired on 15th May 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose a year later; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (The patient received 1st dose of shingles vaccine on an unknown date).   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 Information: GSK Receipt Date: 11-JUN-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The patient received second dose of Shingles vaccine a year later. Additional Supportive Information: The patient received second dose of Shingles vaccine later than recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on face; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received the dose of Shingles vaccine and had rash on face. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Friend got the shot continually fights shingles several times/suspected vaccination failure; Fights shingles several times; awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The reporter was patient's friend. The patient got the shot and continually fights shingles several times a year, anyway. It's been awful for her. The shot did nothing for her. Now her doctor was trying to convince her insurance company to let her have the shot for people over 60 because that one was the better shot. The reporter asked why there was a substandard shot for those under 60. The reporter's doctor told him/her it was only 50% effective, so he/she refused. The reporter wanted to know why the better shot was not available to everyone.  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, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had three shots and I just got shingles/Suspected vaccination failure; I just got shingles; Very painful still; I had three shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient stated that you could still get shingles. The patient had three shingles shots and just got shingles. Not as bad as with out the shots but very painful still. 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingles after taking the vaccines; I had shingles for 5 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient had shingles for 5 weeks After taking the vaccines. 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.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site/The symptom lasted for various weeks; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment:The same day after the Shingrix shot patient felt soreness at the injection site.  The symptom lasted for various weeks and eventually resolved.  The reporter did not consent to follow up. The reporter was provided information per package insert (PI) on adverse reactions and provided medical advise disclaimer.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient was administered (1-June-2022) a pediatric dose; Adult patient was administered (1-June-2022) a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HBV (Engerix B pediatric) (batch number T022566, expiry date 29th December 2022) for prophylaxis.   On 1st June 2022, the patient received the 2nd dose of Engerix B pediatric. On 1st June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: Nurse reported a patient was administered a pediatric dose of the Engerix-b vaccine instead of the adult dose. The reporter consented to follow up. Additional supportive information: The patient received the Engerix-b pediatric instead adult dose which led to underdose and adult use of a child product.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose on 09-jun-2022 1st dose on 22-dec-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (the patient received 1st dose of Twinrix on 22nd December 2021).   On 9th June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 9th June 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 Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comments: On the day of reporting, the patient received a late 2nd dose for Twinrix. The vaccine administration facility was the same as primary reporter. The reporter give consent to follow up. Additional supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Tinnitus
Clinical narrative: Ringing in ears; Runny Nose; This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date 6th July 2023) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, less than a week after receiving Shingrix, the patient experienced ringing in ears and runny nose. On an unknown date, the outcome of the ringing in ears and runny nose were not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears and runny nose to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's comment: The reporter was the pharmacist.  The patient received Shngrix vaccine in right arm the day before reporting. She stated the patient called this morning to report ringing in her ears and a runny nose.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Infanrix and Infanrix 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: 10-JUN-2022 Reporter's Comments: The medical assistance reported that the patient received expired dose of infanrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received expired infanrix, which led to expired vaccine used.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Shingrix. On 9th June 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for herself. The patient received her dose of Shingrix and stated that evening after vaccination she noticed some redness at the injection site. The symptom was not resolved. Provided medical advise disclaimer and referred to health care professional. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: severe redness on arm that comes to axillary area; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient received Shingrix and developed a severe redness on her arm. A 750cm that also comes to the axillary area. At the time of the reporting patient was okay with no symptoms. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month old baby was given Kinrix; Baby was given kinrix instead of infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE.   On 9th June 2022, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The reporter was the office manager and a medical assistant at a pediatric office.  She reported that, the patient was given the wrong vaccine.  She was supposed to receive unspecified pneumococcal (non-GSK) and DTaP ( Infanrix) but instead received unspecified pneumococcal (non-GSK) and DTaP + IVP (Kinrix). The Vaccine Administration Facility was the same as primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Kinrix instead of Infanrix at the age of 15 months, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix administered after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix 1440) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 10th June 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 Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The reporter stated that, Havrix was administered to a patient after the expiration date. The reporter consented to follow up via postal. Additional Supportive Information: Havrix was administered to a patient after the expiration date, which led to expired vaccine used.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 19 month old was administered Kinrix; administered Kinrix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The reporter reported that a 19 month old patient was administered Kinrix instead of Infanrix on the day of reporting. The reporter consented to follow up.  Additional Supportive information: A 19 month old patient was administered Kinrix instead of Infanrix ,which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix that had been reconstituted with sterile water; Shingrix that had been reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The nurse reported she administered a dose of Shingrix that had been reconstituted with sterile water. The Vaccine Administration Facility was the same as Primary Reporter. Follow up was not asked. Additional Supportive Information: Shingrix that had been reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administering expired Infanrix 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 19-month-old male patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix 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.  GSK receipt date: 13-June-2022 Reporter's comment: The reporter was medical assistant. The reporter administered expired Infanrix to patient. No known side effects, for the patient. The reporter consented to follow up. Additional Supportive Information: The patient received infanrix which was already expired which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix 26Jun2019, never had second dose; 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 (received 1st dose on 26th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The pharmacist reported that a patient had her 1st Shingrix  and never had a second dose. The Vaccine Administration Facility is the same as Primary Reporter. The VAERS details reported for 1st dose. The reporter forgot to ask about follow-up. 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: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered at inappropriate site
Clinical narrative: injected just below the deltoid area; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 3rd June 2022, the patient received Boostrix. On 3rd June 2022, unknown after receiving Boostrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: A pharmacist reported that a female patient received a dose of Boostrix that she believed was injected just below the deltoid area on her right side. No symptoms reported. The reporter consented to follow up. The pharmacist that gave vaccine was confidant it was given in deltoid. Additional Supportive Information: The patient received a dose of Boostrix that she believed was injected just below the deltoid area on her right side which led to vaccine administered at inappropriate site.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pain in extremity
Clinical narrative: soreness of the arm; shivering; first dose of Shingrix almost a year ago, had his second shot at this point; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male 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, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, shivering and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and shivering were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm and shivering to be related to Shingrix.     Additional Information: GSK receipt date: 10-June-2022 Reporter's comment: The reporter stated that he had his first dose of Shingrix almost a year ago and experienced soreness of the arm and shivering the day of the vaccination.  The reporter stated he had not had his second shot at the time of reporting but had plan on receiving it in the near future.  The reporter consented to follow up.  Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired dose was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was recovered/resolved.     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: 13-June-2022 Reporter's comment: The nurse reported that an expired dose of Pediarix was given to a patient on the day of reporting. The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix which was already expired which led to expired vaccine used.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: inadvertently reconstituted with sterile water; inadvertently reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640Z, expiry date 30th November 2022) for prophylaxis.   On 11th April 2022, the patient received Menveo. On 11th April 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: MENVEO powder was inadvertently reconstituted with sterile water and administered to patient. The reporter consented to follow up. Additional Supportive Information: MENVEO powder was inadvertently reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 55 year old male. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042a21a and expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 15:00 in left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received additional non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin was not reported and batch number: 032F21A expiry: UNKNOWN) dose was not reported, administered on 26-OCT-2021, 15:00 in left arm for prophylactic vaccination.  On an unspecified date in MAY-2022, the patient experienced covid-19 infection (dose number in series 2). On 17-MAY-2022, the patient took Paxlovid (ritonavir) for covid-19 treatment. On 27-MAY-2022, the patient had covid-19 virus test which resulted in positive (covid-19 infection) after feeling fine for a week (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and Moderna covid-19 vaccine (elasomeran) was not applicable. The patient was recovering from covid-19 infection. This report was non-serious.