chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: Tooth removed; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (Tooth removed) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TOOTH EXTRACTION (Tooth removed). The patient was treated with IBUPROFEN for Tooth extraction, at an unspecified dose and frequency. At the time of the report, TOOTH EXTRACTION (Tooth removed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment: Antibiotics for tooth extraction
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Every night since the injection he wakes up with numbness in fingertips; Pain at the injection site; Every night since the injection he wakes up with severe pain in his arm; Its a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Every night since the injection he wakes up with numbness in fingertips), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PAIN (Every night since the injection he wakes up with severe pain in his arm) and VACCINATION SITE PAIN (Its a burning sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HYPOAESTHESIA (Every night since the injection he wakes up with numbness in fingertips), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PAIN (Every night since the injection he wakes up with severe pain in his arm) and VACCINATION SITE PAIN (Its a burning sensation). On 19-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, HYPOAESTHESIA (Every night since the injection he wakes up with numbness in fingertips), VACCINATION SITE PAIN (Every night since the injection he wakes up with severe pain in his arm) and VACCINATION SITE PAIN (Its a burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: numbness; sharp pain in right thigh; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) and PAIN IN EXTREMITY (sharp pain in right thigh) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (sharp pain in right thigh). On an unknown date, the patient experienced HYPOAESTHESIA (numbness). The patient was treated with PARACETAMOL (TYLENOL) on 18-Apr-2021 for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness) and PAIN IN EXTREMITY (sharp pain in right thigh) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the event included Tylenol on 18Apr2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed her second dose in recommended timeframe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose in recommended timeframe) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose in recommended timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose in recommended timeframe) had resolved. 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.   No concomitant medication reported   No treatment medication reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 20-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. Not Provided          Caller wants to knowif he can take naproxen after getting the vaccine? Does his side effects fall under the normal range? When are the side expected to start? Treatment naproxen  concomitant medication use was not provided  by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: not feeling well; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and HEADACHE (slight headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had tested positive on 03-JAN-2021 for Covid-19.) on 03-Jan-2021.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and HEADACHE (slight headache). At the time of the report, MALAISE (not feeling well) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-083863 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rashes on left arm and going down to her hip; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on left arm and going down to her hip) and PYREXIA (Low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RASH (Rashes on left arm and going down to her hip) and PYREXIA (Low grade fever). At the time of the report, RASH (Rashes on left arm and going down to her hip) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  Treatment medication  included Anti-histamine
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Most of the dose leaked out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Most of the dose leaked out) in a  patient of an unknown age and gender 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 UNDERDOSE (Most of the dose leaked out). At the time of the report, UNDERDOSE (Most of the dose leaked out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, SIMVASTATIN and QUINAPRIL for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to INC.-MOD-2021-083847 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-083847:Case for dose 2
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: itchy on my arm; Hives from head to toe; Rash; Low fever; palms started getting itchy; Achy; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PRURITUS (itchy on my arm), URTICARIA (Hives from head to toe), PAIN IN EXTREMITY (Arm pain) and PRURITUS (palms started getting itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Achy) and PAIN IN EXTREMITY (Arm pain). On 15-Apr-2021, the patient experienced PRURITUS (palms started getting itchy). On an unknown date, the patient experienced PRURITUS (itchy on my arm), URTICARIA (Hives from head to toe), RASH (Rash) and PYREXIA (Low fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Apr-2021, PAIN (Achy) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, PRURITUS (itchy on my arm) had resolved, URTICARIA (Hives from head to toe), PRURITUS (palms started getting itchy) and PYREXIA (Low fever) outcome was unknown and RASH (Rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itchy on my arm; Hives from head to toe; Rash; Low fever; palms started getting itchy; Achy; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PRURITUS (itchy on my arm), URTICARIA (Hives from head to toe), PAIN IN EXTREMITY (Arm pain) and PRURITUS (palms started getting itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Achy) and PAIN IN EXTREMITY (Arm pain). On 15-Apr-2021, the patient experienced PRURITUS (palms started getting itchy). On an unknown date, the patient experienced PRURITUS (itchy on my arm), URTICARIA (Hives from head to toe), RASH (Rash) and PYREXIA (Low fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Apr-2021, PAIN (Achy) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, PRURITUS (itchy on my arm) had resolved, URTICARIA (Hives from head to toe), PRURITUS (palms started getting itchy) and PYREXIA (Low fever) outcome was unknown and RASH (Rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Pyrexia, Vaccination site urticaria
Clinical narrative: left arm under injection site is burning, itchy and has a hive forming; left arm under injection site is burning, itchy and has a hive forming; left arm under injection site is burning, itchy and has a hive forming; fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (left arm under injection site is burning, itchy and has a hive forming), VACCINATION SITE URTICARIA (left arm under injection site is burning, itchy and has a hive forming), INJECTION SITE PAIN (left arm under injection site is burning, itchy and has a hive forming) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced INJECTION SITE PRURITUS (left arm under injection site is burning, itchy and has a hive forming), VACCINATION SITE URTICARIA (left arm under injection site is burning, itchy and has a hive forming) and INJECTION SITE PAIN (left arm under injection site is burning, itchy and has a hive forming). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (left arm under injection site is burning, itchy and has a hive forming), VACCINATION SITE URTICARIA (left arm under injection site is burning, itchy and has a hive forming), INJECTION SITE PAIN (left arm under injection site is burning, itchy and has a hive forming) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered at age of 16; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at age of 16) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at age of 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at age of 16) 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.   Concomitant medications details were not reported  by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 091B21A) with no associated AEs reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included IRON, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), PROBIOTIC 10 and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, FAMOTIDINE (PEPCID AC) for an unknown indication and an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm, red). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for P, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 10-Mar-2021, PAIN IN EXTREMITY (sore arm, red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-083722, MOD21-079818, MOD21-079820 (E2B Linked Report).; Sender's Comments: MOD-202 083722:DOSE 2 MOD21-079818: MOD21-079820:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pain in extremity
Clinical narrative: the vaccine triggered an AFib 18 hours after the 1st shot; sore arm for a couple of days after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (the vaccine triggered an AFib 18 hours after the 1st shot) and PAIN IN EXTREMITY (sore arm for a couple of days after 1st dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days after 1st dose). On 16-Apr-2021 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (the vaccine triggered an AFib 18 hours after the 1st shot). At the time of the report, ATRIAL FIBRILLATION (the vaccine triggered an AFib 18 hours after the 1st shot) had resolved and PAIN IN EXTREMITY (sore arm for a couple of days after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications included Diltiazem.  Company Comment Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Tachycardia
Clinical narrative: felt a rush/felt out of it; increased heart rate; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a rush/felt out of it) and TACHYCARDIA (increased heart rate) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037AZ113) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 FEELING ABNORMAL (felt a rush/felt out of it) and TACHYCARDIA (increased heart rate). On 24-Mar-2021, TACHYCARDIA (increased heart rate) had resolved. At the time of the report, FEELING ABNORMAL (felt a rush/felt out of it) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: increased heart rate (High) Increased heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Fever 99.2F; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 99.2F) and VACCINATION SITE PAIN (Pain at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No adverse event reported in medical history.  Concomitant products included LEVOTHYROXINE, QUINAPRIL and SIMVASTATIN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever 99.2F). 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, PYREXIA (Fever 99.2F) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 99.2 f 99.2 F.         Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-083823 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083823:Case for dose 1
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Fatigue, Headache, Pain in extremity
Clinical narrative: tightness of chest; ears are ringing; very weak; headache; tired; fever; did not sleep well; left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (did not sleep well), PAIN IN EXTREMITY (left arm hurt), CHEST DISCOMFORT (tightness of chest), TINNITUS (ears are ringing) and ASTHENIA (very weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 16-Apr-2021, the patient experienced SLEEP DISORDER (did not sleep well) and PAIN IN EXTREMITY (left arm hurt). On 17-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHEST DISCOMFORT (tightness of chest), TINNITUS (ears are ringing), ASTHENIA (very weak), HEADACHE (headache) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (did not sleep well), PAIN IN EXTREMITY (left arm hurt), CHEST DISCOMFORT (tightness of chest), TINNITUS (ears are ringing), ASTHENIA (very weak), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not mentioned
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Tinnitus
Clinical narrative: tightness of chest; ears are ringing; very weak; headache; tired; fever; did not sleep well; left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (did not sleep well), PAIN IN EXTREMITY (left arm hurt), CHEST DISCOMFORT (tightness of chest), TINNITUS (ears are ringing) and ASTHENIA (very weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 16-Apr-2021, the patient experienced SLEEP DISORDER (did not sleep well) and PAIN IN EXTREMITY (left arm hurt). On 17-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHEST DISCOMFORT (tightness of chest), TINNITUS (ears are ringing), ASTHENIA (very weak), HEADACHE (headache) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (did not sleep well), PAIN IN EXTREMITY (left arm hurt), CHEST DISCOMFORT (tightness of chest), TINNITUS (ears are ringing), ASTHENIA (very weak), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not mentioned
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left arm lymph node got swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left arm lymph node got swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (left arm lymph node got swollen). At the time of the report, LYMPHADENOPATHY (left arm lymph node got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information  were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Fatigue, Headache
Clinical narrative: COVID-19; elevated heartbeat; Dizziness; Fever; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (elevated heartbeat), COVID-19 (COVID-19), PYREXIA (Fever) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BENAZEPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 11-Apr-2021, the patient experienced HEART RATE INCREASED (elevated heartbeat). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, DIZZINESS (Dizziness), HEART RATE INCREASED (elevated heartbeat), COVID-19 (COVID-19), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Pyrexia: other (High) 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication information were provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: COVID-19; elevated heartbeat; Dizziness; Fever; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (elevated heartbeat), COVID-19 (COVID-19), PYREXIA (Fever) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BENAZEPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 11-Apr-2021, the patient experienced HEART RATE INCREASED (elevated heartbeat). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, DIZZINESS (Dizziness), HEART RATE INCREASED (elevated heartbeat), COVID-19 (COVID-19), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Pyrexia: other (High) 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication information were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Feeling abnormal, Headache, Hyperacusis
Clinical narrative: Loud sounds are painful since 2nd vaccination.; Loud sounds are painful since 2nd vaccination; Getting short term headaches 2-3 week.; pre-existing chronic fatigue exacerbated (described as exhausted, beyond tired); cobwebs in the brain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (cobwebs in the brain), HYPERACUSIS (Loud sounds are painful since 2nd vaccination.), EAR PAIN (Loud sounds are painful since 2nd vaccination), HEADACHE (Getting short term headaches 2-3 week.) and FATIGUE (pre-existing chronic fatigue exacerbated (described as exhausted, beyond tired)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cobalamin deficiency, Chronic fatigue, Blood pressure high, Hashimoto's disease and Breast cancer. Concomitant products included EXEMESTANE for Antiestrogen therapy and Breast cancer, LOSARTAN for Blood pressure high, METHYLCOBALAMINE for Cobalamin deficiency, Chronic fatigue and Off label use, LIOTHYRONINE SODIUM (CYTOMEL) for Hashimoto's disease.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (cobwebs in the brain) and FATIGUE (pre-existing chronic fatigue exacerbated (described as exhausted, beyond tired)). On an unknown date, the patient experienced HYPERACUSIS (Loud sounds are painful since 2nd vaccination.), EAR PAIN (Loud sounds are painful since 2nd vaccination) and HEADACHE (Getting short term headaches 2-3 week.). At the time of the report, FEELING ABNORMAL (cobwebs in the brain) had not resolved, HYPERACUSIS (Loud sounds are painful since 2nd vaccination.), EAR PAIN (Loud sounds are painful since 2nd vaccination) and HEADACHE (Getting short term headaches 2-3 week.) outcome was unknown and FATIGUE (pre-existing chronic fatigue exacerbated (described as exhausted, beyond tired)) was resolving.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Events added and outcome of event fatigue was updated.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in lower back, lower extremities; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in lower back, lower extremities) 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 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain in lower back, lower extremities). At the time of the report, ARTHRALGIA (Joint pain in lower back, lower extremities) outcome was unknown.            Concomitant medications and treatment information were not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-083560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083560:Case for Plumbers cousin
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat; Body aches all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches all over) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches all over) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches all over) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Inappropriate schedule of product administration, Nasal congestion, Nasopharyngitis, Oropharyngeal discomfort
Clinical narrative: Inappropriate schedule of vaccine administered; some kind of nasal congestion; hairy throat; felt like cold coming up; hairy throat; dry; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up) and OROPHARYNGEAL PAIN (hairy throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up), OROPHARYNGEAL PAIN (hairy throat) and DRY THROAT (dry). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with ZINC at an unspecified dose and frequency; MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency and HERBAL EXTRACT NOS at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up), OROPHARYNGEAL PAIN (hairy throat) and DRY THROAT (dry) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Inappropriate schedule of vaccine administered; some kind of nasal congestion; hairy throat; felt like cold coming up; hairy throat; dry; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up) and OROPHARYNGEAL PAIN (hairy throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up), OROPHARYNGEAL PAIN (hairy throat) and DRY THROAT (dry). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with ZINC at an unspecified dose and frequency; MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency and HERBAL EXTRACT NOS at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up), OROPHARYNGEAL PAIN (hairy throat) and DRY THROAT (dry) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Nervousness
Clinical narrative: Sleeplessness; Nervousness; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), NERVOUSNESS (Nervousness), FATIGUE (Tiredness) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 19-Mar-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 INSOMNIA (Sleeplessness), NERVOUSNESS (Nervousness), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, INSOMNIA (Sleeplessness), NERVOUSNESS (Nervousness), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash on her left lower back (on top of her left butt), and left thigh/ Rash is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on her left lower back (on top of her left butt), and left thigh/ Rash is very itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash on her left lower back (on top of her left butt), and left thigh/ Rash is very itchy). At the time of the report, RASH PRURITIC (rash on her left lower back (on top of her left butt), and left thigh/ Rash is very itchy) outcome was unknown. Not Provided          No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Secretion discharge
Clinical narrative: a bad nose bleed from her left nostril; appeared to have a long bloody slimy mucus - like a slug (worm); This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (a bad nose bleed from her left nostril) and SECRETION DISCHARGE (appeared to have a long bloody slimy mucus - like a slug (worm)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EPISTAXIS (a bad nose bleed from her left nostril) and SECRETION DISCHARGE (appeared to have a long bloody slimy mucus - like a slug (worm)). At the time of the report, EPISTAXIS (a bad nose bleed from her left nostril) and SECRETION DISCHARGE (appeared to have a long bloody slimy mucus - like a slug (worm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Breast mass, Hepatic mass
Clinical narrative: 11 soft tissues nodules in the left breast (Malignancy was not excluded); 2 heaptic nodules in liver; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (11 soft tissues nodules in the left breast (Malignancy was not excluded)) and HEPATIC MASS (2 heaptic nodules in liver) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL, CARVEDILOL, FENTANYL and MORPHINE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced BREAST MASS (11 soft tissues nodules in the left breast (Malignancy was not excluded)) and HEPATIC MASS (2 heaptic nodules in liver). At the time of the report, BREAST MASS (11 soft tissues nodules in the left breast (Malignancy was not excluded)) and HEPATIC MASS (2 heaptic nodules in liver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Angiogram: 11 nodules in breast and 2 hepatic nodules (abnormal) 11 soft tissues nodules in the left breast. Malignancy was not excluded and 2 hepatic nodules in liver,  CTA of the chest, abdomen, and pelvis..         Concomitant medicines included vacfotan No treatment information were reported  Action taken with the drug in response to events was not applicable.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Pain in extremity, SARS-CoV-2 test
Clinical narrative: shortness of breath; congestion; shooting pain in left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (shooting pain in left leg), DYSPNOEA (shortness of breath) and NASAL CONGESTION (congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 PAIN IN EXTREMITY (shooting pain in left leg), DYSPNOEA (shortness of breath) and NASAL CONGESTION (congestion). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (shooting pain in left leg), DYSPNOEA (shortness of breath) and NASAL CONGESTION (congestion) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided