chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 FATIGUE (Exhausted). At the time of the report, FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Rash pruritic, Urticaria
Clinical narrative: Welt; Red itchy Welt on right cheek; Pin dot size bumps on her neck that got itchy and hot; Little bumps on her forehead; pin dot size bumps on her neck; Felt tingling sensation like she had vapor rub n her; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt tingling sensation like she had vapor rub n her), RASH (Little bumps on her forehead; pin dot size bumps on her neck), RASH PRURITIC (Pin dot size bumps on her neck that got itchy and hot) and URTICARIA (Welt; Red itchy Welt on right cheek) in a 45-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 20-Jan-2021, the patient experienced PARAESTHESIA (Felt tingling sensation like she had vapor rub n her). On 25-Jan-2021, the patient experienced RASH (Little bumps on her forehead; pin dot size bumps on her neck). On 26-Jan-2021, the patient experienced RASH PRURITIC (Pin dot size bumps on her neck that got itchy and hot). On 27-Jan-2021, the patient experienced URTICARIA (Welt; Red itchy Welt on right cheek). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 28-Jan-2021, URTICARIA (Welt; Red itchy Welt on right cheek) had resolved. At the time of the report, PARAESTHESIA (Felt tingling sensation like she had vapor rub n her), RASH (Little bumps on her forehead; pin dot size bumps on her neck) and RASH PRURITIC (Pin dot size bumps on her neck that got itchy and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Limb mass, Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Big red welt around the injection site; Big red welt around the injection site/ red stripe she has that goes down her arm; Lumps on the inside of the elbow; Warmness; Sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Lumps on the inside of the elbow), URTICARIA (Big red welt around the injection site), VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PAIN (Sore) and VACCINATION SITE ERYTHEMA (Big red welt around the injection site/ red stripe she has that goes down her arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LIMB MASS (Lumps on the inside of the elbow), VACCINATION SITE WARMTH (Warmness) and VACCINATION SITE PAIN (Sore). On 21-Jan-2021, the patient experienced URTICARIA (Big red welt around the injection site) and VACCINATION SITE ERYTHEMA (Big red welt around the injection site/ red stripe she has that goes down her arm). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. On 18-Jan-2021, LIMB MASS (Lumps on the inside of the elbow), VACCINATION SITE WARMTH (Warmness) and VACCINATION SITE PAIN (Sore) had resolved. At the time of the report, URTICARIA (Big red welt around the injection site) and VACCINATION SITE ERYTHEMA (Big red welt around the injection site/ red stripe she has that goes down her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm of injection with pimples; arm of injection itchy; arm of injection burning rash; sore arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (arm of injection with pimples), VACCINATION SITE PRURITUS (arm of injection itchy), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE RASH (arm of injection burning rash) in a 73-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 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm of injection). On 27-Jan-2021, the patient experienced RASH PAPULAR (arm of injection with pimples), VACCINATION SITE PRURITUS (arm of injection itchy) and VACCINATION SITE RASH (arm of injection burning rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, VACCINATION SITE PAIN (sore arm of injection) had resolved. At the time of the report, RASH PAPULAR (arm of injection with pimples), VACCINATION SITE PRURITUS (arm of injection itchy) and VACCINATION SITE RASH (arm of injection burning rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Developed a high fever; A spontaneous report was received from a consumer concerning a 43-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a high fever.  The patient's medical history included COVID-19 that ended up with pneumonia. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient developed a high fever.   No treatment information was provided. However, the reporter wanted to know if could alternate between the use of Tylenol and Ibuprofen.  Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event, developed a high fever was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pyrexia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse reaction; A spontaneous report was received from a consumer concerning a unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events adverse reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On an unknown date, the outcome of event adverse reaction was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: redness on the arm with little spots; redness on the arm with little spots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on the arm with little spots) and VACCINATION SITE RASH (redness on the arm with little spots) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included CHLORTHALIDONE, PRAVASTATIN and CITALOPRAM 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 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness on the arm with little spots) and VACCINATION SITE RASH (redness on the arm with little spots). At the time of the report, VACCINATION SITE ERYTHEMA (redness on the arm with little spots) and VACCINATION SITE RASH (redness on the arm with little spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: rash; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and INJECTION SITE PAIN (Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by the reporter.     On 14-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 RASH (rash) and INJECTION SITE PAIN (Injection site pain). At the time of the report, RASH (rash) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Hives; Pain in injection arm; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in injection arm), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and INJECTION SITE URTICARIA (Hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UnknownUnknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR), FUROSEMIDE (LASIX P) and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) 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 22-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in injection arm), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE SWELLING (Swelling). On 29-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Hives). At the time of the report, INJECTION SITE PAIN (Pain in injection arm), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and INJECTION SITE URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site erythema; Vaccination site swelling; Tiredness; vaccination site pain; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (vaccination site pain). On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: silver dollar size rash on arm; A spontaneous report was received from a Consumer concerning a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events silver dollar size rash on arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, reported as a few days the patient experienced the events silver dollar size rash on arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event silver dollar size rash on arm was not reported/unknown on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swollen; redness; left arm started itching last night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (left arm started itching last night), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (left arm started itching last night). On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (left arm started itching last night), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; Running fever; Chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Running fever), CHILLS (Chills) and MYALGIA (Muscle pain) 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 was reported.).    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), PYREXIA (Running fever), CHILLS (Chills) and MYALGIA (Muscle pain). At the time of the report, NAUSEA (Nausea), PYREXIA (Running fever), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown.            Treatment detail was not provided.  Conmeds were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters on her thigh which spread out to her arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters on her thigh which spread out to her arms and legs) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-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 BLISTER (blisters on her thigh which spread out to her arms and legs). At the time of the report, BLISTER (blisters on her thigh which spread out to her arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling under tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling under tongue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (unspecified) and Osteoarthritis. Concomitant products included NSAIDS for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling under tongue). At the time of the report, PARAESTHESIA ORAL (Tingling under tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Growing rash at the injection site; Swelling at the injection site; Burning injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Growing rash at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Burning injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE RASH (Growing rash at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Burning injection site). At the time of the report, INJECTION SITE RASH (Growing rash at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Burning injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: Cramps; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MUSCLE SPASMS (Cramps) and FATIGUE (Fatigue). At the time of the report, MUSCLE SPASMS (Cramps) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Lymphadenopathy, Myalgia
Clinical narrative: stomachache; swelling of lymph nodes of same arm of injection and its spreading to other arm; Body ache; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swelling of lymph nodes of same arm of injection and its spreading to other arm), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (Body ache) and HEADACHE (headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph nodes of same arm of injection and its spreading to other arm), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (Body ache) and HEADACHE (headache). The patient was treated with ANTIBIOTICS-RESISTANT LACTIC ACID BACTERIAE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (swelling of lymph nodes of same arm of injection and its spreading to other arm), ABDOMINAL PAIN UPPER (stomachache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Redness around the injection site; Swelling around the injection site; Chills; Minor Arm pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness around the injection site), INJECTION SITE SWELLING (Swelling around the injection site), CHILLS (Chills), PAIN IN EXTREMITY (Minor Arm pain) and PYREXIA (Fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037v20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (May or may not have had COVID-19) in November 2020 and Pneumonia in November 2020. Concurrent medical conditions included Blood pressure high since 1995, Lymphoma (treated chemo) in 2020 and Drug allergy (allergic to vicadin drug). Concomitant products included AMLODIPINE, HYDRALAZINE and LOSARTAN for Blood pressure, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], TAMSULOSIN, PRAVASTATIN, TOCOPHEROL (VIT E [TOCOPHEROL]), KRILL OIL (KRILL VIT), COLECALCIFEROL (VIT D3) and CYANOCOBALAMIN (VIT B12) 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 PYREXIA (Fever). On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Minor Arm pain). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness around the injection site), INJECTION SITE SWELLING (Swelling around the injection site) and CHILLS (Chills). On 11-Feb-2021, PAIN IN EXTREMITY (Minor Arm pain) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness around the injection site) and INJECTION SITE SWELLING (Swelling around the injection site) outcome was unknown and CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 101-102 (High) 101-102, 104 (High) 104 and 105 (High) 105.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Patient demographic details updated, medical history added, 2nd dose information added, concomitant medication added, events outcome updated to resolved .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Redness around the injection site; Swelling around the injection site; Chills; Minor Arm pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness around the injection site), INJECTION SITE SWELLING (Swelling around the injection site), CHILLS (Chills), PAIN IN EXTREMITY (Minor Arm pain) and PYREXIA (Fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037v20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (May or may not have had COVID-19) in November 2020 and Pneumonia in November 2020. Concurrent medical conditions included Blood pressure high since 1995, Lymphoma (treated chemo) in 2020 and Drug allergy (allergic to vicadin drug). Concomitant products included AMLODIPINE, HYDRALAZINE and LOSARTAN for Blood pressure, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], TAMSULOSIN, PRAVASTATIN, TOCOPHEROL (VIT E [TOCOPHEROL]), KRILL OIL (KRILL VIT), COLECALCIFEROL (VIT D3) and CYANOCOBALAMIN (VIT B12) 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 PYREXIA (Fever). On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Minor Arm pain). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness around the injection site), INJECTION SITE SWELLING (Swelling around the injection site) and CHILLS (Chills). On 11-Feb-2021, PAIN IN EXTREMITY (Minor Arm pain) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness around the injection site) and INJECTION SITE SWELLING (Swelling around the injection site) outcome was unknown and CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 101-102 (High) 101-102, 104 (High) 104 and 105 (High) 105.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Patient demographic details updated, medical history added, 2nd dose information added, concomitant medication added, events outcome updated to resolved .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: sore arm at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) and INJECTION SITE RASH (rash at the injection site) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm at the injection site). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) outcome was unknown and INJECTION SITE RASH (rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Terminal insomnia
Clinical narrative: This reaction; have been waking up at 12 o'clock or 1 o'clock and be wide awake; A spontaneous report was received from a Consumer concerning a female patient (age not mentioned) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced reaction and  have been waking up at 12 o'clock or 1 o'clock and was wide awake.  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) via unknown route ,for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced reaction (not specified) and  the patient have been waking up at 12 o'clock or 1 o'clock and was wide awake.  Lab data was not provided.  Treatment was not taken by the patient.  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of events-reaction and waking up at 12 o'clock or 1 o'clock and  wide awake -was Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Administration site warmth, Arthralgia, Erythema, Injection site erythema
Clinical narrative: Warm to touch, hard in spots and larger than width of all my fingers; itching; Red area getting bigger; swelling; sick to stomach; mild joint pain; fever of 102.5 F; muscle sore; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to stomach), ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger) and ARTHRALGIA (mild joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical History.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), ARTHRALGIA (mild joint pain), PYREXIA (fever of 102.5 F), MYALGIA (muscle sore) and INJECTION SITE ERYTHEMA (injection site red). On 29-Jan-2021, the patient experienced ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger) and SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 29-Jan-2021, PYREXIA (fever of 102.5 F) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (sick to stomach), ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger), ARTHRALGIA (mild joint pain), MYALGIA (muscle sore), INJECTION SITE ERYTHEMA (injection site red) and SWELLING (swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Pyrexia: fever of 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Myalgia, Pyrexia, Swelling
Clinical narrative: Warm to touch, hard in spots and larger than width of all my fingers; itching; Red area getting bigger; swelling; sick to stomach; mild joint pain; fever of 102.5 F; muscle sore; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to stomach), ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger) and ARTHRALGIA (mild joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical History.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), ARTHRALGIA (mild joint pain), PYREXIA (fever of 102.5 F), MYALGIA (muscle sore) and INJECTION SITE ERYTHEMA (injection site red). On 29-Jan-2021, the patient experienced ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger) and SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 29-Jan-2021, PYREXIA (fever of 102.5 F) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (sick to stomach), ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger), ARTHRALGIA (mild joint pain), MYALGIA (muscle sore), INJECTION SITE ERYTHEMA (injection site red) and SWELLING (swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Pyrexia: fever of 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Huge lump at injection site; Lots of arm pain; Fever; Headache; Chills; Major body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Major body aches). At the time of the report, VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Major body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Huge lump at injection site; Lots of arm pain; Fever; Headache; Chills; Major body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Major body aches). At the time of the report, VACCINATION SITE MASS (Huge lump at injection site), PAIN IN EXTREMITY (Lots of arm pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Major body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pain in extremity
Clinical narrative: headache, sore arm, is lightheaded and dizzy, also has some weakness; lightheaded and dizzy; headache, sore arm, is lightheaded and dizzy, also has some weakness; headache, sore arm, is lightheaded and dizzy, also has some weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (headache, sore arm, is lightheaded and dizzy, also has some weakness), DIZZINESS (lightheaded and dizzy), ASTHENIA (headache, sore arm, is lightheaded and dizzy, also has some weakness) and HEADACHE (headache, sore arm, is lightheaded and dizzy, also has some weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (headache, sore arm, is lightheaded and dizzy, also has some weakness), DIZZINESS (lightheaded and dizzy), ASTHENIA (headache, sore arm, is lightheaded and dizzy, also has some weakness) and HEADACHE (headache, sore arm, is lightheaded and dizzy, also has some weakness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (headache, sore arm, is lightheaded and dizzy, also has some weakness), DIZZINESS (lightheaded and dizzy), ASTHENIA (headache, sore arm, is lightheaded and dizzy, also has some weakness) and HEADACHE (headache, sore arm, is lightheaded and dizzy, also has some weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Severe rash over arms, chest and groin; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe rash over arms, chest and groin) and BURNING SENSATION (Burning sensation) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced RASH (Severe rash over arms, chest and groin) and BURNING SENSATION (Burning sensation). At the time of the report, RASH (Severe rash over arms, chest and groin) and BURNING SENSATION (Burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Patient went to HCP where he was given a steroid pack
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection site arm) in a 96-year-old female patient 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.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection site arm). At the time of the report, VACCINATION SITE PAIN (soreness in injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up was attempted on 16-Apr-2021 @ 11:45am: Phone call was made but, patient declined further follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; Little bit itchy; Arm swollen; Arm still hurting; Red with half a dollar coin size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (Little bit itchy), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Arm still hurting) and VACCINATION SITE ERYTHEMA (Red with half a dollar coin size) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (Little bit itchy), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Arm still hurting) and VACCINATION SITE ERYTHEMA (Red with half a dollar coin size). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (Little bit itchy), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Arm still hurting) and VACCINATION SITE ERYTHEMA (Red with half a dollar coin size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Muscle twitching, Nose deformity
Clinical narrative: muscle twitch in legs; left lip swollen; left nose swollen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (muscle twitch in legs), LIP SWELLING (left lip swollen) and NOSE DEFORMITY (left nose swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 MUSCLE TWITCHING (muscle twitch in legs), LIP SWELLING (left lip swollen) and NOSE DEFORMITY (left nose swollen). On 24-Jan-2021, LIP SWELLING (left lip swollen) and NOSE DEFORMITY (left nose swollen) had resolved. At the time of the report, MUSCLE TWITCHING (muscle twitch in legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site was hot to touch; Itching around the injection site; Redness around the injection site; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Tenderness). The patient was treated with CORTISONE (topical) for Adverse event following immunisation, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. In addition to cortisone cream patient reported using cold compresses to help with adverse events following vaccination.