chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Flushing, Headache, Hyperhidrosis, Hypertension
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Lethargy, Lymphadenopathy, Mouth swelling, Nausea
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Paraesthesia, Pruritus, Pyrexia, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Seizure, Swelling face, Swollen tongue, Tachycardia, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus, Tremor, Visual impairment
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site swelling, Rash, Vaccination site induration, Vaccination site swelling
Clinical narrative: Patient had swelling, reddness, and hard where the vaccines were administered.  Patient also got a rash spots on her back all over.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Exercise tolerance decreased, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient came in on 1/31/23 for a vaccine and reported Left shoulder pain immediately following Hepatitis B injection. He states he has pain lifting arm and trouble doing his normal routine exercise. Patient had not followed up with a provider for further evaluation yet.
Sex: U
Vaccine: UNK
Symptoms: Blood disorder, Fatigue, Oropharyngeal discomfort, Pain, Speech disorder
Clinical narrative: Odd coating feeling in the back of the throat ten to fifteen minutes after injection. Coming up from the lungs? Not feeling sliding up, just appearing as a coat.  The next day a HUGE problem that knocked me out of commission for the entire day (around 20 hours). Blood pooled and painfully hardened in my brain and could no longer flow properly. Veins around the outer perimeter felt stiff and hard. The blood felt pooled in the limbic system, like a half-scab. Painful. I could barely speak at a normal tone to my lover by the time I was falling asleep.     Love and peace,
Sex: U
Vaccine: UNK
Symptoms: Vein disorder
Clinical narrative: Odd coating feeling in the back of the throat ten to fifteen minutes after injection. Coming up from the lungs? Not feeling sliding up, just appearing as a coat.  The next day a HUGE problem that knocked me out of commission for the entire day (around 20 hours). Blood pooled and painfully hardened in my brain and could no longer flow properly. Veins around the outer perimeter felt stiff and hard. The blood felt pooled in the limbic system, like a half-scab. Painful. I could barely speak at a normal tone to my lover by the time I was falling asleep.     Love and peace,
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient described having a very sore arm and the area of the vaccination a circular area turned red and swollen and hard.  Patient reported symptoms remained 5 days after recieving vaccine.  Advised patient to contact her physician for further evaluation
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid factor
Clinical narrative: pain in palm,
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Immunisation reaction, Insomnia, Laboratory test normal
Clinical narrative: On January 30th before 6 PM, I was laying down watching TV when I started feeling tenseness in my right shoulder and eventually my left shoulder. After about three hours, I started feeling pain in my chest. I couldn't sleep comfortably that night. The next day I was feeling a little better but around 6 PM experienced pain again my chest. The pain was so intense that I decided to go to the emergency room. The doctors ran tests and said I was fine but kept me over night for observations. A nurse told me that it may have something to do with the vaccine, but they discharged me. The pain continued so I went to my primary doctor who recommended me to see a cardiologist. The cardiologists confirmed that I was experiencing a side effect of the vaccine and prescribed me colchicine. I also take CBD to help with the pain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: On January 30th before 6 PM, I was laying down watching TV when I started feeling tenseness in my right shoulder and eventually my left shoulder. After about three hours, I started feeling pain in my chest. I couldn't sleep comfortably that night. The next day I was feeling a little better but around 6 PM experienced pain again my chest. The pain was so intense that I decided to go to the emergency room. The doctors ran tests and said I was fine but kept me over night for observations. A nurse told me that it may have something to do with the vaccine, but they discharged me. The pain continued so I went to my primary doctor who recommended me to see a cardiologist. The cardiologists confirmed that I was experiencing a side effect of the vaccine and prescribed me colchicine. I also take CBD to help with the pain.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Limb injury
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity, Rheumatoid factor negative
Clinical narrative: Joint Pain in both arms, Elbows, Knees.  Throbbing, Achey feeling.  Patient followed up with PCP provider already for care.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was given another series of shingles vaccine even though she had them done previously in 2018 per pharmacy records.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received primary doses out of country but had no documentation and was to start over primary series with a dose of monovalent Pfizer. Patient was administered bivalent Pfizer instead. No adverse effects were noted during 15 minute observation; patient was advised to come back and get monovalent Pfizer as a second dose per CDC guidelines.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash on bilateral hands
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unable to contact case following hospitalization
Age: 61.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse reaction. Pt was administered wrong age group vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2".  Clinical course: Patient stated that she need a home tester kit for Covid. She was exposed Christmas  she have been quaranting since 26Dec she had Pfizer vaccination complex but she had 3 children with her she need test asap.Her symptoms were mild but no tester was stressful due to onset exposure time and 10-14 days upon results were making her sicker. She was disabled fixed income and did not have money for kit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300036011 same patient/drug, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "disable" (unspecified if ongoing), notes: I am disable fixed income dont have money for kit. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2".  Clinical course: Patients symptoms were mild but no tester was stressful due to the onset exposure time and 10-14 days upon results are making patient sicker.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300036010 same patient/drug, different dose;
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Papilloma viral infection
Clinical narrative: Pharmacist reported that the patient has been diagnosed with HPV infection since receiving 2 of the 3 GARDASIL 9 vaccines 2 years ago; The patient already had 2 of 3 doses of GARDASIL 9 about 2 years ago but did not complete the series not receiving the third and final dose. Pharmacist was seeking advice on restarting vaccination series versus just given the third missed dose; This spontaneous report was received from a pharmacist referring to an adult female patient of unspecified age. The patient's concurrent conditions, historical conditions, concomitant therapies, and allergies were not reported.  In approximately 2021 (reported as about 2 years ago), when the patient was about 23-year-old, she received two (2) of the three (3) dose regimen prescribed by a physician of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL9) injection, administered intramuscularly (strengths, dosages, anatomical sites of application, lot numbers and expiration dates were not reported) for an indication stated as human papillomavirus (HPV) (prophylaxis).   On an unspecified date, since receiving 2 of the 3 HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL9), the patient was diagnosed with HPV infection (papilloma viral infection). Additionally, it was reported that the patient did not complete the series and not received the third and final dose (inappropriate schedule of product administration). Therefore, the pharmacist was seeking for advice on restarting vaccination series versus just giving the third missed dose. It was unknown by the reporter if lab diagnostics or studies were performed, and if any treatment was given for the event. At the reporting time, the outcome of papilloma viral infection was unknown.  The causality assessment between papilloma viral infection and the suspect vaccine was not provided by the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The pharmacist reported that her daughter, received her first dose of GARDASIL 9 and then had a syncopal episode (approximately 10 years ago).; This spontaneous report has been received from a pharmacist, referring a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date (also reported as approximately 10 years ago) 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  (strenght, dose, frequency, administration route, lot number, and expiry date were not provided) indicated as prophylaxis.  On an unknown date, after the first dose, the patient experienced a syncopal episode (syncope).   It was additionally reported that the patient received the second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strenght, dose, frequency, administration route, lot number, and expiry date were not provided) with no adverse effects.  The outcome of the event and the causality assessment were not provided.  Upon internal review, the event syncope was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Deceased/wrongful death; This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2022, the patient received Shingrix (intravenous). On 3rd August 2022, 4 days after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 3rd August 2022. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingrix.  Additional Information: GSK Receipt Date: 22 Feb 2023 Reporter's Comments:The patient allegedly passed away from complications after receiving a shingrix vial kit vaccine.The patient death case arising out of complications from an intravenous vaccine administration which occurred on 30 Jul 2022. The patient was deceased ( date of loss) on 3 Aug 2022 or wrongful . The autopsy was unknown. The patient cause of death was unknown cause of death.; Reported Cause(s) of Death: Deceased
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 3rd patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712814, US-MODERNATX, INC.-MOD-2023-712819, US-MODERNATX, INC.-MOD-2023-712822 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712814:Patient 1 US-MODERNATX, INC.-MOD-2023-712819:Patient 2 US-MODERNATX, INC.-MOD-2023-712822:Patient 4
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/Date(s) of administration of vaccine*: 24Feb2023).    Concomitant medication was not reported. The patient received vaccine at 12:11 PM. Patient received expired Moderna monovalent dose. The vaccine had been frozen with no known temperature excursion before being thawed today for administration. Vial was initially stored in the refrigerator on 24-Feb-2023. Vial did not undergo any temperature excursions.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712705, US-MODERNATX, INC.-MOD-2023-712698 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Live non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705: US-MODERNATX, INC.-MOD-2023-712698:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; For doses administered past the expiration/beyond-use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712878 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712878:Same reporter US-MODERNATX, INC.-MOD-2023-712882:Same reporter
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: He came down with COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He came down with COVID Disease) in a 63-year-old male 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-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced COVID-19 (He came down with COVID Disease). At the time of the report, COVID-19 (He came down with COVID Disease) had not resolved.        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 medications was reported. It was reported that the 64-year-old retired lab worker received 3 Moderna Covid-19 vaccine in 2021 and 4th dose on 1-Dec-2022. She stated that her boyfriend who was the patient also received the same shots as her at the same place. Caller was not 100% sure that he had the Moderna COVID-19 Vaccine. She states that he probably did have Moderna because he was vaccinated at the same time as her. Since 2 weeks ago he has been having fatigue, he is lethargic and has diarrhea. No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s):   An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, unknown manufacturer), for Covid-19 immunization. The following information was reported: MYOCARDITIS (death, medically significant, life threatening), outcome "fatal". The patient date of death was unknown. Reported cause of death: "Myocarditis". It was not reported if an autopsy was performed.  Additional information: The caller reports that he is aware of a patient over the age of 80 and passed away. The caller did not know if the vaccine was Moderna or Pfizer. Agent decided to go ahead and report the adverse event. Elderly Patient in country withheld received A Covid-19 vaccine and developed Myocarditis and subsequently died. The caller did not have any other information on this patient at this time besides what is reported above.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the available information, possible temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event "Myocarditis". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: Myocarditis.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test date=Oct2022 / Covid test result=Positive; Covid test date=Oct2022 / Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "glaucoma" (unspecified if ongoing); "If covid Prior vaccination: Yes" (unspecified if ongoing), notes: If covid Prior vaccination: Yes. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline; Avelox, reaction(s): "Known allergies: Avelox", notes: Known allergies: Avelox. Vaccination history included: shingrix (Shingrix completed 23Oct2020), administration date: 23Oct2020, when the patient was 59-year-old, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Covid test date=Oct2022 / Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Nasal Swab.  Clinical course: Facility type vaccine was noted as pharmacy or drug store. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medication in two weeks. The patient had covid prior to vaccination. Covid test post vaccination was noted as nasal swab on an unspecified date in Oct2022 and result noted as positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300078579 Same patient/vaccine, different dose and event;US-PFIZER INC-202300078592 Same patient/vaccine, different dose and event;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 62 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Feb2023) Positive, notes: Paxlovid Rebound after taking Paxlovid for positive COVID; (Feb2023) Positive, notes: Second positive text six days after absence of symptoms; (Feb2023) negative, notes: three days after negative COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 07Feb2023 to 12Feb2023, the patient received Paxlovid as treatment of Covid-19. The patient had no known allergies.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: HH9702) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "VSD" (unspecified if ongoing), notes: born with congenital heart defect; "several open heart surgeries" (unspecified if ongoing), notes: directly related or tangentially related to defect (repair of VSD, mitral valve repair, oblation); "mitral valve repair" (unspecified if ongoing), notes: directly related or tangentially related to defect (repair of VSD, mitral valve repair, oblation); "ablation" (unspecified if ongoing), notes: directly related or tangentially related to defect (repair of VSD, mitral valve repair, oblation); "currently in and out of A-Fib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 treatment with Paxlovid, from 10Feb2023 till 15Feb2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER8727), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301358a), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Hereditary Hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; LISINOPRIL LUPIN; TAMSULOSIN. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details reported product=COVID 19 Treatment, brand=Paxlovid, treatment start date=11Feb2023, treatment stop date=13Feb2023. Patient did not have known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079607 Same patient/product, different dose/events;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 at 12:00 as dose 1, single (Lot number: EN6198), on 16Mar2021 at 12:00 as dose 2, single (Lot number: EP6955) and on 03Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17May2022 at 12:00 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Thyroid nodule" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Sep1992; CALCIUM, start date: 01Feb1999; WELLBUTRIN, start date: 01Feb2001; TRAZODONE, start date: 01Aug2012, stop date: 14Feb2023; FISH OIL, start date: 01Jul2015; VIT D [VITAMIN D NOS], start date: 01Oct2015. 9
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2023) Positive, notes: After finishing a 5 day course of Paxlovid (from 10Feb2023 to 15Feb2023), patient tested positive for Covid 7 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.