chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: fever; chills; experience swelling in the injection site at her left arm/The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand; The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand. The swelling got so painful; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (experience swelling in the injection site at her left arm/The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand), VACCINATION SITE PAIN (The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand. The swelling got so painful), PYREXIA (fever) and CHILLS (chills) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 23-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-May-2023, the patient experienced VACCINATION SITE SWELLING (experience swelling in the injection site at her left arm/The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand) and VACCINATION SITE PAIN (The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand. The swelling got so painful). On 24-May-2023, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (experience swelling in the injection site at her left arm/The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand), VACCINATION SITE PAIN (The swelling at the injection site of my left deltoid muscle got as big as the size of my right hand and wider than my right hand. The swelling got so painful), PYREXIA (fever) and CHILLS (chills) was resolving.        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.   No concomitant medication details was reported. No treatment medication details was reported. It was reported that the swelling got so painful on May 25, 2023 that patient put Ice on it.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: when i gave pt the second dose she forgot to tell me that when she had the first shot she had hives at the back of her knee. It was very mild that she forgot to tell me thats why i gave her 2nd shot. She was ok. Once she applied hydrocortisone she was fine. She got hives again after the second shot and shw did the same treatment. She is fine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, Rash erythematous
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient called pharmacy 2 days after immunization. Reported body rash seen after showering, redness and bumps, but no pain or itching. Had pain at injection site.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE GENERALIZED TONIC CLONIC EPILEPSY TRANSIENT CEREBRAL ISCHEMIA
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chronic respiratory failure, Neuropathy peripheral, Respiratory failure
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY STABLE ANGINA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Sex: U
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Received this clarification yesterday from the CDC/FDA. It goes against their recent push to simplify vaccination schedules by adding back in another product and having 2 different doses/ This is absolutely unsafe and continues to drive up stress and potential for unintentional errors due to multiple products and complicated dosing schedules. Please lobby for this to be changed. Moderna Bivalent DARK BLUE CAP is now used for ALL AGES (6 months+) to start a primary series - For patients 6 months - 5 years old: Dose 1 and Dose 2 should be administered from the Moderna Bivalent product with a dark blue cap (Previously the 6 year+ product with a gray label stating "booster doses only") 0.25mL per dose - For patients 6 months - 5 years old: Dose 3 (if needed) should be administered from the Moderna Bivalent product with a dark pink cap - 0.2mL per dose (2 doses per vial)
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to multiple patients of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 03-MAR-2023, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024; lot # W007040, expiration date: 29-FEB-2024) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024; lot # W017552, expiration date: 01-JUN-2024) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.    This case is non-valid due to no patients' identifier or number of the patients.  Follow-up information has been received from the nurse referring to a 4-year-old patient of unknown gender on 19-MAY-2023. On 07-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis. No additional adverse event (AE) was reported.  This case was received from the same reporter with another 17 cases: 2305USA009079, 2305USA009080,2305USA009081,2305USA009082,2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the patient was given a dose of VAXNEUVANCE after the dose was stored improperly; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was not provided.  On 02-MAY-2023 the patient was vaccinated with 0.5 milliliter of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # W027275 and expiration date 09-JUL-2024 for prophylaxis (frequency and route of administration were not provided) (product storage error and no adverse event). The reporter stated that the temperature excursion occurred on 02-MAY-2023 lasted for 7 hours, and the temperature measured was 34 Fahrenheit degree.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; No adverse event on patient; This spontaneous report was received by customer refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with one dose of improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775827, expiration date: 27-JUN-2024, or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U032681, expiration date: 26-OCT-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1780876, expiration date:09-NOV-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775811, expiration date: 07-DEC-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# W009829, expiration date: 19-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.    Administered dose of vaccine was exposed to the temperature excursions. Total time 25 minutes (09-SEP-2022 for 8 minutes, 16-SEP-2022 for 5 minutes and 03-JAN-2023 for 12 minutes (product storage error). No additional adverse event (no adverse event).
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; GARDASIL 9 were administered to patient after temperature excursion; This spontaneous report was received by customer refers to a 13-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with one dose of improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775827, expiration date: 27-JUN-2024, or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U032681, expiration date: 26-OCT-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1780876, expiration date:09-NOV-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775811, expiration date: 07-DEC-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# W009829, expiration date: 19-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions. Total time 25 minutes (09-SEP-2022 for 8 minutes, 16-SEP-2022 for 5 minutes and 03-JAN-2023 for 12 minutes (product storage error). No additional adverse event (no adverse event).
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient not experiencing any signs/symptoms of adverse effects / No additional AE; PROQUAD administered to patient after undergoing a temperature excursion that wasn't supported; This spontaneous report was received from a registered nurse and refers to a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumn (rHa) (PROQUAD) injection,lot #X002296, expiration date was estimated as: 21-JUL-2024, administered for prophylaxis (strength and route of administration were not provided). This vaccine was administered to patient after undergoing a temperature excursion (Product storage error). No additional adverse event was reported.
Age: 3.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 3-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 23-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009082,2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 1.5
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to an 18-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 24-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 27-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 1.58
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 19-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 10-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 14-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 24-Mar-2023  This spontaneous report was received from a medical assistant regarding a 19-year-old female patient who received an expired dose of HEPLISAV-B.  The patient had no known drug allergies.  Other medical history was reported as unknown.  Concomitant medications were not specified.    On 24-Mar-2023, a dose of HEPLISAV-B (Lot # 937253, expiration date 11-Mar-2023, and NDC 43528000301), was administered intramuscularly in the right deltoid.  On 24-Mar-2023, the patient received a dose of HEPLISAV-B which was 13 days past the expiry date.   The reporter indicated that the patient has not complained of any side effects following the injection.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diplopia, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Supected Vaccination failure; Shingles outbreak in eye after shot; Had double vision in eye; This serious case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Hz/su + AS01B (intramuscular) and the 1st dose of Hz/su + AS01B (intramuscular). On an unknown date, an unknown time after receiving Hz/su + AS01B and Hz/su + AS01B, the patient experienced vaccination failure (Verbatim: Supected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles outbreak in eye after shot) (serious criteria GSK medically significant) and double vision (Verbatim: Had double vision in eye). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and double vision were resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster and double vision to be possibly related to Hz/su + AS01B and Hz/su + AS01B.   The company considered the vaccination failure, ophthalmic herpes zoster and double vision to be possibly related to Hz/su + AS01B and Hz/su + AS01B.   Additional Information: GSK Receipt Date: 24-MAY-2023 This case was reported by a consumer via market research programs. The patient got Shingles in 2019, could not remember specific dates and reported he had an outbreak of shingles that went into his eye causing double vision in 2019.  The event was recovered in 2019 after a couple of months. There was concern of loss of vision but that did not happen.  The patient was not able to recall if it was Shingrix, which apparently, he got as his second shot or zostavax so he reported in this case.  The reporter thought that the event might had been related to product/device. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pyrexia
Clinical narrative: low grade fever; couldn't lift my arm; I was completely flattened; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of low grade fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID vaccine with an associated reaction of pyrexia (on an unknown date received COVID vaccine).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced low grade fever (Verbatim: low grade fever), mobility decreased (Verbatim: couldn't lift my arm) and activities of daily living impaired (Verbatim: I was completely flattened). The outcome of the low grade fever, mobility decreased and activities of daily living impaired were resolved (duration 24 hrs).   The reporter considered the low grade fever, mobility decreased and activities of daily living impaired to be possibly related to Shingrix.     The company considered the low grade fever, mobility decreased and activities of daily living impaired to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023. This case was reported by a consumer via interactive digital media. The patient received Shingrix and felt completely flattened, low grade fever and could not lift arm for 24 hours.  The patient asked colleague have had shingles, patient would do anything to avoid it.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got their second dose of shingrix just under 4 years after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On unknown date patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient got their second dose of shingrix just under 4 years after the 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient got their second dose of Shingrix just under 4 years after the 1st dose.  The reporter asked were they done with their series. The patient received their first dose at a different pharmacy. Healthcare professional disconnected from the chat so there were no additional details available regarding the patients or events. It was unknown if follow up was permissible. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.  The case is linked with US2023075222, same reporter different patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: acute onset of diarrhea; Pain at injection site/ pain at injection site have improved; Headache; Low grade fever; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 22-MAY-2023, the patient received the 1st dose of Shingrix (left arm). On 23-MAY-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site/ pain at injection site have improved), headache (Verbatim: Headache), fever (Verbatim: Low grade fever) and myalgia (Verbatim: Myalgia). On 24-MAY-2023, the patient experienced diarrhea (Verbatim: acute onset of diarrhea). The outcome of the injection site pain and myalgia were resolving and the outcome of the headache, fever and diarrhea were not resolved.  It was unknown if the reporter considered the injection site pain, headache, fever, myalgia and diarrhea to be related to Shingrix.  It was unknown if the company considered the injection site pain, headache, fever, myalgia and diarrhea to be related to Shingrix.  Additional Information: GSK Receipt Date: 25-MAY-2023  The reporter was the patient. She reported of receiving the first dose of Shingrix in the left arm. She had experienced a low grade fever, dull headache, pain at the injection site, myalgia, and diarrhea. She also reported fever, headache, pain at site, and myalgia began on Tuesday and were ongoing.  2 days after receiving Shingrix, the patient experienced acute diarrhea. She reported that, the onset of diarrhea occurred so rapidly she would have soiled herself, had they not been able to reach a restroom. She reported myalgia and pain at injection site had improved. The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Myalgia, Rhinorrhoea
Clinical narrative: runny nose; weak and tired; muscle aches; loss of appetite; weak and tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of runny nose in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 24-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced runny nose (Verbatim: runny nose), weakness (Verbatim: weak and tired), muscle pain (Verbatim: muscle aches), appetite lost (Verbatim: loss of appetite) and tiredness (Verbatim: weak and tired). The action taken with Shingrix was unknown. The outcome of the runny nose, weakness, muscle pain, appetite lost and tiredness were not resolved.   It was unknown if the reporter considered the runny nose, weakness, muscle pain, appetite lost and tiredness to be related to Shingrix.     It was unknown if the company considered the runny nose, weakness, muscle pain, appetite lost and tiredness to be related to Shingrix.   Additional Information: GSK Receipt date:25-May-2023 The patient experienced lost of appetite, runny nose, muscle aches and was weak and tired. Education provided per content. Referred to HCP. Did not consent to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: severe muscle pain on the left and right side of his neck; he cannot turn his head to the left or right; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 1st dose of Shingrix (injection, right arm). On 24-MAY-2023, 5 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: severe muscle pain on the left and right side of his neck) and mobility decreased (Verbatim: he cannot turn his head to the left or right). The outcome of the muscle pain was not resolved and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the muscle pain and mobility decreased to be related to Shingrix.   It was unknown if the company considered the muscle pain and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023 The patient received Shingrix in his right arm and reported that the day before reporting, he started having severe muscle pain on the left and right side of his neck and he could not turn his head to the left or right. The patient reported that this pain was really severe last night and on the day of reporting. The patient did not have the lot for his dose. The reporter did not consent to follow-up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE 9/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE HYPOXEMIA
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Presented to Drs office on 5/23/21 with R leg swelling x 2 weeks duration. Has previous hx of DVTs related to Factor V Leiden. No additional information available about dx or treatment duration.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: I tested positive for COVID-19 on 5/25/23. I had fever, sore throat, cough, nausea, chills, headache, fatigue, shortness of breath and body aches. I didn't go to the doctor at the time and just took Tylenol for the fever. I ended up going to the Emergency Room, but they did not give me medication because of my Kidney problems. They offered Remdesivir, but I declined that too. This has lasted for about a week, and I am still not feeling well.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Malaise, Nausea, Oropharyngeal pain, Pain
Clinical narrative: I tested positive for COVID-19 on 5/25/23. I had fever, sore throat, cough, nausea, chills, headache, fatigue, shortness of breath and body aches. I didn't go to the doctor at the time and just took Tylenol for the fever. I ended up going to the Emergency Room, but they did not give me medication because of my Kidney problems. They offered Remdesivir, but I declined that too. This has lasted for about a week, and I am still not feeling well.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 5/25/23. I had fever, sore throat, cough, nausea, chills, headache, fatigue, shortness of breath and body aches. I didn't go to the doctor at the time and just took Tylenol for the fever. I ended up going to the Emergency Room, but they did not give me medication because of my Kidney problems. They offered Remdesivir, but I declined that too. This has lasted for about a week, and I am still not feeling well.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Infection, Malaise, No adverse event
Clinical narrative: I did not have a reaction to the Moderna vaccine on 04/25/2023. On 05/25/2023, I started not feeling well with a bad cough. By 05/27/2023, the cough was worse with congestion. I was producing a lot of mucus. I went to an urgent care and received prescriptions for the infection. I did take a COVID-19 test at home on 05/27/2023 and it was negative.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: I did not have a reaction to the Moderna vaccine on 04/25/2023. On 05/25/2023, I started not feeling well with a bad cough. By 05/27/2023, the cough was worse with congestion. I was producing a lot of mucus. I went to an urgent care and received prescriptions for the infection. I did take a COVID-19 test at home on 05/27/2023 and it was negative.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute coronary syndrome
Clinical narrative: ACUTE CORONARY SYNDROME, UNSPECIFIED
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests, Blood test, Facial pain, Full blood count, Laboratory test
Clinical narrative: Vestibular issues, vestibular neuritis, vestibular migraine, severe forehead pain, severe tinnitus. Tx included vestibular rehab and nortryptiline 40mg daily. Medication helped 10%.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging, Metabolic function test, Tinnitus, Vestibular disorder, Vestibular function test
Clinical narrative: Vestibular issues, vestibular neuritis, vestibular migraine, severe forehead pain, severe tinnitus. Tx included vestibular rehab and nortryptiline 40mg daily. Medication helped 10%.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vestibular migraine, Vestibular neuronitis
Clinical narrative: Vestibular issues, vestibular neuritis, vestibular migraine, severe forehead pain, severe tinnitus. Tx included vestibular rehab and nortryptiline 40mg daily. Medication helped 10%.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperacusis, Pain, Tinnitus
Clinical narrative: Severe tinnitus began about 16 hours after the injection accompanied by hyper sensitivity to sound and pain. Unable to match pitches when singing. Today is day 5 after vaccination and the tinnitus and sensitivity are still severe.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Dyspnoea, Ear discomfort, Fatigue
Clinical narrative: I was feeling really cold and was having chills then was so tired that I just laid down on the floor. My nose started running and also got stuffed up. I then started having a fever and then having a sore throat, with pressure in my ears. Thursday, I woke up and I could not breath and this brought on a panic attack, and I went into the clinic and there they tested me for Strep and COVID-19 and I was positive for COVID-19. They gave me an inhaler and put me on Paxlovid as well. I did have the weird metal taste taking the Paxlovid, bad diarrhea and my stomach hurt, on Saturday I was not able to walk. It was like my legs did not work and I had to learn how to walk again, and my symptoms had not improved, and I went back to the clinic and learned this was common with the Paxlovid.  I have tested negative, but I am still tired and fatigued,
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling cold, Nasal congestion, Oropharyngeal pain, Panic attack, Pyrexia
Clinical narrative: I was feeling really cold and was having chills then was so tired that I just laid down on the floor. My nose started running and also got stuffed up. I then started having a fever and then having a sore throat, with pressure in my ears. Thursday, I woke up and I could not breath and this brought on a panic attack, and I went into the clinic and there they tested me for Strep and COVID-19 and I was positive for COVID-19. They gave me an inhaler and put me on Paxlovid as well. I did have the weird metal taste taking the Paxlovid, bad diarrhea and my stomach hurt, on Saturday I was not able to walk. It was like my legs did not work and I had to learn how to walk again, and my symptoms had not improved, and I went back to the clinic and learned this was common with the Paxlovid.  I have tested negative, but I am still tired and fatigued,
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Streptococcus test
Clinical narrative: I was feeling really cold and was having chills then was so tired that I just laid down on the floor. My nose started running and also got stuffed up. I then started having a fever and then having a sore throat, with pressure in my ears. Thursday, I woke up and I could not breath and this brought on a panic attack, and I went into the clinic and there they tested me for Strep and COVID-19 and I was positive for COVID-19. They gave me an inhaler and put me on Paxlovid as well. I did have the weird metal taste taking the Paxlovid, bad diarrhea and my stomach hurt, on Saturday I was not able to walk. It was like my legs did not work and I had to learn how to walk again, and my symptoms had not improved, and I went back to the clinic and learned this was common with the Paxlovid.  I have tested negative, but I am still tired and fatigued,
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chronic spontaneous urticaria, Dizziness, Heat exhaustion
Clinical narrative: After the dose was administered I felt a rush of heat come over my body and I felt sick to my stomach and faint. I waited the 30 minutes and there was no change. After getting home I was I'll for two days with flu like symptoms. On 6/5/21 I started having hives all over my body. I treated them with Benadryl to no avail. I had to wait to get into an allergist. Continuing having those hives. I was later that year diagnosed with chronic idiopathic urticaria. Also along with the hives I have increased heat sensitivity. Where minor interactions with the heat can leave me feeling very ill. I got heat exhaustion twice in 2022. My skin is now also super sensitive to the sun I burn very easily, whereas before I tanned. So I have multiple sensitivities now. I do not sweat like I used to. It is harder for me to cool down my body. And when the hives flare up my body is left in pain. It is inflamed and I am sore in my joints and everything swells.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Influenza like illness, Malaise, Pain
Clinical narrative: After the dose was administered I felt a rush of heat come over my body and I felt sick to my stomach and faint. I waited the 30 minutes and there was no change. After getting home I was I'll for two days with flu like symptoms. On 6/5/21 I started having hives all over my body. I treated them with Benadryl to no avail. I had to wait to get into an allergist. Continuing having those hives. I was later that year diagnosed with chronic idiopathic urticaria. Also along with the hives I have increased heat sensitivity. Where minor interactions with the heat can leave me feeling very ill. I got heat exhaustion twice in 2022. My skin is now also super sensitive to the sun I burn very easily, whereas before I tanned. So I have multiple sensitivities now. I do not sweat like I used to. It is harder for me to cool down my body. And when the hives flare up my body is left in pain. It is inflamed and I am sore in my joints and everything swells.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Sunburn, Swelling, Temperature intolerance, Urticaria
Clinical narrative: After the dose was administered I felt a rush of heat come over my body and I felt sick to my stomach and faint. I waited the 30 minutes and there was no change. After getting home I was I'll for two days with flu like symptoms. On 6/5/21 I started having hives all over my body. I treated them with Benadryl to no avail. I had to wait to get into an allergist. Continuing having those hives. I was later that year diagnosed with chronic idiopathic urticaria. Also along with the hives I have increased heat sensitivity. Where minor interactions with the heat can leave me feeling very ill. I got heat exhaustion twice in 2022. My skin is now also super sensitive to the sun I burn very easily, whereas before I tanned. So I have multiple sensitivities now. I do not sweat like I used to. It is harder for me to cool down my body. And when the hives flare up my body is left in pain. It is inflamed and I am sore in my joints and everything swells.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/26/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bacteraemia, Death, Debridement, Decubitus ulcer, Encephalopathy
Clinical narrative: She was admitted as above.  She was severely encephalopathic throughout her hospital stay.  She often refused food and therapies.  She was maintained on hemodialysis.  Because of her developing malnutrition from lack of oral intake, she developed a severe sacral decubitus ulcer with necrotic and infected tissue and bacteremia.  Efforts to prevent this were unsuccessful as the patient steadfastly refused to allow a feeding tube and refused to take more nutrition.  She was seen by Dr. and taken to the operating room for debridement.  Unfortunately, she remained poorly responsive.  I discussed extensively with her sons over the last few hospital days.  They agreed that she would not want heroic measures to keep her alive.  She deteriorated further with an episode of ventricular tachycardia, and the family decided to pursue comfort measures only.  She passed away peacefully.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Food refusal, General physical health deterioration, Haemodialysis, Hypophagia, Hyporesponsive to stimuli
Clinical narrative: She was admitted as above.  She was severely encephalopathic throughout her hospital stay.  She often refused food and therapies.  She was maintained on hemodialysis.  Because of her developing malnutrition from lack of oral intake, she developed a severe sacral decubitus ulcer with necrotic and infected tissue and bacteremia.  Efforts to prevent this were unsuccessful as the patient steadfastly refused to allow a feeding tube and refused to take more nutrition.  She was seen by Dr. and taken to the operating room for debridement.  Unfortunately, she remained poorly responsive.  I discussed extensively with her sons over the last few hospital days.  They agreed that she would not want heroic measures to keep her alive.  She deteriorated further with an episode of ventricular tachycardia, and the family decided to pursue comfort measures only.  She passed away peacefully.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malnutrition, Necrotising soft tissue infection, Refusal of treatment by patient, Ventricular tachycardia
Clinical narrative: She was admitted as above.  She was severely encephalopathic throughout her hospital stay.  She often refused food and therapies.  She was maintained on hemodialysis.  Because of her developing malnutrition from lack of oral intake, she developed a severe sacral decubitus ulcer with necrotic and infected tissue and bacteremia.  Efforts to prevent this were unsuccessful as the patient steadfastly refused to allow a feeding tube and refused to take more nutrition.  She was seen by Dr. and taken to the operating room for debridement.  Unfortunately, she remained poorly responsive.  I discussed extensively with her sons over the last few hospital days.  They agreed that she would not want heroic measures to keep her alive.  She deteriorated further with an episode of ventricular tachycardia, and the family decided to pursue comfort measures only.  She passed away peacefully.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Haemodialysis, Resuscitation
Clinical narrative: Pt remained with what appeared to be PVS after completion of a complete course of antibiotic therapy as well as multiple rounds of HD to clear any potential intoxicants. He remained relatively stable otherwise and was on TCT and progressing, with possible hope of transfer near family or to have family come to pt. for pt to enter hospice. 5/30, early AM, overnight team paged due to difficulty obtaining O2 sat. Pt was found to be in cardiac arrest and despite resuscitative efforts, expired. Family was contacted by overnight team. Time of death 0212 on 5/30/2023.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Deep vein thrombosis, Hypoxia, Respiratory failure
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging head, Multiple sclerosis, Symptom recurrence
Clinical narrative: In November of 2021, left leg went numb, went to Dr and they thought it was my sciatic nerve. at the beginning of may 2023 the same symptom happened again along with urinary retention. i was diagnosed with multiple sclerosis
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary retention
Clinical narrative: In November of 2021, left leg went numb, went to Dr and they thought it was my sciatic nerve. at the beginning of may 2023 the same symptom happened again along with urinary retention. i was diagnosed with multiple sclerosis
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT