chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypokinesia, Tachycardia
Clinical narrative: Chest pain; tachycardia; could not move; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), TACHYCARDIA (tachycardia) and HYPOKINESIA (could not move) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 immunisation.     Previously administered products included for COVID-19 immunisation: Pfizer BioNTech COVID-19 vaccine (dose 1; chest pains for 9 months) on 13-Mar-2021, Pfizer BioNTech COVID-19 vaccine (dose 1) on 13-Mar-2021, Pfizer BioNTech COVID-19 vaccine (dose 1) on 13-Mar-2021, Pfizer BioNTech COVID-19 vaccine (dose 2) on 16-Aug-2021 and Pfizer BioNTech COVID-19 vaccine (dose 2) on 16-Aug-2021. Past adverse reactions to the above products included Chest pain with Pfizer BioNTech COVID-19 vaccine; Chills with Pfizer BioNTech COVID-19 vaccine; Costochondritis with Pfizer BioNTech COVID-19 vaccine; Myocarditis with Pfizer BioNTech COVID-19 vaccine; and Tachycardia with Pfizer BioNTech COVID-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization) and HYPOKINESIA (could not move) (seriousness criterion hospitalization). The patient was hospitalized on 03-Jun-2022 due to CHEST PAIN, HYPOKINESIA and TACHYCARDIA. At the time of the report, CHEST PAIN (Chest pain), TACHYCARDIA (tachycardia) and HYPOKINESIA (could not move) outcome was unknown.            No concomitant drug was reported.  On 03-Jun-2022, the patient was hospitalized overnight.  No treatment drug was reported.  Company Comment: This is a Spontaneous case concerning a 64-year-old female patient with medical history of interchange of vaccine administration, COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine 1st and 2nd dose with adverse events of chest pains for 9 months, tachycardia, and myocarditis. The patient received 3rd dose with mRNA-1273 and on an unknown date and latency experienced the serious (per hospitalization) unexpected events of Chest pain, Tachycardia and Hypokinesia. The mentioned medical history of adverse reactions after first and second dose with Pfizer BioNTech remains a confounder. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pulmonary embolism
Clinical narrative: Pulmonary embolism/ Pain behind his leg; PAIN BEHIND HIS LEG; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism/ Pain behind his leg) and PAIN IN EXTREMITY (PAIN BEHIND HIS LEG) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (patient received dose 1 of monovalent Moderna COVID-19 vaccine, lot: 002A21A) on 26-Feb-2021, Moderna covid-19 vaccine (patient received dose 2 of monovalent Moderna COVID-19 vaccine, lot: 045A21A.) on 01-Apr-2021, Moderna covid-19 vaccine (patient received dose 3 of monovalent Moderna COVID-19 vaccine, lot: 939905..) on 27-Oct-2021, Moderna covid-19 vaccine (patient received dose 4 of monovalent Moderna COVID-19 vaccine and lot: 066K21A.) on 02-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 25-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism/ Pain behind his leg) (seriousness criteria hospitalization and medically significant) and PAIN IN EXTREMITY (PAIN BEHIND HIS LEG) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism/ Pain behind his leg) and PAIN IN EXTREMITY (PAIN BEHIND HIS LEG) outcome was unknown.            No concomitant drug was reported.   No treatment drug was reported. Company comment- This is a regulatory authority case concerning a 72-year-old male patient with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI pulmonary embolism along with the unexpected and serious (hospitalization) event pain in extremity. It was reported that after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a 5th dose of COVID vaccine schedule the patient had pain behind his leg, was hospitalized, and had a pulmonary embolism. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022; Achy with all doses; Chills with all doses; Exhaustion have had this happen with all doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy with all doses), CHILLS (Chills with all doses), FATIGUE (Exhaustion have had this happen with all doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch nos. 004M21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2022, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced PAIN (Achy with all doses), CHILLS (Chills with all doses) and FATIGUE (Exhaustion have had this happen with all doses). On 27-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022). On 09-Mar-2022, PAIN (Achy with all doses), CHILLS (Chills with all doses) and FATIGUE (Exhaustion have had this happen with all doses) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022) outcome was unknown.            No concomitant medication information was provided. Patient experienced achy, chills, exhaustion and have had this happen with all doses. Patient took Paxlovid for COVID-19 treatment from 30 Sep 2023 to 05 Oct 2023. Patient had medication drugs include Prednisone from 23 Sep 2023 to 28 Sep 2023, Rabeprazole on 24 Mar 2023, Clonazepam on an unknown date, DULOXETINE HCL DR 20 MG CAP CAPSULE,DELAYED RELEASE(DR/EC) on an unknown date. No treatment medication was reported.   This case was linked to MOD-2023-746343 (Patient Link).
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Experienced pain in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Experienced pain in his arm) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Experienced pain in his arm). At the time of the report, PAIN IN EXTREMITY (Experienced pain in his arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: body aches; severe fatigue; slight nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (body aches), FATIGUE (severe fatigue) and NAUSEA (slight nausea) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), FATIGUE (severe fatigue) and NAUSEA (slight nausea). At the time of the report, MYALGIA (body aches), FATIGUE (severe fatigue) and NAUSEA (slight nausea) outcome was unknown.        No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745580:Wife case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She also had some of these after her previous vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She also had some of these after her previous vaccines) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) on 04-Feb-2021 and Pfizer vaccine (Dose 2) on 25-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 09-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She also had some of these after her previous vaccines). At the time of the report, IMMUNISATION REACTION (She also had some of these after her previous vaccines) outcome was unknown.            Concomitant medication not reported.   The patient had Pfizer booster on 11 Oct 2022.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745708.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Viral infection
Clinical narrative: mild virus-like symptoms; muscle aches; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (mild virus-like symptoms), MYALGIA (muscle aches) and CHILLS (Shivers) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (mild virus-like symptoms), MYALGIA (muscle aches) and CHILLS (Shivers). At the time of the report, VIRAL INFECTION (mild virus-like symptoms), MYALGIA (muscle aches) and CHILLS (Shivers) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that, with the previous doses patient had experienced muscle aches, shivers, and mild virus-like symptoms for about a day. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745822 (Linked Report). This case was linked to MOD-2023-745834 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745822:Wife Case
Sex: U
Vaccine: UNK
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:arthritis, on methotrexate low dose.  Concurrent medical conditions included Arthritis. Concomitant products included METHOTREXATE for Arthritis.    On 13-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand). At the time of the report, ARTHRALGIA (The patient had severe joint pains especially on wrists and fingers on both hands but it was more severe on right hand) outcome was unknown.            Treatment medication was not reported.  The patient's arthritic problem was improving on 10-Oct-2023.  On 13-Oct-2023, the patient had spikevax vaccine and had severe joint pains especially on wrists and fingers on both hands, but more severe in right hand.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Live significant Follow-up information added. Reference number added.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: arm pain; lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and SLEEP DEFICIT (lack of sleep) in an 8-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced SLEEP DEFICIT (lack of sleep). On 18-Oct-2023, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) and SLEEP DEFICIT (lack of sleep) outcome was unknown.            Concomitant medication was not reported.  The patient experienced arm pain causing lack of sleep. The patient had to stay home from school also. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: feeling like he had the flu; arm hurting; body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (body ache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21-B, 939906-B, 025B21A and 044A21A) for COVID-19 prophylaxis.     Patient had no allergy or history of Covid-19.  The patient's past medical history included Palpitation (his father and sister). Concurrent medical conditions included Diabetes, Blood pressure high, Cholesterol blood excessive and Palpitation.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (body ache). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medicines for diabetes, high blood pressure and cholesterol. Patient received dose 5 on 23-Sep-2023 (batch no: AS7147B) and dose 6 on 06-Oct-2023 (batch no: unknown).1 month prior to dose 6 patient had received Flu shot and Shingles vaccine.  Patient had usual symptoms like body ache, arm hurting, and feeling like he had the flu. He still went to work with all the vaccinations and did his normal activities. Treatment medication was not reported.   This case was linked to MOD-2023-744827, MOD-2023-746198.
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: feeling like he had the flu; arm hurting; Body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (Body ache) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Patient had no allergy or history of Covid-19.  Family history included Palpitation (his father and sister). Concurrent medical conditions included Diabetes, Blood pressure high, Cholesterol blood excessive and Palpitation.    On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like he had the flu), PAIN IN EXTREMITY (arm hurting) and MYALGIA (Body ache) outcome was unknown.        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.   Concomitant medications included medicines for diabetes, high blood pressure and cholesterol. Patient received dose 1 on19-Mar-2021 (batch no: 044A21A), dose 2 on 16-Apr-2021 (batch no: 025B21A), dose 3 on 04-Nov-2021 (batch no: 939906-B) and dose 4 on 22-Apr-2022 (batch no: 022J21-B).  Patient had usual symptoms like body ache, arm hurting, and feeling like he had the flu. He still went to work with all the vaccinations and did his normal activities. Treatment medication was not reported.   This case was linked to MOD-2023-744827, MOD-2023-746194 (Patient Link).
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Sleep deficit
Clinical narrative: Arm pain causing lack of sleep; Arm pain causing lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain causing lack of sleep) and SLEEP DEFICIT (Arm pain causing lack of sleep) in a 6-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (Arm pain causing lack of sleep) and SLEEP DEFICIT (Arm pain causing lack of sleep). At the time of the report, PAIN IN EXTREMITY (Arm pain causing lack of sleep) and SLEEP DEFICIT (Arm pain causing lack of sleep) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant and treatment medications were not reported.  Reported that patient had arm pain causing lack of sleep and needing to stay home from school.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Urinary incontinence
Clinical narrative: Achy; The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours; Chills; Exhaustion have had this happen with all doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), URINARY INCONTINENCE (The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours), CHILLS (Chills) and FATIGUE (Exhaustion have had this happen with all doses) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy), URINARY INCONTINENCE (The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours), CHILLS (Chills) and FATIGUE (Exhaustion have had this happen with all doses). At the time of the report, PAIN (Achy), CHILLS (Chills) and FATIGUE (Exhaustion have had this happen with all doses) outcome was unknown and URINARY INCONTINENCE (The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours) had resolved.        No concomitant medication information was provided. Patient had dose 3 of moderna vaccine on 30 Oct 2022, Lot No: 076C21A and Location of injection was left arm. Patient had dose 2 of moderna vaccine on 27 May 2022, Lot No: 004M21A and Location of injection was left arm. Patient had dose 1 of moderna vaccine on 02 Mar 2022, Location of injection was right arm. Patient had Paxlvoid for COVID-19 treatment from 30 Sep 2023 to 05 Oct 2023. Patient had medication drugs included Prednisone from 23 Sep 2023 to 28 Sep 2023, Rabeprazole on 24 Mar 2023, Clonazepam on an unknown date, DULOXETINE HCL DR 20 MG CAP CAPSULE, DELAYED RELEASE(DR/EC) on an unknown date. The reported event was achy, chills, exhaustion had that happened with all doses The last shot patient got was in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours. No treatment medication was provided by the reporter.   This case was linked to MOD-2023-745589 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Urine alcohol test positive
Clinical narrative: Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol; This spontaneous case was reported by a consumer and describes the occurrence of URINE ABNORMALITY (Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Lisinopril 20mg (Taking, Lisinopril 20mg), Levothyroxine 25mg (Levothyroxine 25mg), Metoprolol, Lovastatin and HCTZ (HCTZ 25 mg). Past adverse reactions to the above products included No adverse event with HCTZ, Levothyroxine 25mg, Lisinopril 20mg, Lovastatin and Metoprolol. Concurrent medical conditions included Blood pressure high, Hypothyroidism and High cholesterol.    On 06-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINE ABNORMALITY (Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol). At the time of the report, URINE ABNORMALITY (Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine alcohol test: (Positive) Since vaccination he had 2 urine test that showed positive for alcohol in the urine and (Positive) Since vaccination he had 2 urine test that showed positive for alcohol in the urine.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   He states that he had 2 DUI's about 10 months prior to vaccination. The court was making him to take classes and ransom unannounced urine alcohol tests. He states that he had Spikevax at local pharmacy on 06OCT2023. He states that he had been sober for 10 months now. He even got rid of his mouth wash and shaving cream because they had alcohol. He states that he does not had liver disease.  He had received 3 COVID-19 vaccine prior. Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2023: Live follow-up received include Reporter details added, suspect Product dose details updated, inarrative updated.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Fatigue, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy), PRURITUS (sore arm swollen hard left bicep. Became red and itchy), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     HSV 2.  The patient's past medical history included HSV infection. Previously administered products included for Product used for unknown indication: Flu shot (Regular not senior) on 18-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Oct-2023, the patient experienced PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy), PRURITUS (sore arm swollen hard left bicep. Became red and itchy), FATIGUE (fatigue) and PYREXIA (low grade fever). On an unknown date, the patient experienced ERYTHEMA (sore arm swollen hard left bicep. Became red and itchy). The patient was treated with HYDROCORTISONE (topical) at a dose of 1% OTC and ACETAMINOPHEN at a dose of 1/2 dose a day. On 13-Oct-2023, PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy) and PRURITUS (sore arm swollen hard left bicep. Became red and itchy) had resolved with sequelae. At the time of the report, FATIGUE (fatigue), PYREXIA (low grade fever) and ERYTHEMA (sore arm swollen hard left bicep. Became red and itchy) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It is unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Pyrexia
Clinical narrative: sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy), PRURITUS (sore arm swollen hard left bicep. Became red and itchy), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     HSV 2.  The patient's past medical history included HSV infection. Previously administered products included for Product used for unknown indication: Flu shot (Regular not senior) on 18-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Oct-2023, the patient experienced PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy), PRURITUS (sore arm swollen hard left bicep. Became red and itchy), FATIGUE (fatigue) and PYREXIA (low grade fever). On an unknown date, the patient experienced ERYTHEMA (sore arm swollen hard left bicep. Became red and itchy). The patient was treated with HYDROCORTISONE (topical) at a dose of 1% OTC and ACETAMINOPHEN at a dose of 1/2 dose a day. On 13-Oct-2023, PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy) and PRURITUS (sore arm swollen hard left bicep. Became red and itchy) had resolved with sequelae. At the time of the report, FATIGUE (fatigue), PYREXIA (low grade fever) and ERYTHEMA (sore arm swollen hard left bicep. Became red and itchy) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It is unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Sex: F
Vaccine: UNK
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745830, US-MODERNATX, INC.-MOD-2023-745834 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745830:Husband case for previous dose (SPIKEVAX NOS ) US-MODERNATX, INC.-MOD-2023-745834:Husband case for recent dose (SPIKEVAX 2023-2024)
Sex: U
Vaccine: UNK
Symptoms: Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: they felt strange; headache; muscles pains on their legs and thighs; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (they felt strange), HEADACHE (headache) and MYALGIA (muscles pains on their legs and thighs) in an 80-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Surgery (Heart Procedure).   On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) at an unspecified dose. On 13-Oct-2023, the patient experienced HEADACHE (headache) and MYALGIA (muscles pains on their legs and thighs). On an unknown date, the patient experienced FEELING ABNORMAL (they felt strange). The patient was treated with PARACETAMOL (TYLENOL) in October 2023 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (they felt strange) outcome was unknown and HEADACHE (headache) and MYALGIA (muscles pains on their legs and thighs) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Multiple use of single-use product, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Patient reported sore arm; they administered a patient with flu shot and Spikevax using same needle but not the same syringe (caller did not know if Spikevax was administered first or vice versa), because the needle stayed into the patient in between shots.; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Patient reported sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (they administered a patient with flu shot and Spikevax using same needle but not the same syringe (caller did not know if Spikevax was administered first or vice versa), because the needle stayed into the patient in between shots.) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 8058581) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient had not known medical history/conditions, allergy, concomitant diseases and risk factor. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 12-Oct-2023, the patient experienced PAIN IN EXTREMITY (Patient reported sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (they administered a patient with flu shot and Spikevax using same needle but not the same syringe (caller did not know if Spikevax was administered first or vice versa), because the needle stayed into the patient in between shots.). At the time of the report, PAIN IN EXTREMITY (Patient reported sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (they administered a patient with flu shot and Spikevax using same needle but not the same syringe (caller did not know if Spikevax was administered first or vice versa), because the needle stayed into the patient in between shots.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that they administered a patient with flu shot and Spikevax using same needle but not the same syringe (caller did not know if Spikevax was administered first or vice versa), because the needle stayed into the patient in between shots. Patient reported sore arm. No treatment medication was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report T/E for PROQUAD. PROQUAD was administered during a T/E(case#02492293). PROQUAD outcome was supported. No Additional AE reported. No PQC reported.  PROQUAD:  Outcome is supported: Temperature : 12.5F  Time frame: 0 hours 25 minute; This spontaneous report was received from a nurse, referring to a patient of unknown gender and age.  The patient's medical history, concurrent conditions were not reported, allergies, drug reactions and concomitant therapies were not reported.  On 16-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, administered for prophylaxis (lot #X000792, has been confirmed as valid, and expiration date was reported and validated on 07-JUL-2024, therapy type rHA, frequency, scheme, strength, and route of administration were not provided). The vaccine underwent temperature excursion, with a maximum temperature of 12.5 Fahrenheit (F) in a time frame of 25 minutes (Product storage error) (on 13-OCT-2023). No additional side effects were reported.
Sex: U
Vaccine: HPV9, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: has a 4 month old that sees a provider in another town that was mistakenly administered Gardasil 9 instead of Prevnar 20 at their 4 month well check; has a 4 month old that sees a provider in another town that was mistakenly administered Gardasil 9 instead of Prevnar 20 at their 4 month well check; No PQC/additional AE reported.; This spontaneous report was received from a physician referring to a 4 month patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, the patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not provided) for prophylaxis instead of pneumococcal vaccine conj 20v (crm197)(PREVNAR 20) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not provided) (wrong product administered, product administered to patient of inappropriate age).   No adverse event reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: she felt hot from her forehead down to the top of her neck - it was red and warm to touch; she felt hot from her forehead down to the top of her neck - it was red and warm to touch; This spontaneous case was reported by a patient and describes the occurrence of SKIN WARM (she felt hot from her forehead down to the top of her neck - it was red and warm to touch) and ERYTHEMA (she felt hot from her forehead down to the top of her neck - it was red and warm to touch) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRINA-G) for Anticoagulant therapy.    Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ACETYLSALICYLIC ACID (ASPIRINA-G) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SKIN WARM (she felt hot from her forehead down to the top of her neck - it was red and warm to touch) and ERYTHEMA (she felt hot from her forehead down to the top of her neck - it was red and warm to touch). At the time of the report, SKIN WARM (she felt hot from her forehead down to the top of her neck - it was red and warm to touch) and ERYTHEMA (she felt hot from her forehead down to the top of her neck - it was red and warm to touch) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was on blood thinner. She stated that she had the 4 Moderna vaccines and after the 1st dose, she felt hot from her forehead down to the top of her neck - it was red and warm to touch. She did not have this after the succeeding doses as she took Benadryl before and after the injections. She says that she's been on Aspirin even before she took the 1st dose of the Moderna Covid-19 vaccine. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Underdose
Clinical narrative: So there are five of us that were infected.; The rest of us got the you know the half dose for the booster; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (So there are five of us that were infected.), ILLNESS (My wife and I were sick) and UNDERDOSE (The rest of us got the you know the half dose for the booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (So there are five of us that were infected.), ILLNESS (My wife and I were sick) and UNDERDOSE (The rest of us got the you know the half dose for the booster). At the time of the report, COVID-19 (So there are five of us that were infected.) and ILLNESS (My wife and I were sick) had resolved and UNDERDOSE (The rest of us got the you know the half dose for the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   In Dec-2022, the patient husband got infected and ended up infecting the rest of my family. All the family was vaccinated and boosted. The patient and her husband were sick. The family was boosted around the same time, but received half dose for the booster, and nobody got seriously ill and sick. The patient took Paxlovid, the patient was recovered, and it was interesting because when my husband was trying to determine what the appropriate booster was, totally five of us were infected and vaccination records are not available at the time of the call.  All family members received the same number of doses of COVID-19 vaccine except for the caller who works as a HCP.  Patient received 5 or 6 doses of the Moderna COVID19 vaccine.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745748 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Live Follow-up received that contains significant information: Reporter, patient detail, event and refence Ids updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745748:Master case
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Condition aggravated, Depression, Suicidal ideation
Clinical narrative: significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts; significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSION (significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts) and ANXIETY (significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Anxiety and Depression.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced DEPRESSION (significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts) and ANXIETY (significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts). At the time of the report, DEPRESSION (significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts) and ANXIETY (significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  Significant increases in mental health symptoms of depression and anxiety for several days that was included suicidal thoughts. It is unknown if the patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor. There were no lab data/results available.   No treatment medications were provided.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Sleep deficit
Clinical narrative: lack of sleep; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and SLEEP DEFICIT (lack of sleep) in a 10-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023, the patient experienced PAIN IN EXTREMITY (arm pain). On an unknown date, the patient experienced SLEEP DEFICIT (lack of sleep). At the time of the report, PAIN IN EXTREMITY (arm pain) and SLEEP DEFICIT (lack of sleep) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
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 noncontactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid- 19 immunisation; bnt162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL9264), in right arm, on 06Mar2021 at 12:00 as dose 2, single (Lot number: EN6205), in right arm and on 08Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527), in right arm for covid- 19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs, honey bee venom; "honey bee venom" (unspecified if ongoing), notes: Known allergies: Sulfa drugs, honey bee venom. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARSCoV- 2 test: Positive, notes: Tested positive for Covid 4 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 26Sep2023 to 01Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.