chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Confusional state
Clinical narrative: motor; loss of taste; smell loss; shake of arms and legs; mind blur/draws a blank at times/confusion; head foggy/brain fog; disorientation; chills; joint soreness; fatigue; extremely sore arm; headache; nausea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog) and ANOSMIA (smell loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). On 04-Feb-2021, the patient experienced FATIGUE (fatigue). On 05-Feb-2021, the patient experienced DISORIENTATION (disorientation), FEELING ABNORMAL (head foggy/brain fog), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), CHILLS (chills) and ARTHRALGIA (joint soreness). On 15-Feb-2021, the patient experienced AGEUSIA (loss of taste) and ANOSMIA (smell loss). On 05-Apr-2021, the patient experienced MOTOR DYSFUNCTION (motor). At the time of the report, DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog), ANOSMIA (smell loss), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (dizziness), FATIGUE (fatigue), CHILLS (chills) and ARTHRALGIA (joint soreness) had not resolved.      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 had COVID-19 test which showed negative results. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: motor; loss of taste; smell loss; shake of arms and legs; mind blur/draws a blank at times/confusion; head foggy/brain fog; disorientation; chills; joint soreness; fatigue; extremely sore arm; headache; nausea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog) and ANOSMIA (smell loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). On 04-Feb-2021, the patient experienced FATIGUE (fatigue). On 05-Feb-2021, the patient experienced DISORIENTATION (disorientation), FEELING ABNORMAL (head foggy/brain fog), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), CHILLS (chills) and ARTHRALGIA (joint soreness). On 15-Feb-2021, the patient experienced AGEUSIA (loss of taste) and ANOSMIA (smell loss). On 05-Apr-2021, the patient experienced MOTOR DYSFUNCTION (motor). At the time of the report, DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog), ANOSMIA (smell loss), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (dizziness), FATIGUE (fatigue), CHILLS (chills) and ARTHRALGIA (joint soreness) had not resolved.      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 had COVID-19 test which showed negative results. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Muscular weakness, Nausea, Vaccination site pain
Clinical narrative: motor; loss of taste; smell loss; shake of arms and legs; mind blur/draws a blank at times/confusion; head foggy/brain fog; disorientation; chills; joint soreness; fatigue; extremely sore arm; headache; nausea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog) and ANOSMIA (smell loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). On 04-Feb-2021, the patient experienced FATIGUE (fatigue). On 05-Feb-2021, the patient experienced DISORIENTATION (disorientation), FEELING ABNORMAL (head foggy/brain fog), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), CHILLS (chills) and ARTHRALGIA (joint soreness). On 15-Feb-2021, the patient experienced AGEUSIA (loss of taste) and ANOSMIA (smell loss). On 05-Apr-2021, the patient experienced MOTOR DYSFUNCTION (motor). At the time of the report, DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog), ANOSMIA (smell loss), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (dizziness), FATIGUE (fatigue), CHILLS (chills) and ARTHRALGIA (joint soreness) had not resolved.      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 had COVID-19 test which showed negative results. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Tachycardia
Clinical narrative: Rapid heartbeat; Fell really hot; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heartbeat) and FEELING HOT (Fell really hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Rapid heartbeat) and FEELING HOT (Fell really hot). At the time of the report, TACHYCARDIA (Rapid heartbeat) and FEELING HOT (Fell really hot) 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness like four times a day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness like four times a day) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included PROPOFOL for an unknown indication.    On 12-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 DIZZINESS (Dizziness like four times a day). On 16-Feb-2021, DIZZINESS (Dizziness like four times a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sores; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores.    On 26-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 ORAL HERPES (cold sores). At the time of the report, ORAL HERPES (cold sores) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Headache; Fever of 100.4 degree F; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 100.4 degree F) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL and CLOPIDOGREL for an unknown indication.    On 17-Feb-1971, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 100.4 degree F). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 100.4 degree F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100.4 degrees f abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by the patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Hypertension, Tremor, Vaccination site pain
Clinical narrative: high blood pressure; Anxiousness; shaking; chills; Sore arm; A spontaneous report was received from a consumer concerning a 49-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, chills, shaking, anxiousness and high blood pressure (175/115).  No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (027L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced a sore arm, chills, shaking, anxiousness and high blood pressure (175/115).  Treatment for the events included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events sore arm, chills, shaking, anxiousness and high blood pressure (175/115) was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under her right breast; A spontaneous report was received from a consumer concerning her mother, a 94-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  rash under her right breast/rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their dose of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash under her right breast which was about 4 by 21/2 inches in diameter. The rash was not itchy nor hurting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event rash under her right breast was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: delayed injection site fever; arm sore; delayed injection site bad itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (delayed injection site fever), VACCINATION SITE PRURITUS (delayed injection site bad itching) and VACCINATION SITE PAIN (arm sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (delayed injection site bad itching). On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (delayed injection site fever) and VACCINATION SITE PAIN (arm sore). At the time of the report, VACCINATION SITE WARMTH (delayed injection site fever), VACCINATION SITE PRURITUS (delayed injection site bad itching) and VACCINATION SITE PAIN (arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  Treatment for the events included ice and hydrocortisone cream.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscular pain in back and in back of thighs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscular pain in back and in back of thighs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     No medical History was provided by reporter.     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 MYALGIA (Muscular pain in back and in back of thighs). At the time of the report, MYALGIA (Muscular pain in back and in back of thighs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash; Red itchy rash; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced red itchy rash/ rash pruritic and rash erythematous.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced red itchy rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event red itchy rash was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Headaches in the middle of the night; Muscle aches; Slight fever; Injections site sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches in the middle of the night), MYALGIA (Muscle aches), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injections site sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Muscle aches), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injections site sore). On 13-Feb-2021, the patient experienced HEADACHE (Headaches in the middle of the night). At the time of the report, HEADACHE (Headaches in the middle of the night), MYALGIA (Muscle aches), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injections site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included acetaminophen 250mg/ aspirin 250mg/ caffeine 65mg
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (couldn't sleep or get comfortable), MYALGIA (body ache) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Jan-2021 at 6:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 02-Feb-2021, the patient experienced INSOMNIA (couldn't sleep or get comfortable), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, INSOMNIA (couldn't sleep or get comfortable), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown. This case was linked to MOD-2021-103049 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI-Follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Papule, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness is getting bigger; Warm to the touch Injection Site; White spot near injection site; Swollen Injection Site; Red Injection Site (Around the Arm up to near elbow); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), PAPULE (White spot near injection site), CONDITION AGGRAVATED (Redness is getting bigger), VACCINATION SITE ERYTHEMA (Red Injection Site (Around the Arm up to near elbow)) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 032H20A) for COVID-19 vaccination.     No Medical history was provided by reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Injection Site (Around the Arm up to near elbow)). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), PAPULE (White spot near injection site) and VACCINATION SITE SWELLING (Swollen Injection Site). On 20-Feb-2021, the patient experienced CONDITION AGGRAVATED (Redness is getting bigger). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), PAPULE (White spot near injection site), CONDITION AGGRAVATED (Redness is getting bigger), VACCINATION SITE ERYTHEMA (Red Injection Site (Around the Arm up to near elbow)) and VACCINATION SITE SWELLING (Swollen Injection Site) had not resolved.            No relevant concomitant medications were reported  Treatment details included cetirizine, antibiotics (has not taken yet), and ice pack.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Groin pain, Joint swelling, Pain in extremity
Clinical narrative: Back of knee swollen; Hard to stand; Pain in groin; Pain in legs; Achiness in arm; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Pain in groin), PAIN IN EXTREMITY (Pain in legs), PAIN IN EXTREMITY (Achiness in arm), JOINT SWELLING (Back of knee swollen) and DYSSTASIA (Hard to stand) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced GROIN PAIN (Pain in groin), PAIN IN EXTREMITY (Pain in legs) and PAIN IN EXTREMITY (Achiness in arm). On 26-Jan-2021, the patient experienced JOINT SWELLING (Back of knee swollen) and DYSSTASIA (Hard to stand). On 03-Feb-2021, GROIN PAIN (Pain in groin), PAIN IN EXTREMITY (Pain in legs), PAIN IN EXTREMITY (Achiness in arm), JOINT SWELLING (Back of knee swollen) and DYSSTASIA (Hard to stand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Arm had swelling/Arm still touchy/Swollen arm; Spent all day in bed; Couldn't move; Painful/ Tender; Hardness at injection site; Chills; Body ache; Headache; Fever; Very tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender) and VACCINATION SITE INDURATION (Hardness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender), VACCINATION SITE INDURATION (Hardness at injection site) and FATIGUE (Very tired and fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 11-Feb-2021, CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 15-Feb-2021, PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. At the time of the report, BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move) and PAIN (Painful/ Tender) outcome was unknown and FATIGUE (Very tired and fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.2 (High) Fever (100.2).         This case was linked to MOD-2021-250759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26 Apr 2021 and patient's e-mail address updated. On 09-Jul-2021: Follow up received on 09 Jul 2021 included updates in the reported events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Arm had swelling/Arm still touchy/Swollen arm; Spent all day in bed; Couldn't move; Painful/ Tender; Hardness at injection site; Chills; Body ache; Headache; Fever; Very tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender) and VACCINATION SITE INDURATION (Hardness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender), VACCINATION SITE INDURATION (Hardness at injection site) and FATIGUE (Very tired and fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 11-Feb-2021, CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 15-Feb-2021, PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. At the time of the report, BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move) and PAIN (Painful/ Tender) outcome was unknown and FATIGUE (Very tired and fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.2 (High) Fever (100.2).         This case was linked to MOD-2021-250759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26 Apr 2021 and patient's e-mail address updated. On 09-Jul-2021: Follow up received on 09 Jul 2021 included updates in the reported events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Arm had swelling/Arm still touchy/Swollen arm; Spent all day in bed; Couldn't move; Painful/ Tender; Hardness at injection site; Chills; Body ache; Headache; Fever; Very tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender) and VACCINATION SITE INDURATION (Hardness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm), BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move), PAIN (Painful/ Tender), VACCINATION SITE INDURATION (Hardness at injection site) and FATIGUE (Very tired and fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 11-Feb-2021, CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 15-Feb-2021, PERIPHERAL SWELLING (Arm had swelling/Arm still touchy/Swollen arm) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. At the time of the report, BEDRIDDEN (Spent all day in bed), HYPOKINESIA (Couldn't move) and PAIN (Painful/ Tender) outcome was unknown and FATIGUE (Very tired and fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.2 (High) Fever (100.2).         This case was linked to MOD-2021-250759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26 Apr 2021 and patient's e-mail address updated. On 09-Jul-2021: Follow up received on 09 Jul 2021 included updates in the reported events.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Joint swelling
Clinical narrative: Swelling in back of knee; its hard to stand; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in back of knee) and DYSSTASIA (its hard to stand) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced JOINT SWELLING (Swelling in back of knee) and DYSSTASIA (its hard to stand). At the time of the report, JOINT SWELLING (Swelling in back of knee) and DYSSTASIA (its hard to stand) had not resolved.     Patient reported non-drug treatment for symptoms included Heat and TENS unit. Concomitant product use was not provided by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vision blurred
Clinical narrative: little bit of a blurry eye; blurry eye which got worse; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (little bit of a blurry eye) and CONDITION AGGRAVATED (blurry eye which got worse) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VISION BLURRED (little bit of a blurry eye) and CONDITION AGGRAVATED (blurry eye which got worse). At the time of the report, VISION BLURRED (little bit of a blurry eye) and CONDITION AGGRAVATED (blurry eye which got worse) was resolving.      Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; A spontaneous report was received from a healthcare professional concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) covid arm and want to know if there were any report of this during the clinical trial and if the patient can continue to take the 2nd dose of the vaccine.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event covid arm was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; Swelling; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included cortisone
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: terrible pain on her left back (shoulder blade) extending to the armpit and front of the shoulder; tender/very sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender/very sore injection site) and ARTHRALGIA (terrible pain on her left back (shoulder blade) extending to the armpit and front of the shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (tender/very sore injection site). On 16-Feb-2021, the patient experienced ARTHRALGIA (terrible pain on her left back (shoulder blade) extending to the armpit and front of the shoulder). At the time of the report, VACCINATION SITE PAIN (tender/very sore injection site) and ARTHRALGIA (terrible pain on her left back (shoulder blade) extending to the armpit and front of the shoulder) was resolving.        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.   No concomitant medication were provided by reporter  patient took  two doses of Ibuprofen for Treatment.     Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Fatigue; Chills; Joint pain/ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain/ankle pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 28-Jan-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain/ankle pain). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain/ankle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information included updated Email .
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site pruritus, Pyrexia, Rash, Rash pruritic
Clinical narrative: rash on the bottom of her feet and legs that were itchy; right arm red; right arm hot; right arm itchy; rash on right arm; fever of 101.5; high blood pressure 105; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.5), HYPERTENSION (high blood pressure 105), RASH PRURITIC (rash on the bottom of her feet and legs that were itchy), VACCINATION SITE ERYTHEMA (right arm red) and VACCINATION SITE WARMTH (right arm hot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (fever of 101.5) and HYPERTENSION (high blood pressure 105). On 17-Feb-2021, the patient experienced RASH PRURITIC (rash on the bottom of her feet and legs that were itchy), VACCINATION SITE ERYTHEMA (right arm red), VACCINATION SITE WARMTH (right arm hot), INJECTION SITE PRURITUS (right arm itchy) and RASH (rash on right arm). On 17-Feb-2021, PYREXIA (fever of 101.5) and HYPERTENSION (high blood pressure 105) had resolved. On 18-Feb-2021, RASH PRURITIC (rash on the bottom of her feet and legs that were itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (right arm red), VACCINATION SITE WARMTH (right arm hot), INJECTION SITE PRURITUS (right arm itchy) and RASH (rash on right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included Hydrocortisone Cream.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: rash on the bottom of her feet and legs that were itchy; right arm red; right arm hot; right arm itchy; rash on right arm; fever of 101.5; high blood pressure 105; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.5), HYPERTENSION (high blood pressure 105), RASH PRURITIC (rash on the bottom of her feet and legs that were itchy), VACCINATION SITE ERYTHEMA (right arm red) and VACCINATION SITE WARMTH (right arm hot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (fever of 101.5) and HYPERTENSION (high blood pressure 105). On 17-Feb-2021, the patient experienced RASH PRURITIC (rash on the bottom of her feet and legs that were itchy), VACCINATION SITE ERYTHEMA (right arm red), VACCINATION SITE WARMTH (right arm hot), INJECTION SITE PRURITUS (right arm itchy) and RASH (rash on right arm). On 17-Feb-2021, PYREXIA (fever of 101.5) and HYPERTENSION (high blood pressure 105) had resolved. On 18-Feb-2021, RASH PRURITIC (rash on the bottom of her feet and legs that were itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (right arm red), VACCINATION SITE WARMTH (right arm hot), INJECTION SITE PRURITUS (right arm itchy) and RASH (rash on right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included Hydrocortisone Cream.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site rash
Clinical narrative: red splotch on vaccine arm; also noticed splotches on her head and face; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red splotch on vaccine arm) and RASH MACULAR (also noticed splotches on her head and face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOPROLOL, AMLODIPINE and CHLORTHALIDONE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE RASH (red splotch on vaccine arm) and RASH MACULAR (also noticed splotches on her head and face). At the time of the report, VACCINATION SITE RASH (red splotch on vaccine arm) and RASH MACULAR (also noticed splotches on her head and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment details were provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever(101.6); Fatigue; Headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever(101.6)), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever(101.6)), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches). At the time of the report, PYREXIA (fever(101.6)), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Head discomfort, Headache
Clinical narrative: Cough; Chest congestion; Heavy head; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), CHEST DISCOMFORT (Chest congestion), HEAD DISCOMFORT (Heavy head), FATIGUE (Tiredness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced COUGH (Cough), CHEST DISCOMFORT (Chest congestion), HEAD DISCOMFORT (Heavy head), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, COUGH (Cough), CHEST DISCOMFORT (Chest congestion), HEAD DISCOMFORT (Heavy head), FATIGUE (Tiredness) 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 was provided.    Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vasculitis
Clinical narrative: With vasculitis; Extremely painful; Leg was completely red; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (With vasculitis), PAIN IN EXTREMITY (Extremely painful) and ERYTHEMA (Leg was completely red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis, Open heart surgery and Blood transfusion (3 blood transfusion in the past). Previously administered products included for an unreported indication: PREDNISONE (For vasculitis (allergy caused by Forteo injection).) in 2001. Concurrent medical conditions included Cryoglobulinemia (She had a mix essential type 2 cryoglobulinemia. She has been in remission for some time.) and Drug allergy (She took Forteo injection for osteoporosis 10 years ago and had a reaction.At that time, she had her waist down covered with vasculitis, and they gave her prednisone to treat.) in 2001.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VASCULITIS (With vasculitis), PAIN IN EXTREMITY (Extremely painful) and ERYTHEMA (Leg was completely red). At the time of the report, VASCULITIS (With vasculitis), PAIN IN EXTREMITY (Extremely painful) and ERYTHEMA (Leg was completely red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included 1 dose of 20mg prednisone on 18 Feb 2021.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: hot arm; itchy arm; 30 weeks pregnant; tender arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.   This case was linked to MOD-2021-018462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Internal review on 20JUL2021 resulted in updates to pregnancy details.