chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: inadvertently grabbed PROQUAD, instead of MMR II; inadvertently grabbed PROQUAD, instead of MMR II, and concomitantly administered PROQUAD and; No additional AEs reported; This spontaneous report was received from a medical assistant refers to a 16-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included sterile diluent.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection lot # X007356, expiration date: 08-SEP-2024, 0.5 milliliter (once) (route of administration and anatomical location were not reported); and varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # X018954, expiration date: 13-JUL-2025, 0.5 milliliter (once) (route of administration and anatomical location were not reported) for prophylaxis. Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (drug not administered).  It was reported that the patient was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) at a well checkup, but another medical assistant inadvertently grabbed measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and concomitantly administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (wrong product administered, accidental overdose). No additional adverse event reported (no adverse event).
Age: 0.5
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered; This spontaneous report was received from a nurse and refers to a 6-month-old patient.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 03-JAN-2024, the patient was vaccinated with improperly stored doses of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947621, expiration date: 02-MAY-2024 (strength, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X020316, expiration date: 18-OCT-2025 (strength, and route of administration were not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, 1 dose, lot #U7536AA, expiration date: 30-SEP-2025, all administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event.  The vaccines were stored in a temperature of 59.45F for 18 hours 30 minutes. There were previous temperature excursion of 53.29F for 1 Hour 45 Minutes and 49.73F for 1 Hour.
Age: 0.5
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered to a patient; This spontaneous report was received from a nurse, referring to a 6-month-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 12-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 1 dosage form, administered orally for prophylaxis (lot #1947621 which has been confirmed as a valid lot, expiry date was provided and upon internal validation was verified as: 02-MAY-2024); with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, at a dose of 1 dosage form, administered for prophylaxis (lot #X020316 which has been confirmed as a valid lot, expiry date was provided and upon internal validation was verified as: 18-OCT-2025), and with with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (also reported as VAXELIS) injection, 1 dose , administered for prophylaxis (lot #U7536AA  which has been confirmed as a valid lot, expiry date was provided and upon internal validation was verified as: 30-SEP-2025; and for all suspect vaccines vaccination scheme, anatomical location of vaccination, strength, and route of administration were not provided (except for ROTATEQ)); those vaccines were involved in a temperature excursion (Product storage error). It was stated that no patient symptoms had been reported and no additional adverse event (No adverse event). Temperature was at 59.45 degree Fahrenheit (F) for 18 hours 30 minutes; and a previous temperature excursion at 53.29 F for 1 hour and 45 minutes and 49.73 F for 1 hour.
Age: 0.17
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered to a patient since the excursion. Caller stated no patient symptoms have been reported. Caller also provided p; This spontaneous report was received from nurse and refers to a 2-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947621, expiration date: 02-MAY-2024, administered orally for prophylaxis (strength was not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X020316, expiration date: 18-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, 1 dose, lot #U7536AA, expiration date: 30-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE SYRINGE (DEVICE)) injection,  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided). Those vaccines underwent temperature excursion in 59.45 Farenheit for 18 hours 30 minutes (Product storage error). The previous excursions occured in 53.29 Farenheit for 1 hours 45 minutes and in 49.73 Farenheit for 1 hour. No additional adverse events were reported.
Age: 0.33
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no patient symptoms have been reported; Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered to a patient since the excursion. Caller stated no patient symptoms have been reported; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 06-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947621, expiration date: 02-MAY-2024, administered by oral route for prophylaxis (strength, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #X020316, expiration date: 18-OCT-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, 1 dose, lot #U7536AA, expiration date: 30-SEP-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided). The administered vaccines were involved in a temperature excursion: temperature 59.45 F, time frame: 18 Hours 30 Minutes, previous temperature excursion: 53.29 F for 1 Hour 45 Minutes and 49.73 F for 1 Hour 0 Minutes (Product storage error). No symptoms were reported. No additional adverse events (AE).
Age: 1.08
Sex: U
Vaccine: HEPA, PNC15, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC reported; Nurse called and reported VAQTA, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered to a patient since the excursion. Caller stated no patient symptoms have been reported. Caller also provided pat; This spontaneous report was received from a nurse and refers to a 13-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 28-DEC-2023 the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # X010373 and expiration date 13-NOV-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided). On 28-DEC-2023 the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # X020316 and expiration date 18-OCT-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). On 28-DEC-2023 the patient was vaccinated with improperly stored diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(V419) lot # U7536AA and expiration date 30-SEP-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 18 hours 30 minutes in temperature of 59.45 Fahrenheit degrees (F). Previous excursion lasted for 1 hour 45 minutes and 1 hour in following temperatures 53. 29 F and 49.73 F (product storage error and no adverse event).
Sex: U
Vaccine: RSV
Symptoms: Autoimmune disorder
Clinical narrative: Autoimmune disease; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced autoimmune disorder (Verbatim: Autoimmune disease) (serious criteria GSK medically significant). The patient was treated with rituximab (Rituxan). The outcome of the autoimmune disorder was not reported.   It was unknown if the reporter considered the autoimmune disorder to be related to Arexvy.     It was unknown if the company considered the autoimmune disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-JAN-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she had the shot but have autoimmune disease and though it was effective because he/she took Retuxin. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Herpes zoster, Vaccination failure
Clinical narrative: developed shingles/suspected vaccination failure; developed shingles; suffers from anxiety; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: developed shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: developed shingles) and anxiety (Verbatim: suffers from anxiety). The outcome of the vaccination failure was unknown and the outcome of the shingles and anxiety were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and anxiety to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and anxiety to be related to Shingrix.   Additional Information: GSK Receipt date: 10-JAN-2024 An Hcp reported a patient who had received shingles vaccine developed shingles and patient suffered from anxiety. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not agree to follow up from GSK.
Sex: F
Vaccine: DTAP, FLUX, VARCEL
Symptoms: Cardiac arrest, Death, Hepatic failure, Renal failure, Respiratory arrest
Clinical narrative: death; liver failure; Kidney failure; stopped breathing; cardiac arrest; This serious case was reported by a physician via other manufacturer and described the occurrence of unknown cause of death in a 15-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included Varicella (Varicella vaccine) for prophylaxis and Influenza vaccine (Flu) for prophylaxis.   On 17-OCT-2023, the patient received DTaP vaccine, Varicella vaccine and Flu. On 19-OCT-2023, 2 days after receiving DTaP vaccine and Varicella vaccine, the patient experienced breathing arrested (Verbatim: stopped breathing) (serious criteria hospitalization and GSK medically significant) and cardiac arrest (Verbatim: cardiac arrest) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced unknown cause of death (Verbatim: death) (serious criteria death, hospitalization and GSK medically significant), liver failure (Verbatim: liver failure) (serious criteria hospitalization and GSK medically significant) and renal failure (Verbatim: Kidney failure) (serious criteria hospitalization and GSK medically significant). The outcome of the breathing arrested, cardiac arrest, liver failure and renal failure were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death, breathing arrested, cardiac arrest, liver failure and renal failure to be related to DTaP vaccine and Varicella vaccine.     The company considered the unknown cause of death, breathing arrested, cardiac arrest, liver failure and renal failure to be unrelated to DTaP vaccine and Varicella vaccine.   Additional Information: GSK Receipt Date: 10-JAN-2024 The patient received three vaccines (Varicella, DTap, Flu). Two days later, the patient stopped breathing and went into cardiac arrest. The patient died in the hospital. The patient also had liver and kidney failure. It was unknown if reporter considered unknown cause of death, breathing arrested, cardiac arrest, liver failure and renal failure to be related to Flu vaccine. The follow up would not possible as no contact details were available. The case had been linked to US2024AMR005300, reported by the same reporter , for a different patient.; Sender's Comments:  US-GSK-US2024AMR005300:same reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: terrible joint pain; muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: terrible joint pain) and muscle pain (Verbatim: muscle pain). The outcome of the joint pain and muscle pain were not resolved.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Arexvy.  It was unknown if the company considered the joint pain and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-JAN-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient reported that after 10 days he/she still had terrible joint and muscle pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Scab
Clinical narrative: diagnosed as Shingles by her physician; Crusted area on her left upper back; she looked at the spot in the shower because it felt weird; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number E9kh7) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus, multiple sclerosis, pain and crawling sensation (patient often gets pain and a bug crawling sensation of her back as a result of her chronic illnesses). Concomitant products included ocrelizumab (Ocrevus).   On 13-DEC-2023, the patient received the 1st dose of Shingrix (left deltoid). In DEC-2023, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: diagnosed as Shingles by her physician), crust (Verbatim: Crusted area on her left upper back) and weird feeling (Verbatim: she looked at the spot in the shower because it felt weird). The outcome of the shingles was not resolved and the outcome of the crust and weird feeling were not reported.   The reporter considered the shingles and crust to be unrelated to Shingrix. It was unknown if the reporter considered the weird feeling to be related to Shingrix.     The company considered the shingles and crust to be unrelated to Shingrix. It was unknown if the company considered the weird feeling to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JAN-2024 and 04-JAN-2024 The patient self reported this case. The reporter mentioned, two weeks after getting her first dose of Shingrix she noticed a crusted area on her left upper back. The patient states she looked at the spot in the shower because it felt weird. The reporter stated that she currently had two auto-immune diseases consisting of lupus and multiple sclerosis. Reporter gets Ocrevus fusion for multiple sclerosis treatment and was scheduled for her next dose of Ocrevus on 24-Jan-2024. The crusted area, left upper back, was formally diagnosed as shingles by her physician. The reporters shingles had not resolved as of present time (till the time of reporting). The reporter attributes getting shingles to her poor immune response and not the vaccine. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Needle issue, Underdose
Clinical narrative: while administering a dose of Arexvy to a patient, he noticed some vaccine leaking out of the side of the needle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2X7NA, expiry date 23-MAR-2025) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: while administering a dose of Arexvy to a patient, he noticed some vaccine leaking out of the side of the needle). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2024 The pharmacist reported that while administering a dose of Arexvy to a patient, he noticed some vaccine leaking out of the side of the needle, which led to an incomplete dose administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: An early 3rd dose received on 17th May 2010; A late 2nd dose received on 19th Feburary 2010; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix) (batch number AHABB167AA, expiry date 04-SEP-2011) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 17-MAY-2010, the patient received the 3rd dose of Twinrix. On 19-FEB-2010, the patient received the 2nd dose of Twinrix. On 19-FEB-2010, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: A late 2nd dose received on 19th Feburary 2010). On 17-MAY-2010, the patient experienced drug dose administration interval too short (Verbatim: An early 3rd dose received on 17th May 2010). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 05-JAN-2024 The nurse reported that a patient received 1st dose of Twinrix on 19-Nov-2009, then received a late 2nd dose and an early 3rd dose of Twinrix. The reporter consented to follow up via email. The patient received 3rd dose of Twinrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. (Drug dose administration interval too short) minus 4 days. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule (Drug dose administration interval too long) plus 7 days.
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: a pregnant patient was inadvertently administered an Arexvy vaccine; 39 year old patient received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G75S4, expiry date 05-JUL-2025) for prophylaxis.   On 02-JAN-2024, the patient received Arexvy (left deltoid). On 02-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old patient received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant patient was inadvertently administered an Arexvy vaccine). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 09-FEB-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 08-JAN-2024. The pharmacist called to inquire any information on studies on the Arexvy vaccine being administered to a pregnant patient. The registered pharmacist (RPH) confirmed a pregnant patient was inadvertently administered an Arexvy vaccine. RPH unable to provide last menstrual date of patient.  The patient received Arexvy below than the recommended age limit, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Immediate post-injection reaction, Urticaria
Clinical narrative: his wife had hives immediately after receiving her second; econd Shingrix vaccine in November 2023 and had Covid for the past week; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   In NOV-2023, the patient received the 2nd dose of Shingrix and the 2nd dose of COVID-19 VACCINE. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: his wife had hives immediately after receiving her second) and covid-19 (Verbatim: econd Shingrix vaccine in November 2023 and had Covid for the past week). The outcome of the hives and covid-19 were resolved.   It was unknown if the reporter considered the hives and covid-19 to be related to Shingrix.   It was unknown if the company considered the hives and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2024 The reporter was the husband of the patient and reported that she received her Shingrix vaccine and had Covid for the past week and just testing negative for Covid.  The reporter also reported that his wife had hives immediately after receiving her second Covid vaccine in November 2023.  No other information was known. The reporter did not consent to follow-up. It was unknown if reporter considered covid-19 and hives to be related to covid-19 vaccine. The case had been linked to US2024003277, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024003277:1 of 2
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; 2nd dose administered in May 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose was administered at 11 years old).   On 14-DEC-2023, the patient received the 3rd dose of Menveo. In MAY-2023, the patient received the 2nd dose of Menveo. In MAY-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 2nd dose administered in May 2023). On 14-DEC-2023, the patient experienced extra dose administered (Verbatim: 3rd dose administered). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 08-JAN-2024 The pharmacist called to inform that the patient received a 3rd dose of Menveo and 2nd dose in May 2023 (no exact dates were specified by the reporter). The patient received 2nd and 3rd dose of Menveo, which led to extra dose administered. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Priorix orally to  patients instead of Rotarix.; 2 months patient received Priorix; administration of Priorix orally to 2 patients instead of Rotarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received MMR (Priorix) (batch number 3427X, expiry date 11-MAY-2024) for prophylaxis.   On 05-JAN-2024, the patient received Priorix. On 05-JAN-2024, an unknown time after receiving Priorix, the patient experienced wrong vaccine administered (Verbatim: Priorix orally to  patients instead of Rotarix.), inappropriate age at vaccine administration (Verbatim: 2 months patient received Priorix) and subcutaneous injection formulation administered by other route (Verbatim: administration of Priorix orally to 2 patients instead of Rotarix). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route 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: 08-JAN-2024 Medical assistant reported that the administration of Priorix orally to patient instead of Rotarix, which led to wrong vaccine administered and subcutaneous injection formulation administered by another route. The reporter consented to follow-up. The reporter reported that the below recommended age patient received Priorix, which led to inappropriate age at vaccine administration. The case had been linked with the case US2024003303, reported by same reporter.
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: The patient has not yet received the 3rd dose; patient received the first dose of Twinrix in 2017, 2nd dose in Sept 2022; 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 35-year-old male patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received the first dose of Twinrix adult in 2017).   In SEP-2022, the patient received the 2nd dose of Twinrix adult. On an unknown date, the patient did not receive the 3rd dose of Twinrix adult. In SEP-2022, an unknown time after receiving Twinrix adult and not applicable after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Twinrix in 2017, 2nd dose in Sept 2022). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: The patient has not yet received the 3rd dose). 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 Information: GSK Receipt Date: 08-JAN-2024 The pharmacist stated that a patient received the 2nd dose of Twinrix adult and was there today (on the day of reporting) to get the 3rd dose. The reporter asked how to proceed. The patient received 2nd dose of Twinrix adult, delayed than the recommended time interval, which led to lengthening of the vaccination schedule. The patient had not yet (till the time of reporting) received the 3rd dose, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not received the 2nd Shingrix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st October 2021 with batch number 333T3 and expiry date 15th April 2023.).   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 incomplete course of vaccination (Verbatim: not received the 2nd Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:09-JAN-2024 The reporter was request data on administration of 2nd dose Shingrix vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional states that he has reviewed Centers for Disease Control(CDC) recommendations and it looks like the patient does not need to restart series. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; COVID TEST LINE IS VERY DARK AND APPEARED IMMEDIATELY, PAXLOVID REBOUND; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient by a other company (Pfizer Inc.) on 03-JAN-2024 was received on 03-JAN-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: overweight. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included lactoferrin, and melatonin. On 23-DEC-2023, vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced confirmed clinical vaccination failure, covid test line is very dark and appeared immediately, paxlovid rebound, and revaccination with different covid-19 vaccine (Dose number in series 1). Laboratory data included: COVID-19 virus test positive. The action taken with covid-19 vaccine ad26.cov2.s was not reported.  The patient received paxlovid for covid-19. On 23-OCT-2021, the patient received additional non-company suspect vaccine tozinameran (Dose number in series 2) (form of admin, route of admin, and batch number: FH8020) dose was not reported, for covid-19 prophylaxis.   On 09-SEP-2022, the patient received additional non-company suspect vaccine elasomeran (Dose number in series 2) (form of admin, route of admin, and batch number: A57144B) dose was not reported, for covid-19 prophylaxis.   On 11-JUL-2023, the patient received additional non-company suspect vaccine elasomeran (Dose number in series 2) (form of admin, route of admin, and batch number was not reported) dose was not reported, for covid-19 prophylaxis.   On 13-OCT-2023 to left arm, the patient received additional non-company suspect vaccine elasomeran (Dose number in series 2) (form of admin, route of admin, and batch number:3031894) dose was not reported, for covid-19 prophylaxis.  On 23-DEC-2023, following vaccination with tozinameran and elasomeran, the patient experienced confirmed clinical vaccination failure, covid test line is very dark and appeared immediately, paxlovid rebound, and revaccination with different covid-19 vaccine (Dose number in series 2). The action taken with elasomeran, and tozinameran was not reported.  The outcome of confirmed clinical vaccination failure, covid test line is very dark and appeared immediately, paxlovid rebound, and revaccination with different covid-19 vaccine was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Considering that the reported event Vaccination failure is a special situation and owing to its very nature, it is not possible to attribute this occurrence to the suspect vaccine, hence causality is assessed as not related.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: IT'S A SPECIAL KIND OF SKIN CONDITION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported The patient received vaccination with  covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported forcovid-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 an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced it's a special kind of skin condition.(Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it's a special kind of skin condition was not reported. This report was non-serious.  .
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 °F.         Concomitant medications were not reported. Subject ID was reported as  98147-38482 AutoCruitment Subject ID was reported as 5473537 No treatment information was provided.  The events occurred on 18-Dec-2023 and 19-Dec-2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 °F.         Concomitant medications were not reported. Subject ID was reported as  98147-38482 AutoCruitment Subject ID was reported as 5473537 No treatment information was provided.  The events occurred on 18-Dec-2023 and 19-Dec-2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.            Concomitant and treatment medications were not reported.  Reported that patient had mild injection site pain and no interference with activity, mild injection site tenderness (tender to touch), mild fatigue and no interference with activity, mild muscle pain and no interference with activity, joint pain and no interference with activity which occurred on Thursday, Dec 21, 2023, and Friday, Dec 22, 2023.  The Database Subject ID was reported as 5472224.  The Health Authority Subject ID was reported as 35683-71346.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 22 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia
Clinical narrative: Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: No fever (< 100.4 °F.         Patient had experienced myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.  The Subject ID was reported.  The Subject ID was reported.  Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE SWELLING (Mild injection site swelling) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE SWELLING (Mild injection site swelling). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE SWELLING (Mild injection site swelling) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had experienced the events anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, 21-Dec-2023 and Friday, 22-Dec-2023.  No treatment medications were reported.  The Subject ID was reported. The Subject ID was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:same reporter