chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Premature labour
Clinical narrative: Preterm Labor; Pregnancy; Initial Report Received on 02-DEC-2022  This is a spontaneous report received from a Chief Officer from a Hospital in the regarding a pregnant female patient who received HEPLISAV-B for hepatitis B immunisation .   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 17-NOV-2022, dose 1 of HEPLISAV-B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.    When the nurse called the patient to schedule the second dose, the patient stated she was in preterm labor.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given Heplisav-B Three Days Past the Expiration; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a pharmacist in the regarding a 27-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 05-DEC-2022, a dose of HEPLISAV B (Lot #935848, expiration date 02-DEC-2022, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The dose was 3 days past the expiration date. No adverse effects were experienced by the patient to the reporter's knowledge.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Out of Temperature Range Product Administered; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a registered nurse in the regarding a 47-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 01-SEP-2022, dose 1 of HEPLISAV B (Lot #937782, expiration date 25-SEP-2023, NDC # unknown) was administered intramuscularly in the left deltoid for hepatitis B immunisation.    The vaccine was out of temperature range. The amount of time it was out of temperature range is unknown. The reporter denied any other adverse effects reported by the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of Temperature Range Product Administered; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a registered nurse regarding a 27-year-old patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 08-SEP-2022, dose 1 of HEPLISAV B (Lot #937782, expiration date 25-SEP-2023, NDC # 43528-002-01), was administered intramuscularly in the left deltoid for hepatitis B immunisation.    The vaccine was out of temperature range. The amount of time it was out of temperature range is unknown. The reporter denied any other adverse effects reported by the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Out of Temperature Range Product Administered; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a registered nurse in the regarding a 22-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 02-SEP-2022, dose 1 of HEPLISAV B (Lot #937782, expiration date 25-SEP-2023, NDC # 43528-002-01), was administered intramuscularly in the left deltoid for hepatitis B immunisation.    The vaccine was out of temperature range. The amount of time it was out of temperature range is unknown. The reporter denied any other adverse effects reported by the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Received the shot, still got shingles/suspected vaccination failure; still got shingles; Pain was excruciating, months with 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. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving 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: 11-Jan-2023. Reporter's Comment: This case was received from patient via interactive digital media. The reporter stated that even though received the Shingles shot and still got shingles and the pain was excruciating. The reporter stated it was getting better but now going on two months with pain now. 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: U
Vaccine: COVID19, VARZOS
Symptoms: Guillain-Barre syndrome, Muscle disorder, Musculoskeletal disorder
Clinical narrative: Guillain Barre syndrome, autoimmune desease; log muscle problem; leg problem; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a 66-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included guillain barre syndrome (had a case of GBS (guillian barre syndrome) in his/her 20's) and numbness of lower extremities (Could not feel his/her legs from waist down and recovered in about 2 months).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced Guillain Barre syndrome (serious criteria medically significant), muscle disorder and musculoskeletal disorder. On an unknown date, the outcome of the Guillain Barre syndrome, muscle disorder and musculoskeletal disorder were not recovered/not resolved.   It was unknown if the reporter considered the Guillain Barre syndrome, muscle disorder and musculoskeletal disorder to be related to Shingles vaccine.     Additional Information: Receipt Date: 11-JAN-2023 Reporter's Comment: This case was reported by a patient via (social media) interactive digital media. The reporter was in late 60s. The reporter did not want shingles so he/she took the shingles vaccine when it first came out.  The reporter did not know the risk of Guillian Barre syndrome.  The reporter fast forward to now at the age of 66 year and took the shingles vaccine and latter Covid vacine.  The GBS (Guillian Barre syndrome) was an autoimmune disease and his/her roared back with GBS (Guillian Barre syndrome) again suffering leg and long muscle problems and not going away this time.  Only recent did they mentioned a risen in GBS (guillian barre syndrome) in their commercials if he/she had known he/she would not had taken it and not be going through this hell again as an older man.  The reporter stated that, it was rare but could happen to just a few in 100,000 and he/she was one.  The reporter stated that, just waiting for the class action lawsuit and shingles would be better than this. It was unknown if the reporter considered the guillain barre syndrome, muscle disorder and musculoskeletal disorder to be related to Covid-19 vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Sluggishness
Clinical narrative: Brain very sluggish; Could not sleep well last night; This case was reported by a consumer via other manufacturer and described the occurrence of sluggishness in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced sluggishness and poor sleep. On an unknown date, the outcome of the sluggishness and poor sleep were unknown.   It was unknown if the reporter considered the sluggishness and poor sleep to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comments: The patient had reported that she had taken a shingles shot and got a reaction and could not sleep well the night before reporting and her brain was very sluggish. The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Noninfective gingivitis, Oral lichen planus
Clinical narrative: Oral lichen planus; Gums were inflamed; This case was reported by a nurse via sales rep and described the occurrence of oral lichen planus in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced oral lichen planus and gingival inflammation. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the oral lichen planus and gingival inflammation were not recovered/not resolved.   The reporter considered the oral lichen planus and gingival inflammation to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The reporter stated that the patient told her that she was diagnosed with oral lichen, planus by her periodontist following her first shot of Shingrix.  The patient said that her gums were inflamed and that having the Shingrix shot was the only thing that she thought of that she had done differently that had caused this inflammation. The patient was currently being treated with steroids and appropriate care by her periodontist. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose March 2021, 2nd not yet; 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 March 2021).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 10-JAN-2023 Reporters comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient asked that if he/she got the first dose but probably not the second dose (they could not find the record), should he/she start all over. Additional supportive information: The patient did not yet receive the 2nd dose which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Got Shingrix, she hasnt slept; This case was reported by a consumer and described the occurrence of insomnia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was unknown.   It was unknown if the reporter considered the insomnia to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The reporter stated that, his/her sister got the Shingrix vaccine and she had not slept.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Some Vx was lost , no full dose administered; This case was reported by a physician via interactive digital media and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 11-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The medical physician inquiring about an issue with Shingrix administration. The medical physician administered patient's 2nd dose of vaccine and unfortunately, some vaccine was lost at the point where the needle attaches to the syringe and therefore, patient did not get full dose of 2nd vaccine.  The medical physician reported that case she/he administer a 3rd dose of shingrix. The reporter did not consent to follow up  Additional Supportive Information: The patient did not get full dose of 2nd shingrix vaccine., which led to incomplete dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had asked that if he/she could get a reaction or hives two weeks after the first shot. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Used unapproved diluent (sterile water); Used unapproved diluent (sterile water); This case was reported by a physician and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patients received Menveo. On an unknown date, 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: 12-Jan-2023  Reporter's Comments: This report was submitted via the online direct entry reporting system GSK employee reporting ref.  Please process using the related SOP.  Initially the reporter consent to contact given. The physician consent to contact. There was no reporter seriousness for used unapproved diluent (sterile water) and administered only the lyophilized A vial and did not reconstitute with CWY vial or ad-minister CWY. Not Serious Menveo manufacturer unspecified expiry date of Menveo was unknown  The additional context of Menveo which dose of the vaccine was this. I reporter did not know (used unapproved diluent (sterile water) and administered only the lyophilized A vial and did not reconstitute with CWY vial or administer CWY. The reporter was asking for any additional information about the adverse event. The provider who reached out to me stated that this happened with more than one patient.  A nurse had been accidentally reconstituting the lyophilized vial that contains sero-type A with sterile water and only administering that portion of Menveo.  The second liquid/CWY vial was not administered.  No harm to the patient but patients would need revaccinated patient's age. The age group was not related to an existing case. Additional supportive information: Menveo reconstituted with sterile water and administered only the lyophilized A vial and did not reconstitute with CWY vial or administer CWY, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023004489:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Still feel something; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK receipt date :12 Jan 2023 Reporters comment: This case was reported by a consumer via interactive digital media. The patient reported that was going through same thing was vaccinated for more than 2 years and still felt something.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Erythema, Eye infection, Eye swelling, Swelling face
Clinical narrative: eye is infected; face has been red; eye is swollen shut; face with pimples; face has puffed up,; This case was reported by a consumer and described the occurrence of eye infection in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 18th November 2022, the patient received the 1st dose of Shingrix. On an unknown date, 7 weeks after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced eye infection, red face, eye swelling, pimples and facial puffiness. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the eye infection, red face, eye swelling, pimples and facial puffiness were not recovered/not resolved.   It was unknown if the reporter considered the eye infection, red face, eye swelling, pimples and facial puffiness to be related to Shingrix.     Additional Information: GSK Receipt date: 09-Jan-2023. Reporter's Comment: The patient received Shingrix on left arm. The patient  stated from last few days the patient's face was red with pimples and puffed up and his right eye was infected and swollen shut. Patient also reported that he had his last Covid vaccine (unknown manufacturer) 4 weeks before his 1st Shingrix Vaccine. Patient did not have the Lot for his Shingrix vaccine. He had spoken on the phone to his Dermatologist 18 Jan 2023, and had been prescribed valacyclovir. He was an appointment with his Ophthalmologist this morning, 9th Jan 2023, to look at his eye. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain at injection site; redness at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 5th January 2023, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 09-JAN-2023 Reporters comment: The reporter reported that patient received the first dose of shingrix vaccine and experienced injection site pain and injection site redness. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023002199:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient requested a shingrix vaccine yesterday on 1/8/23 / That would be a third dose from yesterday 1/8/2023; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018) and Shingrix (2nd dose received in January 2019).   On 8th January 2023, the patient received the 3rd dose of Shingrix. On 8th January 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The pharmacist inquired any contraindication or any problems about Shingrix vaccine. The RPH (registered pharmacist) reported an over 50 year old patient requested a Shingrix vaccine yesterday (from the reporting date). They administered the vaccine but RPH later found out the patient received a first dose and second dose of Shingrix and that would be a third dose from yesterday (from the reporting date). The RPH declined to provide any patient or vaccine details.  The reporter did not consent to follow-up. Additional supportive information: The patient received additional 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Nausea, Vomiting
Clinical narrative: nausea; vomiting; joint pain; stomach pain; This case was reported by a consumer and described the occurrence of nausea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Shingrix. On 6th January 2023, 1 days after receiving Shingrix, the patient experienced nausea, vomiting, joint pain and stomach pain. On an unknown date, the outcome of the nausea was not recovered/not resolved and the outcome of the vomiting, joint pain and stomach pain were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, joint pain and stomach pain to be related to Shingrix.     Additional Information: GSK receipt date: 09-JAN-2023 Reporters comment: The reporter was the patients wife ,she reported that her husband received first dose of shingrix vaccine and experienced nausea vomiting stomach pain and join pain. The reporter did not consent to follow up. Additional Supportive Information: This case is linked with case US2023002194 reported by same reporter.; Sender's Comments:  US-GSK-US2023002194:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administration of Boostrix vaccine intravenously to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   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: 09-JAN-2023 Reporter's Comments: A pharmacist asked for information about the administration of Boostrix vaccine intravenously to a patient. The reporter did not provide information about the patient and the vaccine administered.  The reporter consented to follow up. Additional supportive information: The patient received Boostrix intravenously, which led to intramuscular formulation administered by other route.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: severe pain in her left arm area; could not move the shoulder area with out experiencing a "horrific pain"(AE no arm movement); incapacitated by pain for 48 hours; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2023, the patient received the 1st dose of Shingrix. In January 2023, less than a week after receiving Shingrix, the patient experienced injected limb mobility decreased, debility and pain in arm. The patient was treated with paracetamol (Tylenol Arthritis) and ibuprofen. In January 2023, the outcome of the debility and pain in arm were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, debility and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's comment: The reporter was a patient who had reported that after getting her first dose of Shingrix vaccine on her left arm at a pharmacy location.  She had an extremely intense side effect with the first Shingrix injection and she was incapacitated by pain for 48 hours.  She also had reported of having severe pain in her left arm area and could not move her shoulder area, without experiencing a horrific pain.  She took a maximum of three tablets of a 200 mg Ibuprofen (600 mg) 3 times a day every 8 hours.  She was around the 2nd or 3rd day. The patient had reported that in addition to that, she had taken two tablets of Tylenol Arthritis 650mg (1300 mg) after the ibuprofen.  The patient had reported that on 09 January 2023 she had a full range of motion in her left arm and had pain in a scale of 1 to 10 as 0.5. Not all information was available. Lot and expiry date unknown. Patient said she had considered going to the Emergency Room (ER) because of how severe it was.  However, no visit to ER was documented. The reporter had consented to follow-up.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administered instead of Boostrix; 17 years old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 09-JAN-2023 Reporters comment: The medical assistant called and reported that a dose of Infanrix was administered to a 17-year patient instead of a Boostrix dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive information: The Infanrix was administered to a 17-year age patient instead of a Boostrix dose which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 4 month-old; Kinrix as 2nd dose in DTAP/IPV series; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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: 09-JAN-2023 Reporter's Comments: No reactions reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received Kinrix as their 2nd dose in the DTAP/IPV series at inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: Redness at injection site; Itching at the injection site; Arm soreness; 1st dose Oct2021, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema, injection site itching, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, injection site itching and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The patient reported case for herself. The patient receiving first dose of Shingrix in October of 2021 and having not yet received the second dose.  The patient was experienced arm soreness, redness, and itching at the injection site after the first dose.  The patient reported all symptoms experienced after the first dose have resolved.  The reporter did not consent 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: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6YO received Boostrix; received Boostrix 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 6-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23rd September 2024) for prophylaxis.   On 9th January 2023, the patient received Boostrix. On 9th January 2023, unknown after receiving Boostrix, 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.   Additional Information: GSK receipt date: 09-Jan-2023 Reporter's comment: The medical assistant called to inquired how to proceed. The reporter was unable to provide what dose in DTaP series patient was supposed to get. The reporter consented to follow-up. Additional supportive information: The 6-year-old patient inadvertently received Boostrix dose on the day of reporting instead of getting the Infanrix dose, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Sore arm  at injection site; Onset of Fever, 100.4 °F; Chills; Upper body pain, aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2022, the patient received the 2nd dose of Shingrix. On 8th January 2023, 11 days after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills and general body pain to be related to Shingrix.     Additional Information: GSK Receipt date: 09-JAN-2023 Reporter's comment: The reporter is the patient.  The patient received his second dose of Shingrix on right arm and experienced a sore arm at the injection site, and it was almost gone the next day.  The patient experienced a sudden onset of fever, chills, and upper body pain or aches.   The patient fever reached a temperature of 100.4 degrees (F).   These symptoms lasted for 4 to 5 hours.  The patient tested negative for COVID (twice).   The patient stated that he was feeling fine on the day of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: 1st dose on 28Dec2021, 2nd not received/2nd dose not administered due to supply shortage; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 28th December 2021 with batch number 5D753 and expiry date 23rd April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The pharmacist called in to report that a patient received the first dose of Shingrix but unfortunately, the second dose was not administered due to a shortage in the supply. Information about the vaccine and patient was relayed. The vaccine administration facility was the same as the primary reporter. The call was transferred to second line. The reporter consented to follow-up. Additional supportive information: The details were reported for the first dose.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: I ordered a monovalent pfizer covid vaccine.  My MA accidentally gave a bivalent covid vaccine.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Incorrect product formulation administered
Clinical narrative: I ordered a monovalent covid vaccine for the pt.  My MA gave a bivalent covid vaccine to the patient.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Headache, Hyperhidrosis, Inflammation, Listless
Clinical narrative: he started inconsolably crying around 12:30, showing severe inflammation, lasting many hours.  He had a horrible headache, nausea and vomitting, fever 105, soaked his christmas sweater with sweat to the point where I could wring the moisture out of it, listless at 1800.  Couldn't lift head or walk.  I had to carry him into the emergency room and the ER doctor agreed it could be an adverse reaction.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Mobility decreased, Nausea, Pyrexia, Vomiting
Clinical narrative: he started inconsolably crying around 12:30, showing severe inflammation, lasting many hours.  He had a horrible headache, nausea and vomitting, fever 105, soaked his christmas sweater with sweat to the point where I could wring the moisture out of it, listless at 1800.  Couldn't lift head or walk.  I had to carry him into the emergency room and the ER doctor agreed it could be an adverse reaction.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in years
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 36 hours after vaccine in left deltoid, large swelling and erythema rash noted on distal biceps near elbow joint with swelling of entire deltoid and biceps.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Infanrix instead of Boostrix; Infanrix administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-year-old 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 10th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and adult use of a child product. On an unknown date, the outcome of the wrong vaccine administered and adult use of a child product 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-JAN-2023 Reporter's Comment: The healthcare professional reported that earlier that day an adult patient accidentally received a dose of Infanrix instead of Boostrix. The reporter did not have enough information regarding the patient or the vaccine but gave consent for the safety team to follow-up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: An adult patient accidentally received a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and adult use of a child product.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 11th January 2023, 1 days after receiving Shingrix, the patient experienced headache. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment:  The reporter was patient's wife. The reporter reported that she and her husband received their 2nd Shingrix dose yesterday. THe patient experienced headache 6 hours after the vaccination.  The patient woke in the night with a headache unresolved by acetaminophen.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 19Jul2021, will be getting 2nd dose today; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 19th July 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-Jan-2023 Reporter's Comment: The reporter stated that the patient had not yet gotten the second dose.  The reporter stated that the patient would be getting the second dose today.  The reporter did not had access to the original dose's lot number and expiration date. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2017, did not know about 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix sometime in 2017 ).   On an unknown date, the patient did not 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: 11-Jan-2023. Reporter's Comments: The patient did not know there was a 2nd dose to complete the series. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose which led to incomplete course of vaccination.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-JAN-2023 Reporter comment: Medical assistant reported that a patient received a twinrix expired dose. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of twinrix vaccine which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given the adjuvant only; given the adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment: The reporter was a registered nurse (RN) from the clinic, where the vaccine was administered.  She had reported that an anonymous patient was given the Shingrix adjuvant only in the early December.  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient was administered only the only the adjuvant portion of the Shingrix which had led to inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPA
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 patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th January 2022) for prophylaxis.   On 11th January 2023, the patient received Havrix. On 11th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-Jan-2023  Reporter's Comments: The clinical coordinator reported that an expired dose of Havrix was inadvertently administered to a patient.  The reporter consented to follow up. The healthcare professional could not provide patient demographics. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.