chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Ocular hyperaemia
Clinical narrative: loss of smell; loss of taste; red eyes; covid-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), ANOSMIA (loss of smell), AGEUSIA (loss of taste) and OCULAR HYPERAEMIA (red eyes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TREPROSTINIL SODIUM since an unknown date. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste) and OCULAR HYPERAEMIA (red eyes). At the time of the report, COVID-19 (covid-19), ANOSMIA (loss of smell), AGEUSIA (loss of taste) and OCULAR HYPERAEMIA (red eyes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, COVID-19: (Inconclusive) Results unknown.         Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Hypokinesia, Neck pain, Sleep paralysis
Clinical narrative: I couldn't turn myself over in bed; Legs wouldn't work; Couldn't stand up; My neck hurt so bad I had to lay flat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Legs wouldn't work), DYSKINESIA (Couldn't stand up), NECK PAIN (My neck hurt so bad I had to lay flat) and SLEEP PARALYSIS (I couldn't turn myself over in bed) 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 COVID-19 in December 2020.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Legs wouldn't work), DYSKINESIA (Couldn't stand up), NECK PAIN (My neck hurt so bad I had to lay flat) and SLEEP PARALYSIS (I couldn't turn myself over in bed). At the time of the report, HYPOKINESIA (Legs wouldn't work), DYSKINESIA (Couldn't stand up), NECK PAIN (My neck hurt so bad I had to lay flat) and SLEEP PARALYSIS (I couldn't turn myself over in bed) had resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-057062 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Swollen lymph node in armpit area that is very sensitive and it hurt for a few days; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node in armpit area that is very sensitive and it hurt for a few days) and RASH (Rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node in armpit area that is very sensitive and it hurt for a few days) and RASH (Rash). On 10-Mar-2021, LYMPHADENOPATHY (Swollen lymph node in armpit area that is very sensitive and it hurt for a few days) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a patient and describes the occurrence of FOOD POISONING (vomiting, feels like food poisoning) 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 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FOOD POISONING (vomiting, feels like food poisoning). At the time of the report, FOOD POISONING (vomiting, feels like food poisoning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. No treatment medications are provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash warm to the touch; Had a rash; Felt a bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Felt a bump), VACCINATION SITE WARMTH (Rash warm to the touch) and VACCINATION SITE RASH (Had a rash) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE MASS (Felt a bump). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Rash warm to the touch) and VACCINATION SITE RASH (Had a rash). At the time of the report, VACCINATION SITE MASS (Felt a bump), VACCINATION SITE WARMTH (Rash warm to the touch) and VACCINATION SITE RASH (Had a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included blood pressure medications and diuretic medications. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact information of reporter was updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Left arm was Red) and VACCINATION SITE PRURITUS (Itching) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm was Red) and VACCINATION SITE PRURITUS (Itching). On 19-Mar-2021, VACCINATION SITE ERYTHEMA (Left arm was Red) and VACCINATION SITE PRURITUS (Itching) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-061461 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: No new information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061461:wife dose 1 case
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: Tachycardia worsening; Intermittent chest pain; Nausea; legs were numb, numbness and tingling in both hands, both feetintermittently on face,; Muscle aches; arm was really sore; hand was really numb, numbness in L hand; really severe fatigue; threw up once; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (arm was really sore), HYPOAESTHESIA (hand was really numb, numbness in L hand), FATIGUE (really severe fatigue), VOMITING (threw up once) and HYPOAESTHESIA (legs were numb, numbness and tingling in both hands, both feetintermittently on face,) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006MZ0A and 011620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Adverse event, ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE) for Birth control pill.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was really sore), HYPOAESTHESIA (hand was really numb, numbness in L hand), FATIGUE (really severe fatigue) and VOMITING (threw up once). On 23-Feb-2021, the patient experienced HYPOAESTHESIA (legs were numb, numbness and tingling in both hands, both feetintermittently on face,) and MYALGIA (Muscle aches). On 24-Feb-2021, the patient experienced CHEST PAIN (Intermittent chest pain) and NAUSEA (Nausea). On 26-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia worsening). The patient was treated with STEROIDS for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm was really sore), HYPOAESTHESIA (hand was really numb, numbness in L hand), FATIGUE (really severe fatigue), VOMITING (threw up once), HYPOAESTHESIA (legs were numb, numbness and tingling in both hands, both feetintermittently on face,), MYALGIA (Muscle aches), CHEST PAIN (Intermittent chest pain), NAUSEA (Nausea) and TACHYCARDIA (Tachycardia worsening) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reports visiting Urgent Care on 24-FEB-2021 for treatment of symptoms.  Patient saw her Primary Care Physician on 26-feb-2021.  Again on 12-MAR-2021, patient saw her PCP and reports Blood Work (NOS) was done.  No results were provided.  On 17-Mar-2021 patient reports seeing PCP again for follow up visit and reports LABS (NOS) were normal.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site pain, Vomiting
Clinical narrative: Tachycardia worsening; Intermittent chest pain; Nausea; legs were numb, numbness and tingling in both hands, both feetintermittently on face,; Muscle aches; arm was really sore; hand was really numb, numbness in L hand; really severe fatigue; threw up once; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (arm was really sore), HYPOAESTHESIA (hand was really numb, numbness in L hand), FATIGUE (really severe fatigue), VOMITING (threw up once) and HYPOAESTHESIA (legs were numb, numbness and tingling in both hands, both feetintermittently on face,) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006MZ0A and 011620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Adverse event, ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE) for Birth control pill.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was really sore), HYPOAESTHESIA (hand was really numb, numbness in L hand), FATIGUE (really severe fatigue) and VOMITING (threw up once). On 23-Feb-2021, the patient experienced HYPOAESTHESIA (legs were numb, numbness and tingling in both hands, both feetintermittently on face,) and MYALGIA (Muscle aches). On 24-Feb-2021, the patient experienced CHEST PAIN (Intermittent chest pain) and NAUSEA (Nausea). On 26-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia worsening). The patient was treated with STEROIDS for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm was really sore), HYPOAESTHESIA (hand was really numb, numbness in L hand), FATIGUE (really severe fatigue), VOMITING (threw up once), HYPOAESTHESIA (legs were numb, numbness and tingling in both hands, both feetintermittently on face,), MYALGIA (Muscle aches), CHEST PAIN (Intermittent chest pain), NAUSEA (Nausea) and TACHYCARDIA (Tachycardia worsening) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reports visiting Urgent Care on 24-FEB-2021 for treatment of symptoms.  Patient saw her Primary Care Physician on 26-feb-2021.  Again on 12-MAR-2021, patient saw her PCP and reports Blood Work (NOS) was done.  No results were provided.  On 17-Mar-2021 patient reports seeing PCP again for follow up visit and reports LABS (NOS) were normal.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Myalgia, Pruritus, Pyrexia
Clinical narrative: slight itching on back, belly, chest, legs; rashes like hives; tested positive for Covid; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), PRURITUS (slight itching on back, belly, chest, legs), URTICARIA (rashes like hives), MYALGIA (body aches) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MYALGIA (body aches). On 24-Mar-2021, the patient experienced PYREXIA (fever). On 25-Mar-2021, the patient experienced COVID-19 (tested positive for Covid). On 26-Mar-2021, the patient experienced PRURITUS (slight itching on back, belly, chest, legs) and URTICARIA (rashes like hives). At the time of the report, COVID-19 (tested positive for Covid) had not resolved and PRURITUS (slight itching on back, belly, chest, legs), URTICARIA (rashes like hives), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 102.3 °F (High) 102.3. On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were taken by patient.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Additional Events along with lot number was added.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: slight itching on back, belly, chest, legs; rashes like hives; tested positive for Covid; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), PRURITUS (slight itching on back, belly, chest, legs), URTICARIA (rashes like hives), MYALGIA (body aches) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MYALGIA (body aches). On 24-Mar-2021, the patient experienced PYREXIA (fever). On 25-Mar-2021, the patient experienced COVID-19 (tested positive for Covid). On 26-Mar-2021, the patient experienced PRURITUS (slight itching on back, belly, chest, legs) and URTICARIA (rashes like hives). At the time of the report, COVID-19 (tested positive for Covid) had not resolved and PRURITUS (slight itching on back, belly, chest, legs), URTICARIA (rashes like hives), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 102.3 °F (High) 102.3. On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were taken by patient.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Additional Events along with lot number was added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Bactrim), Osteopenia, Food allergy (Allergic to Filet of sole) and Latex allergy (Slight latex sensitivity). Concomitant products included CALCIUM for Osteopenia, MONASCUS PURPUREUS (RED YEAST RICE), FISH OIL and VITAMIN E [VITAMIN E NOS] for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient uses unspecified allergy medication one daily since 2010 for unknown indication.  Concomitant drugs included Allergy medication. Treatment medicines were not reported   The patient had Good physical health, swim a mile three times a week.   This case was linked to MOD-2021-057168 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-MAY2021 : updated reporter details ,patient demographics, medical history, Concomitant medicines, dose 2 details, Start date of first dose of moderna vaccine was provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: hardness at the site; swelling on that arm from the vaccine but it is a little bit improved; soreness that lasted for a couple days and that was a little more severe then the usual flu shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at the site), VACCINATION SITE SWELLING (swelling on that arm from the vaccine but it is a little bit improved) and VACCINATION SITE PAIN (soreness that lasted for a couple days and that was a little more severe then the usual flu shot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling on that arm from the vaccine but it is a little bit improved) and VACCINATION SITE PAIN (soreness that lasted for a couple days and that was a little more severe then the usual flu shot). On 22-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the site). At the time of the report, VACCINATION SITE INDURATION (hardness at the site), VACCINATION SITE SWELLING (swelling on that arm from the vaccine but it is a little bit improved) and VACCINATION SITE PAIN (soreness that lasted for a couple days and that was a little more severe then the usual flu shot) had resolved.            No concomitant medications were reported.  No treatment related information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: event outcome updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: nausea; diarrhea; body aches; achiness all over; headache; chills; achiness all over, especially in joints; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (achiness all over), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bacrtrim), Food allergy (filet of sole) and Latex allergy (slight latex sensitivity). Concomitant products included CALCIUM for Osteopenia, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), MONASCUS PURPUREUS (RED YEAST RICE), FISH OIL and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (achiness all over), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (achiness all over, especially in joints). On 25-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nausea) and MYALGIA (body aches). On 26-Mar-2021, DIARRHOEA (diarrhea), NAUSEA (nausea) and MYALGIA (body aches) had resolved. At the time of the report, PAIN (achiness all over), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (achiness all over, especially in joints) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product also include allergy medication,Vitamins and Supplements.  Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information include paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May 2021 Reporter details, patient demographics, medical history, product details, concomitant products, events were updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: nausea; diarrhea; body aches; achiness all over; headache; chills; achiness all over, especially in joints; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (achiness all over), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bacrtrim), Food allergy (filet of sole) and Latex allergy (slight latex sensitivity). Concomitant products included CALCIUM for Osteopenia, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), MONASCUS PURPUREUS (RED YEAST RICE), FISH OIL and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (achiness all over), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (achiness all over, especially in joints). On 25-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nausea) and MYALGIA (body aches). On 26-Mar-2021, DIARRHOEA (diarrhea), NAUSEA (nausea) and MYALGIA (body aches) had resolved. At the time of the report, PAIN (achiness all over), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (achiness all over, especially in joints) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product also include allergy medication,Vitamins and Supplements.  Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information include paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May 2021 Reporter details, patient demographics, medical history, product details, concomitant products, events were updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site swelling
Clinical narrative: Huge rash which is red; raised bumps near injection site; Huge rash which is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Huge rash which is red), VACCINATION SITE SWELLING (raised bumps near injection site) and RASH PRURITIC (Huge rash which is itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Huge rash which is red), VACCINATION SITE SWELLING (raised bumps near injection site) and RASH PRURITIC (Huge rash which is itchy). At the time of the report, RASH ERYTHEMATOUS (Huge rash which is red), VACCINATION SITE SWELLING (raised bumps near injection site) and RASH PRURITIC (Huge rash which is itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was allergic to opioid medications. Patient has been using cortisone creams to alleviate adverse events. No concomitant medications were reported.  No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Mobility decreased, Pain in extremity
Clinical narrative: Arm pain; unbelievable joint pain in hips; not able to walk; chills; could not lie down; chattering teeth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (unbelievable joint pain in hips), MOBILITY DECREASED (not able to walk), CHILLS (chills), ARTHRALGIA (could not lie down) and CHILLS (chattering teeth) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ARTHRALGIA (unbelievable joint pain in hips), MOBILITY DECREASED (not able to walk), CHILLS (chills), ARTHRALGIA (could not lie down) and CHILLS (chattering teeth). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). On 27-Mar-2021, ARTHRALGIA (unbelievable joint pain in hips) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MOBILITY DECREASED (not able to walk), CHILLS (chills), ARTHRALGIA (could not lie down) and CHILLS (chattering teeth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has taken Percocet, Tylenol. concomitant medication include ezetimibe 10mg/day, telmasartan 80/mg/day, Hydrochrolizade 5mg/day   This case was linked to MOD-2021-121653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: VAERS
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye colour change, Ocular hyperaemia, Swelling
Clinical narrative: Red eye; Eyes like purple; Cant stop poops; Lumps inside starting performing; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Red eye), EYE COLOUR CHANGE (Eyes like purple), DIARRHOEA (Cant stop poops) and SWELLING (Lumps inside starting performing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Red eye), EYE COLOUR CHANGE (Eyes like purple), DIARRHOEA (Cant stop poops) and SWELLING (Lumps inside starting performing). At the time of the report, OCULAR HYPERAEMIA (Red eye), EYE COLOUR CHANGE (Eyes like purple), DIARRHOEA (Cant stop poops) and SWELLING (Lumps inside starting performing) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.    This case was linked to MOD-2021-024688 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information received on 13-MAY-2021, Significant Follow up appended On 13-May-2021: Follow up information received on 13-MAY-2021, Non significant follow up appended; Sender's Comments:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidently given moderna vaccine to 17 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidently given moderna vaccine to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), CROMOGLICATE SODIUM (NASALCROM) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 07-Mar-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidently given moderna vaccine to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidently given moderna vaccine to 17 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for an unknown indication.     No Medical History information was reported.    On 11-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 VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: entire face is red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (entire face is red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA (entire face is red). At the time of the report, ERYTHEMA (entire face is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness at tip of both thumbs. Later is started moving up to the hand and now in both arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included VITAMIN D NOS, ASPIRIN [ACETYLSALICYLIC ACID], METHOCARBAMOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ), POTASSIUM CHLORIDE (K-DUR) and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness at tip of both thumbs. Later is started moving up to the hand and now in both arms). At the time of the report, HYPOAESTHESIA (numbness at tip of both thumbs. Later is started moving up to the hand and now in both arms) outcome was unknown. Not Provided      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.   No concomitant medications were reported. No treatment related information has been reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Redness at the injection site; Hot to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE WARMTH (Hot to the touch at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE WARMTH (Hot to the touch at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE WARMTH (Hot to the touch at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Impaired work ability, Mobility decreased
Clinical narrative: Can't bend knee; Can't go up/down steps; Patient is not able to work; Chills; Severe knee joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't bend knee), GAIT DISTURBANCE (Can't go up/down steps), IMPAIRED WORK ABILITY (Patient is not able to work), CHILLS (Chills) and ARTHRALGIA (Severe knee joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 30LZ30A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Can't bend knee), GAIT DISTURBANCE (Can't go up/down steps), IMPAIRED WORK ABILITY (Patient is not able to work), CHILLS (Chills) and ARTHRALGIA (Severe knee joint pain). At the time of the report, MOBILITY DECREASED (Can't bend knee), GAIT DISTURBANCE (Can't go up/down steps), IMPAIRED WORK ABILITY (Patient is not able to work), CHILLS (Chills) and ARTHRALGIA (Severe knee joint pain) outcome was unknown.            Concomitant medications were not provided Treatment information include Advil, ice. Voltaren tablet for pain . Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-017697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: The Additional information document received on 10-MAY-2021.Repoters email id was added. First dose information was added. Treatment  information is added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Palpitations
Clinical narrative: Heart racing; Sick to stomach; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Sick to stomach), FATIGUE (Fatigue) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Sick to stomach), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Sick to stomach), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines included medicines for thyroid, blood pressure and nasal steroids.  Treatment advil
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: edges seem to be irregular, a little lighter; Injection site redness/redness appeared around the site, getting larger; warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter) and VACCINATION SITE ERYTHEMA (Injection site redness/redness appeared around the site, getting larger) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D;VITAMIN E for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (Injection site redness/redness appeared around the site, getting larger). On 26-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter). On 25-Feb-2021, VACCINATION SITE ERYTHEMA (Injection site redness/redness appeared around the site, getting larger) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm) had not resolved and VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant products included 2x high blood pressure medication and cholesterol medication.  Patient has applied cold on and off for the treatment.  The action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy at injection site; Pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Pink at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Pink at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site) was resolving and VACCINATION SITE ERYTHEMA (Pink at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Paraesthesia
Clinical narrative: Tongue and face tingling; Numb tongue and face; Mild allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tongue and face tingling), HYPOAESTHESIA (Numb tongue and face) and HYPERSENSITIVITY (Mild allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PARAESTHESIA (Tongue and face tingling), HYPOAESTHESIA (Numb tongue and face) and HYPERSENSITIVITY (Mild allergic reaction). At the time of the report, PARAESTHESIA (Tongue and face tingling), HYPOAESTHESIA (Numb tongue and face) and HYPERSENSITIVITY (Mild allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Trigger finger
Clinical narrative: very sore from naval to chin; trigger finger; hands painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hands painful), TRIGGER FINGER (trigger finger) and MYALGIA (very sore from naval to chin) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (hands painful). On 25-Feb-2021, the patient experienced TRIGGER FINGER (trigger finger). On 20-Mar-2021, the patient experienced MYALGIA (very sore from naval to chin). At the time of the report, PAIN IN EXTREMITY (hands painful), TRIGGER FINGER (trigger finger) and MYALGIA (very sore from naval to chin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include steroid and ketorolac injection.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE PAIN (Soreness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.