chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Extra dose administered
Clinical narrative: patient who received one extra dose for the schedule of Havrix and Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received HAV (Havrix) (batch number 4KJ79, expiry date 30th October 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number LM992, expiry date 13th December 2022) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received primary vaccination on an unknown date) and Engerix B (received primary vaccination on an unknown date).   On 14th April 2021, the patient received the 3rd dose of Havrix, Havrix Pre-Filled Syringe Device, the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 14th April 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was physician's office manager. The reporter stated that the patient received one extra dose for the schedule of Havrix and Engerix-B, which led to extra dose administered. The patient was fully immunized with both the vaccines, but they did not know at the time of vaccination.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first Shingrix dose on 09/03/2020 / 2nd dose is scheduled for today 04/16/2021; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix on 03rd September 2020 with batch number 59EA2 and expiry date of 13th September 2021.).   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 2nd dose was scheduled on the day of reporting and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose of Havrix to a pediatric patient (4 years, 7 months); adult dose of Havrix to a pediatric patient (4 years, 7 months); This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, 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.  Additional details were provided as follows:  The nurses in clinic inadvertently gave an adult dose of Havrix to the pediatric patient, which led to overdose and adult product administered to child. This was received as a webform, so these are the only details provided email and clinic address available for follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Therapy non-responder
Clinical narrative: received Twinrix / 6-8 years ago / had a test / has no antibodies; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 68-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Twinrix about 6 to 8 years ago from the reporting date and had a test that shows she had no antibodies. The health care professional did not know if the patient received the full Twinrix series and did not had the lot and expiry date of Twinrix. No symptoms reported.  The reporter consented to follow-up. This case had been linked with US2021AMR087423, reported for the same patient, by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087423:same reporter
Age: 52.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Therapy non-responder
Clinical narrative: dose 1 on April 5, 2019, dose 2 on May 8, 2019, and dose 3 on October 7, 2019 / had a recent physical with blood work / does not have enough titer to protect against Hepatitis B; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 54-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On 7th October 2019, the patient received the 3rd dose of Engerix B adult. On 8th May 2019, the patient received the 2nd dose of Engerix B adult. On 5th April 2019, the patient received the 1st dose of Engerix B adult. On 27th February 2021, 509 days after receiving Engerix B adult, 661 days after receiving Engerix B adult and 694 days after receiving Engerix B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were reported as follows: The case was reported by patient herself. The patient reported that she received a full series of Engerix-B adult, formulation not known, and was informed that she has no protection for hepatitis B. The patient had a recent physical with blood work, and the physician checked for hepatitis protection. The patient was informed that she did not have enough titer to protect against Hepatitis B. The reporter did not consent to follow up. The patient was seeking reimbursement and informed of GSK (GlaxoSmithKline) policy.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: First / 10/2019. Due to COVID restrictions / second dose was not received; This case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in October 2019, in left upper arm).   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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination not applicable. Due to COVID restrictions, the second dose was not received. Consented to follow up. This case is linked to the case US2021086465 and US2021AMR087889, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086465:Same reporter US-GLAXOSMITHKLINE-US2021AMR087889:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on 2019 / second dose in 18Apr2021; This case was reported by a pharmacist via and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On 18th April 2021, the patient received the 2nd dose of Shingrix. On 18th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late second dose /first dose/March 16th 2020.; 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) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No information about lot number from first dose was reported. The pharmacist confirmed that the first dose was given in that pharmacy. The reporter consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Product label confusion
Clinical narrative: Different practices do it differently / It's confusing and it's not clear; Different practices do it differently / It's confusing and it's not clear; This case was reported by a nurse via call center representative and described the occurrence of product label confusion in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced product label confusion and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the product label confusion and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse asked about recommendations of use of Menveo for patients with Sickle Cell Disease. The instruction were like dose 1 at age 8 weeks: 4-dose series at 2, 4, 6, 12 months, Dose 1 at age 36 months: 3 or 4 dose series (dose 2 and dose 3 if applicable at least 8 weeks after previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months), Dose 1 at age 723 months: 2 dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) and Dose 1 at age 24 months or older 2 dose series at least 8 weeks apart. Some offices interpreting that can choose between all four option and some interpret as first option was the recommendation and the other three were the catch up recommendation if did not start on time. Upon medical information callback to the reporter, she states she cut and pasted centers for disease control recommendations into email to GSK (GlaxoSmithKline).  Different practices do it differently, asked what are the differences between the recommendations. It was confusing and was not clear on your part and on Centers for Disease Control part and therefore not clear on Health and Human Services part and wanted to clarify on the intention so there was not misinterpretation, which led to product label confusion and circumstance or information capable of leading to medication error. The reporter consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Systemic lupus erythematosus
Clinical narrative: patient started with Lupus 2 weeks after receiving Engerix-B.; This case was reported by a pharmacist via call center representative and described the occurrence of systemic lupus erythematosus in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, 2 weeks after receiving Engerix B, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant). On an unknown date, the outcome of the systemic lupus erythematosus was unknown.   It was unknown if the reporter considered the systemic lupus erythematosus to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Engerix B and experienced lupus. The physician was trying to collect as much information. No details were available from patient. The reporter did not consent to follow up. No further information available.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administers Kinrix to 4 month old infants to prevent giving an extra dose of Hep B; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. A pediatric infectious disease doctor reported knowing that one of the pediatricians in his institution administered  Kinrix to 4 month old infants to prevent giving an extra dose of Hepatitis B, which led to inappropriate age at vaccine administration. No further information was reported. Reporter did not consented to follow-up.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Unevaluable event
Clinical narrative: Patient received two doses of Boostrix in the same day; Dispensing error; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix, the patient experienced accidental overdose and drug dispensing error. On an unknown date, the outcome of the accidental overdose and drug dispensing error 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 reported as follows: This case was reported by pharmacy student. The reporter stated that, due to a dispensing error the patient received two doses of Boostrix on the same day. The reporter consented to follow up. The lot number and expiry date of Boostrix is for the 2nd dose given of the two. The reporter consented follow up.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient over the age of 25 in college received 1 dose of the bexsero.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported but could be more than 25 years as the patient's age was reported as over 25 years. The patient received a dose of the Bexsero at this age, which led to inappropriate age at vaccine administration. The reporter did not have further details.  No reactions reported. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix / were stored in the freezer / patient received one; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B53D, expiry date 10th October 2022) and (batch number 97Y5D, expiry date unknown) for prophylaxis.   In March 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional information was provided as follows: The age at vaccination was not reported but could be 51 or 52 years. The reporter stated that, the vaccine was stored in the freezer due a confusion with Merck's vaccines which led to incorrect storage of drug. The patient received one dose of Shingrix a month ago. The reporter consented to follow up. As per sales data sheet reported batch number for adjuvant was changed from 97YFD to 97Y5D.
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Hypoaesthesia, Paralysis, Sensory disturbance
Clinical narrative: Severe side effects / My whole body is paralyzed; Severe side effects / Numbness to his L arm. /  I can't feel my legs and my face; Severe side effects / Difficulty breathing and kept his mouth open; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 15-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3SM34, expiry date 4th December 2020) for prophylaxis.   In October 2019, the patient received Boostrix. On an unknown date, 10 min after receiving Boostrix, the patient experienced paralysis (serious criteria GSK medically significant), numbness and difficulty breathing. On an unknown date, the outcome of the paralysis, numbness and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the paralysis, numbness and difficulty breathing to be related to Boostrix.  Additional details were provided as follows: This case was reported by patient's mother. The age at vaccination was not reported. The patient received dose of boostrix and experienced whole body is paralyzed,numbness to his left arm, did not felt his legs, face and difficulty breathing. The reporter informed that paralysis lasted about 20 to 30 min and all this happened when she was was driving back home. The reporter stated that place where they went for the injection did not offered to monitor him for 15 min after the injection so called ambulance while driving as there was nothing near by. The reporter provided zip code. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only shingrix adjuvant was administered; Only shingrix adjuvant was administered; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was vaccine coordinator. The age at vaccination was not reported.  The reporter stated that the patient was administered with only shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked how to proceed with vaccination. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, White blood cell count decreased
Clinical narrative: Suspected vaccination failure; expereinced  shingles now on right side under chin, usually on left side (herpes infection ); This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer. Concurrent medical conditions included white blood cell decreased.   On 7th December 2020, the patient received the 2nd dose of Shingrix. On 5th October 2020, the patient received the 1st dose of Shingrix. On 7th December 2020, the dose was an unknown dose. On 12th April 2021, 126 days after receiving Shingrix, 189 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had cancer 11 years before reporting date. The patient had ongoing low WBC (white blood cells). Past week before reporting date, the patient had shingles (herpes infection) on right side under chin. The patient used Valtrex for treatment of herpes, which patient's oncologist always wanted. The patient asked about what happened and asked if she need a booster dose. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. No lot information available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the second dose / first dose was administrated on May 2019; 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 with an associated reaction of no adverse event (received 1st dose in May 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 was provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient was late for the 2nd dose of Shingrix and till the time of reporting, she did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: At least three patient / Received the Engerix-B / after - exposed to below freezing temperatures; This case was reported by a pharmacist 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.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. The Pharmacist reported that at least three patients received Engerix B vaccine that was exposed to below freezing temperatures, which led to incorrect storage of drug. Patient information was unknown at the time of chat and declined to have a follow up. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: selected 2 vials of Adjuvant/ were never mixed/Medication error intercepted; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult patient who received Herpes zoster (Shingrix) (batch number 2EC54, expiry date 11th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Reporter stated that she was about to prepare a Shingrix vaccine by error selected 2 vials of Adjuvant Suspension Component (liquid). Product vials were never mixed ( batch number 2EC54, expiry date 11th November 2022 ) which led to intercepted drug preparation error The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient never got the third dose; first dose of Twinrix on Feb-27-2019 / second dose on Aug-28-2019 / received a late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 27th February 2019).   On 28th August 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 28th August 2019, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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 applicable for 3rd dose. The patient was vaccinated with 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: First dose / "before COVID" / wanting to resume the vaccination schedule; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 42-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Engerix B vaccine before covid situation and did not received further doses. The patient wanted to resume the rest of vaccination schedule. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Patient was given an expired menveo vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th April 2021, the patient received Menveo. On 19th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details was reported as follows: The patient received Menveo vaccine which was expired 19 days before administration, which led to expired vaccine used. The reporter did not consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report was received from a consumer and concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular) dose was not reported, administered on 03-MAR-2021 to left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAR-2021, the patient's wife reported that her husband had received the Janssen COVID-19 vaccine and developed a fever of 103.7 degrees Fahrenheit.  The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient had not recovered from fever.  The patient assessed the event of fever as not related to COVID-19 vaccine Ad26.COV2.S. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Initial insomnia, Myalgia
Clinical narrative: SHAKING; DID NOT SLEEP LAST NIGHT AT ALL; RESTLESSNESS; ACHY MUSCLES IN LEGS; NAUSEA COMES AND GO; SHIVERING; HEADACHE; FEVER; BRAIN FOG AND MEMORY DURING COVID; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and concurrent conditions included allergies (airborne allergies and hay fever). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 180518) on left deltoid, dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date (around thanksgiving), the patient had Covid-19 but was otherwise healthy. On 04-MAR-2021, the patient experienced shaking, fever (did not take temperature), did not sleep at night and shivering all night. The patient also had restlessness, achy muscles in legs, reoccurring nausea, headache and brain fog and memory during COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, shaking, shivering, did not sleep last night at all, restlessness, achy muscles in legs, nausea comes and go, and headache, and the outcome of brain fog and memory during covid was not reported. The reporter assessed the events of fever, shaking, shivering, did not sleep last night at all, achy muscles in legs, nausea and headache as related to covid-19 vaccine ad26.cov2.s and brain fog as not related. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Restlessness, Tremor
Clinical narrative: SHAKING; DID NOT SLEEP LAST NIGHT AT ALL; RESTLESSNESS; ACHY MUSCLES IN LEGS; NAUSEA COMES AND GO; SHIVERING; HEADACHE; FEVER; BRAIN FOG AND MEMORY DURING COVID; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and concurrent conditions included allergies (airborne allergies and hay fever). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 180518) on left deltoid, dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date (around thanksgiving), the patient had Covid-19 but was otherwise healthy. On 04-MAR-2021, the patient experienced shaking, fever (did not take temperature), did not sleep at night and shivering all night. The patient also had restlessness, achy muscles in legs, reoccurring nausea, headache and brain fog and memory during COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, shaking, shivering, did not sleep last night at all, restlessness, achy muscles in legs, nausea comes and go, and headache, and the outcome of brain fog and memory during covid was not reported. The reporter assessed the events of fever, shaking, shivering, did not sleep last night at all, achy muscles in legs, nausea and headache as related to covid-19 vaccine ad26.cov2.s and brain fog as not related. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Pain in jaw
Clinical narrative: BILATERAL LEG BODY ACHE; LEFT JAW PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: 21-MAY-2021) dose was not reported, administered on 03-MAR-2021 at 11:30  hours to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021 at 16:00 hours, patient experienced left jaw pain and also experienced injection site pain (unspecified time). The patient was treated with Tylenol and Advil and with no effect. On 04-MAR-2021, she also developed bilateral leg muscle pain (coded as bilateral leg body ache) upon waking up in morning.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left jaw pain, bilateral leg body ache, and injection site pain. The reporter assessed the events as related to covid-19 vaccine ad26.cov2.s. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: FEVER; CHILLS; MUSCLE ACHE; This spontaneous report was received from a patient and concerned a 65 year old  female. The patient's height, and weight were not reported. The patient's past medical history included prone to side effects. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 04-MAR-2021 at 11:30 AM to left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, around 6:30, the subject experienced fever, chills, muscle ache (right arm more than left arm, though the shot was given left arm). Since prone to side effects, she stayed at the vaccine facility for 1 hour after vaccine administration to make sure she did not experience anaphylaxis.  Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, and muscle ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: CHEST HURTS; SHORTNESS OF BREATH; SHAKING INTENSELY; SORE MUSCLES IN LEGS; FEVER RISING EVERY 20 MINUTES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 12:40) dose was not reported, on 05-MAR-2021 at 17:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021 at 21:30 the subject experienced chest hurts, shortness of breath, shaking intensely/chills, sore muscles in legs,  fever rising every 20 minutes and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaking intensely, and shortness of breath, and had not recovered from sore muscles in legs, fever rising every 20 minutes, chest hurts, and headache. The reporter assessed the events as related to  covid-19 vaccine ad26.cov2.s. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHEST HURTS; SHORTNESS OF BREATH; SHAKING INTENSELY; SORE MUSCLES IN LEGS; FEVER RISING EVERY 20 MINUTES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 12:40) dose was not reported, on 05-MAR-2021 at 17:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021 at 21:30 the subject experienced chest hurts, shortness of breath, shaking intensely/chills, sore muscles in legs,  fever rising every 20 minutes and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaking intensely, and shortness of breath, and had not recovered from sore muscles in legs, fever rising every 20 minutes, chest hurts, and headache. The reporter assessed the events as related to  covid-19 vaccine ad26.cov2.s. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: RIGHT ARM PAIN; DON'T FEEL WELL; CHILLS; FEVER; HEADACHE; SIDE-EFFECTS; SWEAT; FEELS WEAK, TOO ILL; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, smoker, depression, and anxiety, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 14:30 for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, escitalopram oxalate for depression, and gabapentin for sleep disorder. On 03-MAR-2021, the subject experienced side-effects. On 03-MAR-2021, the subject experienced sweat. On 03-MAR-2021, the subject experienced feels weak, too ill. On 03-MAR-2021, the subject experienced don't feel well. On 03-MAR-2021, the subject experienced chills. On 03-MAR-2021, the subject experienced fever. On 03-MAR-2021, the subject experienced headache. On 04-MAR-2021, the subject experienced right arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side-effects, sweat, feels weak, too ill, right arm pain, don't feel well, chills, and fever on 05-MAR-2021, and headache on 04-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: RIGHT ARM PAIN; DON'T FEEL WELL; CHILLS; FEVER; HEADACHE; SIDE-EFFECTS; SWEAT; FEELS WEAK, TOO ILL; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, smoker, depression, and anxiety, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 14:30 for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, escitalopram oxalate for depression, and gabapentin for sleep disorder. On 03-MAR-2021, the subject experienced side-effects. On 03-MAR-2021, the subject experienced sweat. On 03-MAR-2021, the subject experienced feels weak, too ill. On 03-MAR-2021, the subject experienced don't feel well. On 03-MAR-2021, the subject experienced chills. On 03-MAR-2021, the subject experienced fever. On 03-MAR-2021, the subject experienced headache. On 04-MAR-2021, the subject experienced right arm pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side-effects, sweat, feels weak, too ill, right arm pain, don't feel well, chills, and fever on 05-MAR-2021, and headache on 04-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body ache; Chills; Fever; This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch unknown) dose was not reported, administered on 07-MAR-2021 at 08:10 am for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced chills, body ache and fever. The patient's arm was not sore at all. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fever, chills and body ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: MILD FEVER; FELT TIRED; CHILLS; BODY ACHES; WEAKNESS; This spontaneous report was received from a female patient of an unspecified age reporting on herself. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 11:00 for Covid-19 vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced a mild fever, felt tired, chills, body aches, and weakness. It was reported that by 5 pm, she felt tired and had a mild fever. That night she had chills, mild fever, body aches and felt weak. On 07-MAR-2021, the following day she felt achy and tired.  Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever, felt tired, chills, body aches, and weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Overdose
Clinical narrative: ADMINISTERED WHOLE VIAL; FELT A LITTLE TIRED; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805020) 2.5 ml, administered on 05-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced administered whole vial. On an unspecified date, the subject experienced felt a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt a little tired, and the outcome of administered whole vial was not reported. This report was non-serious.  Additional information was received from pharmacist on 17-Mar-2021 following information was updated and incorporated into case narrative: Patient demographic details (age, sex), covid-19 vaccine ad26.cov2.s therapy details (batch number, dose), additional event of felt a little tired, reporter details and other identification numbers was added.  Additional information was received on 19-Mar-2021 following information was updated and incorporated into case narrative:  The case is associated with product quality complaint number 90000173653.  Upon review, the following information was amended: Route of administration corrected, pre-existing medical condition removed, outcome and event rank corrected.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.