chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash erythematous
Clinical narrative: a blotchy red little rash; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a blotchy red little rash) and HEADACHE (slight headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced RASH ERYTHEMATOUS (a blotchy red little rash) and HEADACHE (slight headache). At the time of the report, RASH ERYTHEMATOUS (a blotchy red little rash) and HEADACHE (slight headache) outcome was unknown. Not provided. No concomitant medications were provided. Treatment information was not provided by reporter. This case was linked to MOD21-078429, MOD21-078495, MOD21-078496 (E2B Linked Report). This case was linked to MOD-2021-080606 (Patient Link); Sender's Comments: MOD21-078429: MOD21-078495: MOD21-078496:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included DILTIAZEM and RIOCIGUAT for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 milligram once a day. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Real Sick; Sore arm; Felt like flu; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Real Sick), PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Felt like flu) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain in arm, Heaviness in arm, Sleeplessness and Flu.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Real Sick), PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Felt like flu). At the time of the report, MALAISE (Real Sick), PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Felt like flu) outcome was unknown.            This case was linked to MOD-2021-015804 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up received does not contain any significant information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Overdose, SARS-CoV-2 test
Clinical narrative: Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage; headache/pounding headaches; This spontaneous case was reported by a patient and describes the occurrence of OVERDOSE (Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage) and HEADACHE (headache/pounding headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Mar-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced OVERDOSE (Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage) and HEADACHE (headache/pounding headaches). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at a dose of 200 milligram. At the time of the report, OVERDOSE (Second dose repeated in the opposite arm as she got empty dose/if she gave you a double dosage) outcome was unknown and HEADACHE (headache/pounding headaches) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.         Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Patient demographics, dose details, vaccination facility details added. Event updated. On 19-Jul-2021: Follow up document  received on 19-JUL-2021 .Updated the event( Headache) is still ongoing.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; High Fever; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) since 1997. Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Bad headache). On 16-Feb-2021, CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Bad headache) had resolved.            Treatment information included acetaminophen twice on February 15th and the symptoms went away February 16.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   This case was linked to MOD-2021-018199 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient did not receive the full second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient did not receive the full second 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 19-Apr-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 19-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient did not receive the full second dose). On 19-Apr-2021, ACCIDENTAL UNDERDOSE (patient did not receive the full second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse reported that an unknown amount of the vaccine went down the patient's arm and was concerned that the patient did not receive the full second dose  Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rash on neck, chest and abdomen; Hypersensitivity; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on neck, chest and abdomen) and HYPERSENSITIVITY (Hypersensitivity) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No relevant medical history was provided.     On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced RASH (Rash on neck, chest and abdomen) and HYPERSENSITIVITY (Hypersensitivity). At the time of the report, RASH (Rash on neck, chest and abdomen) and HYPERSENSITIVITY (Hypersensitivity) 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 considered HYPERSENSITIVITY (Hypersensitivity) to be related. No further causality assessment was provided for RASH (Rash on neck, chest and abdomen).    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added Vaccine hypersensitivity/anaphalyxis form
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Skin burning sensation, Skin reaction
Clinical narrative: Warm to the Touch Injection Site Left Arm; Skin Reaction (Nothing visible) on Stomach and Legs; Burning Sensation on Stomach and Legs; COVID Arm (Left Arm); fatigue; Aching body; Flu Like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms), SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs), SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs), PAIN (Aching body) and VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms), PAIN (Aching body) and FATIGUE (fatigue). On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm (Left Arm)). On 29-Mar-2021, the patient experienced SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs) and SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm). On 26-Mar-2021, INFLUENZA LIKE ILLNESS (Flu Like symptoms), PAIN (Aching body) and FATIGUE (fatigue) had resolved. On 03-Apr-2021, VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm) and VACCINATION SITE REACTION (COVID Arm (Left Arm)) had resolved. At the time of the report, SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs) and SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: Warm to the Touch Injection Site Left Arm; Skin Reaction (Nothing visible) on Stomach and Legs; Burning Sensation on Stomach and Legs; COVID Arm (Left Arm); fatigue; Aching body; Flu Like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms), SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs), SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs), PAIN (Aching body) and VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms), PAIN (Aching body) and FATIGUE (fatigue). On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm (Left Arm)). On 29-Mar-2021, the patient experienced SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs) and SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm). On 26-Mar-2021, INFLUENZA LIKE ILLNESS (Flu Like symptoms), PAIN (Aching body) and FATIGUE (fatigue) had resolved. On 03-Apr-2021, VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm) and VACCINATION SITE REACTION (COVID Arm (Left Arm)) had resolved. At the time of the report, SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs) and SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Rash
Clinical narrative: full body rash; weight on his chest; trouble breathing unless still; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (weight on his chest), DYSPNOEA (trouble breathing unless still) and RASH (full body rash) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHEST DISCOMFORT (weight on his chest) and DYSPNOEA (trouble breathing unless still). On 12-Apr-2021, the patient experienced RASH (full body rash). On 03-Apr-2021, CHEST DISCOMFORT (weight on his chest) and DYSPNOEA (trouble breathing unless still) had resolved. At the time of the report, RASH (full body rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient did not receive any treatment for the event.   The had an injury at work and received a tetanus shot 2 days ago and wanted to know how long to wait for second dose of mRNA-1273 (Moderna COVID-19 Vaccine).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Headache, Hypersomnia, Incorrect route of product administration
Clinical narrative: Had headaches; Have dizziness; nauseous; Couldn't eat for a week; Slept all day; she did not feel like that the vaccine is not administered in her muscle but in skin; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had headaches), DIZZINESS (Have dizziness), NAUSEA (nauseous), FEEDING DISORDER (Couldn't eat for a week) and HYPERSOMNIA (Slept all day) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 UNK. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 20-Apr-2021, the patient experienced HEADACHE (Had headaches), DIZZINESS (Have dizziness), NAUSEA (nauseous), FEEDING DISORDER (Couldn't eat for a week), HYPERSOMNIA (Slept all day) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she did not feel like that the vaccine is not administered in her muscle but in skin). At the time of the report, HEADACHE (Had headaches), FEEDING DISORDER (Couldn't eat for a week), HYPERSOMNIA (Slept all day) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she did not feel like that the vaccine is not administered in her muscle but in skin) had resolved and DIZZINESS (Have dizziness) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. The patient used ginger and charcoal supplements as treatment medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-098286 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021. The patient updated that adverse events started on 20-APR-2021 i.e., headaches, dizziness, nausea, slept for all day, and couldn't eat for a week. The patient also believes the pharmacist did not use proper needle and vaccine did not get into the muscle.The patient updated that she used ginger and charcoal supplements to subside the possible adverseevents. The patient also stated that all of the possible adverse events subsided except nausea and dizziness.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098286: Child
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Had headaches; Have dizziness; nauseous; Couldn't eat for a week; Slept all day; she did not feel like that the vaccine is not administered in her muscle but in skin; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had headaches), DIZZINESS (Have dizziness), NAUSEA (nauseous), FEEDING DISORDER (Couldn't eat for a week) and HYPERSOMNIA (Slept all day) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 UNK. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 20-Apr-2021, the patient experienced HEADACHE (Had headaches), DIZZINESS (Have dizziness), NAUSEA (nauseous), FEEDING DISORDER (Couldn't eat for a week), HYPERSOMNIA (Slept all day) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she did not feel like that the vaccine is not administered in her muscle but in skin). At the time of the report, HEADACHE (Had headaches), FEEDING DISORDER (Couldn't eat for a week), HYPERSOMNIA (Slept all day) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she did not feel like that the vaccine is not administered in her muscle but in skin) had resolved and DIZZINESS (Have dizziness) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. The patient used ginger and charcoal supplements as treatment medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-098286 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021. The patient updated that adverse events started on 20-APR-2021 i.e., headaches, dizziness, nausea, slept for all day, and couldn't eat for a week. The patient also believes the pharmacist did not use proper needle and vaccine did not get into the muscle.The patient updated that she used ginger and charcoal supplements to subside the possible adverseevents. The patient also stated that all of the possible adverse events subsided except nausea and dizziness.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098286: Child
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Product storage error, Pyrexia
Clinical narrative: the Dose which was given to him was not stored at correct temperature; Soreness of the arm; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (the Dose which was given to him was not stored at correct temperature), PAIN IN EXTREMITY (Soreness of the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-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 PRODUCT STORAGE ERROR (the Dose which was given to him was not stored at correct temperature), PAIN IN EXTREMITY (Soreness of the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT STORAGE ERROR (the Dose which was given to him was not stored at correct temperature), PAIN IN EXTREMITY (Soreness of the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Malaise, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt as though I had COVID-19 again), BEDRIDDEN (didn't feel good for several days) and SOMNOLENCE (sleepy all day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 from 25-Dec-2020 to 06-Jan-2021. Concomitant products included MULTIVITAMIN FOR WOMEN, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE, METHYLSULFONYLMETHANE (GLUCOSAMINE & CHONDROITIN & MSM) and EMERGEN C for an unknown indication. On 28-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MALAISE (Felt as though I had COVID-19 again) and SOMNOLENCE (sleepy all day). 03-Mar-2021, the patient experienced BEDRIDDEN (didn't feel good for several days). On 07-Mar-2021, MALAISE (Felt as though I had COVID-19 again), BEDRIDDEN (didn't feel good for several days) and SOMNOLENCE (sleepy all day) had resolved. Treatment medication included Ibuprofen. This case was linked to MOD-2021-016297.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Insomnia after 2nd dose; Sore arm after 2nd dose; Headache after 2nd dose; Fatigue after 2nd dose; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), HEADACHE (Headache after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (Fever after 2nd dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included COLCHICINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), HEADACHE (Headache after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (Fever after 2nd dose). At the time of the report, INSOMNIA (Insomnia after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), HEADACHE (Headache after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (Fever after 2nd dose) outcome was unknown. Not Provided          The concomitant medication was provided as anti depressant.  The treatment information was not provided.  The action taken with mRNA 1273 with the events were considered as not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080625 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080625:1st dose vaccine
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Gait disturbance, Influenza like illness, Nausea
Clinical narrative: Restless sensation in his body; like having sunburns, face arm leg burning, he calls it paresthesia; Severe pain in the arm; Fatigued; Very tired; Intense nausea; Extremely dry mouth; Thirstiness; Couldn't sit still; Burning feeling skin; Felt like having the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like having the flu), RESTLESSNESS (Restless sensation in his body), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin) and SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included TESTOSTERONE (ANDRODERM) and SERTRALINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin), DRY MOUTH (Extremely dry mouth), THIRST (Thirstiness), FATIGUE (Very tired) and NAUSEA (Intense nausea). On an unknown date, the patient experienced RESTLESSNESS (Restless sensation in his body), SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia), PAIN IN EXTREMITY (Severe pain in the arm) and FATIGUE (Fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like having the flu), RESTLESSNESS (Restless sensation in his body), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin), SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia), DRY MOUTH (Extremely dry mouth), THIRST (Thirstiness), PAIN IN EXTREMITY (Severe pain in the arm), FATIGUE (Fatigued), FATIGUE (Very tired) and NAUSEA (Intense nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Restlessness, Skin burning sensation, Sunburn, Thirst
Clinical narrative: Restless sensation in his body; like having sunburns, face arm leg burning, he calls it paresthesia; Severe pain in the arm; Fatigued; Very tired; Intense nausea; Extremely dry mouth; Thirstiness; Couldn't sit still; Burning feeling skin; Felt like having the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like having the flu), RESTLESSNESS (Restless sensation in his body), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin) and SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included TESTOSTERONE (ANDRODERM) and SERTRALINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin), DRY MOUTH (Extremely dry mouth), THIRST (Thirstiness), FATIGUE (Very tired) and NAUSEA (Intense nausea). On an unknown date, the patient experienced RESTLESSNESS (Restless sensation in his body), SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia), PAIN IN EXTREMITY (Severe pain in the arm) and FATIGUE (Fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like having the flu), RESTLESSNESS (Restless sensation in his body), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin), SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia), DRY MOUTH (Extremely dry mouth), THIRST (Thirstiness), PAIN IN EXTREMITY (Severe pain in the arm), FATIGUE (Fatigued), FATIGUE (Very tired) and NAUSEA (Intense nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Chest tightness centered on thoracic cavity; Dizziness; Mild headache; Raised, itchy Rash across left arm and torso; Itchiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), PRURITUS (Itchiness), DIZZINESS (Dizziness), RASH PRURITIC (Raised, itchy Rash across left arm and torso) and FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy (Allergy to Shellfish) and Anaphylaxis on 01-Jan-2005.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced PRURITUS (Itchiness). On 05-Mar-2021, the patient experienced RASH PRURITIC (Raised, itchy Rash across left arm and torso). On 06-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), DIZZINESS (Dizziness) and HEADACHE (Mild headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 06-Mar-2021 for Rash, at a dose of 75 milligram benadryl and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Mar-2021 for Rash, at a dose of 50 mg. On 07-Mar-2021, RASH PRURITIC (Raised, itchy Rash across left arm and torso) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), PRURITUS (Itchiness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Mild headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: increased (High) Body temperature slightly increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD-2021-080728, MOD-2021-080775, MOD-2021-080775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow up - Patient demographic details updated. Suspect product Batch number added. AE outcome updated.; 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Chest tightness centered on thoracic cavity; Dizziness; Mild headache; Raised, itchy Rash across left arm and torso; Itchiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), PRURITUS (Itchiness), DIZZINESS (Dizziness), RASH PRURITIC (Raised, itchy Rash across left arm and torso) and FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy (Allergy to Shellfish) and Anaphylaxis on 01-Jan-2005.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced PRURITUS (Itchiness). On 05-Mar-2021, the patient experienced RASH PRURITIC (Raised, itchy Rash across left arm and torso). On 06-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), DIZZINESS (Dizziness) and HEADACHE (Mild headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 06-Mar-2021 for Rash, at a dose of 75 milligram benadryl and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Mar-2021 for Rash, at a dose of 50 mg. On 07-Mar-2021, RASH PRURITIC (Raised, itchy Rash across left arm and torso) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), PRURITUS (Itchiness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Mild headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: increased (High) Body temperature slightly increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD-2021-080728, MOD-2021-080775, MOD-2021-080775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow up - Patient demographic details updated. Suspect product Batch number added. AE outcome updated.; 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: whelp itchy; developed into a 3 inch whelp that is red; whelp that is  sore/whelp tender; little red mark at the injection site on the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (whelp itchy), VACCINATION SITE URTICARIA (developed into a 3 inch whelp that is red), VACCINATION SITE ERYTHEMA (little red mark at the injection site on the left arm) and VACCINATION SITE PAIN (whelp that is  sore/whelp tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (little red mark at the injection site on the left arm). On 11-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (whelp itchy), VACCINATION SITE URTICARIA (developed into a 3 inch whelp that is red) and VACCINATION SITE PAIN (whelp that is  sore/whelp tender). At the time of the report, VACCINATION SITE PRURITUS (whelp itchy), VACCINATION SITE URTICARIA (developed into a 3 inch whelp that is red), VACCINATION SITE ERYTHEMA (little red mark at the injection site on the left arm) and VACCINATION SITE PAIN (whelp that is  sore/whelp tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient had tried Advil, Tylenol, and cold compresses to try to help alleviate her symptoms, none has helped. Local pharmacist suggested she might try Lidocaine cream.
Sex: U
Vaccine: COVID19
Symptoms: Energy increased, Hunger, Initial insomnia, Thirst
Clinical narrative: Hungry; Thirsty; high with energy; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Hungry), THIRST (Thirsty), ENERGY INCREASED (high with energy ) and INITIAL INSOMNIA (couldn't sleep ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (type 2 diabetic).    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HUNGER (Hungry), THIRST (Thirsty), ENERGY INCREASED (high with energy ) and INITIAL INSOMNIA (couldn't sleep ). At the time of the report, HUNGER (Hungry), THIRST (Thirsty), ENERGY INCREASED (high with energy ) and INITIAL INSOMNIA (couldn't sleep ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Urticaria.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm). At the time of the report, PAIN IN EXTREMITY (Soreness of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information included no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Malaise, Neck pain, Pain
Clinical narrative: His leg burns and feels like a burn.; affected her to make her neck and the ball she had in her neck and clavicle; whole body hurts; she feels worse every day,; hip hurts; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (His leg burns and feels like a burn.), NECK PAIN (affected her to make her neck and the ball she had in her neck and clavicle), PAIN (whole body hurts), MALAISE (she feels worse every day,) and ARTHRALGIA (hip hurts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Fall.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (His leg burns and feels like a burn.), NECK PAIN (affected her to make her neck and the ball she had in her neck and clavicle), PAIN (whole body hurts), MALAISE (she feels worse every day,) and ARTHRALGIA (hip hurts). At the time of the report, BURNING SENSATION (His leg burns and feels like a burn.), NECK PAIN (affected her to make her neck and the ball she had in her neck and clavicle), PAIN (whole body hurts), MALAISE (she feels worse every day,) and ARTHRALGIA (hip hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication included the vitamins and stopped taking anti-inflammatory drugs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pain
Clinical narrative: Soreness; Itching; swelling at site; vaccine site swelling/redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, DICLOFENAC SODIUM (VOLTREX [DICLOFENAC SODIUM]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness). On an unknown date, the patient experienced PAIN (Soreness). The patient was treated with PREDNISONE (oral) at a dose of 20 mg once a day and CEFALEXIN (KEFLEX [CEFALEXIN]) (oral) at a dose of 500 mg every eight hours. On 12-Jan-2021, VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness) had resolved. At the time of the report, PAIN (Soreness) had resolved and VACCINATION SITE PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 136/88 (High) 136/88 mmHg. On 08-Jan-2021, Body temperature: 37.2 (normal) (99 F). On 08-Jan-2021, Heart rate: 64 (Low) 64 times per minute. On 08-Jan-2021, Oxygen saturation: 100 (normal) 100%.     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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Soreness; Itching; swelling at site; vaccine site swelling/redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, DICLOFENAC SODIUM (VOLTREX [DICLOFENAC SODIUM]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness). On an unknown date, the patient experienced PAIN (Soreness). The patient was treated with PREDNISONE (oral) at a dose of 20 mg once a day and CEFALEXIN (KEFLEX [CEFALEXIN]) (oral) at a dose of 500 mg every eight hours. On 12-Jan-2021, VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness) had resolved. At the time of the report, PAIN (Soreness) had resolved and VACCINATION SITE PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 136/88 (High) 136/88 mmHg. On 08-Jan-2021, Body temperature: 37.2 (normal) (99 F). On 08-Jan-2021, Heart rate: 64 (Low) 64 times per minute. On 08-Jan-2021, Oxygen saturation: 100 (normal) 100%.     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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nervousness, Pruritus, Rash, Urticaria
Clinical narrative: he is not sleeping due to itching a lot; He is very nervous; rashes on his face neck, back of neck, front, rashes around ear, more rashes on his body.; bumps (hives) around his ear on the top and bottom; not sleeping due to itching a lot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (bumps (hives) around his ear on the top and bottom), PRURITUS (not sleeping due to itching a lot), INSOMNIA (he is not sleeping due to itching a lot), NERVOUSNESS (He is very nervous) and RASH (rashes on his face neck, back of neck, front, rashes around ear, more rashes on his body.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced URTICARIA (bumps (hives) around his ear on the top and bottom), PRURITUS (not sleeping due to itching a lot) and RASH (rashes on his face neck, back of neck, front, rashes around ear, more rashes on his body.). On an unknown date, the patient experienced INSOMNIA (he is not sleeping due to itching a lot) and NERVOUSNESS (He is very nervous). At the time of the report, URTICARIA (bumps (hives) around his ear on the top and bottom), PRURITUS (not sleeping due to itching a lot), INSOMNIA (he is not sleeping due to itching a lot), NERVOUSNESS (He is very nervous) and RASH (rashes on his face neck, back of neck, front, rashes around ear, more rashes on his body.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.