chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: fever; extreme fatigue; loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (extreme fatigue) and AGEUSIA (loss of taste) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020. Concomitant products included NIACIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZINC, BOSWELLIA SERRATA, COLLAGEN, CURCUMA LONGA, HYALURONIC ACID, PIPER NIGRUM, RESVERATROL (INSTAFLEX ADVANCED) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 10-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 PYREXIA (fever), FATIGUE (extreme fatigue) and AGEUSIA (loss of taste). At the time of the report, PYREXIA (fever), FATIGUE (extreme fatigue) and AGEUSIA (loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Positive) Has antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included Multiplex Omega Vitamin  No treatment information was provded   This case was linked to MOD-2021-087491 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Received Additional Information document  on 22-APR-2021. Added new events
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Rash, Vaccination site swelling
Clinical narrative: Very tired; Swelling at the injection area; Rash from the elbow to the shoulder; Lot of pain in the knees; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired), ARTHRALGIA (Lot of pain in the knees), RASH (Rash from the elbow to the shoulder) and VACCINATION SITE SWELLING (Swelling at the injection area) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for an unknown indication.     No medical history was provided by the reporter. .  Concomitant products included CALCIUM, LEVOTHYROXINE, OMEPRAZOLE (PROMEPRAZOLE) and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (Lot of pain in the knees). On 05-Feb-2021, the patient experienced RASH (Rash from the elbow to the shoulder). On an unknown date, the patient experienced FATIGUE (Very tired) and VACCINATION SITE SWELLING (Swelling at the injection area). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, FATIGUE (Very tired) and VACCINATION SITE SWELLING (Swelling at the injection area) outcome was unknown and ARTHRALGIA (Lot of pain in the knees) and RASH (Rash from the elbow to the shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pruritus
Clinical narrative: itching all over her body; swelling, redness, and hives about two inches around the injection site; swelling, redness, and hives about two inches around the injection site.; swelling, redness, and hives about two inches around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over her body), INJECTION SITE SWELLING (swelling, redness, and hives about two inches around the injection site), INJECTION SITE ERYTHEMA (swelling, redness, and hives about two inches around the injection site.) and INJECTION SITE URTICARIA (swelling, redness, and hives about two inches around the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (itching all over her body), INJECTION SITE SWELLING (swelling, redness, and hives about two inches around the injection site), INJECTION SITE ERYTHEMA (swelling, redness, and hives about two inches around the injection site.) and INJECTION SITE URTICARIA (swelling, redness, and hives about two inches around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching all over her body), INJECTION SITE SWELLING (swelling, redness, and hives about two inches around the injection site), INJECTION SITE ERYTHEMA (swelling, redness, and hives about two inches around the injection site.) and INJECTION SITE URTICARIA (swelling, redness, and hives about two inches around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     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 11-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain Injection Site). On 13-Feb-2021, INJECTION SITE PAIN (Pain Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: A swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (A swollen arm) 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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (A swollen arm). At the time of the report, PERIPHERAL SWELLING (A swollen arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go) in an 80-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.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH PRURITIC (red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st dose of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st dose of the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Vaccination site discolouration
Clinical narrative: it got darker; it was a hard red mark; severe itching; could feel the shot; it hurt; 2 by 2 oval like rash on their shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (it was a hard red mark), PRURITUS (severe itching), VACCINATION SITE DISCOLOURATION (it got darker), VACCINATION SITE DISCOMFORT (could feel the shot) and PAIN (it hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eyes (Patient is currently taking medicine for dry eyes). Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], CALCIUM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (could feel the shot), PAIN (it hurt) and RASH (2 by 2 oval like rash on their shoulder). On 04-Feb-2021, the patient experienced PRURITUS (severe itching). On an unknown date, the patient experienced ERYTHEMA (it was a hard red mark) and VACCINATION SITE DISCOLOURATION (it got darker). On 28-Jan-2021, VACCINATION SITE DISCOMFORT (could feel the shot) had resolved. On 05-Feb-2021, PRURITUS (severe itching) had resolved. At the time of the report, ERYTHEMA (it was a hard red mark), VACCINATION SITE DISCOLOURATION (it got darker), PAIN (it hurt) and RASH (2 by 2 oval like rash on their shoulder) 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.   The patient reported that the 2 by 2 oval like rash was very faint pink for the first few days, however it got darker and more red. On the morning of 04-Feb-2021, the patient experienced severe itching and applied unspecified antihistamine cream on it (details not provided) following which, severe itching resolved, however the red mark still persisted (faint pink in color). Patient also reported that hardness went away after the first week or so.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: it got darker; it was a hard red mark; severe itching; could feel the shot; it hurt; 2 by 2 oval like rash on their shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (it was a hard red mark), PRURITUS (severe itching), VACCINATION SITE DISCOLOURATION (it got darker), VACCINATION SITE DISCOMFORT (could feel the shot) and PAIN (it hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eyes (Patient is currently taking medicine for dry eyes). Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], CALCIUM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (could feel the shot), PAIN (it hurt) and RASH (2 by 2 oval like rash on their shoulder). On 04-Feb-2021, the patient experienced PRURITUS (severe itching). On an unknown date, the patient experienced ERYTHEMA (it was a hard red mark) and VACCINATION SITE DISCOLOURATION (it got darker). On 28-Jan-2021, VACCINATION SITE DISCOMFORT (could feel the shot) had resolved. On 05-Feb-2021, PRURITUS (severe itching) had resolved. At the time of the report, ERYTHEMA (it was a hard red mark), VACCINATION SITE DISCOLOURATION (it got darker), PAIN (it hurt) and RASH (2 by 2 oval like rash on their shoulder) 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.   The patient reported that the 2 by 2 oval like rash was very faint pink for the first few days, however it got darker and more red. On the morning of 04-Feb-2021, the patient experienced severe itching and applied unspecified antihistamine cream on it (details not provided) following which, severe itching resolved, however the red mark still persisted (faint pink in color). Patient also reported that hardness went away after the first week or so.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache
Clinical narrative: bones hurt; headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt) and HEADACHE (headache) in an 82-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bones hurt) and HEADACHE (headache). At the time of the report, BONE PAIN (bones hurt) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain
Clinical narrative: Back hurts; Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back hurts), PAIN (Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back hurts), PAIN (Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain) and HEADACHE (Headache). At the time of the report, BACK PAIN (Back hurts), PAIN (Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR document was attached. Patient name was corrected. Email was updated. No other information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back hurts), PAIN (Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back hurts), PAIN (Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain) and HEADACHE (Headache). At the time of the report, BACK PAIN (Back hurts), PAIN (Severe body aches, Pain all over body - shoulder, feet , arms, Right shoulder is in pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR document was attached. Patient name was corrected. Email was updated. No other information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Pain, Vomiting
Clinical narrative: Temperature; Chills; Headache; Body aches; Vomiting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), CHILLS (Chills), HEADACHE (Headache), PAIN (Body aches) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature), CHILLS (Chills), HEADACHE (Headache), PAIN (Body aches) and VOMITING (Vomiting). At the time of the report, BODY TEMPERATURE INCREASED (Temperature), CHILLS (Chills), HEADACHE (Headache), PAIN (Body aches) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Slightly nauseous; Extreme dizziness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness) and NAUSEA (Slightly nauseous) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, VERAPAMIL, POTASSIUM CHLORIDE (KLOR CON), LEVOTHYROXINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ROSUVASTATIN, ZINC, VITAMIN D NOS, GABAPENTIN and HCTZ for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness). On an unknown date, the patient experienced NAUSEA (Slightly nauseous). At the time of the report, DIZZINESS (Extreme dizziness) and NAUSEA (Slightly nauseous) had resolved. 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.   Reportedly, the patient was taking unspecified allergy pills as concomitant medication. She reported that after half an hour of the vaccine injection, she had 3 hours of extreme dizziness, to the point that she could not walk out of her car. Her oxygen stats were fine, she just drank water following which, her symptoms subsided (details not provided). The patient wanted to confirm if she required a medical emergency, or her reaction was a common side effect?   This case was linked to US-MODERNATX, INC.-MOD-2021-085925 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085925:Cross linked to Dose1
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Details regarding concomitant and treatment medications were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling hot
Clinical narrative: tested positive for covid-19; very hot; very tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for covid-19), FEELING HOT (very hot) and FATIGUE (very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid-19), FEELING HOT (very hot) and FATIGUE (very tired). At the time of the report, COVID-19 (tested positive for covid-19), FEELING HOT (very hot) and FATIGUE (very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's friend reported that the patient was  tested positive for covid-19, 7 to 10 days after the injection following an X-ray of lung and a Covid-19 test. Treatment details were not reported. Reportedly, the patient had fully recovered. Concomitant medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Headache
Clinical narrative: Temperature; No appetite; Weakness; Chills; Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), DECREASED APPETITE (No appetite), ASTHENIA (Weakness), CHILLS (Chills) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 20-Jan-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) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature), DECREASED APPETITE (No appetite), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, BODY TEMPERATURE INCREASED (Temperature), DECREASED APPETITE (No appetite), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Temperature; No appetite; Weakness; Chills; Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), DECREASED APPETITE (No appetite), ASTHENIA (Weakness), CHILLS (Chills) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 20-Jan-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) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature), DECREASED APPETITE (No appetite), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, BODY TEMPERATURE INCREASED (Temperature), DECREASED APPETITE (No appetite), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Aura
Clinical narrative: aura (like having a seizure) on the left arm and left leg; This spontaneous case was reported by a consumer and describes the occurrence of AURA (aura (like having a seizure) on the left arm and left leg) in a 58-year-old male patient 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) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced AURA (aura (like having a seizure) on the left arm and left leg). At the time of the report, AURA (aura (like having a seizure) on the left arm and left leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after 1st Dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID-19 after 1st Dose) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19 after 1st Dose). At the time of the report, COVID-19 (tested positive for COVID-19 after 1st Dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     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 information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Large, red circle around injection site; Arm felt tender; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm felt tender) and VACCINATION SITE ERYTHEMA (Large, red circle around injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm felt tender). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large, red circle around injection site). At the time of the report, VACCINATION SITE PAIN (Arm felt tender) and VACCINATION SITE ERYTHEMA (Large, red circle around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My right arm was very sore for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My right arm was very sore for 2-3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.  No Medical History information was reported.  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (My right arm was very sore for 2-3 days). At the time of the report, PAIN IN EXTREMITY (My right arm was very sore for 2-3 days) 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.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received on 06-Jul-2021 contains non significant information of contact details added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: really severe headache; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a really severe headache (headache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, approximately 1 day prior to the onset of the event the patient received their second of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced a really severe headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, really severe headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of headache, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: facial rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (facial rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (facial rash). At the time of the report, RASH (facial rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-018362, MOD-2021-019193, MOD-2021-020875, MOD-2021-021039, MOD-2021-023812, MOD-2021-023822, MOD-2021-023827, MOD-2021-023846, MOD-2021-023852, MOD-2021-023858, MOD-2021-023865, MOD-2021-031172, MOD-2021-031182, MOD-2021-031228, MOD-2021-031235, MOD-2021-031238, MOD-2021-031247, MOD-2021-036084 (E2B Linked Report). This case was linked to MOD21-13071 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. MOD-2021-018362:Same reporter MOD-2021-019193:Same reporter MOD-2021-020875:Same reporter MOD-2021-021039:Same reporter MOD-2021-023812:Same reporter MOD-2021-023822:Same reporter MOD-2021-023827:Same reporter MOD-2021-023846:Same reporter MOD-2021-023852:Same reporter MOD-2021-023858:Same reporter MOD-2021-023865:Same reporter MOD-2021-031172:Same reporter MOD-2021-031182:Same reporter MOD-2021-031228:Same reporter MOD-2021-031235:Same reporter MOD-2021-031238:Same reporter MOD-2021-031247:Same reporter MOD-2021-036084:Same reporter
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headaches; Pain in the whole body; fatigue; Muscle pain; Joint pain; pain in the arm of the injection; redness at the injection site; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old male 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 history reported.).   On 04-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (pain in the arm of the injection), VACCINATION SITE ERYTHEMA (redness at the injection site) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (pain in the arm of the injection), VACCINATION SITE ERYTHEMA (redness at the injection site) and CHILLS (chills) outcome was unknown.            Concomitant products were not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Headaches; Pain in the whole body; fatigue; Muscle pain; Joint pain; pain in the arm of the injection; redness at the injection site; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old male 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 history reported.).   On 04-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (pain in the arm of the injection), VACCINATION SITE ERYTHEMA (redness at the injection site) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (pain in the arm of the injection), VACCINATION SITE ERYTHEMA (redness at the injection site) and CHILLS (chills) outcome was unknown.            Concomitant products were not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Mild fever with both doses; Mild flu like symptoms with both doses; Arm hurt a little with both doses; Extreme itching // 2nd dose; Extreme itching // 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extreme itching // 1st dose), PRURITUS (Extreme itching // 2nd dose), PYREXIA (Mild fever with both doses), INFLUENZA LIKE ILLNESS (Mild flu like symptoms with both doses) and PAIN IN EXTREMITY (Arm hurt a little with both doses) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PRURITUS (Extreme itching // 1st dose). On 09-Feb-2021, the patient experienced PRURITUS (Extreme itching // 2nd dose). On an unknown date, the patient experienced PYREXIA (Mild fever with both doses), INFLUENZA LIKE ILLNESS (Mild flu like symptoms with both doses) and PAIN IN EXTREMITY (Arm hurt a little with both doses). On 26-Jan-2021, PRURITUS (Extreme itching // 1st dose) had resolved. At the time of the report, PRURITUS (Extreme itching // 2nd dose), PYREXIA (Mild fever with both doses), INFLUENZA LIKE ILLNESS (Mild flu like symptoms with both doses) and PAIN IN EXTREMITY (Arm hurt a little with both doses) outcome was unknown.            Concomitant medications used by the patient are birth control pills. Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Movement disorder, Pruritus
Clinical narrative: Itching all day; Arm is red; her arm is off and on; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (her arm is off and on), PRURITUS (Itching all day) and ERYTHEMA (Arm is red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Joint pain.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MOVEMENT DISORDER (her arm is off and on). On 04-Feb-2021, the patient experienced PRURITUS (Itching all day) and ERYTHEMA (Arm is red). At the time of the report, MOVEMENT DISORDER (her arm is off and on) and ERYTHEMA (Arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at the injection site; "Need to itch hard"; Swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PRURITUS ("Need to itch hard") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site) and PRURITUS ("Need to itch hard"). On 01-Feb-2021, VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and PRURITUS ("Need to itch hard") 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.   Patient consumes other medication: for diabetes, blood pressure and cholesterol. Patient put ice on vaccination site. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: arm was also red; my arm is red again where I received the shot; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm was also red) and INJECTION SITE ERYTHEMA (my arm is red again where I received the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (my arm is red again where I received the shot). On an unknown date, the patient experienced ERYTHEMA (arm was also red). On 29-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ERYTHEMA (arm was also red) had resolved and INJECTION SITE ERYTHEMA (my arm is red again where I received the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided. Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Side effects; sore arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Side effects) and PAIN IN EXTREMITY (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine) and Drug allergy (fentanyl).    On 28-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021 at 3:30 PM, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). On 02-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (sore arm) to be related. No further causality assessment was provided for VACCINATION COMPLICATION (Side effects).    Concomitant product use was not provided by the reporter.  Treatment for the event included unspecified different types of medications.  Patient reported he had some questions about side effects and about taking different types of medications to deal with the side effects.   This case was linked to MOD-2021-219446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow-up. Primary contact information updated. On 30-Jul-2021: Follow-up received on 30-Jul-2021, contains updated medical history, updated suspect details and updated event.