chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; Caller is a nurse who is reporting an expired dose of M-M-R II has been administered to a child today/expired vaccine was given in error; This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) and refers to a 1-year-old female patient. It was reported that the patient had none illness at the time of vaccination and none preexisting physician diagnosed allergies, birth defects or medical conditions (both reported as "none vaccine"). Information regarding concomitant medications was not provided.  On 21-MAR-2022, the patient was vaccinated with her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) at a dose of 0.5 milliliter (ml) administered intramuscularly (IM) on her right (R) thigh (vaccination scheme frequency was not reported; lot number T007231 with an expiration date reported and established as 27-FEB-2022) (expired product administered) for prophylaxis. It was stated that the expired vaccine was given in error and that family and manufacturer were contacted. Additionally, that it was found supported by memo that there was no temperature excursion. Also, it was reported that the vaccine was used according to the instruction leaflet by a trained operator and that this was previously reported to the doctor.   Did the experienced abated after stopping the drug and did the experienced reappeared after reintroduction, both were reported as no; however, assessed as not applicable since the suspect medication was a vaccine.  No adverse reaction was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Proquad was administered; No additional Adverse event reported; This spontaneous report was received from a nurse referring to a patient (age and gender unknown).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-MAR-2022, the patient was vaccinated with dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #T032150, expiration date: 20-MAR-2022 for prophylaxis ( route and site of administration were not provided), that was expired. No temperature excursion on the vaccine was reported,  No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was administered an expired dose of PROQUAD; This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) and refers to a patient of unspecified gender and age. Patient's pertinent medical history, concomitant medications and past drug reactions or allergies were not provided.  On 17-MAR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose on 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T0318525 that was verified to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and does not match any company product as confirmed by lot verification team, expiration date reported as 16-MAR-2022) (expired product administered) for prophylaxis.  Also, it was confirmed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had no temperature excursions. The reporter provided the supported disclaimer based on the "post expiry memo".  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Administration of MMR and VARIVAX intramuscularly; This spontaneous report was received from a physician's assistant concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # U029496,  expiration date: 21-SEP-2023, administered intramuscularly (unapproved route) as prophylaxis (strength, was not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U006486, expiration date: 26-FEB-2023, administered intramuscularly (unapproved route) as prophylaxis (strength was not provided).
Sex: U
Vaccine: VARCEL
Symptoms: Device connection issue, Needle issue, Underdose
Clinical narrative: needle came loose and some of the vaccine spilled out; needle came loose and some of the vaccine spilled out; she is unsure if the patient received the entire dose; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-APR-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml (lot #U022320, has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-JUL-2023), administered for prophylaxis (route of administration were not provided). The nurse said that while administering a dose of varicella virus vaccine live (oka/merck) (VARIVAX) to a patient, the needle came loose (needle issue and device connection issue), and some of the vaccine spilled out. The nurse also reported that she was unsure if the patient received the entire dose (underdose).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Customer reported PNEUMOVAX 23 (pfs) was administered past expiration date of administration April 7, 2022.  NO PQC.  NO other issues or concerns noted.  Caller refuse AE letter. LOT: T009743 EXP: Jan 27, 2022 Admin: April 7, 2022; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.         On 07-APR-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T009743 with expiration date 27-JAN-2022, for prophylaxis (strength, dose,  route of administration and anatomical location were not reported). No other issues or concerns noted.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired dose of PROQUAD was administered; This spontaneous report was received from a nurse and refers to a  twin patient of unknown age and gender. The patient's medical history and  concurrent conditions were not reported. Concomitant therapies were not reported.  On an 12-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters (lot #T034825 with an expiration date on 11-APR-2022), administered for prophylaxis (strength, and route of administration were not provided).  No temperature excursion on the vaccine. No additional adverse events were reported.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Ataxia, Dyskinesia, Fear
Clinical narrative: lost control of my arms and legs; lost control of arms and legs/could not stop my movements; very scary; This case was reported by a consumer via interactive digital media and described the occurrence of ataxia 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 ataxia, movements involuntary and fear. On an unknown date, the outcome of the ataxia, movements involuntary and fear were unknown.   It was unknown if the reporter considered the ataxia, movements involuntary and fear to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingles vaccine and experienced lost control of arms and legs, could not stop movements after the shot, which was very scary. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, SARS-CoV-2 test negative
Clinical narrative: put me in bed, make me feel miserable; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingles vaccine 4 days ago of the reporting time and felt miserable. The patient stated that vaccine kept him/her in bed. The patient thought it was COVID but later got the COVID test and patient was COVID-negative. The patient back to his/her life till the time reporting he/she waiting for second dose of Shingles vaccine. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Received 1st dose subcutaneously; This case was reported by a other health professional via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix (subcutaneous). In April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.       Additional Information: GSK Receipt Date:  08-APR-2022 Reporter's Comments: The patient received 1st dose of shingrix subcutaneously. The reporter asked if the patient need another dose intramuscularly. The patient received 1st dose 2 days before day of reporting.   Additional Supportive Information: This case was reported by a other health professional via interactive digital media . The patient received shingrix subcutaneously which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: small rash at shingles injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site 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 injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient reported that he/she had a small rash at shingles injection site. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Filling sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just received dose of Shingles vaccine last night of reporting and felt sore but better than he/she would, if he/she got shingles. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Recommendations if missed the second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   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: 12-Apr-2022 Reporter's comments: This case was received from Shingrix. The reporter asked if someone missed the window 2-6 months for the second dose of Shingrix after receiving the first dose, what was the recommendation. If the patient could restart the series or receive the second dose regardless of time elapsed from the first dose. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; Pain is horrible; 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, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. After receiving Shingles vaccine, the patient still got the shingles. The patient stated that, pain was horrible. Additional Supportive Information: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: went almost two years between first and second shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose almost 2 years ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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: 13-Apr-2022 Reporter's Comments:  The reporter was a consumer and went almost two years between first and second shingrix shot.  The reporter asked if that was okay. Additional Supportive Information:  The case was self-reported by the patient. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the Shingles in February!; The blisters dried up; Nerve pain that's left; 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, blister and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the blister was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine several years ago from the date of reporting and in February of an unknown year got shingles. The blisters dried up, but the nerve pain was left till the time of reporting. Additional Supportive Information: This case was reported via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and still got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine and still got the shingles. Additional Supportive Information: This case was reported via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccination and still got it/suspected vaccination failure; shingles; feel miserable; 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 feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine and still got the shingles. The patient stated that, he/she was miserable but a little better and this was week 4 till the time of reporting. Additional Supportive Information: This case was reported via  interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: mistakenly got 4 vaccinations of Shingrix, got extra doses; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 4th dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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: 13-Apr-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. What if the reporter had mistakenly got 4 vaccinations of Shingrix. Additional Supportive Information:  The case was self-reported by the patient. The patient received 4 doses of Shingrix, which led to extra dose administered. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   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: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine and was still getting the shingles. Additional Supportive Information: This case was reported via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertently gave an expired dose; This case was reported by a pharmacist via other manufacturer and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2022, the patient received Twinrix 1 ml and Twinrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-Apr-2022 Reporter's Comments: Pharmacist reported that, she inadvertently administered an expired dose of Twinrix to a female patient on 14th April 2022. The lot number of the dose was GG3S5, expiration date 28th February 2022. At the time of reporting, dose had not been repeated. The patient did not have any symptoms or adverse effects following administration. No other information provided. No other adverse event / no product quality complaint. The reporter consented to follow up. Additional Supportive Information:  The patient received an expired dose of Twinrix inadvertently, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065257:FU1 - Deleted
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After first dose, developed shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 79-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, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comments:  The reporter stated that, the patient came in on 12th April 2022, which was almost exactly 2 weeks after her first dose of Shingrix, and she had shingles. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Lymph node pain
Clinical narrative: Painful lymph node under arm; This case was reported by a consumer via interactive digital media and described the occurrence of lymph node pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th April 2022, the patient received Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced lymph node pain. On an unknown date, the outcome of the lymph node pain was unknown.   It was unknown if the reporter considered the lymph node pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comments:  The patient stated that he /she had Shingrix vaccination on 13th April 2022 and had a very painful spot, it was lymph node under his/her arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, doesn't move head in order to alleviate it; Nausea, doesn't move head in order to alleviate it; Vomiting; Weakness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2022, the patient received the 1st dose of Shingrix. On 4th April 2022, 7 hrs after receiving Shingrix, the patient experienced dizziness, nausea, vomiting and weakness. On an unknown date, the outcome of the dizziness, nausea, vomiting and weakness were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, nausea, vomiting and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: The reporter was the daughter of the patient. The reporter reported that the patient received her first dose of Shingrix at 3 pm, at 10 pm (Post meridiem) the same day, the patient began experiencing dizziness, nausea, vomiting, and weakness.  The patient's symptoms have not worsened or subsided at the reporting time.  The patient does not move her head in order to alleviate the nausea and dizziness.  Spoke per content. Gave Medical Advice Disclaimer. Referred to HCP (health care professional) The reporter did not wish to provide any further information or details. The reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Occupational exposure to product
Clinical narrative: Pregnant medical assistant splashed Shingrix into her eye; splashed Shingrix into her eye; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of occupational exposure to product via eye in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2022, the patient received Shingrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Shingrix at an unknown time during the pregnancy. On 8th April 2022, unknown after receiving Shingrix, the patient experienced occupational exposure to product via eye. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the occupational exposure to product via eye and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up.       Additional Information: GSK Receipt Date:   08-APR-2022 Reporter's Comments: The pregnant medical assistant splashed Shingrix into her eye. The health care professional disconnected from chat after providing information. Additional Supportive Information: As the pregnant medical assistant splashed Shingrix into her eye, which led to occupational exposure to product via eye and vaccine exposure during pregnancy.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired product; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa (Infanrix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th April 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.   Linked case(s) involving the same patient:  US2022061834   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comments: The case was reported by patient's mother. The mother informed that her daughter received an expired product. The reporter consented to follow up. Additional Supportive Information: The patient received expired vaccine which led expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061834:Same patient
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Was stored in a freezer, may have been administered to patients; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022  Reporter's Comments: Health care professional (HCP) reported that Engerix-B was stored in a freezer and might have been administered to patients, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter. HCP reporting unsure if any vaccines were administered as this was not her regular clinic. HCP above email was person to be followed up with regarding this for the clinic where storage error occurred. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 on March 2020, never received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 13th March 2020).   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-APR-2022 Reporter's comment: The pharmacist reported that a patient never received the second dose of Shingrix. No vaccine detail were available. 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: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammation, Injection site pain, Skin warm
Clinical narrative: Pain at injection site; should is warm; should is inflamed; hurts to move his shoulder upward; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain, skin warm, inflammation and shoulder pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site pain, skin warm, inflammation and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, skin warm, inflammation and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: The reporter was the patient. The patient received first dose of Shingrix in his left upper arm, since then he experienced pain at the injection site, his left shoulder was warm and inflamed and it hurt to move his shoulder upward. The patient has used ice and heat as well as Aleve to alleviate the symptoms. The reporter consented to follow up with HCP (health care professional) (pharmacy).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: diarrhea; Fever; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diarrhea ('sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats'), nausea ('sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats') and vomiting ('sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats').   On 18th August 2021, the patient received the 1st dose of Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced fever, nausea and vomiting. On an unknown date, the patient experienced diarrhea. On an unknown date, the outcome of the fever, nausea and vomiting were recovered/resolved and the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the fever, nausea, vomiting and diarrhea to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR063926   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: The reporter was the patient, who called in regarding adverse reactions she had to Shingrix. The patient reported she received first dose of Shingrix and the same evening after taking vaccine she developed a fever and nausea/ vomiting which lasted 3-5 days after and had since resolved.  The patient also mentioned that since receiving Shingrix, she had an increased sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats.  The patient reported that this had been an issue for her since before taking the vaccine but had become markedly worse since Shingrix. She had been evaluated for a possible alpha gal allergy and did not have a diagnosis as of the reporting time.  The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR063926.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR063926:Same patient/reporter
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: An expired dose of ENGERIX B was given; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 10-day-old female patient who received HBV (Engerix B) (batch number J7H4D, expiry date 23rd March 2022) for prophylaxis.   On 12th April 2022, the patient received Engerix B. On 12th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-APR-2022 Reporter's comment: Physician who called in to report that on the day of reporting (today) an expired dose of Engerix- B was given to a patient.  No other symptoms reported.  The reporter provided information on dosing schedule and warm transferred to medical information and provided medical information agent with case number. Consented to follow up. Additional Supportive Information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 05Feb2019, not received second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th February 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: 12-APR-2022 Reporter's Comments: The nurse reported that the patient received first dose of Shingrix and the patient had not received second dose.  The first dose was administered at a different facility and reporter did not have the lot number or expiration date information. The reporter consented to 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. The case has been linked with case US2022064035 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064035:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 13Sep2019, not received second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th September 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: 12-APR-2022 Reporter's Comments: The nurse reported that the patient received first dose of Shingrix. The patient had not received second dose. The first dose was administered at a different facility and reporter did not have the lot number/expiration date information. The reporter consented to 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. This case has been linked with the case US2022064033 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064033:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: SHINGRIX mixed with COVID vaccine, discarded the mixture; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number 5A9GE, expiry date 3rd June 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.       Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The pharmacist reported that SHINGRIX vaccine was being reconstituted and instead of adjuvant , they mixed the COVID vaccine in with the antigen. The reporter quickly realizing the error, they discarded the mixture. The reporter was asking for a replacement of the adjuvant. The vaccine was not administered to the patient. Additional Supportive Information: The SHINGRIX vaccine was reconstituted with COVID vaccine and patient did not received vaccine which led to intercepted product preparation error.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 9 June 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The pharmacist reported a patient received the first dose of the Shingrix vaccine and not received 2nd dose. 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: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: received a dose wich expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female 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 12th April 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 12th April 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 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: 12-Apr-2022 Reporter's comment: Medical assistant reported that on the day of reporting (12th April 2022) a patient received 1st dose of Pediarix which was already expired on 4th April 2022. The health care professional provided fax number as contact number for follow up.  Consented to follow-up. Additional Supportive Information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Received vx diluted with sterile water; Received vx diluted 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 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7h9ch, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th April 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 11th April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.     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-APR-2022 Reporter's Comments: The patient received Rotarix diluted with sterile water instead of the correspondent diluent. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Rotarix diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case has been linked with case US2022064751 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064751:Same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Severe case of hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2022, the patient received the 1st dose of Shingrix. On 12th April 2022, 23 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comments: The patient called and reported that she had first dose of Shingrix and developed a severe case of hives. The reporter consented to follow up.