chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Multiple patients were administered doses of MMR-II or VAQTA after they were involved in a temperature excursion; No additional AEs were reported; This spontaneous report has been received from a medical assistant, concerning an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection (lot number W029789 with expiration date reported as 23-SEP-2023, was not valid for M-M-R II) (lot number W009107 has been verified to be valid for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live, rHA [M-M-R II], expiration date reported and confirmed as 04-DEC-2023), or hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W028555 has been verified to be valid for hepatitis a vaccine, inactivated [VAQTA], expiration date reported and confirmed as 10-JUL-2024), administered as prophylaxis (exact doses, routes of administration, and anatomical locations were not provided). The vaccine doses were administered after they were involved in a temperature excursion of 9.2 degree Celsius during a time frame of 40 minutes and they did not suffer previous temperature excursions. No additional adverse events (AEs) were reported.  Follow up information was received from the medical assistant on 23-MAY-2023. It was reported that one of the patients was a 13-month-old male patient. On an unknown date, the patient received an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (rHA) (M-M-R II) (lot # 4029789, expiration date not reported, Lot # 4029789 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II))  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2305USA002471:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: she ended up testing positive for HPV, but was unsure about the HPV type she was positive for.; was given GARDASIL as the first dose. She was given GARDASIL as the first dose.; This spontaneous report was received from a physician and refers to a 28-year-old female patient. No information on patient's medical history, current conditions, and concomitant medications. On unknown date patient had colposcopy and the result was not provided.   On an unknown date the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (exact dose, route of administration, lot # and expiration date were not provided).  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (exact dose, route of administration, lot # and expiration date were not provided) (interchange of vaccine products).      On an unknown date the patient experienced human papilloma virus test positive. The outcome of papilloma viral infection was unknown. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No aditional adverse event reported; Inbound call from pharmacist who reports expired GARDASIL 9 was administered to a patient. Product was administered today 31MAY2023 and expired 23MAY2023. Product was stored according to labeling through the date of administration.; This spontaneous report has been received form a pharmacist, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-MAY-2023, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: U007665, which was determined to be valid as syringe, with an expiration date on 23-MAY-2023) (strength, dose, scheme, route and anatomical location of administration were not reported).  No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose; Initial Report Received on 07-DEC-2022 and 08-Dec-2022  This is a spontaneous report, received from a Pharmaceutical Procurement Buyer and a Pharmacy Procurement Technician regarding a female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot #935843, expiration date 08-OCT-2022, NDC # 43528-002-01), was administered   for hepatitis B immunisation.  The dose was reported as being expired when administered.  The reporter indicated that the patient had not reported any other adverse effects.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Was to Receive a Hep-B Booster (not HEPLISAV-B but the GSK Brand); Initial Report Received on 03-Nov-2022 and 04-Nov-2022 (Safety received 14-Mar-2023)   The colleague of a patient reported to the Pregnancy Registry that a patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while more than 30 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site was not provided. The patient was more than 30 weeks pregnant and was to receive a hepatitis B vaccine booster (GSK), not HEPLISAV-B.   The Pregnancy Registry attempted to follow-up with the reporter on 18 Nov 2022 whether the patient was interested in enrolling in the Registry and left a message. Permission for Dynavax to follow-up with the patient was not obtained.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 23-Sep-2022 and 07-Oct-2022 (Safety received 14 Mar 2023)   A nurse reported to the pregnancy registry that a patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site were not provided.   The nurse provided the Registry contact number to the participant and the potential participant seemed interested in enrolling, but the patient was not actually a patient in her department. The Pregnancy Registry made several attempts to the reporter on 20 Oct and 09 Nov 2022 to follow-up on the potential participant, but was told the reporter was not there.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose; Initial Report Received on 08-DEC-2022  This is a spontaneous report, received from a Pharmacy Technician regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot #935843, expiration date 08-OCT-2022, NDC # 43528-002-01), was administered intramuscularly, route and site not specified  for hepatitis B immunisation.  The dose was reported as being expired when administered.  The reporter indicated that the patient had not reported any other adverse effects.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: COVID-19
Clinical narrative: Covid; Initial Report Received on 08-Mar-2023  A pharmacist reported that a male patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had COVID.   Medical history, allergies, and concomitant medications were not reported at the time of vaccination.  On an unknown date in November, the patient received the first dose of HEPLISAV-B vaccine (Lot #, expiration date, NDC #, route, and injection site were unknown) and had COVID since. The patient wanted to receive his second dose of HEPLISAV-B now.    No further information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Received Two Doses of Heplisav-B, No Titers Shown; Initial Report Received on 20-Apr-2023  An advanced nurse practitioner reported that a patient (gender, age, race, and ethnicity unknown), received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had an undetectable titer.   Medical history, allergies, and concomitant medications at the time of vaccination were reported as unknown.  On 09-Feb-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941579; expiration date, NDC #, and route of administration unknown) in the right deltoid.  On 09-Mar-2023, 1 month after receiving the first dose, the patient received the second dose of HEPLISAV-B vaccine (Lot # 941582; expiration date, NDC #, and route of administration unknown) in the left deltoid.   On 19-Apr-2023, 70 days after the first dose of HEPLISAV-B and 42 days after the second dose of HEPLISAV-B, the patient had a titer drawn and the level was "not detected." The patient had no side effects.   No additional information was provided.  Company Comment:  The company assessed the event as non-serious. The event was not immunologically confirmed as the serological test was not provided.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed as the serological test was not provided.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HEPLISAV-B 4 Weeks Ago, Received a Dose of Engerix Today; Initial Report Received on 28-Apr-2023  A pharmacist reported that a patient (gender, age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 4 weeks prior to receiving a dose of "Energix".   Medical history, allergies, and concomitant medications at the time of vaccination were reported as unknown.   On 31-Mar-2023, the patient received a dose of HEPLISAV-B vaccine (Lot #, expiration date, and NDC # unknown) intramuscularly in the left deltoid. No side effects were reported.  On 28-Apr-2023, the patient received a dose of "Energix" (no details reported).   No additional information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Rigors; Fever; Myalgia; Headache; Fatigue; This non-serious case was reported by a physician and described the occurrence of rigors in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised and adrenal cortex insufficiency.   On 25-MAY-2023, the patient received Shingrix. On 26-MAY-2023, 1 days after receiving Shingrix, the patient experienced rigors (Verbatim: Rigors), fever (Verbatim: Fever), myalgia (Verbatim: Myalgia), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). The patient was treated with prednisone. On 27-MAY-2023, the outcome of the rigors, fever, myalgia, headache and fatigue were resolved (duration 1 day).   The reporter considered the rigors, fever, myalgia, headache and fatigue to be related to Shingrix.     The company considered the rigors, fever, myalgia, headache and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter stated this was a subsequent dose. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: Flu like symptoms; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid-19 Vaccine with an associated reaction of malaise (also had experienced unwell).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR074925   Additional Information: GSK receipt date: 24-May-2023 The patient usually had some type of side effects with vaccines like Shingrix, 2 doses, both times I had flu like symptoms for a day or two; Covid the same thing I felt kind of tired and yucky and stuff like that. The reporter was a nurse anesthetist in hospital so was on the first round of getting Covid shots; every time, I have had malaise and did not feel good for a day or so that is how react to most vaccines.   Upon further discussion, the reporter called and stated that the physician recommended Prevnar 20 since I just turned years old.  The physician was recommended that get but reported that had issues with other vaccinations in the past including Shingrix and the Pfizer Covid-19 Vaccine. The reporter reported that had malaise and did not feel good for a day or so after receiving the Pfizer Covid-19 Vaccine.  There was planning to get it today, expecting same side effects as I have had with other vaccinations so ok to take Motrin. The reporter has always heard the debate whether or not I should take Motrin or to just allow the immune response to occur to have vaccine more effective.  After response, stated was a nurse anesthetist agreed to be transferred, but disconnected before successful transfer. Upon further clarification of which Covid vaccination, stated that, it was Pfizer's Covid 19 vaccine.  No additional information and response discussed per PI noting no specific information about impact of Motrin on efficacy of vaccination (reviewed section 7.2 Immunosuppressive Therapies).  Shared most commonly reported adverse reactions and referred to healthcare for further discussion on management recommendations as Pfizer is unable to make recommendations as may vary by individual patient.; Sender's Comments:  US-GSK-US2023AMR074925:Same patient/diffrent vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Vaccine positive rechallenge
Clinical narrative: flu like symptoms for a day or two; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose was received on unknown date refer case - US2023AMR074879) and Pfizer Covid-19 Vaccine with an associated reaction of malaise (also had experienced unwell).  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms for a day or two). Rechallenge with Shingrix was positive. The outcome of the influenza-like symptoms was resolved.  It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.  Linked case(s) involving the same patient: US2023AMR074879  Additional Information: GSK receipt date: 24-MAY-2023 The patient usually had some type of side effects with vaccines like Shingrix, 2 doses, both times he/she had flu like symptoms for a day or two, Covid the same thing that, he/she felt kind of tired and yucky and stuff like that.  The physician was recommended that get, but reported that had issues with other vaccinations in the past including Shingrix and the Pfizer Covid-19 Vaccine. The reporter reported that he/she had malaise and does not felt good for a day or so after receiving the Pfizer Covid-19 Vaccine. The reporter was a nurse anesthetist in hospital so was on the first round of getting Covid shots; every time, he/she have had malaise and did not feel good for a day or so, that was how react to most vaccines. Upon further discussion, the reporter called and stated that the physician had recommended Prevnar 20 since he/she just turned years old. There was plan to get it today(on the day of reporting), expecting same side effects as he/she have had with other vaccinations so ok to take Motrin. The reporter have always heard the debate whether or not he/she should take Motrin or to just allow the immune response to occur to have vaccine more effective. After response, stated that, the anesthetist nurse was an agreed to be transferred, but disconnected before successful transfer. Upon further clarification of which Covid vaccination, stated that, it was Pfizer's Covid 19 vaccine. No additional information and response discussed per Product Information (PI) noting no specific information about impact of Motrin on efficacy of vaccination (reviewed section 7.2 Immunosuppressive Therapies). Shared most commonly reported adverse reactions and referred to healthcare for further discussion on management recommendations as Pfizer was unable to make recommendations as may vary by individual patient. The reporter had denied consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR074879:Same patient 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to come back for the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to come back for the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient forgot to come back for the second dose of Shingrix but returned to the same pharmacy on 16th February 2023.  The patient was informed that he/she had to start over.  When he/she returned at the time of reporting for the second shot they informed him/her the insurance would not cover it because they only cover 2 shots of Shingrix. If he/she got it they would charge him/her.  After speaking to his/her insurance company, they informed him/her the disease control did not recommend getting another shot, so they would not cover it.  Additionally, she said that she could talk to his/her physician and had him administer it in his office so it would not go through his/her prescription coverage.  This was conflicting information. So reporter asked if he/she should get another shot of Shingrix or not. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: RV1
Symptoms: Circumstance or information capable of leading to medication error, Incorrect route of product administration, Product packaging confusion, Wrong technique in product usage process
Clinical narrative: Confusion; Circumstance or information capable of leading to medication error.; administer Rotarix by injection; to administer Rotarix by injection; This non-serious case was reported by a physician via call center representative and described the occurrence of product packaging confusion in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (oral). On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced product packaging confusion (Verbatim: Confusion), circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error.), inappropriate route of vaccination (Verbatim: administer Rotarix by injection) and wrong technique in product usage process (Verbatim: to administer Rotarix by injection). The outcome of the product packaging confusion, circumstance or information capable of leading to medication error, inappropriate route of vaccination and wrong technique in product usage process were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-MAY-2023  Reporter was the healthcare professional(HCP).Reporter stated that her nursing staff mentioned confusion over the presentation of the Rotarix vaccination compared to other GlaxoSmithKline products.  Reporter stated product was a syringe with gray luer-lock cap and they have three other GSK vaccines that come in syringes that look similar.  Reporter was concerned about nursing staff possibly placing a needle on syringe and attempt to administer Rotarix by injection.  Reporter mentioned potential medication errors due to this event. No Product quality complaint filed. Adverse Event filled.  The reporter consented to follow up. The nurses reported confusion in packaging which may led to administration of Rotarix through injection which led to product packaging confusion, circumstance or information capable of leading to medication error, inappropriate route of vaccination  and wrong technique in product usage process.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Administered PEDIARIX instead of INFANRIX; Pediarix was a 4th dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number n7hl3, expiry date 15-APR-2024) for prophylaxis.   Previously administered products included Pediarix (First dose received in 9 weeks of age.), Pediarix (Second dose received at the age of 18 th week) and Pediarix (Third dose received in 7 months of age.).   On 19-MAY-2023, the patient received the 4th dose of Pediarix. On 19-MAY-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Administered PEDIARIX instead of INFANRIX) and extra dose administered (Verbatim: Pediarix was a 4th dose.). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter reported that the patient received Pediarix instead of Infanrix accidently. The reporter did consent to follow up. The reporter reported that the patient accidently received Pediarix vaccine instead of Infanrix, which lead to wrong vaccine administered. The patient received 4th dose of pediarix which led to extra dose administered.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: he had Shingle in the middle of May/ Suspected vaccination failure; he had Shingle in the middle of May, 2023; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-DEC-2022, the patient received Shingrix (injection, unknown arm). In MAY-2023, 5 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: he had Shingle in the middle of May/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he had Shingle in the middle of May, 2023). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 26-MAY-2023 The patient self-reported this case. The patient had Shingle in the middle of May 2023. The customer did not want to give his physicians information. The reporter consent to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix expired first dose administered; Maladministration of Havrix adult dose to a child; Maladministration of Havrix adult dose to a child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix adult) (batch number 7595K, expiry date 30-DEC-2021) for prophylaxis.   On 08-OCT-2020, the patient received the 1st dose of Havrix adult. On 08-OCT-2020, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: Havrix expired first dose administered), overdose (Verbatim: Maladministration of Havrix adult dose to a child) and adult product administered to child (Verbatim: Maladministration of Havrix adult dose to a child). The outcome of the expired vaccine used, overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 26-MAY-2023 Medical Assistant has a 6 year-old patient who was previously vaccinated, with a Havrix adult dose and she has never received Havrix second dose. The reporter declined to follow up. The patient received an expired dose of Havrix, which led to expired vaccine used. The pediatric patient received an adult dose of Havrix (first dose), which led to overdose and adult product administered to child.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose on 25May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 2HC4L, expiry date 09-JUL-2024) for prophylaxis.   Previously administered products included Shingrix (On 9th August 2019, received first dose.).   On 25-MAY-2023, the patient received the 2nd dose of Shingrix. On 25-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose on 25May2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter reported that the patient received late second dose of Shingrix vaccine. Vaccine administration facility was the same as primary reporter  The reporter did consent to follow up via email. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 1st dose of Shingrix on 30 Jun 2019 and a late 2nd dose on 25 May 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 2HC4L, expiry date 09-JUL-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30-JUN-2019).   On 25-MAY-2023, the patient received the 2nd dose of Shingrix. On 25-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received the 1st dose of Shingrix on 30 Jun 2019 and a late 2nd dose on 25 May 2023.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email or postal. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Blindness, Cow pox, Monkeypox, Product administered to patient of inappropriate age
Clinical narrative: She got bells palsy; Monkeypox; Cowpox; Light blindness; She was 180 pounds but went down to 90 pounds; Inappropriate age; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: She got bells palsy) (serious criteria GSK medically significant), monkeypox (Verbatim: Monkeypox) (serious criteria GSK medically significant), cowpox (Verbatim: Cowpox) (serious criteria GSK medically significant), blindness (Verbatim: Light blindness) (serious criteria GSK medically significant), weight loss (Verbatim: She was 180 pounds but went down to 90 pounds) and inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the bell's palsy, monkeypox, cowpox and blindness were resolved and the outcome of the weight loss and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bell's palsy, monkeypox, cowpox, blindness and weight loss to be related to Shingrix.     It was unknown if the company considered the bell's palsy, monkeypox, cowpox, blindness and weight loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 This case reported by the patient for himself. The reporter reported that she received Shingrix and had monkeypox on her toes and cowpox on her legs. She also stated that she got bells palsy and light blindness after the vaccine but had now resolved. The reporter reported that she was currently pregnant with fraternal twins. The reporter stated that she lost 90 pounds she was 180 pounds but went down to 90 pounds. The reporter did not consent to follow up. The reporter was a poor historian and during the conversation she talked about conspiracy theories of kidnappings, killings and cannibalism.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Twin pregnancy, Weight decreased
Clinical narrative: She got bells palsy; Monkeypox; Cowpox; Light blindness; She was 180 pounds but went down to 90 pounds; Inappropriate age; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: She got bells palsy) (serious criteria GSK medically significant), monkeypox (Verbatim: Monkeypox) (serious criteria GSK medically significant), cowpox (Verbatim: Cowpox) (serious criteria GSK medically significant), blindness (Verbatim: Light blindness) (serious criteria GSK medically significant), weight loss (Verbatim: She was 180 pounds but went down to 90 pounds) and inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the bell's palsy, monkeypox, cowpox and blindness were resolved and the outcome of the weight loss and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bell's palsy, monkeypox, cowpox, blindness and weight loss to be related to Shingrix.     It was unknown if the company considered the bell's palsy, monkeypox, cowpox, blindness and weight loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 This case reported by the patient for himself. The reporter reported that she received Shingrix and had monkeypox on her toes and cowpox on her legs. She also stated that she got bells palsy and light blindness after the vaccine but had now resolved. The reporter reported that she was currently pregnant with fraternal twins. The reporter stated that she lost 90 pounds she was 180 pounds but went down to 90 pounds. The reporter did not consent to follow up. The reporter was a poor historian and during the conversation she talked about conspiracy theories of kidnappings, killings and cannibalism.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: administered by error a Havrix pediatric formulation to a 24 year-old female; administered by error a Havrix pediatric formulation to a 24 year-old female; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis.   On 24-MAY-2023, the patient received the 2nd dose of Havrix pediatric. On 24-MAY-2023, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: administered by error a Havrix pediatric formulation to a 24 year-old female) and adult use of a child product (Verbatim: administered by error a Havrix pediatric formulation to a 24 year-old female). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter consented to follow up via email. The adult patient received Havrix pediatric by error, which led to accidental underdose and adult use of a child product.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 30-MAY-2023, the patient received Kinrix. On 30-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-MAY-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal. The reporter stated that an expired dose of Kinrix was administered to a patient, which led to expired vaccine used.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: boostrix dose that was exposed to temperature higher than 77.9°F; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number DH3A2, expiry date 29-SEP-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: boostrix dose that was exposed to temperature higher than 77.9°F). 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 Information: GSK receipt date: 31-May-2023 The reporter consented to follow-up. The patient received a dose of Boostrix that was exposed to temperature higher than 77.9 degree Fahrenheit, which led to incorrect storage of drug.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix -B was administered to patient after being exposed to 73 F to possibly over 216 hrs on 5/19/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 23-year-old female patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 19-MAY-2023, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix -B was administered to patient after being exposed to 73 F to possibly over 216 hrs on 5/19/2023). 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 Information: GSK Receipt Date: 31-MAY-2023 No reactions were reported.  The reporter consented to follow up via email. The reporter reported that the Engerix -B was administered to patient after being exposed to 73 degree F to possibly over 216 hours, which led to incorrect storage of drug.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Menveo was given to a 65 year old patient; Menveo was given instead of Menquadfi in a 65 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA934A, expiry date 06-JUN-2024) for prophylaxis.   On 31-MAY-2023, the patient received the 1st dose of Menveo. On 31-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo was given to a 65 year old patient) and wrong vaccine administered (Verbatim: Menveo was given instead of Menquadfi in a 65 year old patient). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 A pharmacist called and reported that Menveo was given instead of Menquadfi in a patient and wished to know how to proceed.  The information about the event, vaccine and patient were given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. A 65 year old patient received a dose of Menveo instead of Menquadfi, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose back on 1st February 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 1-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY; This spontaneous report received from a patient via a company representative via concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported. expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-MAY-2023, the patient was diagnosed with bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230603307-bell's palsy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Prostatic disorder
Clinical narrative: Prostatic disorder; Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC DISORDER (Prostatic disorder) and BLOOD URINE PRESENT (Blood in urine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No known allergies and relevant medical history were reported.  Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PROSTATIC DISORDER (Prostatic disorder) and BLOOD URINE PRESENT (Blood in urine). At the time of the report, PROSTATIC DISORDER (Prostatic disorder) had not resolved and BLOOD URINE PRESENT (Blood in urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On an unknown date, the patient had experienced prostate problem, bleeding blood in pee. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: Knee replacement; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (Knee replacement) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Pfizer Primary monovalent dose), PFIZER BIONTECH COVID-19 VACCINE (3rd Pfizer dose) and PFIZER BIONTECH COVID-19 VACCINE (2nd Pfizer Primary monovalent dose). Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced KNEE ARTHROPLASTY (Knee replacement). At the time of the report, KNEE ARTHROPLASTY (Knee replacement) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2023-726953 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling face, Tenderness
Clinical narrative: right cheek swollen from her nose to the end of the jaw bone; it was tender to the touch; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (right cheek swollen from her nose to the end of the jaw bone) and TENDERNESS (it was tender to the touch) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement in August 2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 4) on 24-May-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 5) on 14-Nov-2022, PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 3) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 25-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 28-May-2023, the patient experienced SWELLING FACE (right cheek swollen from her nose to the end of the jaw bone) and TENDERNESS (it was tender to the touch). At the time of the report, SWELLING FACE (right cheek swollen from her nose to the end of the jaw bone) and TENDERNESS (it was tender to the touch) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to MOD-2023-726955 (Patient Link).