chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: UNK, UNK
Symptoms: COVID-19
Clinical narrative: COVID; Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID) and SINUS DISORDER (Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: J and J (Lot 042A21A) on 06-Apr-2021, Pfizer (Lot 051F21A) on 11-Nov-2021 and Pfizer (Lot 0H9702) on 10-Oct-2022. Past adverse reactions to the above products included No adverse event with J and J, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy.    On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Oct-2023, the patient experienced COVID-19 (COVID) and SINUS DISORDER (Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired). At the time of the report, COVID-19 (COVID) and SINUS DISORDER (Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided. The patient went to travel and came down with covid. The patient was very careful and even wore masks. The patient had a runny nose for a couple of days, all sinus symptoms, and feels tired the patient also explained that it feels like the vaccine was doing it's job because the patient was not as sick. All symptoms began on 22Oct2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-747283, US-MODERNATX, INC.-MOD-2023-747379, US-MODERNATX, INC.-MOD-2023-747381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747283:Same reporter (Patient 4) US-MODERNATX, INC.-MOD-2023-747381:Same Reporter (Patient 3) US-MODERNATX, INC.-MOD-2023-747379:Same Reporter (Patient 2)
Age: 53.0
Sex: F
Vaccine: UNK, UNK
Symptoms: COVID-19, Fatigue, Rhinorrhoea, Sinus disorder
Clinical narrative: COVID; Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID) and SINUS DISORDER (Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: J and J (Lot 042A21A) on 06-Apr-2021, Pfizer (Lot 051F21A) on 11-Nov-2021 and Pfizer (Lot 0H9702) on 10-Oct-2022. Past adverse reactions to the above products included No adverse event with J and J, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy.    On 22-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Oct-2023, the patient experienced COVID-19 (COVID) and SINUS DISORDER (Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired). At the time of the report, COVID-19 (COVID) and SINUS DISORDER (Patient reports her symptoms such as having a runny nose for a couple of days, all sinus symptoms, and feels tired) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided. The patient went to travel and came down with covid. The patient was very careful and even wore masks. The patient had a runny nose for a couple of days, all sinus symptoms, and feels tired the patient also explained that it feels like the vaccine was doing it's job because the patient was not as sick. All symptoms began on 22Oct2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-747283, US-MODERNATX, INC.-MOD-2023-747379, US-MODERNATX, INC.-MOD-2023-747381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747283:Same reporter (Patient 4) US-MODERNATX, INC.-MOD-2023-747381:Same Reporter (Patient 3) US-MODERNATX, INC.-MOD-2023-747379:Same Reporter (Patient 2)
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: Email received to the  inbox on 22SEP2023 at with a healthcare professional (HCP) AE report from the Merck Manuals Info mailbox. Verbatim: "We had a patient receive the Varicella vaccine post-partum. Instead of it being mixed wit; Wrong product administered; This spontaneous report was received from a Pharmacist and referred to a female patient of age. The patient's concurrent conditions, medical history, Concomitant therapies and historical drugs were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); Instead of it being mixed with the diluent it was mixed with sterile diluent it was mixed with epoetin alfa epbx (RETACRIT) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided) (Wrong product administered, Product preparation issue).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; MMRII was administered after temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #W021191, expiration date: 29-MAR-2024) was stored at 8.9 degree Celsius for 12 hours 20 minutes 0 seconds.   On 16-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #W021191, expiration date: 29-MAR-2024 (strength, route of administration, and indication were not provided) (PT: Product storage error). On 28-AUG-2023, the storage temperature was at 9.4 degree Celsius for 8 hours 20 minutes 0 seconds. No additional adverse event and Product Quality Complaints (PQC) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ  was administered after temperature excursion. No additional AE/no PQC.; ROTATEQ  was administered after temperature excursion. No additional AE/no PQC.; This spontaneous report was received from a Medical Assistant referring to a patient of unspecified age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-SEP-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1968393, expiration date: 24-MAY-2024, administered for prophylaxis (strength not provided).  The administered dose of the vaccine experienced a temperature excursion of 8.9 degrees Celsius for 12 hours and 20 minutes, on 14-AUG-2023, and 9.4 degrees Celsius for 8 hours and 20 minutes, on 28-AUG-2023. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Consumer did not report any side effects; Consumer reported receiving the MMR II and VARIVAX vaccine while pregnant.; This spontaneous report was received from a consumer and refers to herself an 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unknown by reporter, lot #Unknown by reporter, administered for immunisation (strength, expiry date, and route of administration were not provided) while she was pregnant (Exposure during pregnancy). She received the vaccines outside the recommended principal investigator (PI). She did not report any side effects from receiving the vaccines (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Injury associated with device, Skin laceration, Syringe issue, Wound haemorrhage
Clinical narrative: the tip of the GARDASIL 9 PFS broke; her finger was bleeding; The nurse cut her finger; the nurse pulled the GARDASIL 9 PFS out of the tray, the nurse realized that her finger was bleeding; This spontaneous report was received from a Merck FBE and refers to a 20-22-year-old female patient (nurse). No medical history, concurrent conditions nor concomitant medications were reported.  On 13-OCT-2023, the nurse grabbed a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 mL, 1 dosage form, lot #X019862 was valid for formulation pre-filled syringe, expiration date 14-FEB-2025) and the circular part of the tip of the GARDASIL 9 PFS broke (Syringe issue).   The nurse pulled the GARDASIL 9 PFS out of the tray, the nurse realized that her finger was bleeding (Wound haemorrhage). She cut her finger, but was okay (Skin laceration, Injury associated with device). The outcome of the events was unknown.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE/no side effects; Nurse called and reported that an expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The patient did not experienced side effects.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported VARIVAX which had a temperature excursion on 06/01/2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 09/11/2023 after the three-month time period.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age an gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported.  On 11-SEP-2023, the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W031812, expiration date: 05-OCT-2024, (strength, dose, dose#, route of administration and anatomical site of vaccination were not provided) for prophylaxis (product storage error). On 01-JUN-2023, the suspect vaccine was stored at temperature from 47 to 77 Fahrenheit (F) degrees for 2 minutes.  No previous temperature excursions were reported. No additional adverse event (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administration of MMR-II that was after expiration; This spontaneous report was received from pharmacist referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023,  mumps and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml was  administered once, with a lot # U011995 and expiration date of 15-APR-2023, (strength, and route of administration were not provided) for prophylaxis. Albumin status was recombinant human albumin (rHA).   The pharmacist reported that mumps and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had been administered to the patient after expiration (Expired product administered). The pharmacist confirmed that no symptomatic adverse events were reported (No adverse event), and that the product did not have any temperature excursions.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; HCP calling to report AE for expired dose of MMRII that was administered to a patient on 23OCT2023.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, lot #U033041, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The vaccine did not have any previous temperature excursions. No side effects reported.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: asymptomatic/No additional AE; inadvertently administered a dose of PROQUAD and a dose of VARIVAX at the same time; This spontaneous report was received from medical assistant and refers to a 4-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 24-OCT-2023, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) (lot #W039841, expiration date: 12-JUN-2024) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W032507, expiration date: 11-OCT-2024), (both vaccine: strength, and route of administration were not provided) at the same time for prophylaxis (accidental overdose). The patient was asymptomatic at the time of reported. No additional adverse event (AE).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP has no further AE information.; HCP called to report that an expired dose of MMR II, was inadvertently given to a patient. HCP reports no side effects or symptoms. HCP reports that there have been no prior TE's. HCP gives permission to contact herself and gave permission to contac; This spontaneous report as received from a medical assistant and refers to a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 25-OCT-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # W034714 with the valid expiration date of 18-OCT-2023 (dose and route of administration were not reported) for prophylaxis (expired product administered). No side effects or symptoms were reported (no adverse event). There have been no prior temperature excursions (TE's). No further adverse event (AE) information was noted. No product quality complaint (PQC) was noted.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HBP states no symptoms reported from the parents and no additional details provided. No other AE and no PQC; HBP calling to report the administration of an expired dose of MMR II for a one year old patient.  HBP states no symptoms reported from the parents and no additional details provided.  No other AE and no PQC; This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reations, or allergies were not reported.  On 26-OCT-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number W034714, expiration date reported and validated as 18-OCT-2023) as prophylaxis (expired product administered). No symptoms reported from the parents and no additional details provided. No other adverse event (AE).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX has since been administered to one patient. Excursion occurred overnight on 24OCT2023; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, historical drugs, and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 24-OCT-2023, overnight, a varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W021741 was verified to be valid, expiration date reported and confirmed as 10-JUL-2024), suffered a temperature excursion of 14 degree Fahrenheit (F) to 46 F (17.8F), during a time frame of 11 hours 18 minutes 0 seconds; it did not had previous temperature excursions. On 25-OCT-2023, after the reporter was provided stability information for the product (as reported), the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W021741, expiration date 10-JUL-2024) (exact dose, route of administration, and anatomical location were not provided) (Product storage error).   No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HBP called to report inadvertent administration of expired MMR-II; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical conditions, and concomitant therapies were not reported.  On 18-OCT-2017, the patient was inadvertently vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 17-OCT-2017, administered as prophylaxis (exact dose, lot number, route of administration, and anatomical location were not provided) (Expired product administered).  No additional adverse event (AE) was reported.
Sex: M
Vaccine: HEP
Symptoms: Refusal of vaccination, Viral titre
Clinical narrative: negative titers; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, one dose (valid lot number W036194, expiration date 29-SEP-2025), administered intramuscularly for prevention of hepatitis B virus (anatomical location and vaccination scheme was not provided).  On 26-OCT-2023, the patient declined their dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), he was scheduled to receive a second booster dose of the vaccine after he had "negative titers" (hepatitis B surface antibody negative). The outcome of the event hepatitis B surface antibody negative was not provided.  The causal relationship between the event hepatitis B surface antibody negative and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Sex: U
Vaccine: HEP, UNK
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: patient initiated a series with a Hepatitis B vaccine and then received 3 doses of VAXELIS which is also counts as Hepatitis B immunization; No additional AE reported; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not reported.  On an unknown date (reported as "0 months"), the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (manufacturer unknown) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). Then, on unspecified dates (reported as 2, 4 and 6 months), the patient was vaccinated with 3 doses of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported), which was also counted as hepatitis B immunization (interchange of vaccine products). There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: HPV9
Symptoms: Abdominal pain
Clinical narrative: R10.9 Unspecified abdominal pain; This spontaneous report was received from physician via medical records and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUN-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot #, expiry date, route of administration, and anatomical location were not provided).  On 10-DEC-2018, the patient experienced unspecified abdominal pain (R10.9). On 28-DEC-2018, the patient was vaccinated with an additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot #, expiry date, route of administration, and anatomical location were not provided).   At the time of reporting, the outcome of the event unspecified abdominal pain was not reported.   The causal relationship between the event of unspecified abdominal pain and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No AE/PQC reported; adult dose of VAQTA was accidentally administered to 18-month-old patient; This spontaneous report was received from a nurse referring to an 18-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-APR-2023, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered once daily for prophylaxis (lot number: W023489, which was verified to be valid with expiration date: 27-DEC-2023; strength, anatomical site injection, and route of administration were not provided) (incorrect dose administered).  It was reported that the patient did not experienced an adverse event (AE).
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Gait disturbance, Magnetic resonance imaging neck, Magnetic resonance imaging spinal abnormal, Myelitis transverse
Clinical narrative: urinary retention; transverse myelitis; difficulty walking; weakness; Traumatic LP; This serious case was reported by a consumer and described the occurrence of urinary retention in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 6 days after receiving Arexvy, the patient experienced urinary retention (Verbatim: urinary retention) (serious criteria GSK medically significant), myelitis transverse (Verbatim: transverse myelitis) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), weakness (Verbatim: weakness) and traumatic lumbar puncture (Verbatim: Traumatic LP). The outcome of the urinary retention, walking difficulty, weakness and traumatic lumbar puncture were not reported and the outcome of the myelitis transverse was resolving.   It was unknown if the reporter considered the urinary retention, myelitis transverse, walking difficulty, weakness and traumatic lumbar puncture to be related to Arexvy.     It was unknown if the company considered the urinary retention, myelitis transverse, walking difficulty, weakness and traumatic lumbar puncture to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced difficulty walking, weakness, urinary retention, traumatic LP, C-spine MRI with enhancement across spinal cord consistent with transverse myelitis; underwent plasma exchange with improvement. No confounding apparent but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149213, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149213:Same reporter
Sex: M
Vaccine: RSV
Symptoms: Plasmapheresis, Traumatic lumbar puncture, Urinary retention
Clinical narrative: urinary retention; transverse myelitis; difficulty walking; weakness; Traumatic LP; This serious case was reported by a consumer and described the occurrence of urinary retention in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 6 days after receiving Arexvy, the patient experienced urinary retention (Verbatim: urinary retention) (serious criteria GSK medically significant), myelitis transverse (Verbatim: transverse myelitis) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), weakness (Verbatim: weakness) and traumatic lumbar puncture (Verbatim: Traumatic LP). The outcome of the urinary retention, walking difficulty, weakness and traumatic lumbar puncture were not reported and the outcome of the myelitis transverse was resolving.   It was unknown if the reporter considered the urinary retention, myelitis transverse, walking difficulty, weakness and traumatic lumbar puncture to be related to Arexvy.     It was unknown if the company considered the urinary retention, myelitis transverse, walking difficulty, weakness and traumatic lumbar puncture to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced difficulty walking, weakness, urinary retention, traumatic LP, C-spine MRI with enhancement across spinal cord consistent with transverse myelitis; underwent plasma exchange with improvement. No confounding apparent but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149213, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149213:Same reporter
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Gout
Clinical narrative: Gout flare; This non-serious case was reported by a consumer and described the occurrence of gout flare in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A4945) for prophylaxis.   Concomitant products included losartan potassium.   On 19-OCT-2023, the patient received Arexvy 1 ml. On 21-OCT-2023, 2 days after receiving Arexvy, the patient experienced gout flare (Verbatim: Gout flare). The outcome of the gout flare was not resolved.   It was unknown if the reporter considered the gout flare to be related to Arexvy.     It was unknown if the company considered the gout flare to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-OCT-2023 It was reported that patient suffered from gout flare after receiving Arexvy vaccination. The reporter consented to follow up via mail.
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: developed a rash at the injection site; black dot at the site; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of injection site rash in a female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site rash (Verbatim: developed a rash at the injection site) and injection site discoloration (Verbatim: black dot at the site). The outcome of the injection site rash was resolved and the outcome of the injection site discoloration was not resolved.   It was unknown if the reporter considered the injection site rash and injection site discoloration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site rash and injection site discoloration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-OCT-2023 The reporter stated patient administered the Men B vaccine and developed rash at the injection site. The patient went to urgent care as it was getting bigger on the skin. The reporter stated it was now healed. The patient still had a black dot at the site. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received only the liquid portion of Menveo 2 vial; patient received only the liquid portion of Menveo 2 vial; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA9, expiry date 31-OCT-2024) for prophylaxis.   On 23-OCT-2023, the patient received Menveo. On 23-OCT-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid portion of Menveo 2 vial) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid portion of Menveo 2 vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-Oct-2023 The reporter consented to follow-up. The patient received only the liquid portion of Menveo  2 vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: underdose/"3-4 days" ago a female patient received a dose of Arexvy that leaked out the needle during administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: underdose/"3-4 days" ago a female patient received a dose of Arexvy that leaked out the needle during administration). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 23-Oct-2023 A pharmacist was at home during the report and did not had patient information or exact vaccination details during time of report.  The reporter consented to follow-up via email. About 3 to 4 days ago a patient received a dose of Arexvy that leaked out the needle during administration, which led to incomplete dose administered.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received two doses of Menveo one week apart - got one on 16Oct2023, and another on 23Oct2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA985A, expiry date 21-OCT-2024) for prophylaxis.   Concomitant products included MENVEO.   On 23-OCT-2023, the patient received the 2nd dose of Menveo. On 23-OCT-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too short (Verbatim: a patient received two doses of Menveo one week apart - got one on 16Oct2023, and another on 23Oct2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 23-Oct-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up, pharmacy mailing address in HCP details. The patient received 2nd dose of Menveo earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Limb discomfort, Pruritus
Clinical narrative: red arm from injection site to elbow; hot left arm from injection site to elbow; discomfort left arm; itchy left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced itchy upper limbs (Verbatim: itchy left arm). On 18-OCT-2023, the patient experienced erythema of extremities (Verbatim: red arm from injection site to elbow), extremities hot feeling of (Verbatim: hot left arm from injection site to elbow) and limb discomfort (Verbatim: discomfort left arm). The outcome of the erythema of extremities and extremities hot feeling of were resolved and the outcome of the itchy upper limbs and limb discomfort were not resolved.   It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, itchy upper limbs and limb discomfort to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, extremities hot feeling of, itchy upper limbs and limb discomfort to be related to Shingrix.   Additional Information: GSK receipt date: 23-Oct-2023 The caller stated that she received a dose of Shingrix and less than a day after vaccination, experienced red, hot arm from injection site to elbow. In October 2023, the patient also had itchy left arm and discomfort left arm.  She later stated her family member who was a registered pharmacist told her the vaccine was given intramuscular.  Referred to health care professional.  MI phone number was provided. Did not consent to follow-up.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant patient was administered Arexvy on 10/18/2023; pregnant patient was administered Arexvy on 10/18/2023; 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 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy. On 18-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: pregnant patient was administered Arexvy on 10/18/2023). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was administered Arexvy on 10/18/2023). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 23-Oct-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter was unsure of patient's gestational week.  The reporter consented to safety team for follow up. A pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dyskinesia, Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: she experienced shingles after dose two of Shingrix; Shingles; blister on the leg; her legs jumping like they were in pain; her legs jumping like they were in pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included paraplegia (T10 Paraplegic).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: she experienced shingles after dose two of Shingrix) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), blister (Verbatim: blister on the leg), leg pain (Verbatim: her legs jumping like they were in pain) and leg discomfort (Verbatim: her legs jumping like they were in pain). The outcome of the vaccination failure and shingles were unknown and the outcome of the blister, leg pain and leg discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister, leg pain and leg discomfort to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, blister, leg pain and leg discomfort to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter reported that she experienced shingles after dose two of Shingrix.  The reporter did not leave lot number, expiration date or date of birth. The reporter described shingles as a blister on the leg and her legs jumping like they were in pain.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received a dose of Shingrix that had expired on 26/Aug/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number Z42G4, expiry date 26-AUG-2023) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Shingrix. On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: received a dose of Shingrix that had expired on 26/Aug/2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-Oct-2023 The reporter consented to follow-up. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Patient had fever and fatigue.   This case was linked to MOD-2023-747310, MOD-2023-747350 (Patient Link).
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in a 5-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747371 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2023: Upon internal review on 31-OCT-2023, significant correction was performed to update Country of incidence for the event, remove patient details & dose number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747371:Same Reporter (Patient 1)
Sex: U
Vaccine: UNK
Symptoms: Hypersomnia, Pain
Clinical narrative: aching from head to toe; overslept; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching from head to toe) and HYPERSOMNIA (overslept) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID vaccine.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aching from head to toe) and HYPERSOMNIA (overslept). At the time of the report, PAIN (aching from head to toe) and HYPERSOMNIA (overslept) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   No concomitant medications were provided.  It was reported that after vaccine was aching from head to toe, overslept and felt out of it for a couple days.   No treatment information was provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia and non serious event of pain. The events occurred after a dose of SPIKEVAX 2023-2024. As reported, after receiving vaccine patient was aching from head to toe, overslept and felt "out of it" for a couple days. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: his friend's mother got the injection and shortly after had A-Fib; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (his friend's mother got the injection and shortly after had A-Fib) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (his friend's mother got the injection and shortly after had A-Fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (his friend's mother got the injection and shortly after had A-Fib) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. Company Comment: This is a spontaneous case concerning an elderly female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of atrial fibrillation, which occurred on an unknown date after a dose mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. It was reported that patient got the injection and shortly after had A-Fib. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747570 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2023: Nonsignificant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747570:Master case