chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCIENE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCIENE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Confusional state, Eye movement disorder, Head injury, Hyperhidrosis, Syncope
Clinical narrative: patient had vasovagal syncopal episode resulting in her falling backwards, hitting her head. Send to ED via EMS. was confused so CT scan was done but was unremarkable. Pt held for observation under she was at baseline normal and discharged home
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Computerised tomogram normal, Confusional state, Fall, Head injury, Syncope
Clinical narrative: patient had vasovagal syncopal episode resulting in her falling backwards, hitting her head. Send to ED via EMS. was confused so CT scan was done but was unremarkable. Pt held for observation under she was at baseline normal and discharged home
Age: 65.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Contusion, Petechiae
Clinical narrative: thrombocytopenia with bruising platelets of 7000
Age: 65.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Contusion, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: thrombocytopenia with bruising platelets of 7000
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Weight bearing difficulty
Clinical narrative: Severe left knee pain; tightness around the knee and sides; Very unpleasant pain if lifting leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shrimp" (unspecified if ongoing). Concomitant medication(s) included: EMERGEN-C; ACETAMINOPHEN. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol". The following information was reported: ARTHRALGIA (non-serious) with onset 26Sep2023 at 08:00, outcome "not recovered", described as "Severe left knee pain"; PAIN IN EXTREMITY (non-serious) with onset 26Sep2023 at 08:00, outcome "not recovered", described as "Very unpleasant pain if lifting leg"; JOINT STIFFNESS (non-serious) with onset 26Sep2023 at 08:00, outcome "not recovered", described as "tightness around the knee and sides". Therapeutic measures were not taken as a result of arthralgia, joint stiffness, pain in extremity. Additional information: Severe left knee pain: tightness around the knee and sides. Very unpleasant pain if weight/pressure is placed on knee. Very unpleasant pain if lifting leg in order to go up a level of stairs/flooring and more unpleasant while descending. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint stiffness, Pain in extremity
Clinical narrative: Severe left knee pain; tightness around the knee and sides; Very unpleasant pain if lifting leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shrimp" (unspecified if ongoing). Concomitant medication(s) included: EMERGEN-C; ACETAMINOPHEN. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol". The following information was reported: ARTHRALGIA (non-serious) with onset 26Sep2023 at 08:00, outcome "not recovered", described as "Severe left knee pain"; PAIN IN EXTREMITY (non-serious) with onset 26Sep2023 at 08:00, outcome "not recovered", described as "Very unpleasant pain if lifting leg"; JOINT STIFFNESS (non-serious) with onset 26Sep2023 at 08:00, outcome "not recovered", described as "tightness around the knee and sides". Therapeutic measures were not taken as a result of arthralgia, joint stiffness, pain in extremity. Additional information: Severe left knee pain: tightness around the knee and sides. Very unpleasant pain if weight/pressure is placed on knee. Very unpleasant pain if lifting leg in order to go up a level of stairs/flooring and more unpleasant while descending. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: unknown
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No Additional AE; a patient was inadvertently administered PROQUAD after it suffered a TE.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 03-OCT-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHa) (involved lot # was x014623, expiration date: 18-NOV-2024 [verified to be valid]); 0.5 ml/ series, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was -14 degree Celsius (C) and time frame was 40 hours 0 minutes 0 seconds. There was no previous temperature excursion nor report of adverse effect or product quality complaint involved.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE for Supported TE for VARIVAX.; This spontaneous report was received from a Registered Nurse and refers to a 15-month-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 03-OCT-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (involved lot # was X007373, expiration date: 12-MAR-2025 [verified to be valid]); single dose, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was -14 degree Celsius (°C) to -10°C (-13.0 C) and time frame was for 0 hours 18 minutes. There was a previous temperature excursion of -14°C to -10°C (-13.8 C) for 0 hours 26 minutes.   This is one of five reports from the same reporter.; Sender's Comments:  US-009507513-2310USA001220: US-009507513-2310USA001274:Case # 02485000 US-009507513-2310USA001416:Case # 02485005 US-009507513-2310USA001527:Case # 02485007
Sex: U
Vaccine: VARZOS
Symptoms: Spinal operation
Clinical narrative: back surgery; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of back surgery in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced back surgery (Verbatim: back surgery).  The patient was treated with ambiguous medication nos (Cortisone (Nos)). The outcome of the back surgery was unknown.   It was unknown if the reporter considered the back surgery to be related to Shingrix.     It was unknown if the company considered the back surgery to be related to Shingrix.   Additional Information: GSK receipt date: 1-Sept-2023 Pharmacist reported that the patient got a back surgery after receiving the first dose of Shingrix and was taking cortisone for that reason.  The second dose was not administered at the time. The Vaccine Administration Facility was the same as Primary Reporter. Attempt to reach health care professional back to gather information about the vaccination date, patient's identifiers, etc but it was not possible.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: has always has strong side effects, like 2 or 3 days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days). At the time of the report, IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) outcome was unknown.            No relevant concomitant medications were reported.  The patient got all the Moderna shots and had always had strong side effects, like 2 or 3 days. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743238 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743238:
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Injection site erythema, Malaise, Rash, Somnolence
Clinical narrative: It was tender, but not painful or itchy; rash has persisted on her arm; Arm is still red where she got the shot; Hives on the left side of her face and left arm; Had very little food; Slept all day Thursday; feeling sick; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick), HYPOPHAGIA (Had very little food), SOMNOLENCE (Slept all day Thursday), URTICARIA (Hives on the left side of her face and left arm) and VACCINATION SITE PAIN (It was tender, but not painful or itchy) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot in August 2023 and RSV vaccine on 19-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot and RSV vaccine. Concurrent medical conditions included Kidney failure (stage 3 Kidney failure).    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MALAISE (feeling sick). On 28-Sep-2023, the patient experienced HYPOPHAGIA (Had very little food) and SOMNOLENCE (Slept all day Thursday). On 30-Sep-2023, the patient experienced URTICARIA (Hives on the left side of her face and left arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (It was tender, but not painful or itchy), RASH (rash has persisted on her arm) and VACCINATION SITE ERYTHEMA (Arm is still red where she got the shot). At the time of the report, MALAISE (feeling sick), HYPOPHAGIA (Had very little food), SOMNOLENCE (Slept all day Thursday), URTICARIA (Hives on the left side of her face and left arm) and VACCINATION SITE PAIN (It was tender, but not painful or itchy) outcome was unknown and RASH (rash has persisted on her arm) and VACCINATION SITE ERYTHEMA (Arm is still red where she got the shot) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's other Moderna covid-19 vaccination details included: First dose on 03-Feb-2021 with lot number 030L20A, second dose on 04-Mar-2021 with lot number 030L20A, Third dose on 05-Nov-2021 with lot number 022M20A, Fourth dose on 20-Oct-2022 with lot number 031F21A. Patient's vaccination site was tender, but not painful or itchy. Patient queried that if hives a reported side effect with the Moderna Vaccine. Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness, Urticaria
Clinical narrative: It was tender, but not painful or itchy; rash has persisted on her arm; Arm is still red where she got the shot; Hives on the left side of her face and left arm; Had very little food; Slept all day Thursday; feeling sick; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick), HYPOPHAGIA (Had very little food), SOMNOLENCE (Slept all day Thursday), URTICARIA (Hives on the left side of her face and left arm) and VACCINATION SITE PAIN (It was tender, but not painful or itchy) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot in August 2023 and RSV vaccine on 19-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot and RSV vaccine. Concurrent medical conditions included Kidney failure (stage 3 Kidney failure).    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MALAISE (feeling sick). On 28-Sep-2023, the patient experienced HYPOPHAGIA (Had very little food) and SOMNOLENCE (Slept all day Thursday). On 30-Sep-2023, the patient experienced URTICARIA (Hives on the left side of her face and left arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (It was tender, but not painful or itchy), RASH (rash has persisted on her arm) and VACCINATION SITE ERYTHEMA (Arm is still red where she got the shot). At the time of the report, MALAISE (feeling sick), HYPOPHAGIA (Had very little food), SOMNOLENCE (Slept all day Thursday), URTICARIA (Hives on the left side of her face and left arm) and VACCINATION SITE PAIN (It was tender, but not painful or itchy) outcome was unknown and RASH (rash has persisted on her arm) and VACCINATION SITE ERYTHEMA (Arm is still red where she got the shot) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's other Moderna covid-19 vaccination details included: First dose on 03-Feb-2021 with lot number 030L20A, second dose on 04-Mar-2021 with lot number 030L20A, Third dose on 05-Nov-2021 with lot number 022M20A, Fourth dose on 20-Oct-2022 with lot number 031F21A. Patient's vaccination site was tender, but not painful or itchy. Patient queried that if hives a reported side effect with the Moderna Vaccine. Treatment information was not provided.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: she experienced side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (she experienced side effects) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5509B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IMMUNISATION REACTION (she experienced side effects). At the time of the report, IMMUNISATION REACTION (she experienced side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Reporter asked what vial the patient received. Reporter stated that vial was not expired and believed that the syringe was only filled to 0.25mcg but was not 100 percent sure.  Patient only had Moderna vaccines, and this was the first time she experienced side effects.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743797.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Live follow-up received contains non-significant information. On 04-Oct-2023: Live follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743797:Invalid Case (for other children)
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Cough, SARS-CoV-2 test positive
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 95-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose) in January 2021, COVID-19 VACCINE (2nd dose) in February 2021, COVID-19 VACCINE (3rd dose) in November 2021, Covid-19 vaccine (4th dose, this was an additional dose as recommended by her doctor because she is a senior citizen) in July 2022, Covid-19 vaccine on 15-Oct-2022 and bivalent (Pfizer) (6th dose - late Mar2023) in March 2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, Covid-19 vaccine, Covid-19 vaccine and bivalent (Pfizer).    On 26-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 03-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 04-Oct-2023 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that patient was hospitalized due to bronchitis and was in a rehab recuperating when she got the vaccine. She started having cough on 01-Oct-2023. Reporter stated that she was stable and recovering. Company Comment: This is a spontaneous case concerning a 95-year-old female patient with no reported medical history, who experienced the non-serious, unexpected event of COVID-19, which occurred approximately 7 days a after a dose of mRNA-1273.815 (Spikevax 2023-2024 PFS), received as the seventh dose of COVID-19 vaccination schedule. It was reported that patient was hospitalized due to bronchitis and was in a rehab recuperating when she got the vaccine. She started having cough on 5 days after vaccination. Reporter stated that she was stable and recovering. The benefit-risk relationship of mRNA-1273.815 (Spikevax 2023-2024 PFS) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-744633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744633:Son's case, Same reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in April 2020, COVID-19 on 31-Dec-2022 and COVID-19 on 21-May-2023. Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine. Concurrent medical conditions included Meningioma since August 2022. Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Meningioma, INFLUENZA VACCINE for an unknown indication.    On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 05-Oct-2023 at 5:00 AM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had a seizure while she was still in bed. The seizure was mild and lasted for about a minute, after which patient became better and has recovered. It could be because patient received both shots on the same day within minutes of each other.  Treatment medications were not reported. Company comment: This spontaneous case concerns a 55-year-old female patient, with concurrent medical conditions of meningioma in the process of reducing treatment with levetiracetam, who experienced the unexpected and serious (medically significant) AESI of SEIZURE, two days after the dose of mRNA-1273.815 vaccine. The seizure was mild and lasted for about a minute and has recovered. Previously administered products included Pfizer COVID-19 vaccine. Patient´s meningioma in the process of reducing treatment with levetiracetam and the concomitant vaccination with INFLUENZA VACCINE could be confounders for the event. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single at the age of 67 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 16Feb2022 as dose 4 (booster), sngle, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing); "osteoarthritis in knees" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ, start date: Feb2005, stop date: 26Sep2023; LEVOTHYROXINE, start date: May1966; ALENDRONATE, start date: Feb2020; CALCIUM CARBONATE, start date: Feb2020; MULTIVITAMIN ACTIVE WOMAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid from 26Sep2023 to 01Oct2023.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm-no big deal; gotten violent chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm-no big deal"; CHILLS (non-serious), outcome "recovered", described as "gotten violent chills".  Additional Information: She's had 5 previous Covid vaccines, and all of them have been from Pfizer. With the five previous vaccinations, she felt all of them go into her arm muscle. She has managed to get the vaccines and boosters, and managed to never get Covid and she doesn't want to start now. Usually she feels it go into her muscle and she gets a bit of a sore arm-no big deal. Then about twelve hours later on the money every time, she has gotten violent chills that last about another 12 hours or so.   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) : US-PFIZER INC-202300322047 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322049 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322046 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322048 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300318101 Same reporter, Patient / Different AE, Vaccine Dose;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm-no big deal; violent chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Lot number and expiration date not provided.), for covid-19 immunisation, reaction(s): "violent chills", "sore arm-no big deal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm-no big deal"; CHILLS (non-serious), outcome "unknown", described as "violent chills".  Additional Information: She's had 5 previous Covid vaccines, and all of them have been from Pfizer. With the five previous vaccinations, she felt all of them go into her arm muscle. She has managed to get the vaccines and boosters, and managed to never get Covid and she doesn't want to start now. Usually she feels it go into her muscle and she gets a bit of a sore arm-no big deal. Then about twelve hours later on the money every time, she has gotten violent chills that last about another 12 hours or so.   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) : US-PFIZER INC-202300322049 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322048 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322023 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300318101 Same reporter, Patient / Different AE, Vaccine Dose;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm-no big deal; violent chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 81-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "violent chills", "sore arm-no big deal"; Bnt162b2 (Dose 2, single), for Covid-19 immunization, reaction(s): "violent chills", "sore arm-no big deal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm-no big deal"; CHILLS (non-serious), outcome "recovered", described as "violent chills". Additional information: She's had 5 previous Covid vaccines, and all of them have been from Pfizer. With the five previous vaccinations, she felt all of them go into her arm muscle. She has managed to get the vaccines and boosters, and managed to never get Covid and she doesn't want to start now. Usually she feels it go into her muscle and she gets a bit of a sore arm-no big deal. Then about twelve hours later on the money every time, she has gotten violent chills that last about another 12 hours or so.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322023 Same reporter/patient/event, different dose;
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Drug dose omission by device
Clinical narrative: patient did not receive the vaccine since that is the only dose they have left in the Pharmacy; syringe that is attached to the saline water and the spike that goes to the vial fell apart; This is a spontaneous report received from a contactable reporter (Pharmacist), Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG DOSE OMISSION BY DEVICE (non-serious), described as "patient did not receive the vaccine since that is the only dose they have left in the Pharmacy"; DEVICE CONNECTION ISSUE (non-serious), described as "syringe that is attached to the saline water and the spike that goes to the vial fell apart ".  Additional information: The pharmacist reported that the Abrysvo vaccine that he is reconstituting had a problem; stated that the syringe that is attached to the saline water and the spike that goes to the vial fell apart. The patient did not receive the vaccine since that is the only dose they have left in the Pharmacy and will get the shot next week once they received the new order. The pharmacist also requested for a credit on the vial that was not reconstituted.   Causality for "patient did not receive the vaccine since that is the only dose they have left in the pharmacy" and "syringe that is attached to the saline water and the spike that goes to the vial fell apart " was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Device leakage, Product leakage
Clinical narrative: Abrysvo vaccine leaked everywhere; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Abrysvo vaccine leaked everywhere".  The reporter considered "abrysvo vaccine leaked everywhere" not related to rsv vaccine prot.subunit pref 2v. Causality for "abrysvo vaccine leaked everywhere" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to the Pfizer covid vaccine".  Additional information: Caller would like to know what type of vaccine is Abrysvo. Caller added that she also wants to know the ingredients of the vaccine. Upon providing response, Caller mentioned that a patient who is to receive the Abrysvo vaccine is allergic to the Pfizer covid vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Ill-defined disorder
Clinical narrative: as you get older you wake up with a different malady; 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 rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "as you get older you wake up with a different malady".  The information on the batch/lot number for RSV VACCINE PROT.SUBUNIT PREF 2V has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: mild pain/stiffness in the affected arm; mild pain/stiffness in the affected arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613) at the age of 42 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease", start date: 1992 (ongoing), notes: The condition has been stable for the past 30 years - taking levothyroxine. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown" and all described as "mild pain/stiffness in the affected arm".  Additional information: The patient has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. specific relevant test for thromboembolic events with thrombocytopenia: unknown. adverse events for thromboembolic events with thrombocytopenia include specific relevant tests above: "n/a".
Sex: U
Vaccine: UNK
Symptoms: Injection site pain, No adverse event
Clinical narrative: Soreness at site lasted a day; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in 2023 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: VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "recovered" (2023), described as "Soreness at site lasted a day".  Additional information: The COVID vaccine was painless to administer. Soreness at site lasted a day. Little or no side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.