chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with covid) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Diagnosed with covid). At the time of the report, COVID-19 (Diagnosed with covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a 57-year-old female with a nonserious unexpected event of COVID-19. Event onset 8 days after first dose mRNA-1273. Event resolved. 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Shivering; Body Aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering), MYALGIA (Body Aches), HEADACHE (Headache) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (Shivering), MYALGIA (Body Aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Shivering), MYALGIA (Body Aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broken out in hives in many places on my body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broken out in hives in many places on my body) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (Broken out in hives in many places on my body). At the time of the report, URTICARIA (Broken out in hives in many places on my body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Myalgia, Nausea
Clinical narrative: body aches; feeling hot; sleepy; tired; nauseous; headache; arm started to feel more sore; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache) and VACCINATION SITE SWELLING (arm started to feel more sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included MULTI VITAMIN & MINERAL, FISH OIL and WITHANIA SOMNIFERA ROOT (ASHWAGANDHA [WITHANIA SOMNIFERA ROOT]) for an unknown indication.    On 15-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 SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache) and VACCINATION SITE SWELLING (arm started to feel more sore). On 16-Feb-2021, the patient experienced MYALGIA (body aches) and FEELING HOT (feeling hot). At the time of the report, SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache), VACCINATION SITE SWELLING (arm started to feel more sore), MYALGIA (body aches) and FEELING HOT (feeling hot) outcome was unknown.        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.   Treatment and concomitant medications were not provided by reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site swelling
Clinical narrative: body aches; feeling hot; sleepy; tired; nauseous; headache; arm started to feel more sore; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache) and VACCINATION SITE SWELLING (arm started to feel more sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included MULTI VITAMIN & MINERAL, FISH OIL and WITHANIA SOMNIFERA ROOT (ASHWAGANDHA [WITHANIA SOMNIFERA ROOT]) for an unknown indication.    On 15-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 SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache) and VACCINATION SITE SWELLING (arm started to feel more sore). On 16-Feb-2021, the patient experienced MYALGIA (body aches) and FEELING HOT (feeling hot). At the time of the report, SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache), VACCINATION SITE SWELLING (arm started to feel more sore), MYALGIA (body aches) and FEELING HOT (feeling hot) outcome was unknown.        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.   Treatment and concomitant medications were not provided by reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: muscle pain; Rash; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (muscle pain) and RASH (Rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain) and RASH (Rash). At the time of the report, MYALGIA (muscle pain) and RASH (Rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment for the event included acetaminophen (Tylenol).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: The event outcome and product information were 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 event, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vision blurred
Clinical narrative: Chills; Blurry Eyes; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and VISION BLURRED (Blurry Eyes) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included RANOLAZINE, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]), ASA, COLECALCIFEROL (VIT D [COLECALCIFEROL]), METOPROLOL, AMLODIPINE, TAMSULOSIN and ATORVASTATIN for an unknown indication.    On 22-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 CHILLS (Chills) and VISION BLURRED (Blurry Eyes). At the time of the report, CHILLS (Chills) and VISION BLURRED (Blurry Eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Feeling tired; Headache like type of feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Feeling tired) and HEADACHE (Headache like type of feeling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Feeling tired) and HEADACHE (Headache like type of feeling). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Feeling tired) and HEADACHE (Headache like type of feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash at the injection site two weeks after receiving the Moderna COVID-19 Vaccine; Swelling at the injection site two weeks after receiving the Moderna COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site two weeks after receiving the Moderna COVID-19 Vaccine) and VACCINATION SITE SWELLING (Swelling at the injection site two weeks after receiving the Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site two weeks after receiving the Moderna COVID-19 Vaccine) and VACCINATION SITE SWELLING (Swelling at the injection site two weeks after receiving the Moderna COVID-19 Vaccine). At the time of the report, VACCINATION SITE RASH (Rash at the injection site two weeks after receiving the Moderna COVID-19 Vaccine) and VACCINATION SITE SWELLING (Swelling at the injection site two weeks after receiving the Moderna COVID-19 Vaccine) outcome was unknown.        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.   Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash erythematous, Urticaria
Clinical narrative: Hives on arms, legs, back of calf, back of thigh, and behind knee; Rash in armpit area and inside of elbows; Rash is worse in left side of the body; Rash was red and itchy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arms, legs, back of calf, back of thigh, and behind knee), RASH (Rash in armpit area and inside of elbows; Rash is worse in left side of the body), RASH ERYTHEMATOUS (Rash was red and itchy) and PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Jan-2021, the patient experienced URTICARIA (Hives on arms, legs, back of calf, back of thigh, and behind knee), RASH (Rash in armpit area and inside of elbows; Rash is worse in left side of the body) and RASH ERYTHEMATOUS (Rash was red and itchy). On 18-Jan-2021, URTICARIA (Hives on arms, legs, back of calf, back of thigh, and behind knee), RASH (Rash in armpit area and inside of elbows; Rash is worse in left side of the body) and RASH ERYTHEMATOUS (Rash was red and itchy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: nausea; chills; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3).    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 NAUSEA (nausea) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        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.   Concomitant medications also include thyroid and bloodpressure medications.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot to touch; Red rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE ERYTHEMA (Red rash at the injection site) and INJECTION SITE WARMTH (Hot to touch) in a 27-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 16-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 INJECTION SITE ERYTHEMA (Red rash at the injection site). On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (Hot to touch). At the time of the report, INJECTION SITE ERYTHEMA (Red rash at the injection site) and INJECTION SITE WARMTH (Hot to touch) was resolving.        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.   Treatment medication includes Tylenol, and cold compress. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site anaesthesia
Clinical narrative: Wasn't feeling very well; dead arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (dead arm), PYREXIA (fever), CHILLS (chills) and MALAISE (Wasn't feeling very well) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ANAESTHESIA (dead arm), PYREXIA (fever) and CHILLS (chills). On 17-Jan-2021, the patient experienced MALAISE (Wasn't feeling very well). On 18-Jan-2021, VACCINATION SITE ANAESTHESIA (dead arm), PYREXIA (fever), CHILLS (chills) and MALAISE (Wasn't feeling very well) had resolved.            Treatment and concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Extreme side effects; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced extreme side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, extreme side effects was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Not reported medical history.).    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment  information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Hypertension, Pallor
Clinical narrative: chills; dizzine; breathing was fast; her face was pale; blood pressure high measured at 158/98; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergic reaction to bee sting.    On 22-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 CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98). On 22-Jan-2021, CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: blood pressure elevated mmHg (High) 158/98. On 22-Jan-2021, Respiratory rate increased: breathing fast abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: chills; dizzine; breathing was fast; her face was pale; blood pressure high measured at 158/98; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergic reaction to bee sting.    On 22-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 CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98). On 22-Jan-2021, CHILLS (chills), DIZZINESS (dizzine), RESPIRATORY RATE INCREASED (breathing was fast), PALLOR (her face was pale) and HYPERTENSION (blood pressure high measured at 158/98) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: blood pressure elevated mmHg (High) 158/98. On 22-Jan-2021, Respiratory rate increased: breathing fast abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Stress
Clinical narrative: stress related hives; stress related hives; Rash in arm,hand ,shoulder and face; Rash on her arm, little itchy and uncomfortable; red shoulder; Sore arm; Red , swollen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder), PRURITUS (Rash on her arm, little itchy and uncomfortable), ERYTHEMA (red shoulder) and STRESS (stress related hives) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder) and ERYTHEMA (red shoulder). On 25-Jan-2021, the patient experienced PRURITUS (Rash on her arm, little itchy and uncomfortable) and RASH (Rash in arm,hand ,shoulder and face). On an unknown date, the patient experienced STRESS (stress related hives) and URTICARIA (stress related hives). At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder) and ERYTHEMA (red shoulder) had not resolved and PRURITUS (Rash on her arm, little itchy and uncomfortable), STRESS (stress related hives), URTICARIA (stress related hives) and RASH (Rash in arm,hand ,shoulder and face) 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.   Patient was using xyroxen 0.125mg 1/day along with other conmeds. Patient stated that the rash she had was not a reaction to the vaccine but stress related hives, her doctor confirmed it.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: added events and updated case details.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: stress related hives; stress related hives; Rash in arm,hand ,shoulder and face; Rash on her arm, little itchy and uncomfortable; red shoulder; Sore arm; Red , swollen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder), PRURITUS (Rash on her arm, little itchy and uncomfortable), ERYTHEMA (red shoulder) and STRESS (stress related hives) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder) and ERYTHEMA (red shoulder). On 25-Jan-2021, the patient experienced PRURITUS (Rash on her arm, little itchy and uncomfortable) and RASH (Rash in arm,hand ,shoulder and face). On an unknown date, the patient experienced STRESS (stress related hives) and URTICARIA (stress related hives). At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder) and ERYTHEMA (red shoulder) had not resolved and PRURITUS (Rash on her arm, little itchy and uncomfortable), STRESS (stress related hives), URTICARIA (stress related hives) and RASH (Rash in arm,hand ,shoulder and face) 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.   Patient was using xyroxen 0.125mg 1/day along with other conmeds. Patient stated that the rash she had was not a reaction to the vaccine but stress related hives, her doctor confirmed it.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: added events and updated case details.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; A spontaneous report was received on 25-Jan-2021 from a  healthcare professional concerning a unknown aged male patient who received Moderna's COVID-19(mRNA-1273) vaccine and developed joint pain.  The Patient medical history was  not provided. No concomitant medications was reported.  On 28-Dec-2021, prior to the onset of events, patient received  mRNA-1273(Batch: unknown) route of administration unknown  for the prophylaxis of covid-19 infection.  On unknown date, patient experienced joint pain.  No laboratory information was provided.  Treatment information includes Ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was recovered/resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, Urticaria, Vaccination site erythema
Clinical narrative: 15-jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273    Laboratory details was not provided.   treatment information was provided Benadryl, Medrol dose park, Zofran.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are unknown  The reporter assessed the event(s), nauseous, throwing up for 48 hours, fever in arm she received the vaccine in, rash going down the arm, hives going across her back , arm on fire, red and fever as  related to study drug.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: 15-jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273    Laboratory details was not provided.   treatment information was provided Benadryl, Medrol dose park, Zofran.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are unknown  The reporter assessed the event(s), nauseous, throwing up for 48 hours, fever in arm she received the vaccine in, rash going down the arm, hives going across her back , arm on fire, red and fever as  related to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Soreness in the arm of the injection (Left arm); Pain under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm of the injection (Left arm)) and AXILLARY PAIN (Pain under arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm of the injection (Left arm)) and AXILLARY PAIN (Pain under arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm of the injection (Left arm)) and AXILLARY PAIN (Pain under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information and concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email ID received.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dysgeusia, Fatigue, Limb discomfort
Clinical narrative: her fast blood glucose was higher than normal; sore arm; scratchy throat; metallic taste; fatigue; sore muscle; A spontaneous report was received from reporters (a consumer and a health care professional) concerning a 68-years-old diabetic female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events like increased fasting blood glucose, soreness in arm, sore muscle, fatigue, scratchy throat, metallic taste.   The patient was diabetic currently taking Metformin ER 750mg once daily.  On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot/batch: 025J20-2A ;expire- 19-FEB-2021) in the right upper arm for prophylaxis of COVID-19 infection.  The patient experienced increased fasting blood glucose levels for the next two days and became normal the next day, also the patient experienced events like soreness in arm, sore muscle, fatigue, scratchy throat, metallic taste.  On the next day of vaccination was higher than normal about 224BG, the next day 132BG and back to normal 108-110BG on the other day. The patient was on Metformin ER 750mg once daily as she was diabetic. The patient had taken Tylenol PM 500mg once at night to relief soreness in the arm, also water to get relief to the metallic taste.  Action taken with mRNA-1273 in response to the events was not reported.  On 24-JAN-2021, the outcome of the events has been resolved/recovered. The reporter assessed the events as related to the study drug.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Throat irritation
Clinical narrative: her fast blood glucose was higher than normal; sore arm; scratchy throat; metallic taste; fatigue; sore muscle; A spontaneous report was received from reporters (a consumer and a health care professional) concerning a 68-years-old diabetic female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events like increased fasting blood glucose, soreness in arm, sore muscle, fatigue, scratchy throat, metallic taste.   The patient was diabetic currently taking Metformin ER 750mg once daily.  On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot/batch: 025J20-2A ;expire- 19-FEB-2021) in the right upper arm for prophylaxis of COVID-19 infection.  The patient experienced increased fasting blood glucose levels for the next two days and became normal the next day, also the patient experienced events like soreness in arm, sore muscle, fatigue, scratchy throat, metallic taste.  On the next day of vaccination was higher than normal about 224BG, the next day 132BG and back to normal 108-110BG on the other day. The patient was on Metformin ER 750mg once daily as she was diabetic. The patient had taken Tylenol PM 500mg once at night to relief soreness in the arm, also water to get relief to the metallic taste.  Action taken with mRNA-1273 in response to the events was not reported.  On 24-JAN-2021, the outcome of the events has been resolved/recovered. The reporter assessed the events as related to the study drug.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site induration
Clinical narrative: Arm swollen; Arm red; Injection site hot to the touch; redness is growing; Itching at the injection site; Arm hard; Pain at the injection site; A red bump; A spontaneous report  (was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little pain at the injection site and had a red bump. The patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch.  The patient had no medical history and was taking Calcium, Vitamin E, Zirtec, Glucosamine, Turmeric as concomitant medications.  On 15-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:027L2A) in the left arm for prophylaxis of COVID-19 infection.  On 15-JAN-2021, the patient experienced little pain at the injection site and had a red bump. This symptoms subsided in two days. On 22-JAN-2021, a week after vaccination, the patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch. The symptoms are not ongoing, but the redness was growing.  Laboratory tests were not provided. The patient applied cool pads and a cream with Mometasone 0.1% to the zone. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of most of the events was resolving, but the redness was growing . The reporter assessed the events (little pain at the injection site and had a red bump. The patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch) as related to the study drug.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Arm swollen; Arm red; Injection site hot to the touch; redness is growing; Itching at the injection site; Arm hard; Pain at the injection site; A red bump; A spontaneous report  (was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little pain at the injection site and had a red bump. The patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch.  The patient had no medical history and was taking Calcium, Vitamin E, Zirtec, Glucosamine, Turmeric as concomitant medications.  On 15-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:027L2A) in the left arm for prophylaxis of COVID-19 infection.  On 15-JAN-2021, the patient experienced little pain at the injection site and had a red bump. This symptoms subsided in two days. On 22-JAN-2021, a week after vaccination, the patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch. The symptoms are not ongoing, but the redness was growing.  Laboratory tests were not provided. The patient applied cool pads and a cream with Mometasone 0.1% to the zone. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of most of the events was resolving, but the redness was growing . The reporter assessed the events (little pain at the injection site and had a red bump. The patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch) as related to the study drug.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site arm sore/Injection site arm tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site arm sore/Injection site arm tender) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12120A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN 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 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm sore/Injection site arm tender). At the time of the report, VACCINATION SITE PAIN (Injection site arm sore/Injection site arm tender) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: Bulging red patch at injection; Incredibly tired; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site rash and fatigue.  The patient's medical history was not reported. Concomitant medication adverol was reported.  16-JAN-2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (lot/batch:039K20A) for prophylaxis of COVID-19 infection.  25-Jan-2021,when she was going into the shower saw a bulging red patch at injection 3 inches long and a couple inches wide and incredibly tired.  No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events vaccination site rash,fatigue is Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Face injury, Fall
Clinical narrative: she felt on concrete; face got injured; This spontaneous case was reported by a consumer and describes the occurrence of FALL (she felt on concrete) and FACE INJURY (face got injured) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced FALL (she felt on concrete) and FACE INJURY (face got injured). At the time of the report, FALL (she felt on concrete) and FACE INJURY (face got injured) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter causality updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, COVID-19, Hypoaesthesia, Paraesthesia
Clinical narrative: Positive for Covid-19 after receiving vaccine; burning; tingling; numbness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid-19 after receiving vaccine), BURNING SENSATION (burning), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Respiratory disorder (Chronic respiratory conditions, asthma) and Obesity.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) 1 dosage form. On 30-Dec-2020 at 12:00 PM, the patient experienced BURNING SENSATION (burning), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness). On an unknown date, the patient experienced COVID-19 (Positive for Covid-19 after receiving vaccine). At the time of the report, COVID-19 (Positive for Covid-19 after receiving vaccine) outcome was unknown and BURNING SENSATION (burning), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information included reporter details, patient demographics details , product details, event information and causality.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Severe adverse side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe adverse side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe adverse side effects). At the time of the report, VACCINATION COMPLICATION (Severe adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported by reporter. No treatment medication reported by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Nasal congestion, Pain in extremity
Clinical narrative: congestion; coughing; low grade temperature fever; chills; body aches; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches) and COUGH (coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history report provided by the reporter.  Concomitant products included LORAZEPAM, ESTROGENS CONJUGATED (PREMARIN) and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm). On 22-Jan-2021, the patient experienced PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches), COUGH (coughing) and NASAL CONGESTION (congestion). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches), COUGH (coughing) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications and concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: congestion; coughing; low grade temperature fever; chills; body aches; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches) and COUGH (coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history report provided by the reporter.  Concomitant products included LORAZEPAM, ESTROGENS CONJUGATED (PREMARIN) and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm). On 22-Jan-2021, the patient experienced PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches), COUGH (coughing) and NASAL CONGESTION (congestion). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches), COUGH (coughing) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications and concomitant medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Lymph node palpable, Lymphadenopathy, Pain
Clinical narrative: blood pressure has been elevated; started to feel lymph nodes; swollen lymph nodes; fatigue; pain; A spontaneous authority report was received from a  consumer concerning an  42-year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and  experienced Pain, Blood pressure elevated, fatigue, started to feel lymph node on her left armpit, started to feel the one in the collarbone and neck, lymph nodes multiply in collarbone.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications were not reported.  On 05 Jan  2021, the patient received their  first  of two planned doses of mRNA-1273 (lot number  025J20-2A) intramuscularly in the  left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, after vaccination the patient felt pain, fatigue. On 9-Jan 2021 she started to feel lymph nodes on her armpit, lymph node multiply in collarbone.  Treatment information  provided was Ibuprofen for 3 days.  Action taken with mRNA-1273 in response to the events was not reported.  started to feel lymph node on her left armpit, started to feel the one in the collarbone and neck, lymph nodes multiply in collarbone Blood pressure elevated were unknown.   The outcome of the events  pain, fatigue were  Resolved.