chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Acute cardiac event, Disability, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: postherpetic neuralgia; cardiac event; herpes zoster/ rash; Information has been received regarding a case in litigation from a lawyer and referred to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered a rash, herpes zoster, postherpetic neuralgia and a cardiac event. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, postherpetic neuralgia and a cardiac event was considered as not recovered. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events herpes zoster, postherpetic neuralgia and a cardiac event to be disability.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome, Incorrect route of product administration
Clinical narrative: guillain barre syndrome; SQ; This spontaneous report was received from a pharmacist via Agency and refers to friend, a 42-year-old, female patient. Her medical history, concurrent conditions, concomitant medications, laboratory tests, previous drug reactions or allergies were unknown.  On an unspecified date in 2021, reported as a couple weeks ago, the patient was vaccinated with the first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, subcutaneously (SQ) (strength and anatomical location were not reported; dose, lot # and expiration date were unknown) for human papillomavirus (HPV) prevention (incorrect route of product administration).  On an unknown date in approximately 2021, she developed Guillain Barre syndrome which required hospitalization. The patient has been still in the hospital as of the time of this report. The reporter was unable to provide any additional details. It was unknown, if the patient received any treatment for the event. No cancer, congenital anomaly, or overdose were involved. The outcome of guillain-barre syndrome was unknown. The reporter did not assess the causality between the suspect vaccination and the event.  Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist, and refers to an adult patient in 50's. The information about patient's concurrent condition, medical and drug history and concomitant medications were unknown. On 03-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), rHA, dose: 0.5 ml, lot # S022754, expiration date: 22-JUL-2021 as prophylaxis (anatomical location were not provided) (expired product administered). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) did not undergone any temperature excursions. No other adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a physician via company representative, and refers to a 4 month old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 06-DEC-2021 the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), dose: 2 milliliters, lot # 1691133, expiration date: 28-NOV-2021 orally as prophylaxis (anatomical location was not provided) (expired product administered). No temperature excursion and no additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: 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. In November 2021, the patient received the 2nd dose of Shingles vaccine. In November 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got second shot last week and it kicked his/her ass but better than getting shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male 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, unknown after receiving Shingles vaccine, the patient experienced sickness, fever and pain in arm. On an unknown date, the outcome of the sickness, fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the sickness, fever and pain in arm to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter said if you had chickenpox you still get shingles also said if you get the shingles vaccination you could still get shingles, usually a lighter case. The patient just got the shingles vaccination which made him sick, had fever and his arm was sore for over a week. Not sure the patient would go back for second shot. No contact details were available. The case had been linked with US2021AMR248169 reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR248169:same reporter/ invalid report.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: received 1 ml of the vaccine; This case was reported by a consumer via call center representative and described the occurrence of overdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number T7S73, expiry date 17th September 2022) for prophylaxis.   On 24th September 2021, the patient received the 1st dose of Shingrix (intramuscular) 1 ml. On 24th September 2021, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The case was reported by the patient. The patient received first dose in left arm. The patient stated that he received 1 ml of the vaccine, which led to overdose. The reporter did not consent to follow-up. The case has been linked to US2021247338, reported by the same reporter, for a same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021247338:Same patient, different dose
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a consumer via (Shingrix GSK) 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 in 2019) and Shingrix (received 2nd dose in 2019). On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered and extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received shingrix vaccine twice. The patient received 2 shots over last several months from the date of reporting, which led to extra dose administered.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she the physician tried last 2 Shingles shot serious years back to see if it would minimize how often the breakout. Unfortunately, it was just fed the virus. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, 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 Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine and a week later got shingles. The patient stated he/she still dealing with lots of complications. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got shingle. The patient stated he/she year received shingle vaccine and two weeks ago gotten shingles again. Not as full blown, but none the less got shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of chills (1st dose received an unknown date, refer case US2021AMR249126). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved. It was unknown if the reporter considered the unwell to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The reporter reported that the patient was actually in bed for about two days after the second. The reporter said that second shot hit the patient pretty hard.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249126:same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: suspected vacciation failure; All symptoms of whooping cough; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   The reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had an issue with TDAP vaccine, specifically the pertussis or whooping cough portion. The patient experienced all the symptoms of whooping cough. This case was considered as suspected vaccination failure case since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming whooping cough were not reported. The patient further stated that he/she would get the TD vaccine only next time. The researched it afterwards and the vaccine was the new version with more side effects than previous. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249175:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 27th November 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shot of Shingrix past Saturday (from the day of reporting), reported red swollen area around the injection site. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine and got shingles three times afterwards. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 details provided were as follows: The age at vaccination was not reported. The patient had shingles and the vaccine, the patient had prior did help in making shingles less severe. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: got vaccine January of 2021 I have had the shingles 3 times/ suspected vaccination failure; had the shingles 3 times in my left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2021, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle vaccine in January 2021 and had the shingles 3 times in the left eye. The patient stated that the vaccine did not work. 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, Product use issue, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox more than once) and shingles (had shingles more than once).  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 drug use for unapproved schedule. On an unknown date, the outcome of the vaccination failure, shingles and drug use for unapproved schedule were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles more than once and got the shingles vaccine every year, which led to drug use for unapproved schedule. 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: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had first flare upto 2.5 yeas ago, from the day of reporting and had 1 to 2 bumps, was down for the week could not drive or move the arm at all), shingles (few months later after the 1st flare up, had a second flare up and had 1 to 2 bumps, was down for the week could not drive or move the arm at all), nerve pain (experienced nerve pain in right shoulder down the right arm) and pain (worst pain ever). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd 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 details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient got both the shots as soon as he/she could and stated that, now the flare ups were not as bad as earlier. The reporter suggested to get the shot before actually getting shingles and might be that would never cause a flare up. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles shot several years ago. Had outbreak/suspected vaccination failure; outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for covid-19 prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles shot several years ago and had outbreak of shingles after the second corona shot. It was unknown if the reporter considered the shingles to be related to Covid 19 vaccine. Follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Infected cyst
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of infected cyst in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis. The patient's past medical history included surgery (Patient underwent surgical incision and draining of cyst post infection). Previously administered products included Shingrix (1st dose received in 5th January 2021 with batch number 2A3ZA and expiry date 14th October 2022). On 30th July 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced infected cyst and drug dose administration interval too long. On an unknown date, the outcome of the infected cyst and drug dose administration interval too long were unknown. It was unknown if the reporter considered the infected cyst to be related to Shingrix. Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported the patient developed an infection in a pre-existing cyst after receiving the second dose of Shingrix. The patient received first dose on 5th January 2021 and second dose on 30th July 2021, which led to drug dose administration interval too. The patient underwent surgical incision and drainage of cyst post infection. Upon escalation to 2nd line specialist, HCP stated cyst was removed 8 days later (after Shingrix administration). The reporter consented for follow-up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Infanrix instead of Boostrix; Pt of 11 years old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 21st October 2021, 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 details were provided as follows: Nurse reported inadvertent administration of Infanrix instead of Boostrix to an 11 year old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration. Health care professional gave consent for safety team to follow up The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza. On an unknown date, the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the influenza to be related to Shingrix. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient stated that, he received the 1st dose of Shingrix and currently had the flu. The patient was scheduled to get his 2nd dose on 3rd December 2021, but would reschedule. The patient declined to provide full demographics. No other information was provided. The reporter did not consent to follow up.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 2 HAVRIX vaccines, adult and pediatric dose; 19 months old, adult dose administered; This case was reported by a consumer via call center representative and described the occurrence of overdose in a 19-month-old male patient who received HAV (Havrix 1440 adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAV (Havrix pediatric) for prophylaxis.   On 1st December 2021, the patient received Havrix 1440 adult, Havrix Pre-Filled Syringe Device and Havrix pediatric. On 1st December 2021, unknown after receiving Havrix 1440 adult, Havrix Pre-Filled Syringe Device and Havrix pediatric, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's mother. The age at vaccination was not reported. The patient received Havrix pediatric and Havrix adult dose on the same day, which led to overdose. The patient received Havrix adult doe which led to adult product administered to child. The reporter chosen not to answer any questions to file safety report. The reporter did not collect consent and health care professional information.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number Z5225, expiry date 14th April 2023) for prophylaxis. On 30th November 2021, the patient received the 1st dose of Shingrix. On 30th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. Additional details were reported as follows: The nurse reported that the patient received 2 vials containing only the adjuvant component (Diluent) of Shingrix as 1st dose instead of being reconstituted with the powder which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).  On 2nd December 2021, the patient received the 2nd dose of Shingrix. On 2nd December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were reported as follows: The age at vaccination was not reported. A patient received the 2nd dose of Shingrix earlier than recommended interval which led to shortening of vaccination schedule. No symptoms reported. The reporter consented to follow up. Health care professional (HCP) stated the patient was not immunocompromised. The HCP did not have the patient's DOB or the lot/exp.
Sex: F
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a adult female patient who received HAV (Havrix pediatric) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2021, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 1st December 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that an adult patient received a pediatric dose of Havrix for her first dose, which led to accidental underdose and adult use of a child product. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st vaccine 12/14/2018, returning for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date 12th April 2021) for prophylaxis.   On 14th December 2018, the patient received the 1st dose of Shingrix. On 14th December 2018, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The reporter was Pharmacist. The reporter reported that the patient received first dose of Shingrix on 14th December 2018 and had returned for second dose. It was not confirmed whether the patient received the second dose at time of call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received three years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient had not administered second dose yet till the time of reporting, which led to incomplete course of vaccination. The reporter did not know the exact vaccination date, lot number and did not want to share patients demographic information. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Medication error, Product preparation issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the box of 10 doses had one vial of powder remaining, so it was possible that the patient only received vial of liquid only, which led to circumstance or information capable of leading to medication error. The reporter did not determine which patient might have been impacted at this point so did not have any patient details to share yet. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details provided were as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received first dose of Shingrix approximately two months ago of reporting date and experienced rash down entire arm in which dose was received. Rash was resolved after a week. The patient had not yet received second dose of Shingrix. The patient declined to provide demographics or further details regarding event. The patient did not specify which arm rash was on and in which injection was received. The reporter did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd December 2021, 2 days after receiving Shingrix, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to Shingrix. Additional details provided were as follows: The patient self-reported the case. The patient received a dose of Shingrix and had a routine complete blood count laboratory blood test done which showed elevated white blood cells, it was unknown if patient recovered. He had nothing else to report. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided are as follows: The age at vaccination was not applicable for this report. The caller reported that he knew a lot of people that had sore arm after receiving Shingrix. No patient identifiers were known. No specifics were known. The caller declined to provide health care professional information. The caller did not consented to follow-up. The case has been linked with with case US2021172435 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021172435:same reporter - reporter´s case.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the tingling and numbness to be related to Shingrix. Additional details were provided are as follows: The case was reported by patient's wife. The age at vaccination was not reported. The caller stated that she and her husband both received a dose of Shingirx vaccine 5 weeks ago and since receiving the vaccine her husband had experienced tingling and numbing down his neck, arm, leg, and toe. The caller was inquiring if this was normal. The caller was requesting for recommendation regarding next steps. The reporter was given information from Shingrix frequently asked questions content, provided medical advice disclaimer and referred to health care professional. The caller provided permission to contact health care professional. No additional details were provided by the caller. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, Somnolence
Clinical narrative: WOKE UP MISERABLE IN MORNING; SLEEPING; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced unspecified adverse event (dose number in series was 1). Seriousness criteria and outcome not reported for the event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported (dose number in series was 2), 1 in total administered on 10-NOV-2021 at 16:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  As per the report, on 11-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient woke up miserable in the morning and was already feeling better after spending the day with fever and sleeping. The patient was stated that the first one was worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, sleeping, and woke up miserable in morning. (all events dose number in series 2) This report was non-serious. This case, involving the same patient is linked to 20211164612.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Chills, Laboratory test, Pain
Clinical narrative: HIGH BLOOD SUGAR LEVELS; FELT ACHY; CHILLS; This spontaneous report received from a patient concerned a 59 year old female.  The patient's weight was 145 pounds, and height was 65 inches. The patient's concurrent conditions included: type 1 diabetes, non smoker, and alcohol use (4 glasses of wine a week), and other pre-existing medical conditions included: Patient had no known allergies, no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting.  On 11-MAR-2021 15:00, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported (dose number in series 1), 1 total, administered for prophylactic vaccination on left arm. Concomitant medications included insulin aspart for type 1 diabetes, and ramipril for type 1 diabetes.  On 11-MAR-2021, the patient experienced sore arm. (dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from sore arm on 12-MAR-2021.  On SEP-2021, Laboratory data included: Laboratory test (NR: not provided) everything was within normal range.  On 01-NOV-2021, Laboratory data included: Laboratory test (NR: not provided) within normal range.  On 10-NOV-2021 11:30, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A expiry: UNKNOWN) dose was not reported (dose number in series 2), administered for prophylactic vaccination on right arm.  On 10-NOV-2021, the patient experienced high blood sugar levels, felt achy, and experienced chills. Laboratory data included: Blood sugar abnormal (NR: not provided) 250 mg/dL, 301 mg/dL, 200 mg/dL. On 11-NOV-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 125 mg/dL, High, 240 - 250 range.   On 12-NOV-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 250-300 range, 323 mg/dL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from felt achy, and chills on 11-NOV-2021, and had not recovered from high blood sugar levels.  This report was non-serious.  This case, from the same reporter is linked to 20211129839.(husband case)