chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: arm started to swell up; red circle below injection site; itchy below injection site; the are is warm to touch; fatigue; arm was tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was tender and sore), PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site) and INJECTION SITE WARMTH (the are is warm to touch) in a 45-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2DA) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the adult was diagnosed with PAIN IN EXTREMITY (arm was tender and sore). On 26-Jan-2021, the adult was diagnosed with PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Jan-2021, PAIN IN EXTREMITY (arm was tender and sore) had resolved. At the time of the report, PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant conmeds reported.  Treatment provided: Benadryl (diphenhydramine) and Tylenol (paracetamol).
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm started to swell up; red circle below injection site; itchy below injection site; the are is warm to touch; fatigue; arm was tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was tender and sore), PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site) and INJECTION SITE WARMTH (the are is warm to touch) in a 45-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2DA) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the adult was diagnosed with PAIN IN EXTREMITY (arm was tender and sore). On 26-Jan-2021, the adult was diagnosed with PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Jan-2021, PAIN IN EXTREMITY (arm was tender and sore) had resolved. At the time of the report, PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant conmeds reported.  Treatment provided: Benadryl (diphenhydramine) and Tylenol (paracetamol).
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination complication
Clinical narrative: Chills; icky feelings; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and VACCINATION COMPLICATION (icky feelings) in a 48-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. Concomitant products included INFLIXIMAB (REMICADE).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and VACCINATION COMPLICATION (icky feelings). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.            Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site infection, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: infection at the site of injection; itchy - at the site of injection; redness - at the site of injection - size of nickel; swelling - at the site of injection; hot to the touch - at the site of injection; A spontaneous report (United States) was received from a consumer who is a 77-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness - at the site of injection - size of nickel/size of softball, swelling - at the site of injection, hot to the touch - at the site of injection, itchy - at the site of injection, infection at the site of injection.  The patient's medical history was not provided. Concomitant medications reported were Synthroid, Premarin, Xanax, Escitalopram, Losartan, Supplements, Vitamins for unknown indication.  On 16-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24-Jan-2021, the patient experienced the events redness - at the site of injection - size of nickel. swelling - at the site of injection, hot to the touch - at the site of injection, itchy - at the site of injection. On 25-Jan-2021, the patient experienced the increase in the redness - at the site of injection - size of softball. On 26-Jan-2021, the patient was seen by a HCP who suspected a vaccine site infection and provided treatment.  Treatment details included an unspecified antibiotic and an unspecified topical ointment  Action taken with mRNA-1273 in response to the events was not available.  The outcome of events , vaccination site warmth, vaccination site infection, vaccination site erythema, vaccination site swelling and vaccination site pruritus  were unknown.; Reporter'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.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes sore; A spontaneous report was received from a Healthcare Professional concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events herpes sore outbreak.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown Batch Number) intramuscularly in his left deltoid for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the events herpes sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb 2021 the outcome of events herpes sore was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: Dry cough; Little fatigue;  A spontaneous report was received from a Consumer concerning a 79 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, dry cough, little fatigue. The patient's medical history was not provided. Concomitant medications reported were Medication for cholesterol, Medication for high blood pressure for drug use for unknown indication. On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the events, dry cough. little fatigue. Treatment details included Toprol, 1FEB2021 JGrilloBalboa Action taken with mRNA-1273 in response to the events, dry cough, little fatigue was not reported.   On an unknown date the outcome of events include, dry cough, little fatigue was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Tremor
Clinical narrative: Shaking; Chills; Headache; Myalgia; Fatigue; A spontaneous report was received from a healthcare professional concerning a male   patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shaking, chills, headache, myalgia, fatigue.  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) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) shaking, chills, headache, myalgia, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shaking, chills, headache, myalgia, fatigue was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Still itchy; still swollen (little bit); slight temp; arm started to swell up really big; itch; Soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Still itchy), PERIPHERAL SWELLING (arm started to swell up really big), PRURITUS (itch), SWELLING (still swollen (little bit)) and PYREXIA (slight temp) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history information was reported by reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) 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 (Soreness at the vaccination site). On 30-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm started to swell up really big), PRURITUS (itch) and PYREXIA (slight temp). On 02-Feb-2021, the patient experienced PRURITUS (Still itchy) and SWELLING (still swollen (little bit)). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Still itchy), PERIPHERAL SWELLING (arm started to swell up really big), PRURITUS (itch), SWELLING (still swollen (little bit)), PYREXIA (slight temp) and VACCINATION SITE PAIN (Soreness at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination site mass, Vaccination site pain
Clinical narrative: vaccination site was red; swollen; warm; itchy; a little lump formed; arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 reported history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). On 26-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed). On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen) and INJECTION SITE WARMTH (warm). At the time of the report, INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy), VACCINATION SITE MASS (a little lump formed) and VACCINATION SITE PAIN (arm was sore) 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.   patient have given antihistamine but unknown no concomitant medication provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: vaccination site was red; swollen; warm; itchy; a little lump formed; arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 reported history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). On 26-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed). On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen) and INJECTION SITE WARMTH (warm). At the time of the report, INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy), VACCINATION SITE MASS (a little lump formed) and VACCINATION SITE PAIN (arm was sore) 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.   patient have given antihistamine but unknown no concomitant medication provided
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: Ankle started to hurt; It went into his leg a little bit; hurt to walk on; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Ankle started to hurt), PAIN IN EXTREMITY (It went into his leg a little bit) and GAIT DISTURBANCE (hurt to walk on) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Gout. Concomitant products included METFORMIN, GLIMEPIRIDE and RIVAROXABAN (XARELTO).    On 26-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 ARTHRALGIA (Ankle started to hurt), PAIN IN EXTREMITY (It went into his leg a little bit) and GAIT DISTURBANCE (hurt to walk on). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: No specific follow-up information recorded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site abscess, Injection site erythema, Injection site swelling
Clinical narrative: injection site swelling; injection site knot; skin tightening; extreme soreness; fever; headaches; fatigue; blotchy redness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Took ibuprofen for symptoms the first day, then switched to Tylenol 500mg x 2 B.I.D.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash macular, Subcutaneous abscess
Clinical narrative: injection site swelling; injection site knot; skin tightening; extreme soreness; fever; headaches; fatigue; blotchy redness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Took ibuprofen for symptoms the first day, then switched to Tylenol 500mg x 2 B.I.D.   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Developed rash on legs that spread up his legs to his arm; Legs itch; Rash at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Legs itch), RASH (Developed rash on legs that spread up his legs to his arm) and INJECTION SITE RASH (Rash at the injection site) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 INJECTION SITE RASH (Rash at the injection site). On 18-Jan-2021, the patient experienced PRURITUS (Legs itch). On 19-Jan-2021, the patient experienced RASH (Developed rash on legs that spread up his legs to his arm). The patient was treated with PREDNISONE on 29-Jan-2021 at an unspecified dose and frequency; FAMOTIDINE on 29-Jan-2021 at an unspecified dose and frequency and CETIRIZINE on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, PRURITUS (Legs itch), RASH (Developed rash on legs that spread up his legs to his arm) and INJECTION SITE RASH (Rash at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported The patient went to a doctor and was confirmed to have a typical drug allergic reaction. He was given a steroid shot (unknown) and prescribed with Prednisone, Famotidine and Cetirizine
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site lymphadenopathy, Vaccination site mass, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Having a little bit of queasiness; Her lymph node was swollen; cannot move left arm at all - the arm she got her shot in.; Knot in her left arm; excruciating pain in her left arm, so bad she can't even lift her arm; Her left arm was swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm) and VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site). At the time of the report, NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site) 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.   The patient was taking concomitant medications including medicines for blood pressure and thyroid  Treatment details included Tylenol, Asper cream, Heating pad.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Having a little bit of queasiness; Her lymph node was swollen; cannot move left arm at all - the arm she got her shot in.; Knot in her left arm; excruciating pain in her left arm, so bad she can't even lift her arm; Her left arm was swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm) and VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site). At the time of the report, NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site) 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.   The patient was taking concomitant medications including medicines for blood pressure and thyroid  Treatment details included Tylenol, Asper cream, Heating pad.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site urticaria
Clinical narrative: hives at the injection site; fever (100.1°F); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1°F)) 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 reported medical history).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1°F)). At the time of the report, VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1°F)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Dizziness, SARS-CoV-2 test
Clinical narrative: lightheaded; positive COVID test; no appetite; A spontaneous report was received from a consumer concerning a 76-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for covid test 2 days later and had lightheadedness and no appetite after few days of vaccination.   The patient's medical history was not provided. Concomitant medications included Cimzia, methotrexate.  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: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient experienced Covid-19. On 15 Jan 2021, the patient experienced the event no appetite (decreased appetite) and On 22 Jan 2021, the patient experienced lightheadedness (dizziness).   On 20 Jan 2021 infusion Bamlanivimab was received as treatment medication.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the reported events Sar CoV -2 positive, dizziness and decreased appetite was unknown.; Reporter's Comments: This case concerns a 76-year-old male who experienced a serious unexpected event of COVID-19 along with NS events of unexpected dizziness and decreased appetite.  Event onset occurred on Day 3 after the first dose of mRNA-1273. Treatment included bamlanivimab. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Balance disorder, Dizziness, Headache, Malaise
Clinical narrative: Malaise; Headache; Nausea; reactions to the vaccine; Vertigo; Balance issue; dizzy sensation; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (reactions to the vaccine), MALAISE (Malaise), VERTIGO (Vertigo), BALANCE DISORDER (Balance issue) and DIZZINESS (dizzy sensation) in a 35-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 information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ADVERSE EVENT (reactions to the vaccine), VERTIGO (Vertigo), BALANCE DISORDER (Balance issue) and DIZZINESS (dizzy sensation). On 28-Jan-2021, the patient experienced MALAISE (Malaise), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, ADVERSE EVENT (reactions to the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Malaise; Headache; Nausea; reactions to the vaccine; Vertigo; Balance issue; dizzy sensation; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (reactions to the vaccine), MALAISE (Malaise), VERTIGO (Vertigo), BALANCE DISORDER (Balance issue) and DIZZINESS (dizzy sensation) in a 35-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 information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ADVERSE EVENT (reactions to the vaccine), VERTIGO (Vertigo), BALANCE DISORDER (Balance issue) and DIZZINESS (dizzy sensation). On 28-Jan-2021, the patient experienced MALAISE (Malaise), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, ADVERSE EVENT (reactions to the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Ocular discomfort, Ocular hyperaemia, Swelling of eyelid, Vaccination site bruising
Clinical narrative: eyelids were swollen; eyes were all red; felt like sand in the left eye; little bruise on the injection site; numbness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (little bruise on the injection site), INJECTION SITE HYPOAESTHESIA (numbness on the injection site), OCULAR HYPERAEMIA (eyes were all red), OCULAR DISCOMFORT (felt like sand in the left eye) and SWELLING OF EYELID (eyelids were swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN INJECTION, LISINOPRIL, PRAVASTATIN and OMEPRAZOLE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE BRUISING (little bruise on the injection site) and INJECTION SITE HYPOAESTHESIA (numbness on the injection site). On 02-Feb-2021, the patient experienced OCULAR HYPERAEMIA (eyes were all red) and OCULAR DISCOMFORT (felt like sand in the left eye). On an unknown date, the patient experienced SWELLING OF EYELID (eyelids were swollen). On 03-Feb-2021, VACCINATION SITE BRUISING (little bruise on the injection site), OCULAR HYPERAEMIA (eyes were all red), OCULAR DISCOMFORT (felt like sand in the left eye) and SWELLING OF EYELID (eyelids were swollen) had resolved. At the time of the report, INJECTION SITE HYPOAESTHESIA (numbness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: rash on arm has faded but is still there; rash on arm is warm at times; red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash on arm is warm at times), VACCINATION SITE ERYTHEMA (red rash on arm) and VACCINATION SITE RASH (rash on arm has faded but is still there) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 16-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 WARMTH (rash on arm is warm at times) and VACCINATION SITE ERYTHEMA (red rash on arm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on arm has faded but is still there). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (rash on arm is warm at times), VACCINATION SITE ERYTHEMA (red rash on arm) and VACCINATION SITE RASH (rash on arm has faded but is still there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The rash on arm had faded but was still there.  Treatment included diphenhydramine and ice.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Tylenol 650 mg. No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Dizziness, Headache, Musculoskeletal discomfort
Clinical narrative: tachycardia up to 140 resting HR; Blood pressure 180/98; super dizzy; super weak; tingling in hands and feet; hotness in left arm at the injection site; hotness in left shoulder; hotness in left neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia up to 140 resting HR), BLOOD PRESSURE INCREASED (Blood pressure 180/98), DIZZINESS (super dizzy), ASTHENIA (super weak) and PARAESTHESIA (tingling in hands and feet) in a 40-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.     No medical history was provided by the reporter.   Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) 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 TACHYCARDIA (tachycardia up to 140 resting HR), BLOOD PRESSURE INCREASED (Blood pressure 180/98), DIZZINESS (super dizzy), ASTHENIA (super weak), PARAESTHESIA (tingling in hands and feet), VACCINATION SITE WARMTH (hotness in left arm at the injection site), MUSCULOSKELETAL DISCOMFORT (hotness in left shoulder), MUSCULOSKELETAL DISCOMFORT (hotness in left neck) and HEADACHE (headache). On 23-Jan-2021, TACHYCARDIA (tachycardia up to 140 resting HR) and BLOOD PRESSURE INCREASED (Blood pressure 180/98) had resolved. On 26-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, DIZZINESS (super dizzy), ASTHENIA (super weak), PARAESTHESIA (tingling in hands and feet), VACCINATION SITE WARMTH (hotness in left arm at the injection site), MUSCULOSKELETAL DISCOMFORT (hotness in left shoulder) and MUSCULOSKELETAL DISCOMFORT (hotness in left neck) 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.   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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tachycardia, Vaccination site warmth
Clinical narrative: tachycardia up to 140 resting HR; Blood pressure 180/98; super dizzy; super weak; tingling in hands and feet; hotness in left arm at the injection site; hotness in left shoulder; hotness in left neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia up to 140 resting HR), BLOOD PRESSURE INCREASED (Blood pressure 180/98), DIZZINESS (super dizzy), ASTHENIA (super weak) and PARAESTHESIA (tingling in hands and feet) in a 40-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.     No medical history was provided by the reporter.   Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) 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 TACHYCARDIA (tachycardia up to 140 resting HR), BLOOD PRESSURE INCREASED (Blood pressure 180/98), DIZZINESS (super dizzy), ASTHENIA (super weak), PARAESTHESIA (tingling in hands and feet), VACCINATION SITE WARMTH (hotness in left arm at the injection site), MUSCULOSKELETAL DISCOMFORT (hotness in left shoulder), MUSCULOSKELETAL DISCOMFORT (hotness in left neck) and HEADACHE (headache). On 23-Jan-2021, TACHYCARDIA (tachycardia up to 140 resting HR) and BLOOD PRESSURE INCREASED (Blood pressure 180/98) had resolved. On 26-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, DIZZINESS (super dizzy), ASTHENIA (super weak), PARAESTHESIA (tingling in hands and feet), VACCINATION SITE WARMTH (hotness in left arm at the injection site), MUSCULOSKELETAL DISCOMFORT (hotness in left shoulder) and MUSCULOSKELETAL DISCOMFORT (hotness in left neck) 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.   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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: INR 5.8; A spontaneous report was received from a non healthcare professional concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced International normalised ratio increased as 5.8.  The patient's medical history was not provided. Concomitant medications reported were Warfarin used for atrial fibrillation.  On 26 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 29 Jan 2021, 3 days after vaccination the patient experienced International normalised ratio increased as 5.8. The patient called her health care professional and they took her off warfarin and was taken to the hospital. The hospital read her International normalised ratio to be 5.8 and then held the warfarin for 3 days and now she was back to her normal International normalised ratio.  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 International normalised ratio increased as 5.8 was recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Injected limb mobility decreased, Lethargy, Nausea
Clinical narrative: Large red plaque on arm; Not able to lift arm; Severe pain shooting from ear and neck to pinky finger; Arm a rash, 6 inch circle; Fever; Lethargy; Pain localized to arm; Severe Diarrhea; Nausea; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Lethargy), DIARRHOEA (Severe Diarrhea), PAIN (Pain localized to arm), ERYTHEMA (Large red plaque on arm) and INJECTED LIMB MOBILITY DECREASED (Not able to lift arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN (Pain localized to arm) and PYREXIA (Fever). In January 2021, the patient experienced DIARRHOEA (Severe Diarrhea) and NAUSEA (Nausea). On 23-Jan-2021, the patient experienced ERYTHEMA (Large red plaque on arm), INJECTED LIMB MOBILITY DECREASED (Not able to lift arm), PAIN IN EXTREMITY (Severe pain shooting from ear and neck to pinky finger) and RASH (Arm a rash, 6 inch circle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In January 2021, LETHARGY (Lethargy), PAIN (Pain localized to arm), ERYTHEMA (Large red plaque on arm), PAIN IN EXTREMITY (Severe pain shooting from ear and neck to pinky finger) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Severe Diarrhea), INJECTED LIMB MOBILITY DECREASED (Not able to lift arm), RASH (Arm a rash, 6 inch circle) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information includes ice and heat.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.