chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Bodyache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Bodyache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date, Anxiety since an unknown date and Cholesterol since an unknown date. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METFORMIN for Diabetes.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Bodyache). At the time of the report, PYREXIA (Fever) and MYALGIA (Bodyache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included pills for cholesterol.  Reported treatment included Good's Powder for fever. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Bodyache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date, Anxiety since an unknown date and Cholesterol since an unknown date. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METFORMIN for Diabetes.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Bodyache). At the time of the report, PYREXIA (Fever) and MYALGIA (Bodyache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included pills for cholesterol.  Reported treatment included Good's Powder for fever.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Vaccination site pain
Clinical narrative: Fatigue; Injection site pain; Rash at base of skull and behind ears that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash at base of skull and behind ears that comes and goes), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L2OA and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (rash), Hay fever, Fruit allergy (redness, hives) since 01-Jan-2021 and Lichen sclerosis atrophicus since 01-Aug-2020. Concomitant products included ALLIUM SATIVUM BULB, GINKGO BILOBA LEAF, ZINC PICOLINATE (TINNITUS FORMULA) from 01-Mar-2018 to 25-Jun-2021 and ALLIUM SATIVUM BULB, GINKGO BILOBA LEAF, ZINC PICOLINATE (TINNITUS FORMULA) from 01-Mar-2018 to 25-Jun-2021 for Tinnitus, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) from 01-Jan-2018 to 12-Jul-2021 for an unknown indication.   On 21-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced RASH (Rash at base of skull and behind ears that comes and goes). On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On an unknown date, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, VACCINATION SITE PAIN (Injection site pain) outcome was unknown. In April 2021, RASH (Rash at base of skull and behind ears that comes and goes) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH (Rash at base of skull and behind ears that comes and goes) to be not related. No further causality assessments were provided for VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Fatigue).    The patient reported experiencing  a rash on the back of head and neck from January to April. The rash was eventually determined to be a reaction to the sap in pine cones which she was handling during that time frame. The rash resolved as soon as the pine cones were gone. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-Jun-2021 and updated email-id. On 21-Jul-2021: No specific follow-up information recorded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: tested positive for covid; runny nose; Fever; body ache; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-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 RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache). On 24-Mar-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     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 relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-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 RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache). On 24-Mar-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     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 relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Shortness of breath; Weakness; Loss of appetite; Headache; Fever;temp was elevated; Chills; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and PYREXIA (Fever;temp was elevated) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Anxiety, Irritable bowel syndrome and Thyroid disorder. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LEVOTHYROXINE for Thyroid disorder NOS.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Fever;temp was elevated), CHILLS (Chills) and MYALGIA (Body pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Fever;temp was elevated), CHILLS (Chills) and MYALGIA (Body pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included high blood pressure medications, antidepressants, IBS medications and digestive enzyme with water.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR: Follow-up received on 22-6-21 doesn't contain any new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Shortness of breath; Weakness; Loss of appetite; Headache; Fever;temp was elevated; Chills; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and PYREXIA (Fever;temp was elevated) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Anxiety, Irritable bowel syndrome and Thyroid disorder. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LEVOTHYROXINE for Thyroid disorder NOS.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Fever;temp was elevated), CHILLS (Chills) and MYALGIA (Body pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Fever;temp was elevated), CHILLS (Chills) and MYALGIA (Body pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included high blood pressure medications, antidepressants, IBS medications and digestive enzyme with water.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR: Follow-up received on 22-6-21 doesn't contain any new information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen
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 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), DOCOSAHEXAENOIC ACID (DHA) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-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 25-Dec-2020 and the estimated date of delivery was 01-Oct-2021. On 25-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Pregnancy test: positive (Positive) Positive. On 16-Mar-2021, Full blood count: normal (normal) normal. On 16-Mar-2021, Ultrasound antenatal screen: normal (normal) Everything is cleared; baby healthy. On 11-May-2021, Ultrasound antenatal screen: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Hypopnoea, Panic attack
Clinical narrative: heart was beating fast; shallow breathing similar to when she had COVID; thought she was having panic attack; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack). At the time of the report, HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Heart rate: Heart was beating fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack). At the time of the report, HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Heart rate: Heart was beating fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site haemorrhage, Lethargy, Pyrexia
Clinical narrative: His arm is blac and blue and fairely bruised; Lethargy; He began experiencing fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (His arm is blac and blue and fairely bruised), LETHARGY (Lethargy), PYREXIA (He began experiencing fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (His arm is blac and blue and fairely bruised), LETHARGY (Lethargy), PYREXIA (He began experiencing fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE HAEMORRHAGE (His arm is blac and blue and fairely bruised), LETHARGY (Lethargy), PYREXIA (He began experiencing fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 101.5 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia
Clinical narrative: causing her to be unable to sleep at night; body aches that rotate location; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (causing her to be unable to sleep at night) and MYALGIA (body aches that rotate location) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INSOMNIA (causing her to be unable to sleep at night) and MYALGIA (body aches that rotate location). At the time of the report, INSOMNIA (causing her to be unable to sleep at night) and MYALGIA (body aches that rotate location) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included steroid pack
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Sore arm where they gave him the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Sore arm where they gave him the shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 03-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Sore arm where they gave him the shot). At the time of the report, VACCINATION SITE DISCOMFORT (Sore arm where they gave him the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: first dose administer past 6 hours mark; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose administer past 6 hours mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose administer past 6 hours mark). At the time of the report, EXPIRED PRODUCT ADMINISTERED (first dose administer past 6 hours mark) 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   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No new information was provided.; Reporter's Comments: This report refers to a case of Expired product administered,  for mRNA-1273, lot # 0440A21A, with no associated AEs.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: maternal exposure during pregnancy; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021. The most recent information was received on 25-Mar-2021 and was forwarded to Moderna on an unknown date.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 32-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (2016-Live, Full-term Birth 2018-Live, Full-term Birth). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 06-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred on an unknown date.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Ultrasound foetal: normal normal.         Treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Internal review on 25JUN2021 resulted in updates to pregnancy details.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: chills; diarrhea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (chills), PYREXIA (fever), DIARRHOEA (diarrhea) and the second episode of CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced the first episode of CHILLS (chills), PYREXIA (fever) and DIARRHOEA (diarrhea). On 23-Mar-2021, the patient experienced the second episode of CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 23-Mar-2021, PYREXIA (fever) and DIARRHOEA (diarrhea) outcome was unknown. At the time of the report, last episode of CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Chest pain, Depression, Ear pain
Clinical narrative: Tearful; Anxiety; More depressed than usual; Pain in lower abdomen periodically; Pain behind ear; Burning of her chest (like a sunburn); Colder skin; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (Colder skin), TEARFULNESS (Tearful) and ANXIETY (Anxiety) in a 62-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)) and PERIPHERAL COLDNESS (Colder skin). On an unknown date, the patient experienced TEARFULNESS (Tearful), ANXIETY (Anxiety), DEPRESSION (More depressed than usual) and ABDOMINAL PAIN (Pain in lower abdomen periodically). At the time of the report, EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (Colder skin), TEARFULNESS (Tearful), ANXIETY (Anxiety), DEPRESSION (More depressed than usual) and ABDOMINAL PAIN (Pain in lower abdomen periodically) outcome was unknown.            Patient reported having the same symptoms (but more severe) after her first dose.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-066926 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Tearfulness
Clinical narrative: Tearful; Anxiety; More depressed than usual; Pain in lower abdomen periodically; Pain behind ear; Burning of her chest (like a sunburn); Colder skin; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (Colder skin), TEARFULNESS (Tearful) and ANXIETY (Anxiety) in a 62-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)) and PERIPHERAL COLDNESS (Colder skin). On an unknown date, the patient experienced TEARFULNESS (Tearful), ANXIETY (Anxiety), DEPRESSION (More depressed than usual) and ABDOMINAL PAIN (Pain in lower abdomen periodically). At the time of the report, EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (Colder skin), TEARFULNESS (Tearful), ANXIETY (Anxiety), DEPRESSION (More depressed than usual) and ABDOMINAL PAIN (Pain in lower abdomen periodically) outcome was unknown.            Patient reported having the same symptoms (but more severe) after her first dose.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-066926 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: extreme headache; nauseous; threw up; fatique; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headache), NAUSEA (nauseous), VOMITING (threw up) and FATIGUE (fatique) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (extreme headache), NAUSEA (nauseous), VOMITING (threw up) and FATIGUE (fatique). On 24-Mar-2021, HEADACHE (extreme headache), NAUSEA (nauseous) and VOMITING (threw up) outcome was unknown. At the time of the report, FATIGUE (fatique) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product dose omission issue
Clinical narrative: mother has not gotten the second shot yet; Headache, as CC reported; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (mother has not gotten the second shot yet) and HEADACHE (Headache, as CC reported) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (mother has not gotten the second shot yet) and HEADACHE (Headache, as CC reported). At the time of the report, PRODUCT DOSE OMISSION ISSUE (mother has not gotten the second shot yet) had resolved and HEADACHE (Headache, as CC reported) outcome was unknown. Not Provided          The concomitant medications information was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received on 1-jun-2021, new events information was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: A little one spot rash that got really itchy; Labored breathing; Fever; Swelling around injection site; Pain and tenderness around the injection site; Nausea; Joint pain; Muscle pain; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE PAIN (Pain and tenderness around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE PAIN (Pain and tenderness around the injection site), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE PAIN (Pain and tenderness around the injection site), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not provided   This case was linked to MOD-2021-122685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case for 2nd dose created. Patient contact information updated. Added patient's date of birth, age at time of event, route and site of vaccine administration. Dechallange and Rechallenge results changed to positive.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash pruritic, Vaccination site pain, Vaccination site swelling
Clinical narrative: A little one spot rash that got really itchy; Labored breathing; Fever; Swelling around injection site; Pain and tenderness around the injection site; Nausea; Joint pain; Muscle pain; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE PAIN (Pain and tenderness around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE PAIN (Pain and tenderness around the injection site), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE PAIN (Pain and tenderness around the injection site), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not provided   This case was linked to MOD-2021-122685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case for 2nd dose created. Patient contact information updated. Added patient's date of birth, age at time of event, route and site of vaccine administration. Dechallange and Rechallenge results changed to positive.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Dizziness, Feeling abnormal, Headache
Clinical narrative: blood pressure was sky high; couldn't get out of bed; feeling terrible; feeling thirsty; nausea; Headache; feeling weak; dizzy; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo) and HYPOKINESIA (couldn't get out of bed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (L-THYROXIN 1A PHARMA) and ASCORBIC ACID, COLECALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (MULTIVITAMIN HP) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERTENSION (blood pressure was sky high), HYPOKINESIA (couldn't get out of bed) and FEELING ABNORMAL (feeling terrible). At the time of the report, HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), HYPOKINESIA (couldn't get out of bed), FEELING ABNORMAL (feeling terrible), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Computerised tomogram: Inconclusive. On 17-Mar-2021, X-ray: Inconclusive.     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.   Patient was in a bad shape and had go to the hospital. Physician recommended not to get the second shot. 9 days Later patient could not get out of bed. Patient experienced a really bad Vertigo and ambulance took to Emergency room and they kept patient for part of day until blood pressure went back to little lower.   Patient have chosen not to get second dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up information received on 08-APR-2021,  Health care professional details are updated. Patient demographic was updated. Additional events are also added On 11-May-2021: Pt stating she is not getting her 2nd vaccine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypokinesia, Nausea, Polydipsia, Vertigo
Clinical narrative: blood pressure was sky high; couldn't get out of bed; feeling terrible; feeling thirsty; nausea; Headache; feeling weak; dizzy; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo) and HYPOKINESIA (couldn't get out of bed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (L-THYROXIN 1A PHARMA) and ASCORBIC ACID, COLECALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (MULTIVITAMIN HP) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERTENSION (blood pressure was sky high), HYPOKINESIA (couldn't get out of bed) and FEELING ABNORMAL (feeling terrible). At the time of the report, HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), HYPOKINESIA (couldn't get out of bed), FEELING ABNORMAL (feeling terrible), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Computerised tomogram: Inconclusive. On 17-Mar-2021, X-ray: Inconclusive.     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.   Patient was in a bad shape and had go to the hospital. Physician recommended not to get the second shot. 9 days Later patient could not get out of bed. Patient experienced a really bad Vertigo and ambulance took to Emergency room and they kept patient for part of day until blood pressure went back to little lower.   Patient have chosen not to get second dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up information received on 08-APR-2021,  Health care professional details are updated. Patient demographic was updated. Additional events are also added On 11-May-2021: Pt stating she is not getting her 2nd vaccine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: blood pressure was sky high; couldn't get out of bed; feeling terrible; feeling thirsty; nausea; Headache; feeling weak; dizzy; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo) and HYPOKINESIA (couldn't get out of bed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (L-THYROXIN 1A PHARMA) and ASCORBIC ACID, COLECALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (MULTIVITAMIN HP) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERTENSION (blood pressure was sky high), HYPOKINESIA (couldn't get out of bed) and FEELING ABNORMAL (feeling terrible). At the time of the report, HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), HYPOKINESIA (couldn't get out of bed), FEELING ABNORMAL (feeling terrible), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Computerised tomogram: Inconclusive. On 17-Mar-2021, X-ray: Inconclusive.     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.   Patient was in a bad shape and had go to the hospital. Physician recommended not to get the second shot. 9 days Later patient could not get out of bed. Patient experienced a really bad Vertigo and ambulance took to Emergency room and they kept patient for part of day until blood pressure went back to little lower.   Patient have chosen not to get second dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up information received on 08-APR-2021,  Health care professional details are updated. Patient demographic was updated. Additional events are also added On 11-May-2021: Pt stating she is not getting her 2nd vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Left arm felt like someone punched it". It is very sore; Feverish; Chills throughout body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm felt like someone punched it". It is very sore), PYREXIA (Feverish) and CHILLS (Chills throughout body) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea, Diabetes and High cholesterol. Concomitant products included METFORMIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm felt like someone punched it". It is very sore), PYREXIA (Feverish) and CHILLS (Chills throughout body). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Left arm felt like someone punched it". It is very sore), PYREXIA (Feverish) and CHILLS (Chills throughout body) outcome was unknown.            Past medical history includes prostate issue.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-046661 (Patient Link).