chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Experiencing chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Experiencing chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 031120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Experiencing chills). At the time of the report, CHILLS (Experiencing chills) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 16-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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Flushing, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: Severe headache; Nausea; exposure during pregnancy; Throat sore; Cheeks flushed; Mouth numb; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy), OROPHARYNGEAL PAIN (Throat sore), FLUSHING (Cheeks flushed), HYPOAESTHESIA ORAL (Mouth numb) and HEADACHE (Severe headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Shellfish allergy, Vegetable allergy (Egg plant) and Allergy to nuts (Hazelnut).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy), OROPHARYNGEAL PAIN (Throat sore), FLUSHING (Cheeks flushed) and HYPOAESTHESIA ORAL (Mouth numb). On 04-Mar-2021, the patient experienced HEADACHE (Severe headache) and NAUSEA (Nausea). On 03-Mar-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy), OROPHARYNGEAL PAIN (Throat sore), FLUSHING (Cheeks flushed) and HYPOAESTHESIA ORAL (Mouth numb) had resolved. At the time of the report, HEADACHE (Severe headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient doctor recommended not to receive second dose and Patient wanted to know how to proceed if she only received one dose of vaccine . No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received contains No new information .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Severe headache; Nausea; exposure during pregnancy; Throat sore; Cheeks flushed; Mouth numb; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy), OROPHARYNGEAL PAIN (Throat sore), FLUSHING (Cheeks flushed), HYPOAESTHESIA ORAL (Mouth numb) and HEADACHE (Severe headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Shellfish allergy, Vegetable allergy (Egg plant) and Allergy to nuts (Hazelnut).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy), OROPHARYNGEAL PAIN (Throat sore), FLUSHING (Cheeks flushed) and HYPOAESTHESIA ORAL (Mouth numb). On 04-Mar-2021, the patient experienced HEADACHE (Severe headache) and NAUSEA (Nausea). On 03-Mar-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy), OROPHARYNGEAL PAIN (Throat sore), FLUSHING (Cheeks flushed) and HYPOAESTHESIA ORAL (Mouth numb) had resolved. At the time of the report, HEADACHE (Severe headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient doctor recommended not to receive second dose and Patient wanted to know how to proceed if she only received one dose of vaccine . No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received contains No new information .
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: body aches; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B1A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: her arm started to swell; 3 painful bumps at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (her arm started to swell) and VACCINATION SITE MASS (3 painful bumps at site of injection) in a 41-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) , while the parent received the product for COVID-19 vaccination.     No relevant history reported.  Concomitant product exposures included IRON, VITAMIN D [VITAMIN D NOS] and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 09-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Mar-2021, the adult was diagnosed with VACCINATION SITE SWELLING (her arm started to swell) and VACCINATION SITE MASS (3 painful bumps at site of injection). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, VACCINATION SITE SWELLING (her arm started to swell) and VACCINATION SITE MASS (3 painful bumps at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100 F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (fever of 100 F). On 18-Mar-2021, PYREXIA (fever of 100 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100. On 18-Mar-2021, Body temperature: 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment for the event, included ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension, Vaccination complication, Vertigo
Clinical narrative: possible neurological issues; dizziness due to wildly fluctuating blood pressure/extremely dizzy; low blood pressure; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness due to wildly fluctuating blood pressure/extremely dizzy), HYPOTENSION (low blood pressure), VERTIGO (vertigo) and VACCINATION COMPLICATION (possible neurological issues) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.      Medical history was not provided.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (dizziness due to wildly fluctuating blood pressure/extremely dizzy), HYPOTENSION (low blood pressure) and VERTIGO (vertigo). On 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (possible neurological issues). On 20-Mar-2021, DIZZINESS (dizziness due to wildly fluctuating blood pressure/extremely dizzy), HYPOTENSION (low blood pressure), VERTIGO (vertigo) and VACCINATION COMPLICATION (possible neurological issues) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 130/70 (Low) Blood pressure 130/70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown. EKG was done and patient was treated for Vertigo. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-131205, MOD-2021-131205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information received on 27-JUL-2021. Updated outcome of the events.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Mass, Rash, Urticaria
Clinical narrative: Hives; Bumps; Feel like has the "flu"; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), MASS (Bumps), INFLUENZA LIKE ILLNESS (Feel like has the "flu") and RASH (Rash) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A214) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Hives), MASS (Bumps), INFLUENZA LIKE ILLNESS (Feel like has the "flu") and RASH (Rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), MASS (Bumps), INFLUENZA LIKE ILLNESS (Feel like has the "flu") and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness) and VERTIGO (vertigo) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness) and VERTIGO (vertigo) 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 treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (codeine allergy.). Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (1120 GLUCOSAMINE & CHONDROITINE) for Bone density abnormal, ESTRADIOL for Hormone level abnormal, ALENDRONATE SODIUM.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch) had resolved.            No information on treatment medication was provided. CALCIUM MAG POTASSIUM for bone density and D3 & K2 for healthy heart ,ALENDRONATE SODIUM  for pre- osteo are concomitant medication taken by patient.   Patient claims has not had any itching from mosquito bites and thinks the vaccine may have some long term effects and company should act on it.  Residual effects: PATIENT  WALK HER DOG AT DUSK AND CAN FEEL THE MOSQUITOS STING HER , BUT THE RESULTING ITCH IS STILL NOT AS BAD AS BEFORE SHE RECIEVED THE VACCINES.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: TCR Received-AE Outcome and Email Address provided On 28-Jul-2021: significant Follow Up received concomitant medication and allergy added, address updated, vaccine facility info and event updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Lethargy, Nausea, Nodule
Clinical narrative: heartburn; lethargic; Pain at the site of injection; Nausea; CHILLS; fever; Sore arm; warm to the touch at the site of injection; Red knot; itchiness of the lymph nodes in the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit) and DYSPEPSIA (heartburn) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit), VACCINATION SITE PAIN (Pain at the site of injection), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (fever). On 05-Mar-2021, the patient experienced DYSPEPSIA (heartburn) and LETHARGY (lethargic). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit), DYSPEPSIA (heartburn), VACCINATION SITE PAIN (Pain at the site of injection), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (fever) had resolved and LETHARGY (lethargic) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: heartburn; lethargic; Pain at the site of injection; Nausea; CHILLS; fever; Sore arm; warm to the touch at the site of injection; Red knot; itchiness of the lymph nodes in the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit) and DYSPEPSIA (heartburn) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit), VACCINATION SITE PAIN (Pain at the site of injection), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (fever). On 05-Mar-2021, the patient experienced DYSPEPSIA (heartburn) and LETHARGY (lethargic). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit), DYSPEPSIA (heartburn), VACCINATION SITE PAIN (Pain at the site of injection), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (fever) had resolved and LETHARGY (lethargic) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Right leg began to itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Right leg began to itch) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Right leg began to itch). At the time of the report, PRURITUS (Right leg began to itch) 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.   Concomitant information use was not reported.  Treatment information was not provided.       Reporter did not allow further contact; Sender's Comments:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Chronic fatigue syndrome, Headache, Heart rate
Clinical narrative: malaise; chills; red rash all over body; brain fog; Body aches; felt like worst flu ever; heart racing and slowing down; Headache; arm soreness; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (felt like worst flu ever), HEART RATE (heart racing and slowing down), CHRONIC FATIGUE SYNDROME (brain fog), PAIN (Body aches) and PAIN IN EXTREMITY (arm soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (omaxacillin ,tetracycline, erythromycin). Concomitant products included PRAVASTATIN for Cholesterol, BISOPROLOL for Heart rate, ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASOPRIL PLUS), ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 16-Mar-2021, the patient experienced INFLUENZA (felt like worst flu ever), HEART RATE (heart racing and slowing down), PAIN (Body aches) and HEADACHE (Headache). On 18-Mar-2021, the patient experienced CHRONIC FATIGUE SYNDROME (brain fog) and RASH (red rash all over body). On an unknown date, the patient experienced MALAISE (malaise) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 18-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 17-Mar-2021, INFLUENZA (felt like worst flu ever), HEART RATE (heart racing and slowing down), PAIN (Body aches) and HEADACHE (Headache) had resolved. At the time of the report, CHRONIC FATIGUE SYNDROME (brain fog), MALAISE (malaise) and CHILLS (chills) was resolving and RASH (red rash all over body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (Inconclusive) 101.4.         This case was linked to MOD-2021-049485 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: significant follow-up :-  concomitant medications, treatment medications, lab data and events updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise, Pain, Pain in extremity, Rash
Clinical narrative: malaise; chills; red rash all over body; brain fog; Body aches; felt like worst flu ever; heart racing and slowing down; Headache; arm soreness; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (felt like worst flu ever), HEART RATE (heart racing and slowing down), CHRONIC FATIGUE SYNDROME (brain fog), PAIN (Body aches) and PAIN IN EXTREMITY (arm soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (omaxacillin ,tetracycline, erythromycin). Concomitant products included PRAVASTATIN for Cholesterol, BISOPROLOL for Heart rate, ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASOPRIL PLUS), ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 16-Mar-2021, the patient experienced INFLUENZA (felt like worst flu ever), HEART RATE (heart racing and slowing down), PAIN (Body aches) and HEADACHE (Headache). On 18-Mar-2021, the patient experienced CHRONIC FATIGUE SYNDROME (brain fog) and RASH (red rash all over body). On an unknown date, the patient experienced MALAISE (malaise) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 18-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 17-Mar-2021, INFLUENZA (felt like worst flu ever), HEART RATE (heart racing and slowing down), PAIN (Body aches) and HEADACHE (Headache) had resolved. At the time of the report, CHRONIC FATIGUE SYNDROME (brain fog), MALAISE (malaise) and CHILLS (chills) was resolving and RASH (red rash all over body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (Inconclusive) 101.4.         This case was linked to MOD-2021-049485 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: significant follow-up :-  concomitant medications, treatment medications, lab data and events updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: Malaise; Chills; Bain fog; Red rash all over body; Fever of 101.4; Head ache; Body aches; Felt like worst flu ever; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021. The most recent information was received on 25-Jul-2021 and was forwarded to Moderna on 25-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INFLUENZA LIKE ILLNESS (Felt like worst flu ever), FEELING ABNORMAL (Bain fog), RASH (Red rash all over body) and PYREXIA (Fever of 101.4) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A. and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Amoxacillin), Allergy to antibiotic (tetracycline) and Allergy to antibiotic (erythromycin). Concomitant products included PRAVASTATIN for Cholesterol, BISOPROLOL for Heart rate, ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASOPRIL PLUS), ATORVASTATIN, VITAMINS NOS and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS (Felt like worst flu ever), PYREXIA (Fever of 101.4) and HEADACHE (Head ache). On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Bain fog) and RASH (Red rash all over body). On an unknown date, the patient experienced MALAISE (Malaise) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS (Felt like worst flu ever), PYREXIA (Fever of 101.4) and HEADACHE (Head ache) had resolved. At the time of the report, FEELING ABNORMAL (Bain fog), RASH (Red rash all over body), MALAISE (Malaise) and CHILLS (Chills) was resolving.            Heart racing and slowing down (Start Date 16-Mar-2021  and Stop Date 17-Mar-2021) Allergic to IV contrast.   This case was linked to MOD-2021-049483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant follow-up (New events added), Patient demographic details, Concomitant drugs, Facility details and Outcome updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Malaise; Chills; Bain fog; Red rash all over body; Fever of 101.4; Head ache; Body aches; Felt like worst flu ever; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021. The most recent information was received on 25-Jul-2021 and was forwarded to Moderna on 25-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INFLUENZA LIKE ILLNESS (Felt like worst flu ever), FEELING ABNORMAL (Bain fog), RASH (Red rash all over body) and PYREXIA (Fever of 101.4) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A. and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Amoxacillin), Allergy to antibiotic (tetracycline) and Allergy to antibiotic (erythromycin). Concomitant products included PRAVASTATIN for Cholesterol, BISOPROLOL for Heart rate, ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASOPRIL PLUS), ATORVASTATIN, VITAMINS NOS and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS (Felt like worst flu ever), PYREXIA (Fever of 101.4) and HEADACHE (Head ache). On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Bain fog) and RASH (Red rash all over body). On an unknown date, the patient experienced MALAISE (Malaise) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS (Felt like worst flu ever), PYREXIA (Fever of 101.4) and HEADACHE (Head ache) had resolved. At the time of the report, FEELING ABNORMAL (Bain fog), RASH (Red rash all over body), MALAISE (Malaise) and CHILLS (Chills) was resolving.            Heart racing and slowing down (Start Date 16-Mar-2021  and Stop Date 17-Mar-2021) Allergic to IV contrast.   This case was linked to MOD-2021-049483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant follow-up (New events added), Patient demographic details, Concomitant drugs, Facility details and Outcome updated
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Petechiae, Pyrexia, Rash, Vaccination site pain
Clinical narrative: petechia on my face and other areas; red dots throughout body/developed some petechia on face and other areas; fatigue; fever; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechia on my face and other areas), RASH (red dots throughout body/developed some petechia on face and other areas), FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain). On 16-Mar-2021, the patient experienced RASH (red dots throughout body/developed some petechia on face and other areas). On an unknown date, the patient experienced PETECHIAE (petechia on my face and other areas). On 09-Mar-2021, FATIGUE (fatigue) and PYREXIA (fever) had resolved. On 12-Mar-2021, VACCINATION SITE PAIN (arm pain) had resolved. At the time of the report, PETECHIAE (petechia on my face and other areas) and RASH (red dots throughout body/developed some petechia on face and other areas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided Patient stated that  did not experienced any allergic or anaphylactic  reactions after receiving the vaccine   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant FU event added petechia on my face and other areas having outcome unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Mass, Nasopharyngitis
Clinical narrative: Back Pain; shoulder pain; headache; had a little lump; cold; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), MASS (had a little lump), NASOPHARYNGITIS (cold), ARTHRALGIA (shoulder pain) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MASS (had a little lump) and NASOPHARYNGITIS (cold). On 15-Mar-2021, the patient experienced ARTHRALGIA (shoulder pain) and HEADACHE (headache). On an unknown date, the patient experienced BACK PAIN (Back Pain). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back Pain), MASS (had a little lump), NASOPHARYNGITIS (cold), ARTHRALGIA (shoulder pain) and HEADACHE (headache) outcome was unknown.        Concomitant medications were not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Pain
Clinical narrative: BODY ACHES; WEAKNESS; Diarrhea; Stomach ache; SHIVERING; FEVER; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES) and ASTHENIA (WEAKNESS) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES), ASTHENIA (WEAKNESS), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES), ASTHENIA (WEAKNESS), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache) had resolved.            The adverse events lasted for 3 and a half days, and resolved on their own. Patient is doing well.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-112272 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The events were resolved
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: BODY ACHES; WEAKNESS; Diarrhea; Stomach ache; SHIVERING; FEVER; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES) and ASTHENIA (WEAKNESS) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES), ASTHENIA (WEAKNESS), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES), ASTHENIA (WEAKNESS), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache) had resolved.            The adverse events lasted for 3 and a half days, and resolved on their own. Patient is doing well.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-112272 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The events were resolved
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-033154 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033154:Patient case for second dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Diarrhea side effect for covid19 vaccine; Fever; general body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea side effect for covid19 vaccine), PYREXIA (Fever) and MYALGIA (general body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (general body aches). On an unknown date, the patient experienced DIARRHOEA (Diarrhea side effect for covid19 vaccine). At the time of the report, DIARRHOEA (Diarrhea side effect for covid19 vaccine), PYREXIA (Fever) and MYALGIA (general body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, COVID-19: positive (Positive) covid-19 virus infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24 Jul 2021 Patient's demographics was updated On 06-Aug-2021: Follow-up information received on 06 Aug 2021 contain significant follow up (New event added-diarrhea).Further follow-up declined.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: arm soreness; felt off-balance; fuzziness; slowness; disoriented; shortness of breath; few palpitations more than normal; headache; weird feeling in head and body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), BALANCE DISORDER (felt off-balance), FEELING ABNORMAL (fuzziness), SLUGGISHNESS (slowness) and DISORIENTATION (disoriented) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), BALANCE DISORDER (felt off-balance), FEELING ABNORMAL (fuzziness), SLUGGISHNESS (slowness), DISORIENTATION (disoriented), DYSPNOEA (shortness of breath), PALPITATIONS (few palpitations more than normal), HEADACHE (headache) and FEELING ABNORMAL (weird feeling in head and body). On 15-Mar-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), BALANCE DISORDER (felt off-balance), FEELING ABNORMAL (fuzziness), SLUGGISHNESS (slowness), DISORIENTATION (disoriented), PALPITATIONS (few palpitations more than normal), HEADACHE (headache) and FEELING ABNORMAL (weird feeling in head and body) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Sluggishness
Clinical narrative: arm soreness; felt off-balance; fuzziness; slowness; disoriented; shortness of breath; few palpitations more than normal; headache; weird feeling in head and body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), BALANCE DISORDER (felt off-balance), FEELING ABNORMAL (fuzziness), SLUGGISHNESS (slowness) and DISORIENTATION (disoriented) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), BALANCE DISORDER (felt off-balance), FEELING ABNORMAL (fuzziness), SLUGGISHNESS (slowness), DISORIENTATION (disoriented), DYSPNOEA (shortness of breath), PALPITATIONS (few palpitations more than normal), HEADACHE (headache) and FEELING ABNORMAL (weird feeling in head and body). On 15-Mar-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), BALANCE DISORDER (felt off-balance), FEELING ABNORMAL (fuzziness), SLUGGISHNESS (slowness), DISORIENTATION (disoriented), PALPITATIONS (few palpitations more than normal), HEADACHE (headache) and FEELING ABNORMAL (weird feeling in head and body) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling in armpit after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in armpit after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in armpit after first dose). At the time of the report, VACCINATION SITE SWELLING (Swelling in armpit after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter.  Treatment medication was not reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Left arm  soreness; Fever; Chills; Headache; Nausea; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.