chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Product administered to patient of inappropriate age
Clinical narrative: Spikevax (COVID-19 Vaccine, mRNA) 2024-2025 Formula (manufactured by Moderna) for ages 12 years and older was administered to the patient. The patient does not meet the age criteria for this vaccine. The patient experienced increased ADEs secondary to vaccine administration and did not feel well, resulting in a missed day of school.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A patient arrived at the pharmacy today to receive the shingles vaccine. Upon checking in, the patient appeared confused and expressed to the technician that they believed they were there to receive the COVID-19 vaccine instead. The technician confirmed the patient's understanding, and the patient reiterated their desire for the Moderna COVID-19 vaccine. Outcome: patient ended up getting the Moderna Covid Vaccine instead in which he had already gotten a dose of the same vaccine on 10/03/2024. No signs or symptoms were reported post administration. No treatment needed at the moment.
Age: 37.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE. No PQC.; HBP called to report that a dose of expired VAQTA was inadvertently administered to one patient on 10/03/2024. The expiry date on the VAQTA was 10/01/2024. Caller confirmed the product has no history of a temperature excursion. Patient demographic in; dispensing error; This spontaneous report was received from office manager and refers to a patient of a not reported ager or gender.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On 03-OCT-2024, the patient was inadvertently vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #X006702 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA); expiration date: 01-OCT-2024) administered for prophylaxis (strength, dose description, route of administration and anatomical location were not provided) (Expired vaccine used). It was confirmed the vaccine had no history of a temperature excursion. No additional adverse event or PQC were reported.  This case was considered as non-valid due to lack of patient identifiers.  Follow up information has been received from other health care professional on 22-OCT-2024. The patient was a 37-year-old female patient. On 04-OCT-2024 (previously reported as 03-OCT-2024), Hepatitis A vaccine, inactivated (VAQTA) was administered via intramuscularly on left deltoid (expired vaccine used). On the same date, the patient also was vaccinated with the 9th dose of influenza vaccine (INFLUENZA) administered intramuscularly into the left arm (lot #388528, expiration date: 30-JUN-2025; strength, formulation, dose and indication were not provided). On that date, there was a dispensing error (product dispensing error).   This case was previously considered non-valid but upon follow-up it was determined to be valid, as the patient identifiers were received.
Age: 38.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Ageusia, Anosmia, Blindness, CSF test abnormal, Death
Clinical narrative: Rubella infection neurological; Literature Report:   This literature marketed report has been received from the authors of the published article and refers a 38-year-old male patient.    The patient's medical history included common variable immunodeficiency (CVID)-associated granulomatous disease in which magnetic resonance imaging of the brain showed pachymeningeal enhancement along the cavernous sinuses, internal auditory canals, and multiple cranial nerves. Cerebrospinal fluid (CSF) testing showed lymphocytic pleocytosis, hypoglycorrhachia, and elevated protein. The initial evaluation, including an infectious workup, was negative for a specific etiology. So infliximab was initiated, in part due to excellent systemic response in the past. The patient showed a marked clinical and partial radiographic response to treatment that lasted more than 1.5 years. The patient's concurrent conditions and concomitant medications were not provided.   On unspecified date, the patient started Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection and/or Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, frequency, route of administration, vaccination scheme, site of vaccination, lot #, and expiration date were not reported) as a prophylaxis.   On unspecified date reported as ultimately, he developed a precipitous decline, with development of anosmia, ageusia, and blindness. Re-evaluation of Cerebrospinal fluid (CSF) testing with metagenomic next-generation sequencing (mNGS) indicated immunodeficiency-related vaccine-derived rubella virus (iVDRV) (rubella infection neurological) and the patient developed disseminated rubella with multi-organ involvement. Therefore, ribavirin and nitazonavide were started but ultimately passed. At the reporting time, the outcome of the event of rubella infection neurological was not provided.   The causal relationship between suspect vaccines with the event was considered as related.    Upon internal review, the event of rubella infection neurological was considered as medically significant.
Age: 38.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: General physical health deterioration, Metagenomic analysis, Multi-organ disorder, Rubella infection neurological
Clinical narrative: Rubella infection neurological; Literature Report:   This literature marketed report has been received from the authors of the published article and refers a 38-year-old male patient.    The patient's medical history included common variable immunodeficiency (CVID)-associated granulomatous disease in which magnetic resonance imaging of the brain showed pachymeningeal enhancement along the cavernous sinuses, internal auditory canals, and multiple cranial nerves. Cerebrospinal fluid (CSF) testing showed lymphocytic pleocytosis, hypoglycorrhachia, and elevated protein. The initial evaluation, including an infectious workup, was negative for a specific etiology. So infliximab was initiated, in part due to excellent systemic response in the past. The patient showed a marked clinical and partial radiographic response to treatment that lasted more than 1.5 years. The patient's concurrent conditions and concomitant medications were not provided.   On unspecified date, the patient started Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection and/or Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, frequency, route of administration, vaccination scheme, site of vaccination, lot #, and expiration date were not reported) as a prophylaxis.   On unspecified date reported as ultimately, he developed a precipitous decline, with development of anosmia, ageusia, and blindness. Re-evaluation of Cerebrospinal fluid (CSF) testing with metagenomic next-generation sequencing (mNGS) indicated immunodeficiency-related vaccine-derived rubella virus (iVDRV) (rubella infection neurological) and the patient developed disseminated rubella with multi-organ involvement. Therefore, ribavirin and nitazonavide were started but ultimately passed. At the reporting time, the outcome of the event of rubella infection neurological was not provided.   The causal relationship between suspect vaccines with the event was considered as related.    Upon internal review, the event of rubella infection neurological was considered as medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Depressive symptom
Clinical narrative: she was hospitalized at the age of 14/ No details available related to the hospitalization including what may have been the cause.; Sometime after receiving the second dose, the patient "showed signs of depression"; This spontaneous report was received from a Physician regarding to a female patient of unknown age.  The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and on an unspecified date she received her second dose (strength, dose, lot #, expiry date, route of administration, and anatomical site of injection were not provided); both administered for prophylaxis.  On an unknown date, sometime after receiving the second dose, the patient showed signs of depression (Depressive symptom). On an unspecified date, at the age of 14, the patient was admitted to the hospital (Hospitalisation), however, no additional details related to the hospitalization were available, including what may have been the cause. The outcome of the events was not reported.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported,; The physician is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) ROTATEQ (2032252   10/21/2025) Temperature: 8.6C Time fra; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-OCT-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 2032252 established as non-valid for suspect product. for prophylaxis (exact dose, dose number and route of administration were not provided). The excursion lasted for 24 minutes in temperature of 8.6 Celsius degrees (product storage error). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event was reported; Call transferred from a specialist with a LPN on the back line to report an AE. Per the HCP, an expired dose of PNEUMOVAX 23 PFS was inadvertently administered to a patient on 10/18/2024. Dose expired on 09/25/2024. No symptoms reported. No further i; This spontaneous report was received from registered praticional nurse and refers to a patient of unkown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-OCT-2024, the patient was vaccinated with expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 mls, lot #w027449, expiration date: 25-SEP-2024, administered subcutaneously for prophylaxis (strength was not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additionale adverse event was reported; HCP called to report inadvertent administration of a third dose of VARIVAX to a patient. Patient received VARIVAX on 19OCT2020, 22MAR2024, and 11OCT2024. No additional details were known by reporter. No additional AE/PQC.; This spontaneous report was received from medical assistant and refers to a 5-year-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-OCT-2020, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml per dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 22-MAR-2024, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml per dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 11-OCT-2024, the patient was vaccinated with third dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml per dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Extra dose administered). No additional adverse event was reported.
Sex: F
Vaccine: FLUX
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This non-serious case was reported by a consumer and described the occurrence of pityriasis rosea in a 36-year-old female patient who received Flu unspecified (Flu vaccine) (batch number T7245) for prophylaxis.   On 29-AUG-2024, the patient received Flu vaccine .5 ml. On 30-AUG-2024, 1 days after receiving Flu vaccine, the patient experienced pityriasis rosea (Verbatim: Pityriasis rosea). The outcome of the pityriasis rosea was not resolved.   It was unknown if the reporter considered the pityriasis rosea to be related to Flu vaccine.     It was unknown if the company considered the pityriasis rosea to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 24-SEP-2024 This report was submitted via the online direct entry reporting system. The patient received Flu-IIV3 and experienced pityriasis rosea.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Scab
Clinical narrative: Red rash; crusty rash developed on the patient's scalp/forehead/dark rash; Cusry rash; This non-serious case was reported by a physician via sales rep and described the occurrence of red rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2018, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced red rash (Verbatim: Red rash), rash (Verbatim: crusty rash developed on the patient's scalp/forehead/dark rash) and crust (Verbatim: Cusry rash). The outcome of the red rash was not reported and the outcome of the rash and crust were resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix. The reporter considered the rash and crust to be related to Shingrix.     It was unknown if the company considered the red rash to be related to Shingrix. The company considered the rash and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-OCT-2024 A crusty rash developed on the patient's scalp/forehead the day after receiving their Shingrix. There were no blisters, just a red to dark rash.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     The company considered the guillain barre syndrome to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 14-OCT-2024 The case was self reported by patient. The reporter reported that other half of the patient was so lucky to get Guillain- Barre last year when he got his flu vaccine and was hospitalized for 11 days. So, as per his physician he could not took the oral, how do dispose of it.; Sender's Comments: Guillain-Barre syndrome  is a listed event which is considered related to GSK  vaccine Flu vaccine.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: tenderness at injection site; swollen lymph nodes along her jawline; This non-serious case was reported by a consumer and described the occurrence of injection site tenderness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site tenderness (Verbatim: tenderness at injection site) and swollen lymph nodes (Verbatim: swollen lymph nodes along her jawline). The outcome of the injection site tenderness and swollen lymph nodes were not resolved.   It was unknown if the reporter considered the injection site tenderness and swollen lymph nodes to be related to Shingrix.     It was unknown if the company considered the injection site tenderness and swollen lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 The patient reported that after receiving the Shingrix vaccine, she had swollen lymph nodes along her jawline and tenderness at the injection site. The patient also received the flu vaccine at the same time she received Shingrix vaccine. It was unknown if the reporter considered the injection site tenderness and swollen lymph nodes to be related to Influenza vaccine.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received two doses of Arexvy 1 dose on November 2023 and 1 dose on September 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number N9592, expiry date 11-OCT-2026) for prophylaxis.   Previously administered products included Arexvy (1 dose in November 2023).   On 17-SEP-2024, the patient received the 2nd dose of Arexvy. On 17-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received two doses of Arexvy 1 dose on November 2023 and 1 dose on September 2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 01-OCT-2024 The patient received two doses of Arexvy, which led extra dose administered. She wants to know if there was any study of this situation and what should tell the patient to expect. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: erythema at the injection site; tenderness at the injection site; injected site swelling; injection site irritation 3 inches in diameter; induration; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 02-OCT-2024, the patient received Bexsero (injection, right deltoid) .5 ml. In OCT-2024, 2 hrs after receiving Bexsero, the patient experienced injection site erythema (Verbatim: erythema at the injection site), injection site tenderness (Verbatim: tenderness at the injection site), injection site swelling (Verbatim: injected site swelling), injection site irritation (Verbatim: injection site irritation 3 inches in diameter) and induration (Verbatim: induration). In OCT-2024, the outcome of the injection site erythema and injection site tenderness were resolved. The outcome of the injection site swelling, injection site irritation and induration were not reported.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling, injection site irritation and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, injection site tenderness, injection site swelling, injection site irritation and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-OCT-2024 The nurse practitioner who was working at a school reported that a student (patient) received suspect vaccine Bexsero and 2 hours later came back to nurse office with an approximately three inch diameter red area and tenderness at the injection site. The GSK response center agent mentioned redness, induration and tenderness. The reporter stated, within 2 days of vaccination that they had increased swelling in the injection site, pain, more than the normal site reaction post vaccination. The nurse practitioner prescribed Benadryl and also a steroid in case of a more severe site reaction. When she spoke with a physician they mentioned that they also saw slightly unusual symptoms for kid back to back, similar injection site irritation 3 inches in diameter, both site injections were very erythematous and very tender to the touch. This case had been link with US2024123253, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123253:same reporter/different patient
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that Bexsero was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The vaccine administration facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient
Sex: U
Vaccine: HEP, HEPA, RV1
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patients received Havrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Havrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2024 The certified medical assistant requested stability data on  Havrix, Engerix-B, Rotarix (liquid) stored at 26 degree Fahrenheit at unknown time since 06-AUG-2024 and the vaccines had been administered to more than 10 patients, which led to incorrect storage of drug. The health care professional did not had demographics details for patients at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination
Clinical narrative: received only one dose approximately 6 years ago; had fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue (Verbatim: had fatigue) and incomplete course of vaccination (Verbatim: received only one dose approximately 6 years ago). The outcome of the fatigue was resolved (duration 2 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 14-OCT-2024 The patient reported that he experienced fatigue from the first dose of Shingrix which started the evening of the vaccination and lasted two days. The patient called to inquire about restarting the Shingrix series, he received only one dose approximately 6 years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to iincomplete course of vaccination. The patient declined to provide name or contact information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She received dose 2 of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020). Concomitant products included tocilizumab (Actemra).   On 11-OCT-2024, the patient received the 2nd dose of Shingrix. On 11-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: She received dose 2 of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2024 The reporter was the patient. The patient received dose 1 of Shingrix in 2020, she received dose 2 of Shingrix on 11th October 2024 which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pateint did not receive second dose/late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pateint did not receive second dose/late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:14-OCT-2024 The reporter explained that a patient did not get a second dose yet.  The reporter did not want to provide any patient details, and they did not know the expiration date or lot number of the vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Rash
Clinical narrative: almost passed out; Then the patient developed a very bad rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of presyncope in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number B4942, expiry date 06-APR-2026) for prophylaxis.   On 14-AUG-2024, the patient received the 1st dose of Shingrix. On 15-AUG-2024, 1 days after receiving Shingrix, the patient experienced presyncope (Verbatim: almost passed out). In AUG-2024, the patient experienced rash (Verbatim: Then the patient developed a very bad rash). The outcome of the presyncope and rash were unknown.   It was unknown if the reporter considered the presyncope and rash to be related to Shingrix.     It was unknown if the company considered the presyncope and rash to be related to Shingrix.   Additional Information: GSK receipt date:16-Oct-2024 The patient received the Shingrix and the patient almost passed out the next day. Then the patient developed a very bad rash 4 or 5 days afterwards.  The doctor told her that it was a possibility that the rash could have happened after the Shingles vaccine but they did not want to risk her.
Sex: F
Vaccine: COVID19
Symptoms: Malignant neoplasm progression
Clinical narrative: Cancer was exacerbated after receiving the vaccine, died of cancer within 2 years of the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALIGNANT NEOPLASM PROGRESSION (Cancer was exacerbated after receiving the vaccine, died of cancer within 2 years of the vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (18 years in remission).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALIGNANT NEOPLASM PROGRESSION (Cancer was exacerbated after receiving the vaccine, died of cancer within 2 years of the vaccine) (seriousness criteria death and medically significant). The reported cause of death was died of cancer. It is unknown if an autopsy was performed.            Concomitant medication information was not reported.  It was reported that the patient took the original vaccine, and cancer was exacerbated after receiving the vaccine.  Treatment information was not reported.; Reporter's Comments: Medical history of cancer is a confounder for the events. Latency from vaccination and aggravation of previous disease is unknown. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Died of cancer
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: I had long term COVID; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I had long term COVID) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 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. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (I had long term COVID). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I had long term COVID) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that she had both Moderna in the beginning and then had a booster and hasn't had anything else since then. It was also reported that for the last 3 years, she experienced brain fog, tiredness, aches and pains and a cough that goes away, and comes back and consumer's energy level was zapped. Patient also done preliminary rehab and done things trying to get energy and still exhausted. It was also reported that the patient couldn't talk without coughing and she had never gone to the hospital and the only thing consumer did was after taking Spikevax booster was to go to gastro endocrinologist and did a colonoscopy, but results were not available. Patient was also sick.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event, Syringe issue
Clinical narrative: found the rigid cap very difficult to open and you have to 'fight to open it' and it crushes the tip and then you have to throw out the PFS; syringe was "really tiny", and that it was tall and thin and it took a long time to push the vaccine out during administration; No Adverse Effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (found the rigid cap very difficult to open and you have to 'fight to open it' and it crushes the tip and then you have to throw out the PFS), SYRINGE ISSUE (syringe was "really tiny", and that it was tall and thin and it took a long time to push the vaccine out during administration) and NO ADVERSE EVENT (No Adverse Effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    Previously administered products included for Product used for unknown indication: Pfizer (had no problems) in 2023. Past adverse reactions to the above products included No adverse effect with Pfizer.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (found the rigid cap very difficult to open and you have to 'fight to open it' and it crushes the tip and then you have to throw out the PFS), SYRINGE ISSUE (syringe was "really tiny", and that it was tall and thin and it took a long time to push the vaccine out during administration) and NO ADVERSE EVENT (No Adverse Effect). At the time of the report, DEVICE ISSUE (found the rigid cap very difficult to open and you have to 'fight to open it' and it crushes the tip and then you have to throw out the PFS), SYRINGE ISSUE (syringe was "really tiny", and that it was tall and thin and it took a long time to push the vaccine out during administration) and NO ADVERSE EVENT (No Adverse Effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter advised that, if you had rheumatoid you could not open the PFS. The reporter stated that, it was not one syringe in particular but found it difficult with all of the adult doses, as they did not use the pediatric dose frequently. The reporter stated that, she did not use Moderna last year, she used Pfizer and had no problems. The reporter did not have a lot handy as she was not at the Pharmacy at the time of the call.  The Device problem code for Spikevax syringe included FDA code 3265 and IMDRF code A2301 which included Device Handling Problem.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Liver disorder
Clinical narrative: Liver disorder; This spontaneous case was reported by a patient and describes the occurrence of LIVER DISORDER (Liver disorder) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Liver transplant.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (Liver disorder). At the time of the report, LIVER DISORDER (Liver disorder) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient reported that he was a (liver) transplant patient and had a Moderna vaccine before.; Reporter's Comments: Medical history of liver transplant is a confounder for the event. Due to very limited information the event is retained and query raised for further clarification. The benefit-risk relationship of product is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Pollakiuria, Vertigo, Weight, Weight decreased
Clinical narrative: increased urination; she lost 4 lbs overnight; almost passed out from losing all the water and electrolytes; sat down on the floor because the room started to go around; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (increased urination), WEIGHT DECREASED (she lost 4 lbs overnight), DEHYDRATION (almost passed out from losing all the water and electrolytes) and VERTIGO (sat down on the floor because the room started to go around) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (sulfa allergy).    On 03-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 03-Oct-2024, the patient experienced POLLAKIURIA (increased urination), WEIGHT DECREASED (she lost 4 lbs overnight), DEHYDRATION (almost passed out from losing all the water and electrolytes) and VERTIGO (sat down on the floor because the room started to go around). On 04-Oct-2024, POLLAKIURIA (increased urination), WEIGHT DECREASED (she lost 4 lbs overnight), DEHYDRATION (almost passed out from losing all the water and electrolytes) and VERTIGO (sat down on the floor because the room started to go around) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2024, Weight: Weight decreased 4 lbs overnight.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Spikevax had vaccine and went to bed at 9:30 but would then had to go to the bathroom every 20 min she had to go. Caller describes this as water falls and said that she had even wet herself. She mentions that she lost 4 lbs overnight. It was increased urination and not diarrhea. This was not the first time it happens. She had taken 5 series of vaccination so far and this was her sixth. All were Moderna except for one time in 2023 that it was Pfizer. She mentions that these symptoms have occurred before but she does not recall with which vaccine. She almost passed out from losing all the water and electrolytes. She woke up in the morning she got out of bed and sat down on the floor because the room started to go around. She mentions that she finally had some salt crackers and water and that helped resolve the symptoms. Reporter causality was not reported.   This case was linked to MOD-2024-775581 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she has been sick for a year; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she has been sick for a year) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced ILLNESS (she has been sick for a year). At the time of the report, ILLNESS (she has been sick for a year) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  It was reported that patient received Moderna vaccine in 2022 or there abouts and she had been sick for a year.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2024: Live non-significant follow up received, reference number was updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Asthenia, Chills, Insomnia, Myalgia
Clinical narrative: body ached so bad/body aches everywhere/every part of her body hurts terrible; weakness; at night cannot sleep; Every joint in the body was screaming; muscular pain; severe chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body ached so bad/body aches everywhere/every part of her body hurts terrible), ASTHENIA (weakness), INSOMNIA (at night cannot sleep), ARTHROPATHY (Every joint in the body was screaming) and MYALGIA (muscular pain) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID. Past adverse reactions to the above products included No adverse effect with Moderna COVID.    On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 01-Oct-2024, the patient experienced ASTHENIA (weakness), INSOMNIA (at night cannot sleep), ARTHROPATHY (Every joint in the body was screaming), MYALGIA (muscular pain) and CHILLS (severe chills). On 02-Oct-2024, the patient experienced PAIN (body ached so bad/body aches everywhere/every part of her body hurts terrible). The patient was treated with Paracetamol (Tylenol) for Pain relief, at an unspecified dose and frequency. At the time of the report, PAIN (body ached so bad/body aches everywhere/every part of her body hurts terrible), ASTHENIA (weakness), INSOMNIA (at night cannot sleep), ARTHROPATHY (Every joint in the body was screaming), MYALGIA (muscular pain) and CHILLS (severe chills) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient mentioned that she always received the Moderna COVID injections, never have any side effects. But patient got the new Spikevax injection on 01-Oct-2024 afternoon, then at the later that evening, patient had severe chills, patient claimed that can deal with that, but the next day, patient's body ached so bad. Every joint in the body was screaming. Patient still dealing with horrible side effects such as body aches everywhere. Patient mentioned that at night cannot sleep because every part of her body hurts terrible. It was ongoing for 3 weeks, and the symptoms have not ceased. Patient have been taking Tylenol for pain relief which was not helping very much.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2024: Live non-significant information received which had no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body ached so bad/body aches everywhere/every part of her body hurts terrible; weakness; at night cannot sleep; Every joint in the body was screaming; muscular pain; severe chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body ached so bad/body aches everywhere/every part of her body hurts terrible), ASTHENIA (weakness), INSOMNIA (at night cannot sleep), ARTHROPATHY (Every joint in the body was screaming) and MYALGIA (muscular pain) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID. Past adverse reactions to the above products included No adverse effect with Moderna COVID.    On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 01-Oct-2024, the patient experienced ASTHENIA (weakness), INSOMNIA (at night cannot sleep), ARTHROPATHY (Every joint in the body was screaming), MYALGIA (muscular pain) and CHILLS (severe chills). On 02-Oct-2024, the patient experienced PAIN (body ached so bad/body aches everywhere/every part of her body hurts terrible). The patient was treated with Paracetamol (Tylenol) for Pain relief, at an unspecified dose and frequency. At the time of the report, PAIN (body ached so bad/body aches everywhere/every part of her body hurts terrible), ASTHENIA (weakness), INSOMNIA (at night cannot sleep), ARTHROPATHY (Every joint in the body was screaming), MYALGIA (muscular pain) and CHILLS (severe chills) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient mentioned that she always received the Moderna COVID injections, never have any side effects. But patient got the new Spikevax injection on 01-Oct-2024 afternoon, then at the later that evening, patient had severe chills, patient claimed that can deal with that, but the next day, patient's body ached so bad. Every joint in the body was screaming. Patient still dealing with horrible side effects such as body aches everywhere. Patient mentioned that at night cannot sleep because every part of her body hurts terrible. It was ongoing for 3 weeks, and the symptoms have not ceased. Patient have been taking Tylenol for pain relief which was not helping very much.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2024: Live non-significant information received which had no new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: moderna covid-19 vaccine (dose 1), moderna covid-19 vaccine (dose 2), moderna covid-19 vaccine (dose 5), moderna covid-19 vaccine (dose 4) and moderna covid-19 vaccine (dose 3). Past adverse reactions to the above products included No adverse effect with moderna covid-19 vaccine, moderna covid-19 vaccine, moderna covid-19 vaccine, moderna covid-19 vaccine and moderna covid-19 vaccine.    On an unknown date, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced COVID-19 (COVID). In 2024, COVID-19 (COVID) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect vaccine dosage text was reported as unknown. Reporter causality was not reported.  No treatment medication was reported.   Reporter did not allow further contact