chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100.6 degree F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100.6 degree F fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (100.6 degree F fever). At the time of the report, PYREXIA (100.6 degree F fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 100.6 (Inconclusive) 100.6 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Tachycardia
Clinical narrative: Tachycardia; Lymphadenopathy; Arthralgia in the fingers; A spontaneous report  was received from a consumer concerning a 61-Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arthralgia in the fingers, lymphadenopathy and tachycardia.  The patient's medical history was not provided. Concomitant medications reported included Synthroid (levothyroxine sodium) and Lipitor (atorvastatin calcium).  On 08 Jan 2021, 6 days prior to the onset of the event Arthralgia in the fingers the patient received their first of two planned doses of mRNA-1273 (011J20A) in the left arm for prophylaxis of COVID-19 infection.    On 13 Jan 2021, the patient experienced arthralgia in the fingers. On 15 Jan 2021, the patient experienced lymphadenopathy in the left arm. On 25 Jan 2021, the patient experienced tachycardia.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  On 25 Jan 2021, the outcome of the event tachycardia was resolved. The outcome of the events arthralgia in the fingers and lymphadenopathy was not reported.; Reporter's Comments: This case concerns a 61-year-old female who experienced a nonserious unexpected event of tachycardia and nonserious expected events of lymphadenopathy and arthralgia.  Event onset was 6 days after the first dose of mRNA-1273. Treatment not reported.  Tachycardia resolved, but other event outcomes unknown.  Based on 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Muscle discomfort, Pain in extremity
Clinical narrative: Sore arm (R arm of injection); Sore back; when lying down could not relax muscles; felt her entire body was with electricity; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (when lying down could not relax muscles), FEELING ABNORMAL (felt her entire body was with electricity), PAIN IN EXTREMITY (Sore arm (R arm of injection)) and BACK PAIN (Sore back) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MUSCLE DISCOMFORT (when lying down could not relax muscles) and FEELING ABNORMAL (felt her entire body was with electricity). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (R arm of injection)) and BACK PAIN (Sore back). At the time of the report, MUSCLE DISCOMFORT (when lying down could not relax muscles), FEELING ABNORMAL (felt her entire body was with electricity), PAIN IN EXTREMITY (Sore arm (R arm of injection)) and BACK PAIN (Sore back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       herbal products used as a Concomitant medication. Patient take 13mg of Magnesium tablet  for very effective muscle relaxer in treatment Medication.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 14 hours later she was sick; classic body ache; heart palpitation; high blood pressure; weak in both legs; felt dizzy; Fatigue; Fever; Vomiting; Nausea; very bad headache; Chills; arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure) and ASTHENIA (weak in both legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251(L)20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 16-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little). At the time of the report, ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little) outcome was unknown and PYREXIA (Fever) had not resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Illness, Myalgia, Nausea, Palpitations
Clinical narrative: 14 hours later she was sick; classic body ache; heart palpitation; high blood pressure; weak in both legs; felt dizzy; Fatigue; Fever; Vomiting; Nausea; very bad headache; Chills; arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure) and ASTHENIA (weak in both legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251(L)20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 16-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little). At the time of the report, ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little) outcome was unknown and PYREXIA (Fever) had not resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: 14 hours later she was sick; classic body ache; heart palpitation; high blood pressure; weak in both legs; felt dizzy; Fatigue; Fever; Vomiting; Nausea; very bad headache; Chills; arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure) and ASTHENIA (weak in both legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251(L)20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 16-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little). At the time of the report, ILLNESS (14 hours later she was sick), MYALGIA (classic body ache), PALPITATIONS (heart palpitation), HYPERTENSION (high blood pressure), ASTHENIA (weak in both legs), DIZZINESS (felt dizzy), FATIGUE (Fatigue), VOMITING (Vomiting), NAUSEA (Nausea), HEADACHE (very bad headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm hurt a little) outcome was unknown and PYREXIA (Fever) had not resolved.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: pain in the hands; high temperature; chills; body ache; head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the hands), PYREXIA (high temperature), CHILLS (chills), PAIN (body ache) and HEADACHE (head ache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L70A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the hands), PYREXIA (high temperature), CHILLS (chills), PAIN (body ache) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, qd. At the time of the report, PAIN IN EXTREMITY (pain in the hands), PYREXIA (high temperature), CHILLS (chills), PAIN (body ache) and HEADACHE (head ache) had not resolved. Not Provided          Patient take 2 Tylenol in morning and an Advil in the afternoon.  No concomitant medications reported by investigator   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site mass
Clinical narrative: lump in her arm; redness; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in her arm), VACCINATION SITE ERYTHEMA (redness) and INJECTION SITE WARMTH (hot to the touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in her arm), VACCINATION SITE ERYTHEMA (redness) and INJECTION SITE WARMTH (hot to the touch). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump in her arm), VACCINATION SITE ERYTHEMA (redness) and INJECTION SITE WARMTH (hot to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used Concomitant medicines like Lexapro and second concomitant which name was not clear.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swelling
Clinical narrative: Swollen glands of the neck; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen glands of the neck) and OROPHARYNGEAL PAIN (Sore throat) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced SWELLING (Swollen glands of the neck) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, SWELLING (Swollen glands of the neck) and OROPHARYNGEAL PAIN (Sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Lightheadedness; Injection site has itching; Injection site a little puffy; Injection site has redness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), VACCINATION SITE PRURITUS (Injection site has itching), VACCINATION SITE SWELLING (Injection site a little puffy) and VACCINATION SITE ERYTHEMA (Injection site has redness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATENOLOL, ACETAMINOPHEN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MELOXICAM and HYDROCORTISONE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness), VACCINATION SITE PRURITUS (Injection site has itching), VACCINATION SITE SWELLING (Injection site a little puffy) and VACCINATION SITE ERYTHEMA (Injection site has redness). At the time of the report, DIZZINESS (Lightheadedness) had resolved and VACCINATION SITE PRURITUS (Injection site has itching), VACCINATION SITE SWELLING (Injection site a little puffy) and VACCINATION SITE ERYTHEMA (Injection site has redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. Hydrocortisone cream is applied at injection site  The patient reported that she got the vaccine and was doing well.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received, contains additional event dizziness.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchiness at the injection site; hardness at the injection site; rash underneath the injection site (4 inches long and 2 inches wide); swollen at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE RASH (rash underneath the injection site (4 inches long and 2 inches wide)) and VACCINATION SITE SWELLING (swollen at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 003A21A) for COVID-19 vaccination.     No medical history was provided.  Concurrent medical conditions included Iodine allergy.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE RASH (rash underneath the injection site (4 inches long and 2 inches wide)) and VACCINATION SITE SWELLING (swollen at injection site). On 26-Feb-2021, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE RASH (rash underneath the injection site (4 inches long and 2 inches wide)) and VACCINATION SITE SWELLING (swollen at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: supplements, fish oil, vitamins, COQ10 and vitamin D   This case was linked to MOD-2021-097393 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: completed Moderna VAER form
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy; sore; swollen; Red pancake circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red pancake circle), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE SWELLING (swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red pancake circle). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE SWELLING (swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red pancake circle) had not resolved and VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator Patient used Allergy cream and Benadryl used as Treatment medication
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: lump in her arm; redness; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in her arm), ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to the touch) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in her arm), ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to the touch). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump in her arm), ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used Lexapro and second concomitant which name was not clear.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red running towards her elbow) and SKIN WARM (warm to the touch) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l2oa) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included HYDROCODONE for an unknown indication. On 09-Feb-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 19-Feb-2021, the patient experienced ERYTHEMA (red running towards her elbow) and SKIN WARM (warm to the touch). At the time of the report, ERYTHEMA (red running towards her elbow) and SKIN WARM (warm to the touch) had not resolved. Patient use Stomach medicine for concomitant medication. Patient used no treatment medication.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a unknown aged male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown)  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date, the outcome of event headache was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Sleep disorder, Vaccination site pain
Clinical narrative: kept me awake all night; Pain; Very sore; Very tender all night long; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (kept me awake all night), PAIN (Pain), MYALGIA (Very sore) and VACCINATION SITE PAIN (Very tender all night long) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (kept me awake all night), PAIN (Pain), MYALGIA (Very sore) and VACCINATION SITE PAIN (Very tender all night long). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (kept me awake all night), PAIN (Pain), MYALGIA (Very sore) and VACCINATION SITE PAIN (Very tender all night long) outcome was unknown.            No concomitant medication was provided.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Little Stiffness Injection Site; Minor Swelling Injection Site; minor soreness injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Little Stiffness Injection Site), VACCINATION SITE SWELLING (Minor Swelling Injection Site) and VACCINATION SITE PAIN (minor soreness injection site) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-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 18-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Little Stiffness Injection Site), VACCINATION SITE SWELLING (Minor Swelling Injection Site) and VACCINATION SITE PAIN (minor soreness injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Little Stiffness Injection Site), VACCINATION SITE SWELLING (Minor Swelling Injection Site) and VACCINATION SITE PAIN (minor soreness injection site) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Peripheral swelling, Rash
Clinical narrative: bumps left arm; swollen left arm; redness ans warm to the touch left arm; Rash left arm; Wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bumps left arm), PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (redness ans warm to the touch left arm), RASH (Rash left arm) and ARTHRALGIA (Wrist pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ARTHRALGIA (Wrist pain). On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (bumps left arm), PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (redness ans warm to the touch left arm) and RASH (Rash left arm). At the time of the report, PERIPHERAL SWELLING (bumps left arm), PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (redness ans warm to the touch left arm), RASH (Rash left arm) and ARTHRALGIA (Wrist pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red mark at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red mark at the injection arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ERYTHEMA (Red mark at the injection arm). At the time of the report, ERYTHEMA (Red mark at the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Antibiotic and Steroid Cream used as a Treatment Medication.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Inappropriate affect, Influenza, SARS-CoV-1 test positive
Clinical narrative: Feel tired; Feel like im recovering from flu; Dont feel terrible; mildly sick; Tested positive for covid; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid), FATIGUE (Feel tired), INFLUENZA (Feel like im recovering from flu), INAPPROPRIATE AFFECT (Dont feel terrible) and ILLNESS (mildly sick) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). On an unknown date, the patient experienced FATIGUE (Feel tired), INFLUENZA (Feel like im recovering from flu), INAPPROPRIATE AFFECT (Dont feel terrible) and ILLNESS (mildly sick). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROXYCHLOROQUINE at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) had not resolved and FATIGUE (Feel tired), INFLUENZA (Feel like im recovering from flu), INAPPROPRIATE AFFECT (Dont feel terrible) and ILLNESS (mildly sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-1 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Feel tired; Feel like im recovering from flu; Dont feel terrible; mildly sick; Tested positive for covid; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid), FATIGUE (Feel tired), INFLUENZA (Feel like im recovering from flu), INAPPROPRIATE AFFECT (Dont feel terrible) and ILLNESS (mildly sick) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). On an unknown date, the patient experienced FATIGUE (Feel tired), INFLUENZA (Feel like im recovering from flu), INAPPROPRIATE AFFECT (Dont feel terrible) and ILLNESS (mildly sick). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROXYCHLOROQUINE at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) had not resolved and FATIGUE (Feel tired), INFLUENZA (Feel like im recovering from flu), INAPPROPRIATE AFFECT (Dont feel terrible) and ILLNESS (mildly sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-1 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Dizziness, Gait inability, Incoherent
Clinical narrative: less appetite; unable to walk; incohernet speech; COVID; injection site pain; little dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (little dizzy), GAIT INABILITY (unable to walk), INCOHERENT (incohernet speech), COVID-19 (COVID) and DECREASED APPETITE (less appetite) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (little dizzy) and VACCINATION SITE PAIN (injection site pain). On 23-Jan-2021, the patient experienced GAIT INABILITY (unable to walk), INCOHERENT (incohernet speech) and COVID-19 (COVID). On 26-Jan-2021, the patient experienced DECREASED APPETITE (less appetite). On 23-Jan-2021, GAIT INABILITY (unable to walk) and INCOHERENT (incohernet speech) had resolved. On 26-Jan-2021, DIZZINESS (little dizzy) and VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, COVID-19 (COVID) and DECREASED APPETITE (less appetite) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator Patient Take intravenous fluids as a Treatment medication
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: less appetite; unable to walk; incohernet speech; COVID; injection site pain; little dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (little dizzy), GAIT INABILITY (unable to walk), INCOHERENT (incohernet speech), COVID-19 (COVID) and DECREASED APPETITE (less appetite) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (little dizzy) and VACCINATION SITE PAIN (injection site pain). On 23-Jan-2021, the patient experienced GAIT INABILITY (unable to walk), INCOHERENT (incohernet speech) and COVID-19 (COVID). On 26-Jan-2021, the patient experienced DECREASED APPETITE (less appetite). On 23-Jan-2021, GAIT INABILITY (unable to walk) and INCOHERENT (incohernet speech) had resolved. On 26-Jan-2021, DIZZINESS (little dizzy) and VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, COVID-19 (COVID) and DECREASED APPETITE (less appetite) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator Patient Take intravenous fluids as a Treatment medication
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Whole left side of body numb; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Whole left side of body numb) and VACCINATION SITE PAIN (Pain in arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 HYPOAESTHESIA (Whole left side of body numb) and VACCINATION SITE PAIN (Pain in arm). On 20-Jan-2021, HYPOAESTHESIA (Whole left side of body numb) and VACCINATION SITE PAIN (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Malaise
Clinical narrative: blood pressure went up; I was not feeling well; it went down (that night; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure went up), MALAISE (I was not feeling well) and BLOOD PRESSURE DECREASED (it went down (that night) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included CARVEDILOL, CHOLESTYRAMINE, METOPROLOL, FINASTERIDE and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure went up), MALAISE (I was not feeling well) and BLOOD PRESSURE DECREASED (it went down (that night). The patient was treated with LISINOPRIL for Blood pressure, at a dose of 10 milligram. On 12-Feb-2021, BLOOD PRESSURE INCREASED (blood pressure went up) had resolved. At the time of the report, MALAISE (I was not feeling well) and BLOOD PRESSURE DECREASED (it went down (that night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE ERYTHEMA (bright red area about 2.5 inches in diameter) and RASH (tiny little bumps/bumps on her chest, neck,) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032I20a) for COVID-19 vaccination. Concurrent medical conditions included Prickly heat. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (bright red area about 2.5 inches in diameter) and RASH (tiny little bumps/bumps on her chest, neck,). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In February 2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (arm itching) and VACCINATION SITE ERYTHEMA (bright red area about 2.5 inches in diameter) outcome was unknown and RASH (tiny little bumps/bumps on her chest, neck,) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information also included antibacterial soap. No concomitant medication was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash macular, Vaccination site pain
Clinical narrative: when was getting ready for bed, noticed a dime red spot, like a sunburn; low grade fever. , shivery, knew it wasn't high; shivery; pain at the injection site; felt pretty lousy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (when was getting ready for bed, noticed a dime red spot, like a sunburn), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (felt pretty lousy), PYREXIA (low grade fever. , shivery, knew it wasn't high) and CHILLS (shivery) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included TRAZODONE, LAMOTRIGINE, VENLAFAXINE and VITAMINS NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), FATIGUE (felt pretty lousy) and CHILLS (shivery). On an unknown date, the patient experienced RASH MACULAR (when was getting ready for bed, noticed a dime red spot, like a sunburn) and PYREXIA (low grade fever. , shivery, knew it wasn't high). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (when was getting ready for bed, noticed a dime red spot, like a sunburn), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (felt pretty lousy), PYREXIA (low grade fever. , shivery, knew it wasn't high) and CHILLS (shivery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Injection site pruritus, Insomnia, Pain in extremity
Clinical narrative: Could not sleep; Burning sensation 3 to 4 inches below the injection site; Itching sensation 3 to 4 inches below the injection site; It's irritated /it's annoying; Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), BURNING SENSATION (Burning sensation right below where they got the shot), DISCOMFORT (It's irritated /it's annoying), INSOMNIA (Could not sleep) and BURNING SENSATION (Burning sensation 3 to 4 inches below the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). On 16-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation right below where they got the shot), DISCOMFORT (It's irritated /it's annoying), BURNING SENSATION (Burning sensation 3 to 4 inches below the injection site) and INJECTION SITE PRURITUS (Itching sensation 3 to 4 inches below the injection site). On 18-Feb-2021, the patient experienced INSOMNIA (Could not sleep). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), BURNING SENSATION (Burning sensation right below where they got the shot), DISCOMFORT (It's irritated /it's annoying), INSOMNIA (Could not sleep), BURNING SENSATION (Burning sensation 3 to 4 inches below the injection site) and INJECTION SITE PRURITUS (Itching sensation 3 to 4 inches below the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included blood pressure pill and cholesterol pill.   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2021: No specific follow-up information recorded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot; injection site swelling; injection site red; injection site pain; hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE INDURATION (hard at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE, LEVOTHYROXINE, METFORMIN, OMEPRAZOLE, VARENICLINE TARTRATE (CHANTIX), TROSPIUM, FLUOXETINE HYDROCHLORIDE (PROZAC), ROPINIROLE, CALCITRIOL and CALCIUM CITRATE for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE INDURATION (hard at the injection site). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE INDURATION (hard at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Felt itchy all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Felt itchy all over) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Heart disorder. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Felt itchy all over). At the time of the report, PRURITUS (Felt itchy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medication, blood thinners and heart medicine.  Treatment information included unspecified lotion and rubbing alcohol.   This case was linked to MOD-2021-018473 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Severe nose bleed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k2014 and 029k2074) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Seasonal allergy and Bronchiectasis (More coughing, increased inflammation). Concomitant products included CELECOXIB for Arthritis, LOSARTAN POTASSIUM for Blood pressure high, RISEDRONATE SODIUM (ACTONEL) from 24-Feb-2021 to an unknown date for Bone density abnormal, ATORVASTATIN for Cholesterol, CITALOPRAM for Depression and Hot flashes.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced EPISTAXIS (Severe nose bleed). At the time of the report, EPISTAXIS (Severe nose bleed) had resolved.            Treatment for the events included packing her nose with gauze for the first two episodes and cauterization for the final episode.    This case was linked to MOD-2021-018593, MOD-2021-018593 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: The patient's demographics and medical history was updated. The Batch/Lot numbers for mRNA-1273 were updated.  Concomitant products used were reported. Two additional events of nose bleed and treatment for all events was reported. Medically confirmed has been updated.