chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mental impairment, Myopericarditis
Clinical narrative: PFIZER #1 2/4/2021 PFIZER #2 2/24/2021 PFIZER #3  11/4/2024 DEVELOPED VACCINE INDUCED POST-EXERTIONAL MALAISE, LOST OF MENTAL CLARITY, VACCINE SUBCLINICAL MYOPERICARDITIS AND SMALL BOWEL INTUSSUSCEPTION.   TREATED WITH COLCHICINE  COSEVELAM AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Injection site swelling, Limb discomfort, Night sweats, Peripheral swelling
Clinical narrative: Pt started sweating in the middle of the night and stated that her stomach, she got on the computer at 10am and her arm started feeling heavy and like it was bruised. Mom stated that the arm looks swollen around the site and the lower arm looks swollen and hard to touch, it is not warm to touch and there is no streaking visable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PATIENT RECIEVED PEDICATRIC DOSAGE INSTEADOF PEDS. PATIENT HAS NO ADVERSE REACTIONS OR SIDE EFFECTS.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Right Elbow joint swelling on day seven. By evening, arm hurt to move. Next day, joint pain around right shoulder down to hands. Day nine, joint pain in neck. Swelling in elbow has not gone down.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Blood test, Haematuria, Muscular weakness, Pyrexia
Clinical narrative: Patient self reported muscle weakness in the arms and some in the legs. She was unable to operate her phone in the morning nor hold her cigarette. She had a fever all weekend, but had resolved by Monday. She could not grasp anything. She also told me that the doctor stated that there was blood in urine and low back pain. She reported to the ER. They called it an adverse event and sent her on her way. They did not provide any treatment.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Thrombosis
Clinical narrative: Exhaustion, dizziness and severe chills. In addition, developed two blood clots. One in my L arm about 14? long in September of 2022 and another in my L lower leg in August of 2023.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Pt was given the wrong vaccine, was given Meningococcal Group B at age 12 instead of Meningococcal ACWY
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client received COVID-19 for ages 12 and up rather than the 5y to 11 y dosing. Parent was notified of the error at 5:00 pm on 9/27/2024. Parent reported that client was doing well and showing no signs of adverse reactions. Parent understood to monitor the patient and seek immediate medical assistance if anything changed.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Patient was given vaccine at local pharmacy.  Had immediate stiffness and soreness.  She came to my office on October 1, 2024 with complaints of left upper arm and shoulder stiffness and pain. Pain is improving with conservative treatment of heat and stretching.  The arm is neurovascularly intact. She does not yet have full range of motion in the glenohumeral joint. Recommend heat, stretching.  May require PT if not improving
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Our program received the updated COVID vaccine for 2024-25 on 9/19/24. Our administrative assistant followed the usual process for receiving a vaccine shipment, but it wasn't until the following day that we realized the cold chain had not been maintained during shipping to our site. As it turned out, we had a clinic scheduled early on the morning of 9/20/24 and by the time it was discovered by our vaccine coordinator that the cold chain was not maintained, six (6) vaccines had been administered to patients.  After confirmation from our state health department and the manufacturer, we then contacted the patients to let them know that they need to be revaccinated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Our program received the updated COVID vaccine for 2024-25 on 9/19/24. Our administrative assistant followed the usual process for receiving a vaccine shipment, but it wasn't until the following day that we realized the cold chain had not been maintained during shipping to our site. As it turned out, we had a clinic scheduled early on the morning of 9/20/24 and by the time it was discovered by our vaccine coordinator that the cold chain was not maintained, six (6) vaccines had been administered to patients.  After confirmation from our state health department and the manufacturer, we then contacted the patients to let them know that they need to be revaccinated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Our program received the updated COVID vaccine for 2024-25 on 9/19/24. Our administrative assistant followed the usual process for receiving a vaccine shipment, but it wasn't until the following day that we realized the cold chain had not been maintained during shipping to our site. As it turned out, we had a clinic scheduled early on the morning of 9/20/24 and by the time it was discovered by our vaccine coordinator that the cold chain was not maintained, six (6) vaccines had been administered to patients.  After confirmation from our state health department and the manufacturer, we then contacted the patients to let them know that they need to be revaccinated.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: CP called to report TE for GARDASIL 9; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 mL, lot #1965046, expiration date 22-JAN-2026, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursion of 8.6 degree Celsius (C) was reported. No additional adverse event or product quality complaint (No adverse event).  This is one of few reports from the same reporter. ; Sender's Comments:  US-009507513-2409USA004203: US-009507513-2409USA003853: US-009507513-2409USA004145: US-009507513-2409USA004119: US-009507513-2409USA003916:
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; product storage error; This spontaneous report was received from a nurse and refers to a 6-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2024, the patient was vaccinated with improperly stored second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (PROQUAD) subcutaneous injection (lot #Y004547 was valid, expiration date: 19-AUG-2025, administered subcutaneously in  left arm, exact dose was not provided) for prophylaxis (Product storage error). Temperature excursion (TE) of -12 degree Celsius (C) for 37 minutes was reported. Previous TE reported. No additional adverse effect or product quality complaint (No adverse event).   This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2408USA005168:MSD
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; MMR II with expiry date of 9/8/2024 was administered to a patient on 9/9/2024; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 09-SEP-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot #W028734 was valid, expiration date: 08-SEP-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired product administered). Product did not experience temperature excursion through the date of administration. No additional adverse event (AE) (No adverse event). No product quality complaint (PQC).
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC reported.; Pharmacist called and reported that a patient received their 2nd dose of PROQUAD before 4 years of age. Caller stated patient received their 1st dose at 15 months old and their 2nd dose at 3 years and 8 months old. Caller stated the 2nd dose was admi; This spontaneous report was received from a pharmacist and refers to a 3-year-old patient (3 years and 8 months) of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On unknown date (when the patient was 15-month-old) the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 19-JUL-2024 the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # Y008283 and expiration date 21-OCT-2025 for prophylaxis (exact dose, route and site of administration were not provided). Pharmacist called and reported that a patient received their 2nd dose of PROQUAD before 4 years of age (product administered to patient of inappropriate age). No patient symptoms have been reported (no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain
Clinical narrative: A consumer's mother called and reported her daughter received her third dose of GARDASIL 9 too early; some redness and soreness/ pain at the injection site; some redness and soreness/ pain at the injection site; This spontaneous report was received from a patient's mother and refers to a 12-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.  On 02-FEB-2024, the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #2014634, expiration date: 20-SEP-2025, administered for Human Papilloma Virus immunisation (anatomical location, strength, and route of administration were not provided). On 23-AUG-2024, the patient was vaccinated with 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X019862, expiration date: 14-FEB-2025, administered for Human Papilloma Virus immunisation (anatomical location, strength, and route of administration were not provided). On 24-SEP-2024, the patient was vaccinated with 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for Human Papilloma Virus immunisation (anatomical location, strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration).  On an unknown date in 2024, the patient complained of some redness and soreness/ pain at the injection site. There was no treatment given. At the time of report, the patient did not recovered from the events. No additional information provided to further clarify the details. No additional adverse event 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 not known.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; HCP called regarding an MMR II vaccine that expired 9/15/2024 and was administered to a patient on 9/26/2024. Consent to contact is yes. No adverse side effects were reported. Product was supported. No additional information available at this time. N; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-SEP-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W029538, expiration date: 15-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of GARDASIL 9 at 26 or 27 years old. Patient never received second or third dose of GARDASIL 9 after. Patient is now 28 years old and would like to resume the GARDASIL 9 series; No additional AE reported; This spontaneous report was received from a pharmacy intern and refers to a 28-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (at 26 or 27 years old), the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided). Patient never received the second or third dose after and would like to resume the series now (Inappropriate schedule of product administration). No additional AE reported.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose 11May2024, Second Dose Given 30Jul2024; Initial report received on 29-Aug-2024.  A consumer in the reported that she, a 52-year-old female patient (race and ethnicity not provided), received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given the second dose late.  Medical history and concomitant medications were not reported.  On 11-May-2024, the patient received the first dose of HEPLISAV-B (Lot number 943888; expiration date, NDC number, route and injection site not reported).   On 30-Jul-2024, 81 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B late (Lot number 943191, expiration date, NDC number, route and injection site not reported).   No other 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: F
Vaccine: HEP
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Medication Leaked Out Patient Did not Receive Full Dose; Fluid Leaked Out Where the Needle Attaches; Initial report received on 30-Aug-2024.  A pharmacist in the reported that a 31-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the product leaked at the needle attachment onto the patient's skin and the patient did not receive the full dose.  No medical history was reported.    No concomitant medications were reported.    On 27-Jul-2024, the patient received the first dose of HEPLISAV-B (lot # 943888, expiration date 14-May-2026, NDC # 43528-003-05, route not reported) in the right arm.   On 30-Aug-2024, the patient received the second dose of HEPLISAV-B (lot # 944920, expiration date 04-Dec-2024, and NDC # 43528-003-05, route not reported) in the right arm.  On 30-Aug-2024, during administration of HEPLISAV-B, the space between the needle and actual syringe was loose or not attached correctly. As the reporter pressed the plunger, medication leaked onto the patient's arm. The reporter stated that she made sure the needle and syringe were tight first, but upon pushing the plunger, medication ended up on the patient's skin on her arm. The reporter is unsure if this was an issue with the product quality or with attaching the needle to the syringe as she has never had this happen in the past. The fluid leaked out where the needle attaches.  The patient did not receive the full dose. No adverse reaction was reported by patient.  No additional information was reported.    Company Comment: The company assessed the events as non-serious; Sender's Comments: The company assessed the events as non-serious
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A Couple of Weeks Late For The Second Dose; Initial report received on 09-Sep-2024.  A pharmacist in the reported that a patient (age, gender, race, and ethnicity unknown) was a couple of weeks late for their appointment for the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications were not reported.   On an unknown date, the patient received the first dose of HEPLISAV-B (Lot number, expiration date, NDC, and injection site not reported) intramuscularly.   At the time of report, the patient was "a couple of weeks" late for their appointment for the second dose of HEPLISAV-B (Lot number, expiration date, NDC, and injection site unknown) intramuscularly. The patient had no further side effects.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; breakthrough case of Herpes zoster; he revaccinates patients with additional dose of Shingrix; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 3rd dose of Shingrix (unknown arm), the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: breakthrough case of Herpes zoster) and extra dose administered (Verbatim: he revaccinates patients with additional dose of Shingrix). The outcome of the vaccination failure and herpes zoster were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-SEP-2024 The patients were in 30S decades. The pharmacist reported that he revaccinated patients with additional dose of Shingrix if had a breakthrough case of Herpes zoster after receiving both doses of Shingrix, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1), Shingrix (dose 2) and Shingrix (dose 3).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product use in unapproved indication, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; I have shingles and have taken at least 2 shots of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and drug use for unapproved indication (Verbatim: I have shingles and have taken at least 2 shots of Shingrix). The outcome of the vaccination failure and shingles were not reported and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2024 This case was self-reported by patient. The patient had shingles and had taken at least 2 shots of Shingrix. After the shots, the patients condition was improved, but within 1 to 2 years, the shingles was return. The reporter asked, was there any options to help rid of this very troublesome illness. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation for shingles was unknown at the time of reporting. The patient had shingles and still received 2 shots of Shingrix, which led to drug use for unapproved indication.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix (1st dose)and Shingrix(2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: I had the vaccine. The only thing it prevented was itching and oozing of the blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect (Verbatim: I had the vaccine. The only thing it prevented was itching and oozing of the blisters). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2024 This case was reported by a patient via interactive digital media. The patient had Shingles vaccine and the only thing it prevented was itching and oozing of the blisters, which led unexpected therapeutic benefit. This case was linked with case US2024AMR117939 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2024AMR117939:same reporter different patient
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: The only thing it prevented was itching and oozing of the blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect (Verbatim: The only thing it prevented was itching and oozing of the blisters). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK receipt date: 20-SEP-2024 This case was reported the patient via interactive digital media. The patient had the vaccine and the only thing it prevented was itching and oozing of the blisters. The case was linked with US2024AMR117836, by same reporter.; Sender's Comments:  US-GSK-US2024AMR117836:same reporter different patient
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: accidentally administered IV instead of IM; This non-serious case was reported by a nurse and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 11-SEP-2024, the patient received Boostrix (intravenous). On 11-SEP-2024, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: accidentally administered IV instead of IM). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2024 The nurse reported that today (on the reporting day) a dose of Tdap Boostrix was accidentally administered intravenous (IV) instead of intramuscular (IM) in the emergency department, which led to intramuscular formulation administered by other route. They had contacted poison control, reported the event as required by their facility and the doctor was involved as well. At the current time, patient was with no symptoms and was stable.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B virus test, Incomplete course of vaccination
Clinical narrative: giving a double dose of hepatitis b; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included hepatitis b (on an unknown date received 1st dose) and engerix b (on an unknown date received 2nd dose). Concurrent medical conditions included hiv positive.   On an unknown date, the patient  did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: giving a double dose of hepatitis b). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 11-SEP-2024 Based off the recommendations for hepatitis b for her patients who are HIV positive, NP (removed) was giving a double dose of hepatitis b to her patients because they were coming back with low titers for hepatitis b. The reporter asked if she could gave Twinrix at an accelerated dosing schedule to help with hepatitis b. The reporter asked if she should revaccinate her patients that were no seroconverting every year. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient received only 2 dose of hepatitis b, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Mental disorder, Physical disability
Clinical narrative: TEMPORARILY CRIPPLED; LOSE MENTAL FACILITIES; PERMANENTLY DEBILITATED; This spontaneous report received from a patient via J&J managed social media site. The patient's weight, height, and medical history were not reported. The patient received haloperidol (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient received covid-19 vaccine ad26.cov2.s (Dose series: 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced Temporarily crippled and subsequently, placed involuntarily on Haldol, and proceeded to lose  mental facilities and added that the combination of the two permanently debilitated patient life (Dose Series;1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable for the events of temporarily crippled, lose mental facilities and permanently debilitated, and haloperidol was not applicable for the event of temporarily crippled; and action taken with haloperidol was not reported for the events of  lose mental facilities and permanently debilitated. The outcome of the temporarily crippled, lose mental facilities and permanently debilitated was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: feels sickly/still feel terrible; Interfering with his daily life and misses his work; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feels sickly/still feel terrible) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with his daily life and misses his work) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 20-Sep-2024, the patient experienced MALAISE (feels sickly/still feel terrible) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with his daily life and misses his work). At the time of the report, MALAISE (feels sickly/still feel terrible) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with his daily life and misses his work) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 23-Sep-2024, patient reported that, he still felt terrible. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2024: Live non-significant follow up received. Reference number added. On 23-Sep-2024: Live non-significant follow up received. Verbatim updated.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: congestive heart failure; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The got booster last year in November 2023 had not reaction. In January 2024 their Physician informed them they had congestive heart failure. No treatment medication was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Cardiac failure congestive, which occurred approximately 2 months after SPIKEVAX 2023-2024 vaccine, administered as booster dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Scan, Ultrasound eye
Clinical narrative: Acute Macular Neuroretinopathy; This spontaneous case was reported by a patient and describes the occurrence of ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) (seriousness criterion medically significant). The patient was treated with CELECOXIB (CELEBREX) for Pain behind eyes, at a dose of 200 milligram. At the time of the report, ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: CTA and CT scans of head negative. On an unknown date, Blood test: Blood work for MS, RA, and other Autoimmune disorders negative.. On an unknown date, Computerised tomogram head: CTA and CT scans of head negative. On an unknown date, Magnetic resonance imaging head: MRI of brain, neck, spine all negative to lesions.. On an unknown date, Magnetic resonance imaging neck: MRI of brain, neck, spine all negative to lesions.. On an unknown date, Magnetic resonance imaging spinal: MRI of brain, neck, spine all negative to lesions.. On an unknown date, Scan: Scan of blood vessels behind left eye- positive for vessels not providing blood flow to left eye.. On an unknown date, Ultrasound eye: negative.         No relevant concomitant medications were reported. Patient had black eye floaters for months then loss of color, blurred vision, and large para-central scotoma. It was unknown if the patient experienced any additional symptoms/events. Company comment: This spontaneous case concerns a 64-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Acute Macular Neuroretinopathy after one dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine, dose not reported. The event onset date and the suspect start date seem to be discrepancy, hence, the company causality was conservatively retained as related. Blood tests were negative for autoimmune disorders. Computerized tomogram of the head was negative. Magnetic resonance imaging of brain, neck, spine was negative to lesions. A scan of blood vessels behind left eye revealed that vessels were not providing blood flow to left eye. An angiogram and an ultrasound were negative. No treatment medication was reported. The event had not resolved. No further clinical information was available for medical review. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Epstein-Barr virus test, Fatigue, Headache, Myalgia
Clinical narrative: Fever; Headache; Muscle aches; Diarrhea; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042388) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol.    On 05-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 06-Sep-2024, the patient experienced PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 200 milligram, 5 or 6 times over 3 weeks. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Epstein-Barr virus test: High antibodies but no active virus..     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient still had fatigue, diarrhea and aches ongoing three weeks later.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; Muscle aches; Diarrhea; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042388) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol.    On 05-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 06-Sep-2024, the patient experienced PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 200 milligram, 5 or 6 times over 3 weeks. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Epstein-Barr virus test: High antibodies but no active virus..     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient still had fatigue, diarrhea and aches ongoing three weeks later.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: body aches; pain at the injection site; fatigue; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (fatigue) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 on 22-Nov-2023.   On 26-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 27-Sep-2024, the patient experienced PAIN (body aches), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) (oral use) on 26-Sep-2024 at a dose of 325 milligram and PARACETAMOL (TYLENOL) (oral use) on 27-Sep-2024 at a dose of 325 milligram. At the time of the report, PAIN (body aches), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (fatigue) and CHILLS (chills) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported.  Patient took vaccines (Covid-19 and flu vaccine) around 3:15 pm on 26-Sep-2024. Patient woke up around 5 am with pain at the injection site (mild in the arm with the flu vaccine, and moderate in the arm with the covid-19 vaccine) Patient quickly started feeling better after taking Tylenol. The patient did not experience any additional symptoms/events and had no concomitant disease or risk factor.   This case was linked to MOD-2022-670155 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: long COVID-19, tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long COVID-19, tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2024, the patient experienced POST-ACUTE COVID-19 SYNDROME (long COVID-19, tested positive for COVID-19). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long COVID-19, tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, SARS-CoV-2 test: Positive.     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 was reported. Suspect product dosage text was reported as unknown. The patient stated he wants to get the latest vaccine, but his doctor had told him it's up to him to decide. No treatment medication was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Still very itchy and red.; Still very itchy and red.; Itchy 2 inches x 4 inches lump developed at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Still very itchy and red.), VACCINATION SITE ERYTHEMA (Still very itchy and red.) and VACCINATION SITE MASS (Itchy 2 inches x 4 inches lump developed at injection site) in an 82-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080433) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 19-Sep-2024, the patient experienced VACCINATION SITE PRURITUS (Still very itchy and red.), VACCINATION SITE ERYTHEMA (Still very itchy and red.) and VACCINATION SITE MASS (Itchy 2 inches x 4 inches lump developed at injection site). At the time of the report, VACCINATION SITE PRURITUS (Still very itchy and red.), VACCINATION SITE ERYTHEMA (Still very itchy and red.) and VACCINATION SITE MASS (Itchy 2 inches x 4 inches lump developed at injection site) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. It was reported that itchy (2 inches x 4 inches) lump developed at injection site. The lump lasted 6 days. It was still very itchy and red. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    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 COVID-19 (covid 19) (seriousness criterion death). The patient died in 2022. The reported cause of death was covid-19. It is unknown if an autopsy was performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. Company comment: This fatal spontaneous case concerns a female patient of an unknown age, with no medical history reported, who received an unspecified dose of SPIKEVAX COVID-19 VACCINE NOS vaccine and experienced the unexpected and fatal (serious due to death) event of COVID-19. The vaccination date was not provided; hence, latency could not be assessed. No details of previous doses were provided. The reported cause of death was covid-19. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774192:Reporter's case(Master case); Reported Cause(s) of Death: COVID-19
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: injection site had large red painful itchy welts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (injection site had large red painful itchy welts) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 26-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE URTICARIA (injection site had large red painful itchy welts). At the time of the report, VACCINATION SITE URTICARIA (injection site had large red painful itchy welts) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       The concomitant medication was not reported by reporter.   After new covid injection within 24 hours injection site patient had large red painful itchy welts, It was unknown if the patient experienced any additional symptoms/events.  The treatment medication was not reported by reporter.   Reporter causality was not reported.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HBP called to report inadvertent administration of VAXELIS and VAXNEUVANCE after a temperature excursion; This spontaneous safety report was received by the partner on 06-JUN-2024 and forwarded to agency on 07-JUN-2024 from a consumer.  Due to the nature of the event, the causality between the event and the product was not applicable.  This case is non-valid due to no patient identifiers.  Further information is expected.  Significant Follow-up information was received by the partner on 31-JUL-2024 and forwarded to agency on 01-AUG-2024, from consumer. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "HBP called to report inadvertent administration of VAXELIS and VAXNEUVANCE after a temperature excursion" and Vaxelis was not applicable.  No further information is expected.