chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Foreign body in skin or subcutaneous tissue, Occupational exposure to product, Syringe issue
Clinical narrative: No additional adverse event was reported; the needle and it instead came off the syringe and caused a needle stick in the staff members left hand.; CALLER CONFIRMED JUST THE NEEDLE CAME OFF, NO PART OF THE SYRINGE CAME OFF/ needle pooped off; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; device connection issue; Poor quality device used; This spontaneous report was received from registered nurse and refers to a 30-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-JAN-2025, the patient was vaccinated with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, unk, lot #1973259, expiration date: 03-MAR-2026 (strength, route of administration, and indication were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #X026222, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that the needle popped off a diluent syringe after it was used to administered a vaccine. The problem occurred when the staff member tried to engage the safety on the needle and it instead came off the syringe and caused a needle stick in the staff member left hand (Injury associated with device, needle issue, device connection issue and poor quality device used). The product was administered to the patients body fluids (Occupational exposure to product and accidental exposure to product). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report T/E. HCP stated PROQUAD (s) are not back in range. PROQUAD was administered during a temperature excursion on 1/23/2025.   No additional AE reported. NO PQC reported.   Was the product administered?  YES, PROQUAD  Y013583 2/03/2; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-JAN-2025, the patient was vaccinated with the first, improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y013583 has been verified to be a valid lot number, expiration date was not provided, but upon internal validation was established as 03-FEB-2026 (exact dose, route of administration and anatomical location were nor provided) for prophylaxis.        On 23-JAN-2025, administered dose of vaccine was exposed to the temperature excursion (product storage error). No more information available. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered during a temperature excursion on 1/23/2025.; This spontaneous report was received from a medical assistant, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection experienced a temperature excursion (TE), for unknown time at unknown temperature. No previous TE reported.   On 23-JAN-2025, the patient was vaccinated with the first dose of the vaccine involved in the TE measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, and route of administration were not provided;  lot #Y013583 has been verified to be valid for this vaccine, expiration date reported and confirmed as 03-FEB-2026). (Product use issue). No additional adverse event was reported (No adverse event).
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Fatigue, Herpes zoster, Vaccination failure
Clinical narrative: after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure; outbreaks on my lower back; extra dose administered; This serious case was reported by a other health professional and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included hip replacement (The patient underwent hip replacement surgery 5 years ago.). Concomitant products included valaciclovir (Valacyclovir).   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: outbreaks on my lower back) and extra dose administered (Verbatim: extra dose administered). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JAN-2025 The drug dosage for Shingles was reported as 30mg. It was reported that after the patient had a hip replacement 5 years ago and after 3 vaccines, the patient still got outbreaks on her lower back (exhaustion), which led to extra dose administered. The outcome for exhaustion was reported as resolved with sequelae. The symptoms were treated. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1, 2 & 3).
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: General malaise; This non-serious case was reported by a consumer via sales rep and described the occurrence of general malaise in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JAN-2025, the patient received the 1st dose of Shingrix (left arm). On 12-JAN-2025, 1 days after receiving Shingrix, the patient experienced general malaise (Verbatim: General malaise). On 13-JAN-2025, the outcome of the general malaise was resolved (duration 1 day).   The reporter considered the general malaise to be related to Shingrix.     The company considered the general malaise to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JAN-2025 The reporter reported that the patient received receive first dose of Shingrix. The patient had general malaise.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-JAN-2025 The reporter reported that the patient received the 2 shots of Shingrix vaccine and experienced the Shingles. Shingles did not eliminate in fact they moved to other side of body. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2025AMR010378   Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. Patient got two of the shots and they both made him/her sick. For tolerance of the 2nd dose, refer linked case US2025AMR010378, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR010378:same patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Paralysis, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Ramsey Hunt Syndrome; paralysis; post herpetic nerve damage; shingles right side of face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: Ramsey Hunt Syndrome) (serious criteria GSK medically significant), paralysis (Verbatim: paralysis) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: post herpetic nerve damage) and facial herpes zoster (Verbatim: shingles right side of face). The outcome of the vaccination failure, ramsay-hunt syndrome and facial herpes zoster were not reported and the outcome of the paralysis and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, paralysis, post herpetic neuralgia and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, ramsay-hunt syndrome and paralysis to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles shot and booster as soon as turned 50, still developed shingles on the right side of face which developed to Ramsey Hunt Syndrome. Still suffered from post herpetic nerve damage and paralysis. The reporter would still recommend the shots though because who know if it would have been worst. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster oticus  and Paralysis  are unlisted events which are considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspceted vaccination failure; had the vaccine and still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine and still got them). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles and asked do he/she need another. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles about every two months on torso; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles about every two months on torso). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The patient have had the vaccine and still get shingles about every two months on torso but well, the patient's were painful just an annoyance. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal pain upper
Clinical narrative: Right upper quadrant pain; This non-serious case was reported by a physician via call center representative and described the occurrence of upper abdominal pain in a adult male patient who received HAB (Twinrix) (batch number 4KF75) for prophylaxis.   On 02-JUL-2024, the patient received the 1st dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced upper abdominal pain (Verbatim: Right upper quadrant pain). The outcome of the upper abdominal pain was resolved.   It was unknown if the reporter considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the upper abdominal pain to be related to Twinrix and Twinrix 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: Follow-up information received on 31-DEC-2024. The reporter contacted Medical Information call Center and provided additional information on case AE-117102 about side effects after Twinrix vaccination. The patient experienced right upper quadrant pain after Twinrix and it ran away. Follow up by Safety Team was accepted to his personal email. Summary of changes: Patient tab, product tab, event tab and narrative was updated.; Sender's Comments:  US-GSK-US2024AMR166318:For dose 2nd
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: absolute fatigue, it started after I got the RSV shot; I couldn't even walk my dogs; Couldn't get out of bed for a week; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a female 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 fatigue (Verbatim: absolute fatigue, it started after I got the RSV shot), activities of daily living impaired (Verbatim: I couldn't even walk my dogs) and bedridden (Verbatim: Couldn't get out of bed for a week). The outcome of the fatigue, activities of daily living impaired and bedridden were not resolved.   It was unknown if the reporter considered the fatigue, activities of daily living impaired and bedridden to be related to Arexvy.     It was unknown if the company considered the fatigue, activities of daily living impaired and bedridden to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-JAN-2025 Consumer reported that her problem was a absolute fatigue, it started after she got the RSV shot, at the and she couldn't get out of bed for a week, except to just you know go to bathroom, and essentials like that.  She couldn't even walk her dogs, and then it has just continued on. Here it was a year and half latter, and she talk to the doctor, she went to rheumatologist, she talk to the pharmacist and it just doesn't let up. She was wondering is there is anything you know and asked for help.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water; Inappropriate dose of vaccine administered; 1mL was administered to the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis.   On 02-JAN-2025, the patient received Menveo. On 02-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and overdose (Verbatim: 1mL was administered to the patient). The outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and overdose were unknown.   It was unknown if the reporter considered the overdose to be related to Menveo.     It was unknown if the company considered the overdose to be related to Menveo.   Additional Information: GSK Receipt Date: 03-JAN-2025 The Healthcare Professional reported that Menveo 1 vial was reconstituted with sterile water from the MMR vaccine and 1ml was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister rupture, Rash, Rash vesicular
Clinical narrative: The patient states "it is maybe a mild shingles; an acne like break out; they popped when I showered; is creeping to the upper part of the back; bumpy blistery rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included The patient was red haired person.   On 08-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 13-DEC-2024, 5 days after receiving Shingrix, the patient experienced rash (Verbatim: is creeping to the upper part of the back) and blistery rash (Verbatim: bumpy blistery rash). On an unknown date, the patient experienced shingles (Verbatim: The patient states "it is maybe a mild shingles), acne (Verbatim: an acne like break out) and blister (Verbatim: they popped when I showered). The patient was treated with hydrocortisone (Cortaid). The outcome of the shingles was unknown and the outcome of the rash was not resolved and the outcome of the blistery rash and blister were resolved and the outcome of the acne was not reported.   It was unknown if the reporter considered the shingles, rash, blistery rash, acne and blister to be related to Shingrix.     It was unknown if the company considered the shingles, rash, blistery rash, acne and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JAN-2025 The reporter reported that the patient received Shingrix and had a rash as a bumpy blistery rash on patient back, with very small blisters.  The reporter describes it as an acne like break out.  The reporter reported about the blisters as they popped when patient showered.  The blisters went away but not the rash.  The reporter states the rash was creeping to the upper part of the back. It was maybe a mild shingles.  The rash first appeared on the right section of the back, and it has moved to the upper left part of the back, near the neck and the shoulder.  It has moved from right to left.  The patient will see a dermatologist next week but states that the nurse recommended to take an oral antihistamine and to apply Cortaid topical cream.  The patient has used this for a week and states it has helped.  The reporter wanted to share the fact that she was a red-haired person.  The reporter states red-haired people react differently to medications, and it was a real thing, it was crazy.  The reporter stated we can overreact to medications, and with anesthesia they give less or more depending on the patient, and the patient always overreact to medications.
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Respiratory disorder
Clinical narrative: respiratory issues; the patient had received two total doses of Arexvy; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of respiratory disorder in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date) and Arexvy (received 1st dose of  Arexvy vaccine in 2023).   On an unknown date, the patient received the 2nd dose of Shingrix and the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced respiratory disorder (Verbatim: respiratory issues) and extra dose administered (Verbatim: the patient had received two total doses of Arexvy). The outcome of the respiratory disorder and extra dose administered were unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Shingrix and Arexvy.     It was unknown if the company considered the respiratory disorder to be related to Shingrix and Arexvy.   Additional Information: GSK Receipt Date: 15-JAN-2025 Pharmacist reported that the patient was vaccinated with Shingrix at the same time as receiving her second dose of Arexvy which led to extra dose administered.  After vaccination the patient had respiratory issues and was transported to the emergency department by personnel was made aware of the the vaccinations administered to the patient, however, was not informed the patient had received two total doses of Arexvy. No further information was known such as medical history of patient, demographics of patient, dates of administration for both doses of Arexvy and the dose of Shingrix, or the patient was admitted into the hospital or released from the emergency department.  This case was linked with case US2025005052, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2025005052:Same reporter/Different Patient
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Erythema, Headache
Clinical narrative: lose all muscle control in arms, legs; loose of control bladder; lots of sleeping most of the day; dizzy; fever; chills; nausea; terrific headache; loss of appetite; redness and lump on my arm are flaming; redness and lump on my arm are flaming; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming) and DECREASED APPETITE (loss of appetite) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included Levothyroxine sodium, Rosuvastatin calcium (Rosuvastatin) and Ezetimibe for an unknown indication.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 23-Nov-2024, the patient experienced LIMB MASS (redness and lump on my arm are flaming) and ERYTHEMA (redness and lump on my arm are flaming). On an unknown date, the patient experienced MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache). At the time of the report, MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming), DECREASED APPETITE (loss of appetite), ERYTHEMA (redness and lump on my arm are flaming), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache) had not resolved.      Patient had received Moderna Covid vaccines and their booster doses every year since their availability.  Patient had reactions to vaccine which caused patient to be bedridden for a few days. Patient had reactions which included losing all muscle control in arms, legs, and bladder; lots of sleeping most of the day; fever, chills, nausea, dizzy, terrific headache, and loss of appetite. It was like a nightmare for the patient. Since 23-Nov-2024, the patient had redness and lump on the arm.  It was reported that patient researched online for side affects, but could not find anything close to what patient continued to experience. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow up received with no new information. On 17-Dec-2024: Live non-significant follow up received with no new information.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersomnia, Limb mass, Muscular weakness, Nausea, Pyrexia
Clinical narrative: lose all muscle control in arms, legs; loose of control bladder; lots of sleeping most of the day; dizzy; fever; chills; nausea; terrific headache; loss of appetite; redness and lump on my arm are flaming; redness and lump on my arm are flaming; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming) and DECREASED APPETITE (loss of appetite) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included Levothyroxine sodium, Rosuvastatin calcium (Rosuvastatin) and Ezetimibe for an unknown indication.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 23-Nov-2024, the patient experienced LIMB MASS (redness and lump on my arm are flaming) and ERYTHEMA (redness and lump on my arm are flaming). On an unknown date, the patient experienced MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache). At the time of the report, MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming), DECREASED APPETITE (loss of appetite), ERYTHEMA (redness and lump on my arm are flaming), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache) had not resolved.      Patient had received Moderna Covid vaccines and their booster doses every year since their availability.  Patient had reactions to vaccine which caused patient to be bedridden for a few days. Patient had reactions which included losing all muscle control in arms, legs, and bladder; lots of sleeping most of the day; fever, chills, nausea, dizzy, terrific headache, and loss of appetite. It was like a nightmare for the patient. Since 23-Nov-2024, the patient had redness and lump on the arm.  It was reported that patient researched online for side affects, but could not find anything close to what patient continued to experience. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow up received with no new information. On 17-Dec-2024: Live non-significant follow up received with no new information.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: lose all muscle control in arms, legs; loose of control bladder; lots of sleeping most of the day; dizzy; fever; chills; nausea; terrific headache; loss of appetite; redness and lump on my arm are flaming; redness and lump on my arm are flaming; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming) and DECREASED APPETITE (loss of appetite) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included Levothyroxine sodium, Rosuvastatin calcium (Rosuvastatin) and Ezetimibe for an unknown indication.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 23-Nov-2024, the patient experienced LIMB MASS (redness and lump on my arm are flaming) and ERYTHEMA (redness and lump on my arm are flaming). On an unknown date, the patient experienced MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache). At the time of the report, MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming), DECREASED APPETITE (loss of appetite), ERYTHEMA (redness and lump on my arm are flaming), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache) had not resolved.      Patient had received Moderna Covid vaccines and their booster doses every year since their availability.  Patient had reactions to vaccine which caused patient to be bedridden for a few days. Patient had reactions which included losing all muscle control in arms, legs, and bladder; lots of sleeping most of the day; fever, chills, nausea, dizzy, terrific headache, and loss of appetite. It was like a nightmare for the patient. Since 23-Nov-2024, the patient had redness and lump on the arm.  It was reported that patient researched online for side affects, but could not find anything close to what patient continued to experience. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow up received with no new information. On 17-Dec-2024: Live non-significant follow up received with no new information.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Culture, Gastritis viral, Heart rate, Heart rate decreased
Clinical narrative: low blood pressure and pulse; low blood pressure and pulse; viral gastritis//vomiting; Calf pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE DECREASED (low blood pressure and pulse), HYPOTENSION (low blood pressure and pulse) and GASTRITIS VIRAL (viral gastritis//vomiting) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: High dose flu vaccine (High dose) on 27-Dec-2024. Past adverse reactions to the above products included No adverse effect with High dose flu vaccine.    On 15-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In January 2025, the patient experienced GASTRITIS VIRAL (viral gastritis//vomiting) (seriousness criterion hospitalization). On 16-Jan-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (Calf pain). On 18-Jan-2025, the patient experienced HEART RATE DECREASED (low blood pressure and pulse) (seriousness criterion hospitalization) and HYPOTENSION (low blood pressure and pulse) (seriousness criterion hospitalization). The patient was hospitalized on 18-Jan-2025 due to GASTRITIS VIRAL, HEART RATE DECREASED and HYPOTENSION. On 19-Jan-2025, HEART RATE DECREASED (low blood pressure and pulse) and HYPOTENSION (low blood pressure and pulse) was resolving. On 20-Jan-2025, PAIN IN EXTREMITY (Calf pain) had resolved. At the time of the report, GASTRITIS VIRAL (viral gastritis//vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Culture: Negative. On an unknown date, Heart rate: Low. On an unknown date, Laboratory test: normal.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 18-Jan-2025, patient started vomiting and admitted to the hospital due to low blood pressure and pulse. Blood clots were ruled out. Vomiting stopped. Patient would be released from hospital on 21-Jan-2025. The final diagnosis was viral gastritis.   No treatment medications were reported.; Reporter's Comments: Company comment: Causality of event gastritis viral was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Laboratory test, Pain in extremity
Clinical narrative: low blood pressure and pulse; low blood pressure and pulse; viral gastritis//vomiting; Calf pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE DECREASED (low blood pressure and pulse), HYPOTENSION (low blood pressure and pulse) and GASTRITIS VIRAL (viral gastritis//vomiting) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: High dose flu vaccine (High dose) on 27-Dec-2024. Past adverse reactions to the above products included No adverse effect with High dose flu vaccine.    On 15-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In January 2025, the patient experienced GASTRITIS VIRAL (viral gastritis//vomiting) (seriousness criterion hospitalization). On 16-Jan-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (Calf pain). On 18-Jan-2025, the patient experienced HEART RATE DECREASED (low blood pressure and pulse) (seriousness criterion hospitalization) and HYPOTENSION (low blood pressure and pulse) (seriousness criterion hospitalization). The patient was hospitalized on 18-Jan-2025 due to GASTRITIS VIRAL, HEART RATE DECREASED and HYPOTENSION. On 19-Jan-2025, HEART RATE DECREASED (low blood pressure and pulse) and HYPOTENSION (low blood pressure and pulse) was resolving. On 20-Jan-2025, PAIN IN EXTREMITY (Calf pain) had resolved. At the time of the report, GASTRITIS VIRAL (viral gastritis//vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Culture: Negative. On an unknown date, Heart rate: Low. On an unknown date, Laboratory test: normal.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 18-Jan-2025, patient started vomiting and admitted to the hospital due to low blood pressure and pulse. Blood clots were ruled out. Vomiting stopped. Patient would be released from hospital on 21-Jan-2025. The final diagnosis was viral gastritis.   No treatment medications were reported.; Reporter's Comments: Company comment: Causality of event gastritis viral was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient contracted COVID in April of 22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient contracted COVID in April of 22) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D71F21A, 028A21A and D121A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Patient contracted COVID in April of 22). At the time of the report, COVID-19 (Patient contracted COVID in April of 22) had resolved.            No concomitant medication was reported.  On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Patient received 5h dose of Spikevax vaccine on OCT-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: the device broke and the solution fell everywhere/solution fell all over the ground; This is a spontaneous report received from a Pharmacist from product quality group, Program ID:.  A patient should have received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the device broke and the solution fell everywhere/solution fell all over the ground". NDC Number: 0069034401. UPC Number: 300690344010. The reporter considered "the device broke and the solution fell everywhere/solution fell all over the ground" not related to rsv vaccine prot.subunit pref 2v. Causality for "the device broke and the solution fell everywhere/solution fell all over the ground" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: I had the covid shot the vaccination shot and i got really sick from the shot.; Caller had the covid virus and they gave her Paxlovid to take; Caller had the covid virus and they gave her Paxlovid to take; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "My kidneys are a little bit low" (unspecified if ongoing); "I also has a heart problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2025, outcome "unknown" and all described as "Caller had the covid virus and they gave her Paxlovid to take"; ILLNESS (non-serious), outcome "unknown", described as "I had the covid shot the vaccination shot and i got really sick from the shot". It was reported that the patient had the covid shot the vaccination shot and she got really sick from the shot. Caller had the covid virus. Patient had fever. They gave her Paxlovid to take. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2025) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Balance disorder, Bone pain, Condition aggravated, Eye disorder
Clinical narrative: affected balance, eyes, hands; affected balance, eyes, hands; affected balance, eyes, hands; every bone in body hurts; triggered an attack on lupus; triggered an attack on lupus; This is a spontaneous report received from a Consumer or other non HCP.  A 91-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Nov2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Lupus", start date: 2023 (ongoing), notes: under the care of a dermatologist, doing fine; "Covid-19", start date: 2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (medically significant, disability) with onset 2024, outcome "not recovered", SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant, disability), outcome "not recovered" and all described as "triggered an attack on lupus"; BALANCE DISORDER (disability), EYE DISORDER (disability), LIMB DISCOMFORT (disability), outcome "not recovered" and all described as "affected balance, eyes, hands"; BONE PAIN (disability), outcome "not recovered", described as "every bone in body hurts". Clinical course: The patient got lupus 2 years ago (2023) when got covid (2023), but she has been under the care of a dermatologist. The patient was doing fine and the day after thanksgiving she got RSV vaccination shot, and patient has been sick ever since. The RSV shot triggered an attack on lupus, the shot also affected her balance, eyes, hands and every bone in body hurts. Patient stated that Pfizer was going to say the age, 91, had a lot to do with it but that's not true. Now patient was suffering from these debilitating side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.