chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Renal pain, Sluggishness, Vomiting
Clinical narrative: After his most recent dose, he felt sluggish the next day.; The next morning (Sunday) he had no energy and couldn't get out of bed all day.; He has had no appetite and only ate a slice of toast yesterday; He was achy in his lower back, muscles, and kidneys; He had extreme nausea and vomited 5 times Saturday night; He had extreme nausea and vomited 5 times Saturday night; He was achy in his lower back, muscles, and kidneys; He was achy in his lower back, muscles, and kidneys; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.), BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.) and DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2023 at 6:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), MYALGIA (He was achy in his lower back, muscles, and kidneys), NAUSEA (He had extreme nausea and vomited 5 times Saturday night) and VOMITING (He had extreme nausea and vomited 5 times Saturday night). On 15-Oct-2023, the patient experienced ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.) and DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday). On an unknown date, the patient experienced SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.). At the time of the report, SLUGGISHNESS (After his most recent dose, he felt sluggish the next day.), BACK PAIN (He was achy in his lower back, muscles, and kidneys), RENAL PAIN (He was achy in his lower back, muscles, and kidneys), ASTHENIA (The next morning (Sunday) he had no energy and couldn't get out of bed all day.), DECREASED APPETITE (He has had no appetite and only ate a slice of toast yesterday), MYALGIA (He was achy in his lower back, muscles, and kidneys), NAUSEA (He had extreme nausea and vomited 5 times Saturday night) and VOMITING (He had extreme nausea and vomited 5 times Saturday night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2023, SARS-CoV-2 test: Negative.         Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745822 (E2B Linked Report). This case was linked to MOD-2023-745830 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745822:Wife Case
Sex: U
Vaccine: COVID19
Symptoms: Generalised bullous fixed drug eruption
Clinical narrative: Generalised bullous cutaneous reaction; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED BULLOUS FIXED DRUG ERUPTION (Generalised bullous cutaneous reaction) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERALISED BULLOUS FIXED DRUG ERUPTION (Generalised bullous cutaneous reaction) (seriousness criterion medically significant). At the time of the report, GENERALISED BULLOUS FIXED DRUG ERUPTION (Generalised bullous cutaneous reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company Comment This spontaneous case concerns a patient of unknown age and gender with no medical history reported who experienced the seriousness criterion medically significant AESI of generalised bullous fixed drug eruption unknown days after a dose of mRNA-1273 vaccine. At the time of the report, the outcome of the event was unknown.  Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273 vaccine  is not affected by this report.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-745839 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745839:same patient spikevax 2023-24
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: red or warm around the injection site; Feels a little sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red or warm around the injection site) and PAIN (Feels a little sore) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, 017B21A, 033F21A and 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-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 ERYTHEMA (red or warm around the injection site) and PAIN (Feels a little sore). At the time of the report, ERYTHEMA (red or warm around the injection site) and PAIN (Feels a little sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-746010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746010:Monovalent case
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Urinary tract infection, Vaccination site erythema, Vaccination site warmth
Clinical narrative: UTI; feel a little sore; she only had maybe red or warm around the injection site for a couple days; she only had maybe red or warm around the injection site for a couple days; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (UTI), PAIN (feel a little sore), VACCINATION SITE WARMTH (she only had maybe red or warm around the injection site for a couple days) and VACCINATION SITE ERYTHEMA (she only had maybe red or warm around the injection site for a couple days) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 055F22B and 069H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Chronic bronchitis, Atrial fibrillation, Blood pressure high, Dust allergy (allergies to stuff in the air), Arthritis (Arthritis - different kinds) and Drug allergy (allergy to narcotics).   On 06-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 01-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), PAIN (feel a little sore), VACCINATION SITE WARMTH (she only had maybe red or warm around the injection site for a couple days) and VACCINATION SITE ERYTHEMA (she only had maybe red or warm around the injection site for a couple days). The patient was treated with NITROFURANTOIN for UTI, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (UTI) and PAIN (feel a little sore) outcome was unknown and VACCINATION SITE WARMTH (she only had maybe red or warm around the injection site for a couple days) and VACCINATION SITE ERYTHEMA (she only had maybe red or warm around the injection site for a couple days) had resolved.            No relevant concomitant medications were reported. Patient received first Moderna dose - 04Mar2021, lot number 029A21A, second dose - 02Apr2021, lot number 017B21A, third dose- 03Dec2021, lot number 033F21A fourth dose - 15Apr2022, lot number 056M21A, fifth dose - 06Oct2022, bivalent lot number 055F22B sixth dose -01May2023, bivalent lot number 069H22A. With all these doses patient experienced only red or warm around the injection site for a couple days and felt a little sore and in "her mind she would call that nothing". The patient received seventh Spikevax dose - 12Oct2023, lot number 203F23A (right arm). She also had flu and Respiratory Syncytial Virus (RSV) vaccines at the same time with the Spikevax but these 2 were administered on her left arm.   This case was linked to MOD-2023-746010 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: coming down with the flu; felt terrible; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (coming down with the flu) and FEELING ABNORMAL (felt terrible) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (first COVID shot with Pfizer in 2020) in 2020. Past adverse reactions to the above products included No adverse reaction with Pfizer.    On 27-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 INFLUENZA (coming down with the flu) and FEELING ABNORMAL (felt terrible). At the time of the report, INFLUENZA (coming down with the flu) and FEELING ABNORMAL (felt terrible) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He had his first COVID shot with Pfizer in 2020 and he had five since then.  He had a reaction like he couldn't believe. It wasn't anything serious. He felt terrible, like he was coming down with the flu. He was reminded that he has to have a booster.  No treatment medication was reported.   Reporter did not allow further contact
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Hypersomnia, Pyrexia
Clinical narrative: sweating; he slept a lot the day after the shot; chills; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweating), HYPERSOMNIA (he slept a lot the day after the shot), CHILLS (chills) and PYREXIA (fever) in a 14-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 15-Oct-2023, the patient experienced HYPERHIDROSIS (sweating), HYPERSOMNIA (he slept a lot the day after the shot), CHILLS (chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), CHILLS (chills) and PYREXIA (fever) had resolved and HYPERSOMNIA (he slept a lot the day after the shot) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medication not reported.   The patient received shot around 2pm on 14 Oct 2023 and developed symptoms overnight of chills, fever and sweating. Symptoms lasted the entire next day, and he slept a lot the day after the shot. It was unknown if the patient experienced any additional symptoms or events.  Treatment medication not reported. Company Comment: This is a spontaneous case concerning a 14-year-old male patient with no reported medical history, who experienced the non-serious unexpected, AESI event of Hypersomnia, which occurred on the following day after a dose of mRNA-1273.815 (Spikevax 2023-2024 PFS) vaccine, together with other non-serious events. It was reported that the patient received shot and developed symptoms overnight of chills, fever and sweating. Symptoms lasted the entire next day, and he slept a lot the day after the shot. The benefit-risk relationship of mRNA-1273.815 (Spikevax 2023-2024 PFS) vaccine is not affected by this report.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Infertility, Nausea, Pain in extremity, Premature menopause
Clinical narrative: infertility; early menopause; soreness in her arm; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFERTILITY (infertility), PREMATURE MENOPAUSE (early menopause), PAIN IN EXTREMITY (soreness in her arm) and NAUSEA (nauseous) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFERTILITY (infertility), PREMATURE MENOPAUSE (early menopause), PAIN IN EXTREMITY (soreness in her arm) and NAUSEA (nauseous). At the time of the report, INFERTILITY (infertility), PREMATURE MENOPAUSE (early menopause), PAIN IN EXTREMITY (soreness in her arm) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745838 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745838:Same Reporter Patient 1
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, No adverse event, Pain in extremity
Clinical narrative: Arm is also sore that started yesterday evening; Itching started 15 minutes after she got it around the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm is also sore that started yesterday evening) and INJECTION SITE PRURITUS (Itching started 15 minutes after she got it around the injection site) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1), Moderna COVID-19 vaccine (Dose 2), Moderna COVID-19 vaccine (Dose 3) and MODERNA COVID-19 VACCINE (Dose 4). 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 16-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Oct-2023, the patient experienced PAIN IN EXTREMITY (Arm is also sore that started yesterday evening) and INJECTION SITE PRURITUS (Itching started 15 minutes after she got it around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is also sore that started yesterday evening) and INJECTION SITE PRURITUS (Itching started 15 minutes after she got it around the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax, Moderna COVID-19 vaccine and Spikevax. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Spikevax and Spikevax. Concurrent medical conditions included Meat allergy (Alpha Gal Syndrome).    In 2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Apr-2023, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient didnot have any reactions except a sore arm for a few days. Patient wife stated that her husband used to have Alpha Gal Syndrome (Allergy to red meat). His allergy was gone for a long time, but 6 months ago it came back more severe than ever. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: My arm is red and is itchy; My arm is red and is itchy; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (My arm is red and is itchy) and ERYTHEMA (My arm is red and is itchy) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 14-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PRURITUS (My arm is red and is itchy) and ERYTHEMA (My arm is red and is itchy). At the time of the report, PRURITUS (My arm is red and is itchy) and ERYTHEMA (My arm is red and is itchy) had not resolved.            The patient had Flu vaccine within the same month.  Concomitant medication not reported.   Treatment medication not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tenderness
Clinical narrative: her arm was sore and tender to the touch; tiredness; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (her arm was sore and tender to the touch) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 014M20A and 032F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (her arm was sore and tender to the touch) and FATIGUE (tiredness). At the time of the report, TENDERNESS (her arm was sore and tender to the touch) and FATIGUE (tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient received fourth dose on 19-Oct-2022 and lot number was AS7164B. Patient doesn't remember with which of the 4 shots but stated that at most her arm was sore and tender to the touch, and maybe she felt some tiredness. However, these side effects never interfered with her daily functioning the following day. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain injection site/Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain injection site/Soreness at the injection site) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 02-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (Pain injection site/Soreness at the injection site). At the time of the report, INJECTION SITE PAIN (Pain injection site/Soreness at the injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.,  Pain and soreness at the injection site, its been almost 4 weeks since injection and getting worse It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore knee; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (sore knee) 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 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore knee). The patient was treated with MELOXICAM for Pain in knee, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (sore knee) outcome was unknown.            No concomitant medication was reported.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High fever) in a 25-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 microgram. On 18-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-474092 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-474092:Same patient, different vaccine
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram ambulatory, Supraventricular tachycardia, Ultrasound scan
Clinical narrative: irregular heartbeat/ spell where it was out of rhythm; This spontaneous case was reported by a patient and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (irregular heartbeat/ spell where it was out of rhythm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (lot number HAH8A21A) on 22-Feb-2021 and Moderna covid-19 vaccine (lot number 027H21B) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 03-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2023, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (irregular heartbeat/ spell where it was out of rhythm). The patient was treated with METOPROLOL SUCCINATE for Tachycardia supraventricular, at a dose of 25 milligram once a day. At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (irregular heartbeat/ spell where it was out of rhythm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Electrocardiogram ambulatory: supraventricular tachycardia. In 2023, Ultrasound scan: supraventricular tachycardia.         No concomitant medication was reported.  Company Comment This spontaneous case concerns  a 72-years-old-female patient with medical history of appropriate Primary schedule of moderna vaccination without adverse events who experienced the AESI of supraventricular tachycardia approximately 11 months after 3rd. dose of mRNA-1273 BIVALENT .222 vaccine. At the time of the report, the event had not resolved.    The age could be a contributor for events  The benefit-risk relationship of mRNA-1273 BIVALENT .222  vaccine  is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Gait disturbance, Retching
Clinical narrative: she could hardly walk; dry heaving; Her stomach muscles hurt from the dry heaving; dizzy; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (she could hardly walk), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (Her stomach muscles hurt from the dry heaving) and DIZZINESS (dizzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Diabetes.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (she could hardly walk), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (Her stomach muscles hurt from the dry heaving) and DIZZINESS (dizzy). In March 2021, GAIT DISTURBANCE (she could hardly walk), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (Her stomach muscles hurt from the dry heaving) and DIZZINESS (dizzy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  She stated that this was following her second Moderna vaccine. She was fine the very next day. She did a bunch of stuff. The third day, she woke up and she was so dizzy she could hardly walk. She started dry heaving. She dry heaved for about 40 minutes or so. Then she climbed back into bed and went to sleep. She did not know how long later, but she was fine when she woke up. Her stomach muscles hurt from the dry heaving.  Patient received dose 3 of Moderna vaccine on 03 NOV 2021, batch number: 014F21A. She received Pfizer vaccine on 10 MAY 2022 and Pfizer bivalent vaccine on 14 OCT 2023.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I'm just a little shaky; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I'm just a little shaky) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TREMOR (I'm just a little shaky). At the time of the report, TREMOR (I'm just a little shaky) 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.   Concomitant and treatment medications were not reported.  It was reported that caller called just to find out that patient just had, this Spikevax shot today and feel fine. Patient just a little shaky and patient wonder can i take Advil, if somebody gets this vaccine, can they take Advil? or should they take Tylenol.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Injection site reaction, No reaction on previous exposure to drug, Pain, SARS-CoV-2 test positive
Clinical narrative: positive for covid; injection site reactions; It hurt for like a day or two; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive for covid), INJECTION SITE REACTION (injection site reactions) and INJECTION SITE PAIN (It hurt for like a day or two) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031281) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (First dose (batch no. 010M20A)) on 16-Feb-2021, Moderna (second dose (batch no. 044AZIA)) on 27-Mar-2021, Moderna (Third dose (batch no. 013F21A)) on 11-Nov-2021, Moderna (fourth dose (batch no. 054A22A).) on 01-Jul-2022 and Moderna (fifth dose (batch no. AS7167B)) on 15-Dec-2022; for Product used for unknown indication: INFLUENZA VACCINE (Flu shot about 3 weeks ago). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Dust allergy.    On 13-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced INJECTION SITE PAIN (It hurt for like a day or two). On 19-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (positive for covid) and INJECTION SITE REACTION (injection site reactions). In October 2023, INJECTION SITE PAIN (It hurt for like a day or two) had resolved. At the time of the report, COVID-19 (positive for covid) and INJECTION SITE REACTION (injection site reactions) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Reported that patient received bronchial shot about 3 weeks ago. Concomitant medication reported as antidepressants.  Reported that patient had come down with a severe cold like 6 days later, does not felt so good. patient took a test at home, and it was positive for covid. Caller was gone to a pharmacy and got tested for it. patient has never had covid before. patient was not really feeling themselves. patient experienced some injection site reactions. It hurt for like a day or two.  No treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Therapeutic response unexpected
Clinical narrative: The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies; sore deltoid muscle; localized swelling with redness at the injection site; localized swelling with redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies), MYALGIA (sore deltoid muscle), INJECTION SITE SWELLING (localized swelling with redness at the injection site) and INJECTION SITE ERYTHEMA (localized swelling with redness at the injection site) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Exercise induced asthma (mild) and Chronic myeloid leukemia (which is in remission for 20 years.). Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) for Leukemia, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) from August 2023 to 08-Oct-2023 for Seasonal allergy, FUROSEMIDE and POTASSIUM for an unknown indication.   On 03-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In October 2023, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies), MYALGIA (sore deltoid muscle), INJECTION SITE SWELLING (localized swelling with redness at the injection site) and INJECTION SITE ERYTHEMA (localized swelling with redness at the injection site). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies) outcome was unknown and MYALGIA (sore deltoid muscle), INJECTION SITE SWELLING (localized swelling with redness at the injection site) and INJECTION SITE ERYTHEMA (localized swelling with redness at the injection site) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Reported that starting 12 months after her fourth vaccine the allergies came back and resolved 5 days after her 5th dose. The patient started her Claritin at the end of August and found that 5 days after her 5th Spikevax vaccine she could stop taking her Claritin because all of her seasonal allergies were resolved.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746358 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746358:Same patient, Monovalent Dose
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: experienced a site reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (experienced a site reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (experienced a site reaction). At the time of the report, VACCINATION SITE ERYTHEMA (experienced a site reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient stated with very first dose of Moderna COVID-19 when it recently came out, patient experienced a site reaction, patient had a red arm for a day or 2, but with additional Moderna booster doses (not specified dates) patient did not experience any other side effects. Patient wanted to know was patient eligible to get Spikevax after reaction to the 1st dose of Moderna.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Computerised tomogram, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: headache; tired; general feeling unwell; This Initial case was previously missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 18Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: Illness/AE: Covid-19, Onset date: 06Jan2021, pertinent details: 4 days in hospital breathing issues-on oxygen for 3 mo.; "Polymyalgia", start date: Jun2023 (ongoing), notes: Patient's Medical history:, Illness/AE: Polymyalgia, Onset date: early Jun2023, Stop date: Ongoing.; "I have had palpitations since pre-teen" (unspecified if ongoing), notes: I have had palpitations since pre-teen; "osteoporosis" (unspecified if ongoing); "Polymyalgia Rheumatica" (unspecified if ongoing); "thyroid (low)" (unspecified if ongoing); "cholesterol (A.gh)" (unspecified if ongoing); "Protect stomachache from prednisone" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE SODIUM oral taken for osteoporosis (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); PRAVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, First dose of Pfizer covid vaccine: 15Apr2021, Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "headache", "tired", "general feeling unwell"; bnt162b2 (DOSE 2, SINGLE, Second dose of Pfizer covid vaccine: 06May2021, Lot: EW0172, Time: 8 AM, Anatomical site of injection: Left arm, Route of Administration: Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "headache", "tired", "general feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321140 Same patient, different vaccine dose and event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Malaise
Clinical narrative: headache; tired; general feeling unwell; This Initial case was previously missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 18Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: Illness/AE: Covid-19, Onset date: 06Jan2021, pertinent details: 4 days in hospital breathing issues-on oxygen for 3 mo.; "Polymyalgia", start date: Jun2023 (ongoing), notes: Patient's Medical history:, Illness/AE: Polymyalgia, Onset date: early Jun2023, Stop date: Ongoing.; "I have had palpitations since pre-teen" (unspecified if ongoing), notes: I have had palpitations since pre-teen; "osteoporosis" (unspecified if ongoing); "Polymyalgia Rheumatica" (unspecified if ongoing); "thyroid (low)" (unspecified if ongoing); "cholesterol (A.gh)" (unspecified if ongoing); "Protect stomachache from prednisone" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE SODIUM oral taken for osteoporosis (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); PRAVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, First dose of Pfizer covid vaccine: 15Apr2021, Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "headache", "tired", "general feeling unwell"; bnt162b2 (DOSE 2, SINGLE, Second dose of Pfizer covid vaccine: 06May2021, Lot: EW0172, Time: 8 AM, Anatomical site of injection: Left arm, Route of Administration: Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "headache", "tired", "general feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321140 Same patient, different vaccine dose and event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Computerised tomogram, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: headache; tired; general feeling unwell; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (18Oct2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: She also had covid before any of the Pfizer shots; "Osteoporosis" (unspecified if ongoing); "Rheumatic polymyalgia" (unspecified if ongoing); "polymyalgia", start date: Jun2023 (ongoing); "Thyroid (low)" (unspecified if ongoing); "Colesterol (high)" (unspecified if ongoing); "immunization" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 29Sep2023 as dose number unknown, single; ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for rheumatic disorder, myalgia (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Lot: EW0172, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot number: FE3590, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM7553, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 13Jun2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321140 Same patient, different vaccine dose and event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Malaise
Clinical narrative: headache; tired; general feeling unwell; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (18Oct2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: She also had covid before any of the Pfizer shots; "Osteoporosis" (unspecified if ongoing); "Rheumatic polymyalgia" (unspecified if ongoing); "polymyalgia", start date: Jun2023 (ongoing); "Thyroid (low)" (unspecified if ongoing); "Colesterol (high)" (unspecified if ongoing); "immunization" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 29Sep2023 as dose number unknown, single; ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for rheumatic disorder, myalgia (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Lot: EW0172, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot number: FE3590, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM7553, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 13Jun2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321140 Same patient, different vaccine dose and event;