chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Can't lift his arm that he received the vaccine in; Moving his arm is so painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift his arm that he received the vaccine in) and VACCINATION SITE PAIN (Moving his arm is so painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift his arm that he received the vaccine in) and VACCINATION SITE PAIN (Moving his arm is so painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift his arm that he received the vaccine in) and VACCINATION SITE PAIN (Moving his arm is so painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up 1: Event outcomes were changed from not recovered to recovered.
Sex: U
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: dose administered with gray particulates from vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial) in a not specif patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Mar-2021, the patient experienced PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial). On 09-Mar-2021, PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Swelling under left arm; Limited range of motion; Rotator cuff tendonitis, left; Acute pain of both shoulders; Fatigue; Achiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion), PAIN (Achiness), ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy, Pollen allergy, Allergy to plants (Pine), Allergy to animals (Rabbit hair), Allergic to cats, Hypothyroidism since 19-Jul-2017, Seasonal allergic rhinitis (Acute) and Hypercholesterolemia since 19-Jul-2017. Concomitant products included CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) for Allergy, BUPROPION from 09-Dec-2020 to an unknown date for Depression, ATORVASTATIN from 17-Jul-2017 to an unknown date for Hypercholesteremia, LEVOTHYROXINE from 17-Jul-2017 to an unknown date for Hypothyroidism, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 17-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Achiness) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion) and ARTHRALGIA (Acute pain of both shoulders). 19-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form; Physical therapy (Exercises daily) for Mobility decreased; Physical therapy for Rotator cuff syndrome and Physical therapy for Arthralgia. On 21-Feb-2021, PERIPHERAL SWELLING (Swelling under left arm) had resolved. At the time of the report, MOBILITY DECREASED (Limited range of motion) was resolving, PAIN (Achiness) and FATIGUE (Fatigue) outcome was unknown and ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Additional information received on 05-Jun-2021 had updated patient details, other relevant history. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fatigue, pain, rotator cuff tendonitis of the left shoulder. Updated the time of first dose.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff syndrome
Clinical narrative: Swelling under left arm; Limited range of motion; Rotator cuff tendonitis, left; Acute pain of both shoulders; Fatigue; Achiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion), PAIN (Achiness), ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy, Pollen allergy, Allergy to plants (Pine), Allergy to animals (Rabbit hair), Allergic to cats, Hypothyroidism since 19-Jul-2017, Seasonal allergic rhinitis (Acute) and Hypercholesterolemia since 19-Jul-2017. Concomitant products included CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) for Allergy, BUPROPION from 09-Dec-2020 to an unknown date for Depression, ATORVASTATIN from 17-Jul-2017 to an unknown date for Hypercholesteremia, LEVOTHYROXINE from 17-Jul-2017 to an unknown date for Hypothyroidism, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 17-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Achiness) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling under left arm), MOBILITY DECREASED (Limited range of motion) and ARTHRALGIA (Acute pain of both shoulders). 19-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form; Physical therapy (Exercises daily) for Mobility decreased; Physical therapy for Rotator cuff syndrome and Physical therapy for Arthralgia. On 21-Feb-2021, PERIPHERAL SWELLING (Swelling under left arm) had resolved. At the time of the report, MOBILITY DECREASED (Limited range of motion) was resolving, PAIN (Achiness) and FATIGUE (Fatigue) outcome was unknown and ROTATOR CUFF SYNDROME (Rotator cuff tendonitis, left) and ARTHRALGIA (Acute pain of both shoulders) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Additional information received on 05-Jun-2021 had updated patient details, other relevant history. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fatigue, pain, rotator cuff tendonitis of the left shoulder. Updated the time of first dose.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: vertigo; headache; nauses; Needed to rest it out/ fatigue/ lightheaded; Rough night/ trouble sleeping; stomach issues; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Needed to rest it out/ fatigue/ lightheaded), INSOMNIA (Rough night/ trouble sleeping), ABDOMINAL DISCOMFORT (stomach issues), VERTIGO (vertigo) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ATENOLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (Rough night/ trouble sleeping) and ABDOMINAL DISCOMFORT (stomach issues). On 06-Mar-2021, the patient experienced FATIGUE (Needed to rest it out/ fatigue/ lightheaded). On 08-Mar-2021, the patient experienced VERTIGO (vertigo), HEADACHE (headache) and NAUSEA (nauses). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, FATIGUE (Needed to rest it out/ fatigue/ lightheaded), INSOMNIA (Rough night/ trouble sleeping), ABDOMINAL DISCOMFORT (stomach issues), VERTIGO (vertigo), HEADACHE (headache) and NAUSEA (nauses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; headache; nauses; Needed to rest it out/ fatigue/ lightheaded; Rough night/ trouble sleeping; stomach issues; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Needed to rest it out/ fatigue/ lightheaded), INSOMNIA (Rough night/ trouble sleeping), ABDOMINAL DISCOMFORT (stomach issues), VERTIGO (vertigo) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ATENOLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (Rough night/ trouble sleeping) and ABDOMINAL DISCOMFORT (stomach issues). On 06-Mar-2021, the patient experienced FATIGUE (Needed to rest it out/ fatigue/ lightheaded). On 08-Mar-2021, the patient experienced VERTIGO (vertigo), HEADACHE (headache) and NAUSEA (nauses). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, FATIGUE (Needed to rest it out/ fatigue/ lightheaded), INSOMNIA (Rough night/ trouble sleeping), ABDOMINAL DISCOMFORT (stomach issues), VERTIGO (vertigo), HEADACHE (headache) and NAUSEA (nauses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea exertional
Clinical narrative: Diarrhea; Shortness of breath upon exertion; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM gas for Secondary pulmonary arterial hypertension and TADALAFIL for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 24-Nov-2020, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TADALAFIL (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion). At the time of the report, DIARRHOEA (Diarrhea) and DYSPNOEA EXERTIONAL (Shortness of breath upon exertion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event ,was not provided.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Product dose omission issue, Pyrexia
Clinical narrative: Missed her second Moderna; Got 104 F fever just 1 day before second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna) and PYREXIA (Got 104 F fever just 1 day before second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Got 104 F fever just 1 day before second dose). On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna) had resolved. At the time of the report, PYREXIA (Got 104 F fever just 1 day before second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 104 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received their first dose of Moderna vaccine 04-Feb-2021 and was perfectly fine after that dose, The patient's second dose was scheduled on 04-Mar-2021, but the patient missed their second Moderna dose as on 03-Mar-2021 in night the patient got 104 F fever.  The patient took Tylenol and Ibuprofen for the symptoms, but symptoms didn't go away. The patient visited doctors and they prescribed antibiotics and steroids.  Reportedly, the doctor said that if it was viral infection then the patient has to take these medications.  No Concomitant product use was reported.  Treatment medications prescribed to the patient included antibiotics and steroids.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pharyngeal swelling, Speech disorder, Swelling
Clinical narrative: no voice due to swelling in her throat; hives; redness; Swelling; allergic reaction; cannot speak; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat) and SPEECH DISORDER (cannot speak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (History of allergies.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In January 2021, the patient experienced SPEECH DISORDER (cannot speak). On 22-Jan-2021, the patient experienced URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (no voice due to swelling in her throat). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat), SPEECH DISORDER (cannot speak) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: no voice due to swelling in her throat; hives; redness; Swelling; allergic reaction; cannot speak; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat) and SPEECH DISORDER (cannot speak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (History of allergies.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In January 2021, the patient experienced SPEECH DISORDER (cannot speak). On 22-Jan-2021, the patient experienced URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (no voice due to swelling in her throat). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat), SPEECH DISORDER (cannot speak) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Pyrexia
Clinical narrative: Extreme lower back pain; Fever of 102 Degrees; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Extreme lower back pain), PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LOSARTAN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness). On an unknown date, the patient experienced BACK PAIN (Extreme lower back pain). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Extreme lower back pain) had not resolved and PYREXIA (Fever of 102 Degrees) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 102 (High) 102 F.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Other treatment information included heating pad.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache
Clinical narrative: sick to stomach; diarrhea; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (sick to stomach), DIARRHOEA (diarrhea), CHILLS (Chills) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (sick to stomach), DIARRHOEA (diarrhea), CHILLS (Chills) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN UPPER (sick to stomach), DIARRHOEA (diarrhea), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Vaccination site pain
Clinical narrative: Unable to breathe for a few minutes; Chest pain; Joint pain; Pain at the injection site; A spontaneous report was received from a consumer  concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pain, pain at the injection site, chest pain and unable to breathe for a few minutes..  The patient's medical history, as provided by the reporter, included gallbladder surgery and allergy to lentils. No relevant concomitant medications were reported.  On 6 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient experienced the event(s) joint pain, pain at the injection site, chest pain and unable to breathe for a few minutes.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 6 Mar 2021 the outcome of event, unable to breathe for a few minutes was resolved. On 8 Mar 2021 the outcome of event, joint pain, pain at the injection site, chest pain was resolved.; Reporter's Comments: 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. Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: on injection site itchy; on injection site red; on injection site warm to the touch; on injection site rash; on injection site rash getting bigger; on injection site hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash) and VACCINATION SITE RASH (on injection site rash getting bigger) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Narcolepsy, Cirrhosis of liver, Squamous cell carcinoma and Melanoma (Left arm). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Narcolepsy, FUROSEMIDE, PREDNISONE, SPIRONOLACTONE and PREGABALIN (LYRICA) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash), VACCINATION SITE RASH (on injection site rash getting bigger) and VACCINATION SITE MASS (on injection site hard). At the time of the report, VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash), VACCINATION SITE RASH (on injection site rash getting bigger) and VACCINATION SITE MASS (on injection site hard) outcome was unknown.            No treatment details reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   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) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PAIN (Aches) and FATIGUE (Fatigue). At the time of the report, PAIN (Aches) and FATIGUE (Fatigue) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had a reaction to report) in a male patient of an unknown age 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 ADVERSE REACTION (had a reaction to report). At the time of the report, ADVERSE REACTION (had a reaction to report) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Paraesthesia oral
Clinical narrative: very tired; tingling in lips; chest tightening; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening), HEADACHE (slight headache) and FATIGUE (very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening) and HEADACHE (slight headache). On 03-Mar-2021, the patient experienced FATIGUE (very tired). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at a dose of UNK dosage form. On 03-Mar-2021, PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening) and HEADACHE (slight headache) had resolved. On 07-Mar-2021, FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Injection site reaction, Nausea
Clinical narrative: Nausea; dizzy; feels like burn from shoulder up to the elbow.; L arm swelling; L arm extremely itchy; Arm is red as the day when she got the injection; fever low grade; immediate fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy) and INJECTION SITE REACTION (Arm is red as the day when she got the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal disorder NOS, Migraine and Allergy NOS. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Gastrointestinal disorder, ALPRAZOLAM (XANAX), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and BACLOFEN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade) and FATIGUE (immediate fatigue). On 04-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade), FATIGUE (immediate fatigue) and NAUSEA (Nausea) outcome was unknown.            Additional concomitant medications included loinzeff for gastro issues and migraines medicines (once a month) which was stopped on 03 Feb 2021.  Treatment for the event included diphenhydramine (Benadryl) and acetaminophen (Tylenol). The patient took the medicine when she felt bad.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; dizzy; feels like burn from shoulder up to the elbow.; L arm swelling; L arm extremely itchy; Arm is red as the day when she got the injection; fever low grade; immediate fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy) and INJECTION SITE REACTION (Arm is red as the day when she got the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastrointestinal disorder NOS, Migraine and Allergy NOS. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Gastrointestinal disorder, ALPRAZOLAM (XANAX), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and BACLOFEN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade) and FATIGUE (immediate fatigue). On 04-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), BURNING SENSATION (feels like burn from shoulder up to the elbow.), INJECTION SITE REACTION (L arm swelling), INJECTION SITE REACTION (L arm extremely itchy), INJECTION SITE REACTION (Arm is red as the day when she got the injection), PYREXIA (fever low grade), FATIGUE (immediate fatigue) and NAUSEA (Nausea) outcome was unknown.            Additional concomitant medications included loinzeff for gastro issues and migraines medicines (once a month) which was stopped on 03 Feb 2021.  Treatment for the event included diphenhydramine (Benadryl) and acetaminophen (Tylenol). The patient took the medicine when she felt bad.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Covid arm; itchiness on the left arm; a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (itchiness on the left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away) and VACCINATION SITE PRURITUS (itchiness on the left arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (itchiness on the left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Events and second dose details updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Lymphadenopathy, Pain in extremity
Clinical narrative: Soreness of arm; Depression; Swollen glands of breast; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), DEPRESSION (Depression) and LYMPHADENOPATHY (Swollen glands of breast) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm), DEPRESSION (Depression) and LYMPHADENOPATHY (Swollen glands of breast). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), DEPRESSION (Depression) and LYMPHADENOPATHY (Swollen glands of breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia, Pain, Pyrexia, Rash pruritic
Clinical narrative: BODY ACHES; COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET; COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET; MUSCLE ACHES; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER). At the time of the report, PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Positive for COVID-19). On 22-Jan-2021, COVID-19 (Positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  On 11JAN2021 patient had COVID 19 symptoms (eye pain, sore throat and headache).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Motion sickness, Pain in extremity, Pyrexia
Clinical narrative: vomiting; arm is sore; Stomach issue; motion sickness; temp was 99/temperature went up to 100/checked her temperature again and it is 99.1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M208) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness) and PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99 (High) 99, 100 (High) 100 and 99.1 (High) 99.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment for the events included acetaminophen (Tylenol), ginger and motion sickness medicine unspecified.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; arm is sore; Stomach issue; motion sickness; temp was 99/temperature went up to 100/checked her temperature again and it is 99.1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M208) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness) and PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is sore), ABDOMINAL DISCOMFORT (Stomach issue), MOTION SICKNESS (motion sickness), PYREXIA (temp was 99/temperature went up to 100/checked her temperature again and it is 99.1) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99 (High) 99, 100 (High) 100 and 99.1 (High) 99.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment for the events included acetaminophen (Tylenol), ginger and motion sickness medicine unspecified.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Rash, Swelling
Clinical narrative: swelling; allergic reaction related to vaccine because I've never had a problem with Bacitracin before; rash; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before), RASH (rash), SWELLING (swelling) and PAIN IN EXTREMITY (pain in arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before) and RASH (rash). On 09-Mar-2021, the patient experienced SWELLING (swelling). On 05-Mar-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before), RASH (rash) and SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient believes the allergic reaction to Bacitracin could be related to the Moderna Covid-19 vaccine. She reports that she applied Cortizone cream to help with the itching but the symptoms are ongoing. Treatment details included Bacitracin topical ointment, Cortizone cream.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; 103.0 fever reduced to 100.9; Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) 103.0 fever has come down to 100. 9..         Concomitant product use was not provided by the reporter. Lab details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; 103.0 fever reduced to 100.9; Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) 103.0 fever has come down to 100. 9..         Concomitant product use was not provided by the reporter. Lab details were not provided.