chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Pain
Clinical narrative: SEVERE MENSTRUAL CRAMPING, NO DISCHARGE; DOUBLING OVER IN PAIN; FATIGUE (COULD GO LAY DOWN AND TAKE A NAP); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient had finished period last week (Saturday). The patient was taking vitamins in past. The patient was previously treated with sertraline for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced severe menstrual cramping, no discharge. On 14-OCT-2021, the patient experienced doubling over in pain. On 14-OCT-2021, the patient experienced fatigue (could go lay down and take a nap). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe menstrual cramping, no discharge, fatigue (could go lay down and take a nap), and doubling over in pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Alopecia, Hypoaesthesia, Visual impairment
Clinical narrative: HARD TIME TO SEE/VISION HAS GONE VERY LOW; LOST THOUSANDS OF HAIR/2/3 OF HAIR FALLING; SEVERE NUMBNESS IN TOES AND LEFT ARMS; VERY BAD REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced very bad reaction. On an unspecified date, the patient experienced hard time to see/vision has gone very low, lost thousands of hair/2/3 of hair falling, and severe numbness in toes and left arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very bad reaction, hard time to see/vision has gone very low, lost thousands of hair/2/3 of hair falling and severe numbness in toes and left arms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 14-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea for 3-4 days after 1st shot; Fever  for 3-4 days after 1st shot; Chills for 3-4 days after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea for 3-4 days after 1st shot), PYREXIA (Fever  for 3-4 days after 1st shot) and CHILLS (Chills for 3-4 days after 1st shot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced NAUSEA (Nausea for 3-4 days after 1st shot), PYREXIA (Fever  for 3-4 days after 1st shot) and CHILLS (Chills for 3-4 days after 1st shot). In August 2021, NAUSEA (Nausea for 3-4 days after 1st shot), PYREXIA (Fever  for 3-4 days after 1st shot) and CHILLS (Chills for 3-4 days after 1st shot) had resolved.            No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-331006 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a 42 year-old, female patient with no relevant medical history, who experienced the expected non-serious adverse event of chills, nausea and pyrexia. The event occurred on unknown date approximately 3 or 4 days after the first dose of Spikevax (Moderna COVID-19 vaccine) according to narrative. The rechallenge was positive for the events of chills and pyrexia as this events have resolved after the first dose and then recurred after the second dose. For the event nausea, the rechallenge is negative since it is not described after the second dose. The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA levels were much more aggressive; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels were much more aggressive) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 05-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 an unknown date, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels were much more aggressive). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA levels were much more aggressive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: increased (High) PSA levels were much more aggressive.         Patient was not sure to get his booster shot.  No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received includes non-significant information. On 07-Oct-2021: FU 2 contains no new information.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue
Clinical narrative: Felt a little bit of confusion; Had some mild fatigue for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Felt a little bit of confusion) and FATIGUE (Had some mild fatigue for 24 hrs) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (Had some mild fatigue for 24 hrs). On 06-Feb-2021, the patient experienced CONFUSIONAL STATE (Felt a little bit of confusion). On 06-Feb-2021, FATIGUE (Had some mild fatigue for 24 hrs) had resolved. At the time of the report, CONFUSIONAL STATE (Felt a little bit of confusion) outcome was unknown.            No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-343870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow-up received on 8-Oct-2021,contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: arm pain; Fever; headache; strong fatigue; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (strong fatigue) and NAUSEA (nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (strong fatigue) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (strong fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a subject with unknown age and gender, with no reported medical history, who experienced the expected non-serious event of arm pain. The rechallenge was not applicable, as there is limited information available. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Disturbance in attention, Fatigue, Insomnia, Pyrexia
Clinical narrative: Disrupts sleep; disrupts concentration on daily activities; fatigue; fever (102); ringing in ear getting worse(louder)/ increased; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ear getting worse(louder)/ increased), INSOMNIA (Disrupts sleep), DISTURBANCE IN ATTENTION (disrupts concentration on daily activities), FATIGUE (fatigue) and PYREXIA (fever (102)) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa antibiotics.), Allergic reaction to analgesics (Allergic to drug Codeine.), Hypertension since 2009, Hyperlipidemia since 2009, Hypothyroidism since 2009 and Tinnitus (Mild tinnitus) since 1978. Concomitant products included ROSUVASTATINE [ROSUVASTATIN] from 2009 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 2009 to an unknown date, BENAZEPRIL from 2009 to an unknown date and AMLODIPINE from 2009 to an unknown date for Hypertension, LEVOTHYROXINE from 2009 to an unknown date for Hypothyroidism.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced TINNITUS (ringing in ear getting worse(louder)/ increased). On 28-Aug-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever (102)). On an unknown date, the patient experienced INSOMNIA (Disrupts sleep) and DISTURBANCE IN ATTENTION (disrupts concentration on daily activities). On 29-Aug-2021, FATIGUE (fatigue) and PYREXIA (fever (102)) had resolved. At the time of the report, TINNITUS (ringing in ear getting worse(louder)/ increased) had not resolved and INSOMNIA (Disrupts sleep) and DISTURBANCE IN ATTENTION (disrupts concentration on daily activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 102 (High) Fever 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient had mild tinnitus from the past years but the intensity was increased just a few hours after the first dose of vaccination  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non-Significant FU, updated reporter information. On 07-Oct-2021: Significant follow up received included patient demographics, relevant Medical history, lab investigation Concomitant medications; Outcome of the event tinnitus updated from unknown to not recovered; Events Fatigue, pyrexia, Disrupts sleep, disrupts concentration on daily activities;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Disrupts sleep; disrupts concentration on daily activities; fatigue; fever (102); ringing in ear getting worse(louder)/ increased; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ear getting worse(louder)/ increased), INSOMNIA (Disrupts sleep), DISTURBANCE IN ATTENTION (disrupts concentration on daily activities), FATIGUE (fatigue) and PYREXIA (fever (102)) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa antibiotics.), Allergic reaction to analgesics (Allergic to drug Codeine.), Hypertension since 2009, Hyperlipidemia since 2009, Hypothyroidism since 2009 and Tinnitus (Mild tinnitus) since 1978. Concomitant products included ROSUVASTATINE [ROSUVASTATIN] from 2009 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 2009 to an unknown date, BENAZEPRIL from 2009 to an unknown date and AMLODIPINE from 2009 to an unknown date for Hypertension, LEVOTHYROXINE from 2009 to an unknown date for Hypothyroidism.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced TINNITUS (ringing in ear getting worse(louder)/ increased). On 28-Aug-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever (102)). On an unknown date, the patient experienced INSOMNIA (Disrupts sleep) and DISTURBANCE IN ATTENTION (disrupts concentration on daily activities). On 29-Aug-2021, FATIGUE (fatigue) and PYREXIA (fever (102)) had resolved. At the time of the report, TINNITUS (ringing in ear getting worse(louder)/ increased) had not resolved and INSOMNIA (Disrupts sleep) and DISTURBANCE IN ATTENTION (disrupts concentration on daily activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 102 (High) Fever 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient had mild tinnitus from the past years but the intensity was increased just a few hours after the first dose of vaccination  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non-Significant FU, updated reporter information. On 07-Oct-2021: Significant follow up received included patient demographics, relevant Medical history, lab investigation Concomitant medications; Outcome of the event tinnitus updated from unknown to not recovered; Events Fatigue, pyrexia, Disrupts sleep, disrupts concentration on daily activities;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Nasopharyngitis
Clinical narrative: Progressed to her hands shaking; Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine; Whole body got cold and felt miserable; Whole body felt sore and ached; Fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Progressed to her hands shaking), FEELING ABNORMAL (Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine), NASOPHARYNGITIS (Whole body got cold and felt miserable), MYALGIA (Whole body felt sore and ached) and FATIGUE (Fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Progressed to her hands shaking). an unknown date, the patient experienced FEELING ABNORMAL (Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine), NASOPHARYNGITIS (Whole body got cold and felt miserable), MYALGIA (Whole body felt sore and ached), FATIGUE (Fatigued) and CHILLS (Chills). At the time of the report, TREMOR (Progressed to her hands shaking), FEELING ABNORMAL (Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine), NASOPHARYNGITIS (Whole body got cold and felt miserable), MYALGIA (Whole body felt sore and ached), FATIGUE (Fatigued) and CHILLS (Chills) had resolved.            Concomitant medications were not reported. Treatment details not provided.    This case was linked to MOD-2021-275188 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Significant Follow up outcome of the events updated.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Progressed to her hands shaking; Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine; Whole body got cold and felt miserable; Whole body felt sore and ached; Fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Progressed to her hands shaking), FEELING ABNORMAL (Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine), NASOPHARYNGITIS (Whole body got cold and felt miserable), MYALGIA (Whole body felt sore and ached) and FATIGUE (Fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Progressed to her hands shaking). an unknown date, the patient experienced FEELING ABNORMAL (Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine), NASOPHARYNGITIS (Whole body got cold and felt miserable), MYALGIA (Whole body felt sore and ached), FATIGUE (Fatigued) and CHILLS (Chills). At the time of the report, TREMOR (Progressed to her hands shaking), FEELING ABNORMAL (Whole body rattled like a skeleton for hours / felt miserable/felt weird/unusual experience/second shot was much more unpleasant than she could imagine), NASOPHARYNGITIS (Whole body got cold and felt miserable), MYALGIA (Whole body felt sore and ached), FATIGUE (Fatigued) and CHILLS (Chills) had resolved.            Concomitant medications were not reported. Treatment details not provided.    This case was linked to MOD-2021-275188 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Significant Follow up outcome of the events updated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Migraine, Swelling face
Clinical narrative: She had swelling of the face; Migraine; Hypersensitivity reaction; She had severe headache for a week; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (She had swelling of the face), MIGRAINE (Migraine), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (She had severe headache for a week) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever and Hashimoto's disease. Concurrent medical conditions included Asthma and Endometriosis.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (She had swelling of the face), MIGRAINE (Migraine), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (She had severe headache for a week). The patient was treated with ADRENALINE [EPINEPHRINE] at an unspecified dose and frequency. At the time of the report, SWELLING FACE (She had swelling of the face), MIGRAINE (Migraine), HYPERSENSITIVITY (Hypersensitivity reaction) and HEADACHE (She had severe headache for a week) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Unspecified antihistamines and steroids along with oxygen was use for the treatment of events Patient had to visit emergency 3 times due to events   No concomitant use were reported.   This case was linked to MOD-2021-278924 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Upon follow-up receipt: Medical information and events updated. Suspect dose 2 were deleted. Action taken updated no change from not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.; her head throbbed.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.) and HEADACHE (her head throbbed.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hives since 1993, Drug allergy (Allergy to NSAIDS), Penicillin allergy and Shellfish allergy. Concomitant products included LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) from 1996 to an unknown date for Hives, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced TINNITUS (Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.) and HEADACHE (her head throbbed.). At the time of the report, TINNITUS (Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.) had not resolved and HEADACHE (her head throbbed.) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Added reporter information, added patient information, Added relevant history, Added suspect doses information, Added Zyrtec indication, Updated reporter's causality to Possible
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Troponin: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported.  Patient symptoms began few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram. Patient also visited hospital for chest pain. Patient received supportive care.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-245527, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.-MOD-2021-284004. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported.   Patient received supportive care. Patient symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-245527, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Incorrect E2B Company Number was removed. Incorrect reports were generated. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.   Company Comment: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-245527, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284008 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.  Company Comment: This is a literature report of Myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-245527, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284010 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of Myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.   Company Comment: This is a literature report of myocarditis in an adult male after receiving the product. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-245527, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male after receiving the product. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.   Company Comment: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-245527, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pruritus, Skin irritation, Urticaria
Clinical narrative: itching and being irritating; itching and being irritating; Intentional administration of >2doses, Intentional dose administration < or > 1 month; Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives), PRURITUS (itching and being irritating), SKIN IRRITATION (itching and being irritating) and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 013M20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS and Chronic kidney disease stage 3.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives) and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month). On 27-Aug-2021, the patient experienced PRURITUS (itching and being irritating) and SKIN IRRITATION (itching and being irritating). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Hives, at an unspecified dose and frequency. On 27-Aug-2021, URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives) had resolved. At the time of the report, PRURITUS (itching and being irritating) and SKIN IRRITATION (itching and being irritating) had not resolved and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Patient received Benadryl and cortisone cream as treatment.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 infection post vaccination; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection post vaccination) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Development of COVID-19 infection in transplant recipients after SARS-CoV-2 vaccination. Transplantation. 2021;105(9):e104-6     The patient's past medical history included Kidney transplant (16 months). Concurrent medical conditions included Immunosuppression. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19 infection post vaccination) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 infection post vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (Covid-19 infection post vaccination) to be possibly related.    This case related to patient 2 as per article and initial symptoms included were Cough, fatigue.  No treatment was reported for the patient.  Outcome of the event was reported as alive  Company Comment: This is a literature report of mild COVID-19 in a kidney immunosuppressed patient of 68 years old, 4 days after receiving the second dose of the product. Doses dates are not provided, thus appropriateness of product administration schedule is not assessable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   This case was linked to MOD-2021-303225, MOD-2021-303228, MOD-2021-303227, MOD-2021-303226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received by safety 2-Sep-2021 included an Email with FTA received from Regulatory Authority team and does not contain any new information.; Sender's Comments: This is a literature report of mild COVID-19 in a kidney immunosuppressed patient of 68 years old, 4 days after receiving the second dose of the product. Doses dates are not provided, thus appropriateness of product administration schedule is not assessable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.