chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site rash, Pain in extremity
Clinical narrative: Feeling tired; rash red, stinging and hot; rash at injection site extending to elbow; Itching rash; headache; chill; throwing up/ vomitting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chill), VOMITING (throwing up/ vomitting), INJECTION SITE RASH (rash at injection site extending to elbow) and PRURITUS (Itching rash) in a 76-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.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache). 05-Mar-2021, the patient experienced CHILLS (chill), VOMITING (throwing up/ vomitting) and PAIN IN EXTREMITY (sore arm). On 07-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site extending to elbow), PRURITUS (Itching rash) and RASH ERYTHEMATOUS (rash red, stinging and hot). On 08-Mar-2021, the patient experienced FATIGUE (Feeling tired). At the time of the report, HEADACHE (headache), CHILLS (chill), VOMITING (throwing up/ vomitting), INJECTION SITE RASH (rash at injection site extending to elbow), PRURITUS (Itching rash), FATIGUE (Feeling tired), PAIN IN EXTREMITY (sore arm) and RASH ERYTHEMATOUS (rash red, stinging and hot) 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 medication include blood pressure medicine. Not provided the name.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Vomiting
Clinical narrative: Feeling tired; rash red, stinging and hot; rash at injection site extending to elbow; Itching rash; headache; chill; throwing up/ vomitting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chill), VOMITING (throwing up/ vomitting), INJECTION SITE RASH (rash at injection site extending to elbow) and PRURITUS (Itching rash) in a 76-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.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache). 05-Mar-2021, the patient experienced CHILLS (chill), VOMITING (throwing up/ vomitting) and PAIN IN EXTREMITY (sore arm). On 07-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site extending to elbow), PRURITUS (Itching rash) and RASH ERYTHEMATOUS (rash red, stinging and hot). On 08-Mar-2021, the patient experienced FATIGUE (Feeling tired). At the time of the report, HEADACHE (headache), CHILLS (chill), VOMITING (throwing up/ vomitting), INJECTION SITE RASH (rash at injection site extending to elbow), PRURITUS (Itching rash), FATIGUE (Feeling tired), PAIN IN EXTREMITY (sore arm) and RASH ERYTHEMATOUS (rash red, stinging and hot) 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 medication include blood pressure medicine. Not provided the name.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Day 39 and still have not gotten their second dose; A spontaneous report was received from a healthcare professional concerning a 63-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and on day 39 and still have not gotten their second dose(missed dose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001M20A) for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient experienced the event, day 39 and still have not gotten their second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, day 39 and still have not gotten their second dose (Missed dose ) was unknown.; Reporter's Comments: This refers to a 63-year patient who missed their second dose administration appointment. No associated AE/SAEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Lactating mother; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating mother) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included No adverse event (No medical history provided).    MEDICAL HISTORY (Patient): The patient's past medical history included Pregnancy (Delivered in Dec 2020).   In January 2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating mother). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating mother) outcome was unknown.            No concomitant medication reported   No treatment medication reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Pain
Clinical narrative: excruciating pain in the back - like I strained something - really really bad even at sitting, it will; excruciating pain in the right side - like I strained something - really really bad even at sitting, it; have trouble almost walking and is needing wheelchair to fly back from out of town; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating pain in the back - like I strained something - really really bad even at sitting, it will), PAIN (excruciating pain in the right side - like I strained something - really really bad even at sitting, it) and GAIT DISTURBANCE (have trouble almost walking and is needing wheelchair to fly back from out of town) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 BACK PAIN (excruciating pain in the back - like I strained something - really really bad even at sitting, it will), PAIN (excruciating pain in the right side - like I strained something - really really bad even at sitting, it) and GAIT DISTURBANCE (have trouble almost walking and is needing wheelchair to fly back from out of town). At the time of the report, BACK PAIN (excruciating pain in the back - like I strained something - really really bad even at sitting, it will), PAIN (excruciating pain in the right side - like I strained something - really really bad even at sitting, it) and GAIT DISTURBANCE (have trouble almost walking and is needing wheelchair to fly back from out of town) 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Nauseous; slight headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), HEADACHE (slight headache) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ALPRAZOLAM (XANAX) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NAUSEA (Nauseous), HEADACHE (slight headache) and PAIN IN EXTREMITY (sore arm). On 22-Feb-2021, HEADACHE (slight headache) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) in a 36-year-old female patient (gravida 10, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2-0A and 025121A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism and Live birth on 23-Aug-2015. Concomitant products included HYDROXYCHLOROQUINE, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC), DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) and VITAMIN B6 for an unknown indication.   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. The patient's last menstrual period was on 31-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 06-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 06-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. It was reported that there was maternal history of subfertility  Also, This was an in-vitro fertilization. It was reported that the consumer had 9 miscarriages (spontaneous abortions) No complications or acute illness were reported during this pregnancy to date. There was no family history of congenital anomalies/ genetic disease. The prior use of alcohol was reported by the consumer. The laboratory tests were reported as:  On an unknown date, Ultrasound at 7 weeks and genetic testing of embryo before implantation were reported. Estimated date of conception was reported as 31-JUL-2020.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: Shingles Outbreak; Rash; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles Outbreak), RASH (Rash) and BACK PAIN (Back Pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HERPES ZOSTER (Shingles Outbreak), RASH (Rash) and BACK PAIN (Back Pain). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Herpes zoster, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles Outbreak), RASH (Rash) and BACK PAIN (Back Pain) 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.   The consumer was taking "Valacyclovir", an antiviral medication, as advised by HCP to try to alleviate the symptoms.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Vaccination site pruritus
Clinical narrative: itchiness at injection site; flushing at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site) and FLUSHING (flushing at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LABETALOL HYDROCHLORIDE (TRANDATE), Salyres and THROMBIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site) and FLUSHING (flushing at injection site). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site) and FLUSHING (flushing at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Arm a little bit swollen at the injection site; red mark at the injection site; She believes she started to run a fever; chills; tired; Excruciating joint pain even on her fingernails; Body pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), VACCINATION SITE ERYTHEMA (red mark at the injection site), ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains) and PYREXIA (She believes she started to run a fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Angina pectoris, VITAMINS NOS for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains), CHILLS (chills) and FATIGUE (tired). On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), VACCINATION SITE ERYTHEMA (red mark at the injection site) and PYREXIA (She believes she started to run a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (chills) had resolved. On 06-Mar-2021, VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains) and PYREXIA (She believes she started to run a fever) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red mark at the injection site) and FATIGUE (tired) outcome was unknown.            Action taken with mRNA-1273 in response to the events were Not Applicable.   This case was linked to MOD-2021-230178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-jun-2021 no new information was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Arm a little bit swollen at the injection site; red mark at the injection site; She believes she started to run a fever; chills; tired; Excruciating joint pain even on her fingernails; Body pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), VACCINATION SITE ERYTHEMA (red mark at the injection site), ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains) and PYREXIA (She believes she started to run a fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Angina pectoris, VITAMINS NOS for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains), CHILLS (chills) and FATIGUE (tired). On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), VACCINATION SITE ERYTHEMA (red mark at the injection site) and PYREXIA (She believes she started to run a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (chills) had resolved. On 06-Mar-2021, VACCINATION SITE SWELLING (Arm a little bit swollen at the injection site), ARTHRALGIA (Excruciating joint pain even on her fingernails), MYALGIA (Body pains) and PYREXIA (She believes she started to run a fever) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red mark at the injection site) and FATIGUE (tired) outcome was unknown.            Action taken with mRNA-1273 in response to the events were Not Applicable.   This case was linked to MOD-2021-230178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-jun-2021 no new information was updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Tenderness, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching under the injection site; Injection site red spot of 2 inches; Little swelling; Pain; Tenderness; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (Little swelling), PAIN (Pain), TENDERNESS (Tenderness), VACCINATION SITE PRURITUS (Itching under the injection site) and VACCINATION SITE ERYTHEMA (Injection site red spot of 2 inches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, GLIPIZIDE, METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HCL), LOSARTAN and SIMVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SWELLING (Little swelling), PAIN (Pain) and TENDERNESS (Tenderness). On 08-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching under the injection site) and VACCINATION SITE ERYTHEMA (Injection site red spot of 2 inches). At the time of the report, SWELLING (Little swelling), PAIN (Pain), TENDERNESS (Tenderness), VACCINATION SITE PRURITUS (Itching under the injection site) and VACCINATION SITE ERYTHEMA (Injection site red spot of 2 inches) 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 reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: did antibody testing had none; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (did antibody testing had none) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included APIXABAN (ELIQUIS), GLIMEPIRIDE, DEXLANSOPRAZOLE (DEXILANT), ATORVASTATIN, LISINOPRIL, METOPROLOL, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), TRIAMCINOLONE ACETONIDE (NASACORT), GLUCOSAMINE and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (did antibody testing had none). At the time of the report, ANTIBODY TEST NEGATIVE (did antibody testing had none) outcome was unknown.            No treatment information was provided Action taken with mRNA-1273 in response to the events were Not Applicable
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reactions) 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 (No reported medical history).    On 25-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 ALLERGY TO VACCINE (Allergic reactions). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Allergic reaction, at a dose of 10 mg. At the time of the report, ALLERGY TO VACCINE (Allergic reactions) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-048496 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Lymphadenopathy, Migraine
Clinical narrative: Daily Migraine; joint pain; minor ache; pain in neck progress to migraine; armpits are tender under both arms; fatigue; Lymph node pain and enlargement; Migraine/Chronic migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine/Chronic migraine), NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), MIGRAINE (Daily Migraine) and ARTHRALGIA (joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic migraine in 1956. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) and FLUOXETINE HYDROCHLORIDE (FLOXETINE) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MIGRAINE (Migraine/Chronic migraine). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node pain and enlargement). On 18-Mar-2021, the patient experienced NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), ARTHRALGIA (joint pain), MYALGIA (minor ache) and FATIGUE (fatigue). On 10-Apr-2021, the patient experienced MIGRAINE (Daily Migraine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 27-Mar-2021, MIGRAINE (Migraine/Chronic migraine) had resolved. On 01-Apr-2021, LYMPHADENOPATHY (Lymph node pain and enlargement) had resolved. On 30-Apr-2021, MIGRAINE (Daily Migraine) had resolved. At the time of the report, NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), ARTHRALGIA (joint pain), MYALGIA (minor ache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first dose on 12 March 2021 in left upper arm (non-dominant) with lot #040A21A . Patient is prone to migraines. She had a migraine for 4 days in a row (March13-16). She did not have one yesterday. Today she woke up with pain starting in back of neck and progressed to a migraine. Today her armpits are tender under both arms. She is fatigued, has minor aches and joint pain. She is drinking lots of water and has taken Tylenol.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient demographics is updated, medical history is updated, vaccine information is updated, Events information is updated, concomitant product information is updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain
Clinical narrative: Daily Migraine; joint pain; minor ache; pain in neck progress to migraine; armpits are tender under both arms; fatigue; Lymph node pain and enlargement; Migraine/Chronic migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine/Chronic migraine), NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), MIGRAINE (Daily Migraine) and ARTHRALGIA (joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic migraine in 1956. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) and FLUOXETINE HYDROCHLORIDE (FLOXETINE) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MIGRAINE (Migraine/Chronic migraine). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node pain and enlargement). On 18-Mar-2021, the patient experienced NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), ARTHRALGIA (joint pain), MYALGIA (minor ache) and FATIGUE (fatigue). On 10-Apr-2021, the patient experienced MIGRAINE (Daily Migraine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 27-Mar-2021, MIGRAINE (Migraine/Chronic migraine) had resolved. On 01-Apr-2021, LYMPHADENOPATHY (Lymph node pain and enlargement) had resolved. On 30-Apr-2021, MIGRAINE (Daily Migraine) had resolved. At the time of the report, NECK PAIN (pain in neck progress to migraine), AXILLARY PAIN (armpits are tender under both arms), ARTHRALGIA (joint pain), MYALGIA (minor ache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first dose on 12 March 2021 in left upper arm (non-dominant) with lot #040A21A . Patient is prone to migraines. She had a migraine for 4 days in a row (March13-16). She did not have one yesterday. Today she woke up with pain starting in back of neck and progressed to a migraine. Today her armpits are tender under both arms. She is fatigued, has minor aches and joint pain. She is drinking lots of water and has taken Tylenol.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient demographics is updated, medical history is updated, vaccine information is updated, Events information is updated, concomitant product information is updated
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine after temperature excursion; A spontaneous report (United States) was received from a consumer concerning a 56-year-old, of an unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) after temperature excursion.   The patient's medical history, as provided by the reporter, was unknown. Concomitant medications reported was unknown.  On 18 Mar, the patient received the mRNA-1273 (Lot number: Unknown) via unknown route of administration in an unknown location for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.  No treatment information was provided.  The outcome of the event, received vaccine after temperature excursion was considered as resolved.; Reporter's Comments: This report refers to a case of product storage error for mNA-1273, lot # unknown with no associated AEs.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: red dots all over body; itchiness all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red dots all over body) and PRURITUS (itchiness all over body) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 300042721 and 3000493) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced RASH (red dots all over body) and PRURITUS (itchiness all over body). The patient was treated with LORATADINE (LORATADINE HEXAL) for Rash all over and Itching all over, at an unspecified dose and frequency.   At the time of the report, RASH (red dots all over body) and PRURITUS (itchiness all over body) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site oedema, Vaccination site pruritus
Clinical narrative: around the injection site she has "like a spider bite"; Around the injection site, it itches; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (around the injection site she has "like a spider bite"), VACCINATION SITE PRURITUS (Around the injection site, it itches) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE OEDEMA (around the injection site she has "like a spider bite") and VACCINATION SITE PRURITUS (Around the injection site, it itches). On 07-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE OEDEMA (around the injection site she has "like a spider bite") and VACCINATION SITE PRURITUS (Around the injection site, it itches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Pain in extremity, Vision blurred
Clinical narrative: Confusion; Balance was off; Vision was blurred; General sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), VISION BLURRED (Vision was blurred) and PAIN IN EXTREMITY (General sore arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX), OLANZAPINE, OXYCODONE and BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) for an unknown indication.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), VISION BLURRED (Vision was blurred) and PAIN IN EXTREMITY (General sore arm). At the time of the report, CONFUSIONAL STATE (Confusion), BALANCE DISORDER (Balance was off), VISION BLURRED (Vision was blurred) and PAIN IN EXTREMITY (General sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: CC said that consumer was calling to report symptom; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (CC said that consumer was calling to report symptom) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (CC said that consumer was calling to report symptom). At the time of the report, ADVERSE REACTION (CC said that consumer was calling to report symptom) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medication were not reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over; Mainly itching her upper body; Non stop itching the last four days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over), PRURITUS (Mainly itching her upper body) and PRURITUS (Non stop itching the last four days) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 02-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 PRURITUS (itching all over), PRURITUS (Mainly itching her upper body) and PRURITUS (Non stop itching the last four days). At the time of the report, PRURITUS (itching all over), PRURITUS (Mainly itching her upper body) and PRURITUS (Non stop itching the last four days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Different itching cream.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant 1 week after she received the 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant 1 week after she received the 1st dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concomitant products included PROGESTERONE for Pregnancy.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 13-Oct-2021. On 19-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant 1 week after she received the 1st dose). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant 1 week after she received the 1st dose) had resolved.            Concomitant medication include allergy medications and supplements. No treatment medication details was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: pain in the body; INAPPROPRIATE DRUG SCHEDULE; fever; A spontaneous report was received from Consumer concerning herself 26 years old Female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in the body, fever and inappropriate drug schedule.  The patient's medical history was not provided. Concomitant products Rosal as contraceptive pill and omeprazol for reflux.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) by intramuscular route for prophylaxis of COVID-19 infection and on 19 Feb 2021 the patient received the second of two planned doses of mRNA-1273 (Batch Number: 300042722,) by intramuscular route for prophylaxis of COVID-19 infection.   After the vaccination got fever and body aches after 24 hours. Already 19th evening she experienced little fever and pain.  Treatment was Alvedon and Ipren for her symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event pain in the body was resolved on 21 Feb 2021, fever was resolved on 20 Feb 2021 and inappropriate drug schedule was resolved on 19 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # 300042722. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 01-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.    This case was linked to MOD-2021-028714 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHE; feeling body ache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (HEADACHE) and MYALGIA (feeling body ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (HEADACHE) and MYALGIA (feeling body ache). On 21-Mar-2021, HEADACHE (HEADACHE) and MYALGIA (feeling body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: tinnitus; Patient recieved late second dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) and PRODUCT DOSE OMISSION ISSUE (Patient recieved late second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient recieved late second dose). On an unknown date, the patient experienced TINNITUS (tinnitus). On 28-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient recieved late second dose) had resolved. At the time of the report, TINNITUS (tinnitus) outcome was unknown.            The patient stated that after couple of weeks  from the second dose of vaccine she felt tinnitus. She cannot confirm the exact date. Concomitant medications were not provided. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter details, product start date updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), ATEZOLIZUMAB, CARBOPLATIN, MORPHINE SULFATE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), PRIMIDONE, FLUOXETINE, ONDANSETRON, PROCHLORPERAZINE (COMPAZINE SPANSULE), RANITIDINE, ALPRAZOLAM (XANAX) and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) 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.   Other medication: Albuterol inhaler and nebulizer.   This case was linked to US-MODERNATX, INC.-MOD-2021-054191 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054191:2 dose
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive with covid-19 after receiving first dose of vaccine; A spontaneous report was received from a consumer, concerning a 47-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Covid-19 positive after first dose of vaccine and take the appointment for second dose on 9May2021/missed dose.  The patient's medical history, as provided by the reporter, was high blood pressure, pulmonary issue, cholesterol.  Concomitant medications reported included pill for high blood pressure, ssue, statin for cholesterol and aspirin.  On 22 Jan 2021, approximately 6 days prior to the onset of the symptoms the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left hand for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient developed Covid-19 positive after receiving first dose. On Feb 2021 the patient received  monoclonal antibody infusion on doctor's recommendation. He wants to know if he should take the 2nd dose  of vaccine scheduled for 9 Feb 2021.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event  Covid-19 positive after first dose of vaccine and take the appointment for second dose on 9May2021/missed dose was unknown.; 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Second episode of fever; First episode of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and PYREXIA in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CALCIUM, and VITAMIN D3 for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA. On 23-Mar-2021, the patient experienced PYREXIA. The patient was treated with TYLENOL for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA had resolved and PYREXIA outcome was unknown.            No concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Thirst
Clinical narrative: Thirsty; Tired; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirsty), FATIGUE (Tired) and PAIN IN EXTREMITY (Pain in the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced THIRST (Thirsty) and FATIGUE (Tired). At the time of the report, THIRST (Thirsty), FATIGUE (Tired) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.