chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertently administered to patient <18yrs of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertently administered to patient <18yrs of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE outcome was unknown.        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 were provided to the patient.  No treatment details were provided.    This case was linked to MOD21-070436, MOD21-069812, MOD21-069804, MOD21-069810, MOD21-069811, MOD21-069813, MOD21-069814, MOD21-070440, US-MODERNATX, INC.-MOD-2021-072886. Sender's Comments:  MOD21-070436: MOD21-069812: MOD21-069804: MOD21-069810: MOD21-069811: MOD21-069813: MOD21-069814: MOD21-070440: US-MODERNATX, INC MOD-2021-072886.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash returning on her other arm, abdomen and neck; Red rash that started on her left forearm and has spread; Rash that started on her left arm and spread; Hot rash that started on her left forearm and has spread; Itchy rash that started on her left forearm and has spread; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot rash that started on her left forearm and has spread), VACCINATION SITE PRURITUS (Itchy rash that started on her left forearm and has spread), RASH (Rash returning on her other arm, abdomen and neck), VACCINATION SITE ERYTHEMA (Red rash that started on her left forearm and has spread) and VACCINATION SITE RASH (Rash that started on her left arm and spread) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021 at 2:00 AM, the patient experienced VACCINATION SITE WARMTH (Hot rash that started on her left forearm and has spread), VACCINATION SITE PRURITUS (Itchy rash that started on her left forearm and has spread), VACCINATION SITE ERYTHEMA (Red rash that started on her left forearm and has spread) and VACCINATION SITE RASH (Rash that started on her left arm and spread). On 06-Apr-2021, the patient experienced RASH (Rash returning on her other arm, abdomen and neck). On 06-Apr-2021, VACCINATION SITE WARMTH (Hot rash that started on her left forearm and has spread), VACCINATION SITE PRURITUS (Itchy rash that started on her left forearm and has spread), VACCINATION SITE ERYTHEMA (Red rash that started on her left forearm and has spread) and VACCINATION SITE RASH (Rash that started on her left arm and spread) had resolved. At the time of the report, RASH (Rash returning on her other arm, abdomen and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Axillary pain, Breast pain, Chest pain, Neck pain
Clinical narrative: chest pain; left side "spleen" pain; neck pain; Pain in breasts; pain in underarms; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), ABDOMINAL PAIN (left side "spleen" pain), NECK PAIN (neck pain), BREAST PAIN (Pain in breasts) and AXILLARY PAIN (pain in underarms) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHEST PAIN (chest pain), ABDOMINAL PAIN (left side "spleen" pain), NECK PAIN (neck pain), BREAST PAIN (Pain in breasts) and AXILLARY PAIN (pain in underarms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and METHYLPREDNISOLONE for Adverse event, at a dose of UNK dosage form. On 10-Feb-2021, CHEST PAIN (chest pain) had resolved. On 17-Feb-2021, ABDOMINAL PAIN (left side "spleen" pain) had resolved. At the time of the report, NECK PAIN (neck pain) had not resolved and BREAST PAIN (Pain in breasts) and AXILLARY PAIN (pain in underarms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient received the second shot on right arm on 09-Mar-2021. Lot number (014M20A). The patient visited physician and received steroid shot for the events as treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-069815 (2nd dose case) (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: new events of breast pain and pain in underarms added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069815 (2nd dose case):
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Tinnitus
Clinical narrative: ringing in his ears or tinnitus; pressure headaches that lasted for a second or two; Soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on his arm), HEADACHE (pressure headaches that lasted for a second or two) and TINNITUS (ringing in his ears or tinnitus) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness on his arm). On 28-Mar-2021, the patient experienced HEADACHE (pressure headaches that lasted for a second or two) and TINNITUS (ringing in his ears or tinnitus). On 27-Mar-2021, PAIN IN EXTREMITY (Soreness on his arm) had resolved. At the time of the report, HEADACHE (pressure headaches that lasted for a second or two) and TINNITUS (ringing in his ears or tinnitus) outcome was unknown. 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.   Treatment information included Advil for the headaches.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash
Clinical narrative: sight rash on the R arm and legs; reaction below the injection site: large rectangular red blooded area of two inches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (reaction below the injection site: large rectangular red blooded area of two inches) and RASH (sight rash on the R arm and legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included THYROID and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (reaction below the injection site: large rectangular red blooded area of two inches) and RASH (sight rash on the R arm and legs). At the time of the report, INJECTION SITE ERYTHEMA (reaction below the injection site: large rectangular red blooded area of two inches) and RASH (sight rash on the R arm and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Tinnitus
Clinical narrative: flu like symptoms; bodyache; slight fever of 100.4 F; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (bodyache), TINNITUS (tinnitus) and PYREXIA (slight fever of 100.4 F) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced TINNITUS (tinnitus). On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (bodyache) and PYREXIA (slight fever of 100.4 F). On 01-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (bodyache) and PYREXIA (slight fever of 100.4 F) had resolved. At the time of the report, TINNITUS (tinnitus) had not resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: 2nd dose given less than 26 days after 1st dose; up moaning all night; left arm started hurting; crippling pain to the point where he couldn't even lift his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm started hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (crippling pain to the point where he couldn't even lift his arm), INSOMNIA (up moaning all night) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 26 days after 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025a21a and 045a21a) for COVID-19 vaccination.     Concurrent medical conditions included Ankle injury (left ankle injury). Concomitant products included AMOXICILLIN for Infection prophylaxis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm started hurting) and VACCINATION SITE MOVEMENT IMPAIRMENT (crippling pain to the point where he couldn't even lift his arm). On 26-Mar-2021, the patient experienced INSOMNIA (up moaning all night). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 26 days after 1st dose). At the time of the report, PAIN IN EXTREMITY (left arm started hurting) had resolved and VACCINATION SITE MOVEMENT IMPAIRMENT (crippling pain to the point where he couldn't even lift his arm), INSOMNIA (up moaning all night) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 26 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included Ibuprofen (Advil).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: non-significant followup received On 26-May-2021: follow up contain no new information
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Peripheral swelling, Vaccination site pain
Clinical narrative: a sore arm, pain in her whole arm; her left hand is swollen; Numbness in fingers; joint pain in her wrist, elbow; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a sore arm, pain in her whole arm), ARTHRALGIA (joint pain in her wrist, elbow), PERIPHERAL SWELLING (her left hand is swollen) and HYPOAESTHESIA (Numbness in fingers) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided). Concomitant products included LEVOTHYROXINE, METFORMIN, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (joint pain in her wrist, elbow), PERIPHERAL SWELLING (her left hand is swollen) and HYPOAESTHESIA (Numbness in fingers). On 06-Apr-2021 at 3:00 AM, the patient experienced VACCINATION SITE PAIN (a sore arm, pain in her whole arm). At the time of the report, VACCINATION SITE PAIN (a sore arm, pain in her whole arm), ARTHRALGIA (joint pain in her wrist, elbow), PERIPHERAL SWELLING (her left hand is swollen) and HYPOAESTHESIA (Numbness in fingers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events included Tylenol and ibuprofen.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Missed dose; Has not received 2nd dose of the Moderna COVID-19 vaccine; Severe shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Severe shingles), PRODUCT DOSE OMISSION ISSUE (Missed dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received 2nd dose of the Moderna COVID-19 vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 24-Feb-2021, the patient experienced HERPES ZOSTER (Severe shingles). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received 2nd dose of the Moderna COVID-19 vaccine). At the time of the report, HERPES ZOSTER (Severe shingles), PRODUCT DOSE OMISSION ISSUE (Missed dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received 2nd dose of the Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MODERNATX, INC.-MOD-2021-068308:Husband case
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle fatigue, Muscular weakness, Pain in extremity
Clinical narrative: muscle fatigue; arms began hurting; arm getting to the point they don't want to work and at this point he can't even drive; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MUSCLE FATIGUE (muscle fatigue), PAIN IN EXTREMITY (arms began hurting) and MUSCULAR WEAKNESS (arm getting to the point they don't want to work and at this point he can't even drive) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis since an unknown date, Diabetes since an unknown date and Arthritis since an unknown date. Concomitant products included AZATHIOPRINE and WARFARIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (chills). On 29-Mar-2021, the patient experienced MUSCLE FATIGUE (muscle fatigue), PAIN IN EXTREMITY (arms began hurting) and MUSCULAR WEAKNESS (arm getting to the point they don't want to work and at this point he can't even drive). On 12-Mar-2021, CHILLS (chills) outcome was unknown. At the time of the report, MUSCLE FATIGUE (muscle fatigue), PAIN IN EXTREMITY (arms began hurting) and MUSCULAR WEAKNESS (arm getting to the point they don't want to work and at this point he can't even drive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Tinnitus
Clinical narrative: Non Moderna Vaccine (Second Vaccine); Ringing on left side of ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing on left side of ear) and INTERCHANGE OF VACCINE PRODUCTS (Non Moderna Vaccine (Second Vaccine)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced TINNITUS (Ringing on left side of ear). On 18-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Non Moderna Vaccine (Second Vaccine)). At the time of the report, TINNITUS (Ringing on left side of ear) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Non Moderna Vaccine (Second Vaccine)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment drug were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Case Received From removed. Action taken added in product tab. Tinnitus deleted as additional event. Outcome updated to resolved for Interchange of vaccine products.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in arm for 3 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ATORVASTATIN, OMEPRAZOLE, FAMOTIDINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    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 MYALGIA (pain in arm for 3 days). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, MYALGIA (pain in arm for 3 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068266:2nd dose of vaccine
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Tinnitus
Clinical narrative: Tinnitus got noticeably worse; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus got noticeably worse) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain injury (Brain injury from combat.) and Tinnitus.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced TINNITUS (Tinnitus got noticeably worse) and CHILLS (Chills). At the time of the report, TINNITUS (Tinnitus got noticeably worse) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Heart rate: increased (High) A racing heart rate.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-068294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains significant information: The outcome of the events changed from unknown to not resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, SARS-CoV-2 test, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: bruising on Arm; Swelling under arm; soreness in her arm; swollen lymph nodes under her arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on Arm), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under her arm), LYMPHADENOPATHY (Swelling under arm) and VACCINATION SITE PAIN (soreness in her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under her arm) and VACCINATION SITE PAIN (soreness in her arm). On 25-Apr-2021, the patient experienced CONTUSION (bruising on Arm) and LYMPHADENOPATHY (Swelling under arm). The patient was treated with Manual therapy (cold compress) for Vaccination site lymphadenopathy and Manual therapy (cold compress) for Vaccination site pain. On 02-May-2021, CONTUSION (bruising on Arm) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under her arm), LYMPHADENOPATHY (Swelling under arm) and VACCINATION SITE PAIN (soreness in her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  The patient had her second dose on an unknown date and the batch number was 041b21a.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Significant follow up report received included information about the outcome of events Pain in arm and Vaccination site lymphadenopathy that was updated to not recovered. On 29-Jun-2021: Follow up report received included additional events of Bruising of arm and Swelling under arm. Lab data added
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Hot flush, Hyperhidrosis, Oropharyngeal discomfort
Clinical narrative: shortness of breath; felt warm in her arm; sweating; hot flash.; running nose; throat started to close up; wheezing; swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.) and RHINORRHOEA (running nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.), RHINORRHOEA (running nose), OROPHARYNGEAL DISCOMFORT (throat started to close up), WHEEZING (wheezing) and SWOLLEN TONGUE (swollen tongue). At the time of the report, DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.), RHINORRHOEA (running nose), OROPHARYNGEAL DISCOMFORT (throat started to close up), WHEEZING (wheezing) and SWOLLEN TONGUE (swollen tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included EpiPen.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Swollen tongue, Wheezing
Clinical narrative: shortness of breath; felt warm in her arm; sweating; hot flash.; running nose; throat started to close up; wheezing; swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.) and RHINORRHOEA (running nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.), RHINORRHOEA (running nose), OROPHARYNGEAL DISCOMFORT (throat started to close up), WHEEZING (wheezing) and SWOLLEN TONGUE (swollen tongue). At the time of the report, DYSPNOEA (shortness of breath), FEELING HOT (felt warm in her arm), HYPERHIDROSIS (sweating), HOT FLUSH (hot flash.), RHINORRHOEA (running nose), OROPHARYNGEAL DISCOMFORT (throat started to close up), WHEEZING (wheezing) and SWOLLEN TONGUE (swollen tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included EpiPen.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Gastrointestinal disorder, Malaise, Muscle tightness
Clinical narrative: Diarrhea; Lower GI/stomach problems since I got the vaccine; Haven't felt really good since I got the vaccine; Not been able to have a good bowel movement; Have tightness in my shoulder and neck; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), GASTROINTESTINAL DISORDER (Lower GI/stomach problems since I got the vaccine), MALAISE (Haven't felt really good since I got the vaccine), BOWEL MOVEMENT IRREGULARITY (Not been able to have a good bowel movement) and MUSCLE TIGHTNESS (Have tightness in my shoulder and neck) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), GASTROINTESTINAL DISORDER (Lower GI/stomach problems since I got the vaccine), MALAISE (Haven't felt really good since I got the vaccine), BOWEL MOVEMENT IRREGULARITY (Not been able to have a good bowel movement) and MUSCLE TIGHTNESS (Have tightness in my shoulder and neck). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), GASTROINTESTINAL DISORDER (Lower GI/stomach problems since I got the vaccine), MALAISE (Haven't felt really good since I got the vaccine), BOWEL MOVEMENT IRREGULARITY (Not been able to have a good bowel movement) and MUSCLE TIGHTNESS (Have tightness in my shoulder and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Feeling of body temperature change, Flushing
Clinical narrative: flushed; hot and cold; Feeling face was on fire; feeling achey; legs and knees felt like they were on fire; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and BURNING SENSATION (Feeling face was on fire) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol, sulfa, -toprolol). Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), MONTELUKAST, ATORVASTATIN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), BURNING SENSATION (Feeling face was on fire) and ARTHRALGIA (legs and knees felt like they were on fire). At the time of the report, CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), BURNING SENSATION (Feeling face was on fire) and ARTHRALGIA (legs and knees felt like they were on fire) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068271:First Dose.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: flushed; hot and cold; Feeling face was on fire; feeling achey; legs and knees felt like they were on fire; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and BURNING SENSATION (Feeling face was on fire) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol, sulfa, -toprolol). Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), MONTELUKAST, ATORVASTATIN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), BURNING SENSATION (Feeling face was on fire) and ARTHRALGIA (legs and knees felt like they were on fire). At the time of the report, CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), BURNING SENSATION (Feeling face was on fire) and ARTHRALGIA (legs and knees felt like they were on fire) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068271:First Dose.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Palpitations, Tinnitus
Clinical narrative: tinnitus became even more severe after the second vaccination; Off and On a racing heart rate; chills; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus became even more severe after the second vaccination), CHILLS (chills) and PALPITATIONS (Off and On a racing heart rate) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus became even more severe after the second vaccination), CHILLS (chills) and PALPITATIONS (Off and On a racing heart rate). At the time of the report, TINNITUS (tinnitus became even more severe after the second vaccination), CHILLS (chills) and PALPITATIONS (Off and On a racing heart rate) outcome was unknown. Not Provided          Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received both Moderna and Pfizer-BioNTech vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received both Moderna and Pfizer-BioNTech vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received both Moderna and Pfizer-BioNTech vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received both Moderna and Pfizer-BioNTech vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose missed (more than 42 days); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose missed (more than 42 days)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Clotting disorder.  On 11-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 PRODUCT DOSE OMISSION ISSUE (2nd dose missed (more than 42 days)). On 11-Jan-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose missed (more than 42 days)) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant products information is provided   No treatment products information is provided   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Updated reporter email Id, updated patient demographics and changed action taken from unknown to withdrawn.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discharge, Fatigue, Migraine, Myalgia
Clinical narrative: migraine headache; diarrhea; discharge was liquid; achy all over; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DISCHARGE (discharge was liquid), MIGRAINE (migraine headache), MYALGIA (achy all over) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced MYALGIA (achy all over) and FATIGUE (tired). On 05-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and DISCHARGE (discharge was liquid). On 06-Apr-2021, the patient experienced MIGRAINE (migraine headache). At the time of the report, DIARRHOEA (diarrhea), DISCHARGE (discharge was liquid), MIGRAINE (migraine headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Imodium, probiotic fluids, Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Covid arm; red rash size of her hand; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), RASH ERYTHEMATOUS (red rash size of her hand) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), RASH ERYTHEMATOUS (red rash size of her hand) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, RASH ERYTHEMATOUS (red rash size of her hand) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate increased, Nausea, Peripheral swelling
Clinical narrative: foggy; Almost Past out; Nauseated; dizzy slightly; swelling of right arm; rapid heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of right arm), HEART RATE INCREASED (rapid heart beat), DIZZINESS (dizzy slightly), NAUSEA (Nauseated) and FEELING ABNORMAL (foggy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling of right arm) and HEART RATE INCREASED (rapid heart beat). On 04-Apr-2021, the patient experienced DIZZINESS (dizzy slightly) and NAUSEA (Nauseated). On 05-Apr-2021, the patient experienced FEELING ABNORMAL (foggy) and PRESYNCOPE (Almost Past out). On 03-Apr-2021, PERIPHERAL SWELLING (swelling of right arm) and HEART RATE INCREASED (rapid heart beat) had resolved. On 04-Apr-2021, DIZZINESS (dizzy slightly) and NAUSEA (Nauseated) had resolved. On 05-Apr-2021, FEELING ABNORMAL (foggy) and PRESYNCOPE (Almost Past out) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional information 1
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: foggy; Almost Past out; Nauseated; dizzy slightly; swelling of right arm; rapid heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of right arm), HEART RATE INCREASED (rapid heart beat), DIZZINESS (dizzy slightly), NAUSEA (Nauseated) and FEELING ABNORMAL (foggy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling of right arm) and HEART RATE INCREASED (rapid heart beat). On 04-Apr-2021, the patient experienced DIZZINESS (dizzy slightly) and NAUSEA (Nauseated). On 05-Apr-2021, the patient experienced FEELING ABNORMAL (foggy) and PRESYNCOPE (Almost Past out). On 03-Apr-2021, PERIPHERAL SWELLING (swelling of right arm) and HEART RATE INCREASED (rapid heart beat) had resolved. On 04-Apr-2021, DIZZINESS (dizzy slightly) and NAUSEA (Nauseated) had resolved. On 05-Apr-2021, FEELING ABNORMAL (foggy) and PRESYNCOPE (Almost Past out) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional information 1
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Fatigue, Feeling hot, Formication
Clinical narrative: Rash on Arm; Swollen Arm; poping sensation; Hot arm; Lump and blister on Arm; Red Arm; Fatigue; Achiness; Headache; sinus cogestion; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (sinus cogestion), PERIPHERAL SWELLING (Swollen Arm), FORMICATION (poping sensation), RASH (Rash on Arm) and FEELING HOT (Hot arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SINUS CONGESTION (sinus cogestion), FATIGUE (Fatigue), MYALGIA (Achiness) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm), FORMICATION (poping sensation), FEELING HOT (Hot arm), BLISTER (Lump and blister on Arm) and ERYTHEMA (Red Arm). On 04-Apr-2021, the patient experienced RASH (Rash on Arm). At the time of the report, SINUS CONGESTION (sinus cogestion), PERIPHERAL SWELLING (Swollen Arm), FORMICATION (poping sensation), RASH (Rash on Arm), FEELING HOT (Hot arm), BLISTER (Lump and blister on Arm), ERYTHEMA (Red Arm), FATIGUE (Fatigue), MYALGIA (Achiness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information  included cortisone cream, Benadryl, and Neosporin ointment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Peripheral swelling, Rash, Sinus congestion
Clinical narrative: Rash on Arm; Swollen Arm; poping sensation; Hot arm; Lump and blister on Arm; Red Arm; Fatigue; Achiness; Headache; sinus cogestion; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (sinus cogestion), PERIPHERAL SWELLING (Swollen Arm), FORMICATION (poping sensation), RASH (Rash on Arm) and FEELING HOT (Hot arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SINUS CONGESTION (sinus cogestion), FATIGUE (Fatigue), MYALGIA (Achiness) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm), FORMICATION (poping sensation), FEELING HOT (Hot arm), BLISTER (Lump and blister on Arm) and ERYTHEMA (Red Arm). On 04-Apr-2021, the patient experienced RASH (Rash on Arm). At the time of the report, SINUS CONGESTION (sinus cogestion), PERIPHERAL SWELLING (Swollen Arm), FORMICATION (poping sensation), RASH (Rash on Arm), FEELING HOT (Hot arm), BLISTER (Lump and blister on Arm), ERYTHEMA (Red Arm), FATIGUE (Fatigue), MYALGIA (Achiness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information  included cortisone cream, Benadryl, and Neosporin ointment.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Low grade fever; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Low grade fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY REPORTED).    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). On 05-Apr-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Low grade fever) outcome was unknown. Related          Treatment included Tylenol.