chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity, Rash, Vaccination site pain
Clinical narrative: Painful area from Injection Site to Elbow; Itching Injection Site Red Spot; Red Spot Spread From Injection Site to the elbow; Swollen area from Injection Site to Elbow; Red spot (Rash) under the Injection Site; Diarrhea; Fatigue; Pain in the Left Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), FATIGUE (Fatigue) and VACCINATION SITE PRURITUS (Itching Injection Site Red Spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-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 VACCINATION SITE PAIN (Pain in the Left Arm Injection Site). On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Painful area from Injection Site to Elbow; Itching Injection Site Red Spot; Red Spot Spread From Injection Site to the elbow; Swollen area from Injection Site to Elbow; Red spot (Rash) under the Injection Site; Diarrhea; Fatigue; Pain in the Left Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), FATIGUE (Fatigue) and VACCINATION SITE PRURITUS (Itching Injection Site Red Spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-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 VACCINATION SITE PAIN (Pain in the Left Arm Injection Site). On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: A spontaneous report was received from a 83-years-old female patient concerning herself  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event back ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient experienced the event back ache.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, back ache,  was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hunger, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Very hungry; Swelling at the injection site; Pain at the injection site; Muscle pain; Tiredness or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Very hungry), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue). On 07-Mar-2021, the patient experienced HUNGER (Very hungry). On 06-Mar-2021, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue) had resolved. At the time of the report, HUNGER (Very hungry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Extreme diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 08-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea). At the time of the report, DIARRHOEA (Extreme diarrhea) outcome was unknown.            No concomitant medication nor treatment provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (NO ADVERSE EVENT) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was prescribed antibiotics for a sinus infection that started BEFORE the shot. Has not started taking it. Fluticasone (has been taking off an on), The dentist prescribed Augmentin and she wants to start it today 875mg 2/day for 10 days.    Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Additional (contact information updated)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vacciantion.     Concomitant products included VITAMINS NOS, FOLIC ACID, IRON (PRENATAL [FOLIC ACID;IRON]), ESCITALOPRAM and BUPROPION for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test was 07-Nov-2020 and gestational stage was second trimester. Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 26-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 26-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     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 06-Mar-2021, the patient experienced NAUSEA (nausea). On 07-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: memory loss; it was strange feeling; hard time to concentrate; headache; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss), FEELING ABNORMAL (it was strange feeling), DISTURBANCE IN ATTENTION (hard time to concentrate) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke. Concurrent medical conditions included Hypothyroidism, Hypertension, Overweight and Arrhythmia. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced AMNESIA (memory loss), FEELING ABNORMAL (it was strange feeling), DISTURBANCE IN ATTENTION (hard time to concentrate) and HEADACHE (headache). On 07-Mar-2021, AMNESIA (memory loss), FEELING ABNORMAL (it was strange feeling) and HEADACHE (headache) had resolved. At the time of the report, DISTURBANCE IN ATTENTION (hard time to concentrate) outcome was unknown.            No treatment drugs were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Chalky Taste in Mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Chalky Taste in Mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     no medical history provided by reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    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 DYSGEUSIA (Chalky Taste in Mouth). At the time of the report, DYSGEUSIA (Chalky Taste in Mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue
Clinical narrative: Around 3 to 5 pm had no balance felt over.; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Around 3 to 5 pm had no balance felt over.) and FATIGUE (extremely tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy (Patient had no allergy reaction with vaccine but had reacted to peanuts on one occasion years ago), Blood pressure high and Cholesterol.   On 05-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 06-Mar-2021, the patient experienced BALANCE DISORDER (Around 3 to 5 pm had no balance felt over.) and FATIGUE (extremely tired). On 06-Mar-2021, BALANCE DISORDER (Around 3 to 5 pm had no balance felt over.) had resolved. At the time of the report, FATIGUE (extremely tired) had resolved.            The patient is taking medication for blood pressure twice a day and for cholesterol. On follow-up, the patient reported that post vaccine difficulties were misreported and that he had no reaction at all at the time of the injection and thereafter.   Most recent FOLLOW-UP information incorporated above includes:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Mobility decreased, Pyrexia
Clinical narrative: Cannot Move; Weakness; Fever; Cannot stand up; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Cannot Move), ASTHENIA (Weakness), PYREXIA (Fever) and DYSSTASIA (Cannot stand up) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension, HYDROCHLOROTHIAZIDE and SOTALOL HYDROCHLORIDE (SOTALOL [SOTALOL HYDROCHLORIDE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Cannot Move), ASTHENIA (Weakness), PYREXIA (Fever) and DYSSTASIA (Cannot stand up). The patient was treated with PARACETAMOL (TYLENOL) for Mobility decreased, Fever and Difficulty in standing, at an unspecified dose and frequency and VITAMINS NOS for Vitamin supplementation, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Cannot Move), ASTHENIA (Weakness), PYREXIA (Fever) and DYSSTASIA (Cannot stand up) had not resolved.        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.   Patient has taken treatment but he didn't find any improvement.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient received the Moderna Vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the Moderna Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the Moderna Vaccine). On 04-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient received the Moderna Vaccine) had resolved.        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 was not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Suspect product dosage details and Current condition of patient; Sender's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot number: 027A21A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling hot, Influenza like illness
Clinical narrative: nausea; Chills; brain fog; flu like symptoms; hot; mild fever; fatigue, exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever) and FATIGUE (fatigue, exhausted) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Mar-2021, the patient experienced NAUSEA (nausea). In March 2021, the patient experienced FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever) and FATIGUE (fatigue, exhausted) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Mar-2021, the patient experienced NAUSEA (nausea). In March 2021, the patient experienced FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea; Chills; brain fog; flu like symptoms; hot; mild fever; fatigue, exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever) and FATIGUE (fatigue, exhausted) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Mar-2021, the patient experienced NAUSEA (nausea). In March 2021, the patient experienced FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever) and FATIGUE (fatigue, exhausted) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Mar-2021, the patient experienced NAUSEA (nausea). In March 2021, the patient experienced FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fog), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (hot), PYREXIA (mild fever), FATIGUE (fatigue, exhausted), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Dizziness; Upset stomach; Bad diarrhea; Sweatiness; Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else; Difficulty sleeping; Dull headache; Nauseous; Chills; Fatigue/stayed in bed and couldn't do much; Nauseous/felt like vomitting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness) and FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else) in a 39-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 04-Mar-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting). On 07-Mar-2021, DIARRHOEA (Bad diarrhea) had resolved. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-049818 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Initial and FU information processed together and in this FU case became serious upon addition of new event. However we have not marked this FU as Significant as it leads to change in regulatory clock start date. On 13-Mar-2021: Consumer reported that her own symptoms resolved in about a week.; Sender's Comments:  MOD21-049818:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Insomnia, Nausea
Clinical narrative: Dizziness; Upset stomach; Bad diarrhea; Sweatiness; Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else; Difficulty sleeping; Dull headache; Nauseous; Chills; Fatigue/stayed in bed and couldn't do much; Nauseous/felt like vomitting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness) and FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else) in a 39-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 04-Mar-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting). On 07-Mar-2021, DIARRHOEA (Bad diarrhea) had resolved. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-049818 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Initial and FU information processed together and in this FU case became serious upon addition of new event. However we have not marked this FU as Significant as it leads to change in regulatory clock start date. On 13-Mar-2021: Consumer reported that her own symptoms resolved in about a week.; Sender's Comments:  MOD21-049818:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness; Upset stomach; Bad diarrhea; Sweatiness; Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else; Difficulty sleeping; Dull headache; Nauseous; Chills; Fatigue/stayed in bed and couldn't do much; Nauseous/felt like vomitting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness) and FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else) in a 39-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 04-Mar-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting). On 07-Mar-2021, DIARRHOEA (Bad diarrhea) had resolved. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-049818 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Initial and FU information processed together and in this FU case became serious upon addition of new event. However we have not marked this FU as Significant as it leads to change in regulatory clock start date. On 13-Mar-2021: Consumer reported that her own symptoms resolved in about a week.; Sender's Comments:  MOD21-049818:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Skin warm, Skin weeping
Clinical narrative: discomfort in her arm; "had a bit of heat"; redness; it was "festering"; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in her arm), SKIN WARM ("had a bit of heat"), ERYTHEMA (redness) and SKIN WEEPING (it was "festering") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (discomfort in her arm), SKIN WARM ("had a bit of heat"), ERYTHEMA (redness) and SKIN WEEPING (it was "festering"). At the time of the report, LIMB DISCOMFORT (discomfort in her arm), SKIN WARM ("had a bit of heat"), ERYTHEMA (redness) and SKIN WEEPING (it was "festering") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient was fine until 07-Mar-2021 when she started experiencing events.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-JUL-2021 ,Containing Consumer wanted the forms to be mailed to their mailing address
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: Wasn't feeling well; Tested COVID positive; Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wasn't feeling well), SARS-COV-2 TEST POSITIVE (Tested COVID positive) and CHEST PAIN (Chest pains) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Wasn't feeling well), SARS-COV-2 TEST POSITIVE (Tested COVID positive) and CHEST PAIN (Chest pains). At the time of the report, FEELING ABNORMAL (Wasn't feeling well) and CHEST PAIN (Chest pains) outcome was unknown and SARS-COV-2 TEST POSITIVE (Tested COVID positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) positive.         No concomitant product use was reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded for the events of chest pain and wasn't feeling well. The event COVID-19 is assessed as unlikely related to mRNA-1273 since the vaccine does not contain virus capable of transmitting infection.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction from Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction from Moderna shot) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction from Moderna shot). At the time of the report, VACCINATION COMPLICATION (Reaction from Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: swollen arm; Hot arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-010219 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-010219 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Could not move arm for one day after receiving the vaccine; A spontaneous report was received from nurse concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not move his arm for one day after receiving the vaccine/ vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient could not move his arm for one day after receiving the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event could not move his arm for one day after receiving the vaccine was resolved (for one day after receiving the vaccine) on an unspecified date.; Reporter'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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on back of leg; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on back of leg) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-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 URTICARIA (hives on back of leg). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. On 20-Feb-2021, URTICARIA (hives on back of leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain
Clinical narrative: everything tastes salty; slight soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (everything tastes salty) and VACCINATION SITE PAIN (slight soreness at the site of injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced TASTE DISORDER (everything tastes salty). 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight soreness at the site of injection). At the time of the report, TASTE DISORDER (everything tastes salty) and VACCINATION SITE PAIN (slight soreness at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash pruritic, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: rash (itchy); tingling sensation all over the body; rash (hard); rash (hot to touch); 3 inch rash in the injection site; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash (itchy)), PARAESTHESIA (tingling sensation all over the body), VACCINATION SITE INDURATION (rash (hard)), VACCINATION SITE RASH (rash (hot to touch)) and VACCINATION SITE ERYTHEMA (3 inch rash in the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RASH PRURITIC (rash (itchy)), PARAESTHESIA (tingling sensation all over the body), VACCINATION SITE INDURATION (rash (hard)), VACCINATION SITE RASH (rash (hot to touch)), VACCINATION SITE ERYTHEMA (3 inch rash in the injection site) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, RASH PRURITIC (rash (itchy)), PARAESTHESIA (tingling sensation all over the body), VACCINATION SITE INDURATION (rash (hard)), VACCINATION SITE RASH (rash (hot to touch)), VACCINATION SITE ERYTHEMA (3 inch rash in the injection site) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.            No concomitant medication was reported.  No treatment details were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash (itchy); tingling sensation all over the body; rash (hard); rash (hot to touch); 3 inch rash in the injection site; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash (itchy)), PARAESTHESIA (tingling sensation all over the body), VACCINATION SITE INDURATION (rash (hard)), VACCINATION SITE RASH (rash (hot to touch)) and VACCINATION SITE ERYTHEMA (3 inch rash in the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RASH PRURITIC (rash (itchy)), PARAESTHESIA (tingling sensation all over the body), VACCINATION SITE INDURATION (rash (hard)), VACCINATION SITE RASH (rash (hot to touch)), VACCINATION SITE ERYTHEMA (3 inch rash in the injection site) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, RASH PRURITIC (rash (itchy)), PARAESTHESIA (tingling sensation all over the body), VACCINATION SITE INDURATION (rash (hard)), VACCINATION SITE RASH (rash (hot to touch)), VACCINATION SITE ERYTHEMA (3 inch rash in the injection site) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.            No concomitant medication was reported.  No treatment details were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pruritus
Clinical narrative: Feeling achy; Hot to the touch at the injection site; Itchy at the injection site; Headache; Swollen lymph nodes in the arm at the injection site; Big red spot on the arm close to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling achy), VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the arm at the injection site) and VACCINATION SITE ERYTHEMA (Big red spot on the arm close to the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the arm at the injection site) and VACCINATION SITE ERYTHEMA (Big red spot on the arm close to the injection site). On 08-Mar-2021, the patient experienced PAIN (Feeling achy), VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and HEADACHE (Headache). On 08-Mar-2021, VACCINATION SITE ERYTHEMA (Big red spot on the arm close to the injection site) had resolved. At the time of the report, PAIN (Feeling achy), VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the arm at the injection site) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.