chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Gait disturbance, Pruritus, Rash
Clinical narrative: Big red circle on her arm, 3 inches wide and hot; Itching; Knees and back were affected, couldn't hardly walk; Big red circle on her arm hot to touch; Rash on arms; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red circle on her arm, 3 inches wide and hot), PRURITUS (Itching), GAIT DISTURBANCE (Knees and back were affected, couldn't hardly walk), FEELING HOT (Big red circle on her arm hot to touch) and RASH (Rash on arms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS and Allergy (Allergic to oranges). Concomitant products included LEVOTHYROXINE, TRAMADOL, GABAPENTIN and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 21-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 ERYTHEMA (Big red circle on her arm, 3 inches wide and hot), PRURITUS (Itching), GAIT DISTURBANCE (Knees and back were affected, couldn't hardly walk), FEELING HOT (Big red circle on her arm hot to touch) and RASH (Rash on arms). At the time of the report, ERYTHEMA (Big red circle on her arm, 3 inches wide and hot), PRURITUS (Itching), GAIT DISTURBANCE (Knees and back were affected, couldn't hardly walk), FEELING HOT (Big red circle on her arm hot to touch) and RASH (Rash on arms) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included unspecified allergy pills. Additional concomitant medication included unspecified blood pressure pills.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Paraesthesia oral
Clinical narrative: swollen around mouth; Tingly around mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (swollen around mouth) and PARAESTHESIA ORAL (Tingly around mouth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     Concomitant products included CALCIUM and VITAMINS NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MOUTH SWELLING (swollen around mouth) and PARAESTHESIA ORAL (Tingly around mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and LORATADINE (CLARITINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOUTH SWELLING (swollen around mouth) and PARAESTHESIA ORAL (Tingly around mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications include unspecified cosmetic facial fillers.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: intermittent numbness on the right side of my lips and tongue; intermittent numbness on the right side of my lips and tongue; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HYPOAESTHESIA ORAL (intermittent numbness on the right side of my lips and tongue) and the second episode of HYPOAESTHESIA ORAL (intermittent numbness on the right side of my lips and tongue) in a not specif patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of HYPOAESTHESIA ORAL (intermittent numbness on the right side of my lips and tongue) and the second episode of HYPOAESTHESIA ORAL (intermittent numbness on the right side of my lips and tongue). At the time of the report, last episode of HYPOAESTHESIA ORAL (intermittent numbness on the right side of my lips and tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction after receiving covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction after receiving covid-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction after receiving covid-19 vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction after receiving covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter called to inquire about the adverse side effects after receiving a Moderna COVID-19 vaccine.  No Concomitant product use was reported. No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: Diarrhea; Vomiting; Aches and pain in the whole body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Aches and pain in the whole body) and VOMITING (Vomiting) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes.    On 16-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 PAIN (Aches and pain in the whole body). On 19-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 19-Jan-2021, PAIN (Aches and pain in the whole body) had resolved. On 20-Jan-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has underlying conditions and take blood pressure pills, and has high cholesterol and diabetes.   Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Arm discomfort, at an unspecified dose and frequency and NAPROXEN (MOTRIN [NAPROXEN]) for Arm discomfort, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Erection increased
Clinical narrative: erection; This spontaneous case was reported by a consumer and describes the occurrence of ERECTION INCREASED (erection) in a male 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERECTION INCREASED (erection). At the time of the report, ERECTION INCREASED (erection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site induration, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Burning hot; Itchy; Welted up; tender; Egg shaped spot, nos is beige colored and still there; Sore arm; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up) and FATIGUE (Really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B COMPOUND [CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for Supplementation therapy, LOSARTAN, PROGESTERONE, ESTRADIOL (E2), ESCITALOPRAM OXALATE (LEXAPRO) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Really tired). On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up), VACCINATION SITE PAIN (tender) and VACCINATION SITE LYMPHADENOPATHY (Egg shaped spot, nos is beige colored and still there). The patient was treated with PARACETAMOL (TYLENOL) on 15-Jan-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved, FATIGUE (Really tired) was resolving. On 25-Jan-2021, VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up) and VACCINATION SITE PAIN (tender) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Egg shaped spot, nos is beige colored and still there) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included: turmeric. Additional event treatment included: cryotherapy.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Burning hot; Itchy; Welted up; tender; Egg shaped spot, nos is beige colored and still there; Sore arm; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up) and FATIGUE (Really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B COMPOUND [CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for Supplementation therapy, LOSARTAN, PROGESTERONE, ESTRADIOL (E2), ESCITALOPRAM OXALATE (LEXAPRO) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (Really tired). On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up), VACCINATION SITE PAIN (tender) and VACCINATION SITE LYMPHADENOPATHY (Egg shaped spot, nos is beige colored and still there). The patient was treated with PARACETAMOL (TYLENOL) on 15-Jan-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved, FATIGUE (Really tired) was resolving. On 25-Jan-2021, VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up) and VACCINATION SITE PAIN (tender) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Egg shaped spot, nos is beige colored and still there) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included: turmeric. Additional event treatment included: cryotherapy.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PAIN (aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PAIN (aches). At the time of the report, CHILLS (Chills) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oxygen saturation, Pain in extremity
Clinical narrative: headache; great pain in the arm/now only a little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (great pain in the arm/now only a little pain) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood pressure high and Gastritis. Concomitant products included LOSARTAN for Blood pressure high, OMEPRAZOLE (OMEPRAZEN [OMEPRAZOLE]) for Gastritis.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (great pain in the arm/now only a little pain). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (great pain in the arm/now only a little pain) was resolving and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 95 OTHER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Full blood count, Prothrombin time, Rash macular
Clinical narrative: Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertension. Concomitant products included METFORMIN for Hypertension, GLIMEPIRIDE, ATORVASTATIN, AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced RASH MACULAR (Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot). At the time of the report, RASH MACULAR (Reddish blue patches, with irregular margins, not confluent, not raised, & with no associated features on the skin, around malleoli at both ankles & dorsum of foot) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Activated partial thromboplastin time: within reference ranges. On 12-Jan-2021, Full blood count: within reference ranges. On 12-Jan-2021, Prothrombin time: within reference ranges.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication was not reported.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm at the injection site; Itches at the injection site; Redness at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itches at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itches at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itches at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: fatigue; HEADACHE; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (HEADACHE) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (HEADACHE). On 23-Jan-2021, the patient experienced FATIGUE (fatigue). At the time of the report, NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (HEADACHE) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) 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 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Dyspnoea, Influenza like illness
Clinical narrative: Side effects due to the Moderna vaccine; Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects due to the Moderna vaccine), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 08-Feb-2021, the patient experienced DYSPNOEA (Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain). On an unknown date, the patient experienced ADVERSE EVENT (Side effects due to the Moderna vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 07-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. On 08-Feb-2021, DYSPNOEA (Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain) had resolved. At the time of the report, ADVERSE EVENT (Side effects due to the Moderna vaccine) outcome was unknown. Not Provided          This case was linked to MOD-2021-031127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow-up information includes concomitant ,treatment and events were added. On 06-Jul-2021: Follow-up information includes contact information were updated.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Developed a red blotch on her arm three inches long by two inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Developed a red blotch on her arm three inches long by two inches wide) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 05-Feb-2021, the patient experienced RASH MACULAR (Developed a red blotch on her arm three inches long by two inches wide). At the time of the report, RASH MACULAR (Developed a red blotch on her arm three inches long by two inches wide) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 contains telephone contact report.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, COVID-19, Fatigue, Gait disturbance
Clinical narrative: Sweats; Vertigo; Tenderness; Pain in the arm; Pain in the shoulder; Pain in the left breast; Pretty much all the symptoms of covid except loss of taste and smell; Could not walk; Headache; Fatigue; Could not roll out of bed; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 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 6 Feb 2021, the patient experienced the events could not walk, headache, fatigue, could not roll out of bed. On 7 Feb 2021, the patient experienced the events sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Sweats; Vertigo; Tenderness; Pain in the arm; Pain in the shoulder; Pain in the left breast; Pretty much all the symptoms of covid except loss of taste and smell; Could not walk; Headache; Fatigue; Could not roll out of bed; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 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 6 Feb 2021, the patient experienced the events could not walk, headache, fatigue, could not roll out of bed. On 7 Feb 2021, the patient experienced the events sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Sweats; Vertigo; Tenderness; Pain in the arm; Pain in the shoulder; Pain in the left breast; Pretty much all the symptoms of covid except loss of taste and smell; Could not walk; Headache; Fatigue; Could not roll out of bed; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 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 6 Feb 2021, the patient experienced the events could not walk, headache, fatigue, could not roll out of bed. On 7 Feb 2021, the patient experienced the events sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not walk, headache, fatigue, could not roll out of bed, sweats, shakes, vertigo, tenderness, pain in the arm, pain in the shoulder, pain in the left breast, pretty much all the symptoms of covid except loss of taste and smell was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Face felt flush; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face felt flush) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 25-Jan-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced FLUSHING (Face felt flush). On 25-Jan-2021, FLUSHING (Face felt flush) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling arm; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen arm.  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 had the arm swollen (peripheral swelling).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Pyrexia, Sinus operation
Clinical narrative: fever of 100.6°F; tested positive for COVID-19; Congestion; sinus drainage; A spontaneous report was received from a Physician  concerning a 68-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events congestion, sinus drainage, fever of 100.6f, tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) Intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient experienced the event congestion, sinus drainage. On 20 Jan 2021, the patient experienced the event fever of 100.6f,On 19 Jan 2021, the patient experienced the event tested positive for covid-19.  Treatment details included For the symptoms: Tylenol, Aspirin and Monoclonal infusion., Other: Lotrel for her blood pressure and Melatonin for sleeping., 09Feb2021. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), congestion, sinus drainage, fever of 100.6, tested positive for covid-19 was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red; Swollen; vaccinatio site Super itchy/extremely itchy reaction at injection site; Vaccination site Swelling; Vaccination site Redness; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain), ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 21-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Pain), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE SWELLING (Vaccination site Swelling). On 28-Jan-2021, the patient experienced ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 24-Jan-2021, PAIN (Pain), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE SWELLING (Vaccination site Swelling) had resolved. At the time of the report, ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used ice packs as treatment.   This case was linked to MOD-2021-229974 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-significant Follow-up received. Reporter AE contact information was updated. On 21-Jun-2021: Significant follow up appended to AER. Updated details:: Pregnant: No. Race: private. Dose1 time. Concomitant Drug: Vesicare.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Red; Swollen; vaccinatio site Super itchy/extremely itchy reaction at injection site; Vaccination site Swelling; Vaccination site Redness; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain), ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 21-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Pain), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE SWELLING (Vaccination site Swelling). On 28-Jan-2021, the patient experienced ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 24-Jan-2021, PAIN (Pain), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE SWELLING (Vaccination site Swelling) had resolved. At the time of the report, ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used ice packs as treatment.   This case was linked to MOD-2021-229974 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-significant Follow-up received. Reporter AE contact information was updated. On 21-Jun-2021: Significant follow up appended to AER. Updated details:: Pregnant: No. Race: private. Dose1 time. Concomitant Drug: Vesicare.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vomiting
Clinical narrative: Vomited; Soreness at the injection site; A spontaneous report (United States) was received from a healthcare professional concerning a 76-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at the injection site, vomited.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) soreness at the injection site,On 4 Feb 2021, the patient experienced the event(s) vomited.  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 event(s), soreness at the injection site was resolved. The outcome of event(s), vomited was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Temperature went up and actually got to 105.3; Chills and could not get warm; A spontaneous report was received from a consumer concerning a 80 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Chills and could not get warm, Temperature went up and actually got to 105.3(pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, 11 am 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.  Patient had the virus in July, previously checked several times to see that still had the antibodies. On 15 Jan 2021 6:15 pm patient experienced  Chills and could not get warm, Temperature went up and actually got to 105.3.  No treatment information was provided.  On 15-JAN-2021 laboratory information included body temperature of 105.3 degree F.  Action taken with mRNA-1273 in response to the events was not reported.   The events  Chills and could not get warm, Temperature went up and actually got to 105.3 concerned to be unknown.; 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.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal dryness, Nasopharyngitis
Clinical narrative: Cold; Cough dried up; Snotty nose dried up; A spontaneous report was received from a 77-years-old  male patient concerning himelf who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cold disappeared, cough dried up and snotty nose dried up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events cold disappeared, cough dried up and snotty nose dried up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, cold disappeared, cough dried up and snotty nose dried up was unknown.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm became red at the injection site/Redness in streaks near injection site; Arm became itchy at the injection site; A spontaneous report was received from a consumer concerning a 89 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm became red at injection site, redness in streaks near injection site/vaccination site erythema, arm became itchy at the injection site/vaccination site pruritus.  The patient's medical history, was not provided by the reporter. Concomitant medications reported included atenolol, multivitamins and vitamin D 1000.  On 28 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch number: 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   About nine to ten days later, the patient's arm became itchy and red at the injection site. The redness occurred in streaks near the injection site  Treatment for the event included loratadine which help to treat the side effects.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event arm became itchy and red at the injection site and the redness occurred in streaks near the injection site were unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Received the 1st dose while having COVID; A spontaneous report was received from a healthcare professional concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events received the 1st dose while having covid/ SARS-CoV-2 test positive.  The patient's medical history was not provided. Concomitant medications reported were Metoprolol, Levothyroxine, Wellbutrin used for unknown indication.  On 6 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 6 Jan 2021, the patient received the first dose of mRNA-1273  while having covid.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 6 Jan 2021 the outcome of event(s), received the 1st dose while having covid was resolved.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pain, Pyrexia
Clinical narrative: the muscles in my neck is achy and sore; painful to turn but not excruciating; fever; chills; My body is achy; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (the muscles in my neck is achy and sore), PAIN (painful to turn but not excruciating), PYREXIA (fever), CHILLS (chills) and PAIN (My body is achy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced NECK PAIN (the muscles in my neck is achy and sore), PAIN (painful to turn but not excruciating), PYREXIA (fever), CHILLS (chills) and PAIN (My body is achy). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (the muscles in my neck is achy and sore), PAIN (painful to turn but not excruciating), PYREXIA (fever), CHILLS (chills) and PAIN (My body is achy) outcome was unknown.            Treatment medication included Tylenol and ibuprofen.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: swollen; super itchy; red; Injection site swelling; Injection site pain; redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swollen), PRURITUS (super itchy), ERYTHEMA (red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PAIN (Injection site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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 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 INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (redness). On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), PRURITUS (super itchy) and ERYTHEMA (red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) for Itching, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Swelling, at an unspecified dose and frequency. On 24-Jan-2021, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (redness) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen), PRURITUS (super itchy) and ERYTHEMA (red) 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.