chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: received a dose from a vial that was opened for more than 6 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of OUT OF SPECIFICATION PRODUCT USE (received a dose from a vial that was opened for more than 6 hours) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced OUT OF SPECIFICATION PRODUCT USE (received a dose from a vial that was opened for more than 6 hours). On 29-Mar-2021, OUT OF SPECIFICATION PRODUCT USE (received a dose from a vial that was opened for more than 6 hours) had 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.   No treatment information was provided.   This report refers to a case of 23-years-old male patient who experienced non-serious unexpected event of received a dose from a vial that was opened for more than 6 hours (out of specification product use) for mRNA-1273, lot # 037A21B), Exp date-unknown. There were no reported AEs associated with this case of out of specification product use.; Sender's Comments: This report refers to a case of 23-years-old male patient who experienced non-serious unexpected event of received a dose from a vial that was opened for more than 6 hours (out of specification product use) for mRNA-1273, lot # 037A21B), Exp date-unknown. There were no reported AEs associated with this case of out of specification product use.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Vaccination site oedema, Vaccination site pain
Clinical narrative: he has mild spot at the injection site its fading away; liquid around the injection site; big burst in his arm when he was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (liquid around the injection site), INJECTION SITE REACTION (he has mild spot at the injection site its fading away) and VACCINATION SITE PAIN (big burst in his arm when he was vaccinated) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 98D21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (big burst in his arm when he was vaccinated). On 29-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (liquid around the injection site). On an unknown date, the patient experienced INJECTION SITE REACTION (he has mild spot at the injection site its fading away). At the time of the report, VACCINATION SITE OEDEMA (liquid around the injection site) outcome was unknown, INJECTION SITE REACTION (he has mild spot at the injection site its fading away) was resolving and VACCINATION SITE PAIN (big burst in his arm when he was vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up information received on 05-Jun-2021 included new event injection site reaction and outcome of the event big burst in arm was updated from unknown to recovered/resolved; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Worsening ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Worsening ringing in the ears) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced TINNITUS (Worsening ringing in the ears). At the time of the report, TINNITUS (Worsening ringing in the ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: Back pain / Shots of pain in back; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain / Shots of pain in back) and CHILLS (Cold chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain / Shots of pain in back) and CHILLS (Cold chills). At the time of the report, BACK PAIN (Back pain / Shots of pain in back) and CHILLS (Cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Pain in extremity, Palpitations, Vaccination site joint movement impairment
Clinical narrative: Palpitaton; Couldnt lift her arm; Diarrhea; Pain in arm; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitaton), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift her arm), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Lightheadedness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR) and ATORVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PALPITATIONS (Palpitaton), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift her arm), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Lightheadedness). At the time of the report, PALPITATIONS (Palpitaton), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift her arm), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication includes Mobocertinib Oncology trial drug. Treatment information includes fluids and nutrition drinks.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Hypoaesthesia oral, Swelling face
Clinical narrative: Cheeks and both sides of face were numb; Lips went numb; Cheeks puffy; Tip of nose will turn ice cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Cheeks and both sides of face were numb), HYPOAESTHESIA ORAL (Lips went numb), SWELLING FACE (Cheeks puffy) and FEELING COLD (Tip of nose will turn ice cold) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergic to sulfa.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Cheeks and both sides of face were numb), HYPOAESTHESIA ORAL (Lips went numb), SWELLING FACE (Cheeks puffy) and FEELING COLD (Tip of nose will turn ice cold). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Cheeks and both sides of face were numb) had not resolved and HYPOAESTHESIA ORAL (Lips went numb), SWELLING FACE (Cheeks puffy) and FEELING COLD (Tip of nose will turn ice cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The event lips went numb was reported as soon as she got the shot. Patient spoke to HCP who said it sounded like an allergic reaction to an ingredient in the vaccine. Treatment for the events included levocetirizine.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Dizziness, Dry mouth
Clinical narrative: lightheadedness; anxiety; hot flash; dry mouth; headache; pain in the right wrist and hand; chills; general pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheadedness), ANXIETY (anxiety), HOT FLUSH (hot flash), DRY MOUTH (dry mouth) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (lightheadedness), ANXIETY (anxiety), HOT FLUSH (hot flash), DRY MOUTH (dry mouth), HEADACHE (headache), ARTHRALGIA (pain in the right wrist and hand), CHILLS (chills) and INJECTION SITE PAIN (general pain at the injection site). On 19-Feb-2021, HOT FLUSH (hot flash) outcome was unknown. At the time of the report, DIZZINESS (lightheadedness), ANXIETY (anxiety), DRY MOUTH (dry mouth), HEADACHE (headache), ARTHRALGIA (pain in the right wrist and hand), CHILLS (chills) and INJECTION SITE PAIN (general pain at the injection site) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    Concomitant product use was not provided/unknown by the reporter.  Treatment information was not provided/unknown.   This case was linked to MOD21-034353 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Injection site pain
Clinical narrative: lightheadedness; anxiety; hot flash; dry mouth; headache; pain in the right wrist and hand; chills; general pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheadedness), ANXIETY (anxiety), HOT FLUSH (hot flash), DRY MOUTH (dry mouth) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (lightheadedness), ANXIETY (anxiety), HOT FLUSH (hot flash), DRY MOUTH (dry mouth), HEADACHE (headache), ARTHRALGIA (pain in the right wrist and hand), CHILLS (chills) and INJECTION SITE PAIN (general pain at the injection site). On 19-Feb-2021, HOT FLUSH (hot flash) outcome was unknown. At the time of the report, DIZZINESS (lightheadedness), ANXIETY (anxiety), DRY MOUTH (dry mouth), HEADACHE (headache), ARTHRALGIA (pain in the right wrist and hand), CHILLS (chills) and INJECTION SITE PAIN (general pain at the injection site) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    Concomitant product use was not provided/unknown by the reporter.  Treatment information was not provided/unknown.   This case was linked to MOD21-034353 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower back pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced BACK PAIN (Severe lower back pain). At the time of the report, BACK PAIN (Severe lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment information provided. Case is based off of a social media post and filed with limited information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010aq1a and 003b21a) for COVID-19 vaccination.     The patient's past medical history included Back surgery (Patient reports having back surgery twice.) since an unknown date.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site rash, Malaise, Myalgia
Clinical narrative: rash just below the injection site; little nauseated; head ache; extremely tired; sore arm; not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), MALAISE (not feeling good), NAUSEA (little nauseated), HEADACHE (head ache) and FATIGUE (extremely tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 MYALGIA (sore arm), MALAISE (not feeling good), HEADACHE (head ache) and FATIGUE (extremely tired). On 26-Mar-2021, the patient experienced NAUSEA (little nauseated). On 27-Mar-2021, the patient experienced INJECTION SITE RASH (rash just below the injection site). The patient was treated with IBUPROFEN at a dose of UNK dosage form. On 26-Mar-2021, NAUSEA (little nauseated) had resolved. On 27-Mar-2021, MYALGIA (sore arm), MALAISE (not feeling good), HEADACHE (head ache) and FATIGUE (extremely tired) had resolved. At the time of the report, INJECTION SITE RASH (rash just below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: rash just below the injection site; little nauseated; head ache; extremely tired; sore arm; not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), MALAISE (not feeling good), NAUSEA (little nauseated), HEADACHE (head ache) and FATIGUE (extremely tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 MYALGIA (sore arm), MALAISE (not feeling good), HEADACHE (head ache) and FATIGUE (extremely tired). On 26-Mar-2021, the patient experienced NAUSEA (little nauseated). On 27-Mar-2021, the patient experienced INJECTION SITE RASH (rash just below the injection site). The patient was treated with IBUPROFEN at a dose of UNK dosage form. On 26-Mar-2021, NAUSEA (little nauseated) had resolved. On 27-Mar-2021, MYALGIA (sore arm), MALAISE (not feeling good), HEADACHE (head ache) and FATIGUE (extremely tired) had resolved. At the time of the report, INJECTION SITE RASH (rash just below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling, Tenderness, Type IV hypersensitivity reaction
Clinical narrative: swelling; red circle; tenderness; redness; hot to touch; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (red circle), TENDERNESS (tenderness), ERYTHEMA (redness) and FEELING HOT (hot to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and PROTEIN SUPPLEMENTS for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), ERYTHEMA (red circle), TENDERNESS (tenderness), ERYTHEMA (redness), FEELING HOT (hot to touch) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm). At the time of the report, SWELLING (swelling), ERYTHEMA (red circle), TENDERNESS (tenderness), ERYTHEMA (redness), FEELING HOT (hot to touch) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was unknown
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced NAUSEA (nauseous). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of UNK dosage form. At the time of the report, NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: right arm is swollen the size of a baseball; pain in arm; tching; pain started going up her neck; can't turn her neck to the right; burned a little when she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (burned a little when she got the shot), VACCINATION SITE SWELLING (right arm is swollen the size of a baseball), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (tching) and NECK PAIN (pain started going up her neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010aq1a and 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), Liothyronine, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), POTASSIUM, Methocarbin and FISH OIL.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (burned a little when she got the shot). On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (right arm is swollen the size of a baseball), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (tching), NECK PAIN (pain started going up her neck) and NECK PAIN (can't turn her neck to the right). On 24-Mar-2021, VACCINATION SITE PAIN (burned a little when she got the shot) had resolved. At the time of the report, VACCINATION SITE SWELLING (right arm is swollen the size of a baseball), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (tching), NECK PAIN (pain started going up her neck) and NECK PAIN (can't turn her neck to the right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-061155 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061155:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The events which patient experienced upset stomach and diarrhea was not related to vaccine.The scheduled second dose for the patient was on 30-MAR-2021. She asked can she postponed and for how long her second vaccination and if her diagnosis for upset would be stomach infection or COVID can she made the second injection or not.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Pyrexia
Clinical narrative: fever 101, high fever; arm is hurting; sick to stomach; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101, high fever), PAIN IN EXTREMITY (arm is hurting) and ABDOMINAL DISCOMFORT (sick to stomach) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products were not provided.   On 28-Mar-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 29-Mar-2021, the patient experienced PYREXIA (fever 101, high fever), PAIN IN EXTREMITY (arm is hurting) and ABDOMINAL DISCOMFORT (sick to stomach). At the time of the report, PYREXIA (fever 101, high fever), PAIN IN EXTREMITY (arm is hurting) and ABDOMINAL DISCOMFORT (sick to stomach) outcome was unknown.  Treatment products were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: red inner and outer arm (progressive); swollen inner and outer arm (progressive); warm arm (progressive); painful to touch arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red inner and outer arm (progressive)), PERIPHERAL SWELLING (swollen inner and outer arm (progressive)), SKIN WARM (warm arm (progressive)) and PAIN IN EXTREMITY (painful to touch arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Heart disorder and Hypercholesterolemia. Concomitant products included ETANERCEPT, LISINOPRIL and DIPHENHYDRAMINE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ERYTHEMA (red inner and outer arm (progressive)), PERIPHERAL SWELLING (swollen inner and outer arm (progressive)), SKIN WARM (warm arm (progressive)) and PAIN IN EXTREMITY (painful to touch arm). At the time of the report, ERYTHEMA (red inner and outer arm (progressive)), PERIPHERAL SWELLING (swollen inner and outer arm (progressive)), SKIN WARM (warm arm (progressive)) and PAIN IN EXTREMITY (painful to touch arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 29-MAR-2021 treatment for the events was taken with Benadryl and ice pack, self administered by the patient. Patient's past history also includes multiple joint replacements.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: Tremendous amount of fatigue, could not get out of bed; flu like symptoms; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tremendous amount of fatigue, could not get out of bed), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Tremendous amount of fatigue, could not get out of bed), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache). On 11-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 22-Mar-2021, FATIGUE (Tremendous amount of fatigue, could not get out of bed) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment with Tylenol.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Lymphadenitis
Clinical narrative: fever; out of breath; chills; fatigue; body aches; Headache; swelling under the armpit; Patient experienced arm pain 30 minutes after receiving the dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain 30 minutes after receiving the dose), PYREXIA (fever), DYSPNOEA (out of breath), CHILLS (chills) and FATIGUE (fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C18B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 PAIN IN EXTREMITY (Patient experienced arm pain 30 minutes after receiving the dose). On 26-Mar-2021, the patient experienced PYREXIA (fever), DYSPNOEA (out of breath), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (Headache) and LYMPHADENITIS (swelling under the armpit). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain 30 minutes after receiving the dose), PYREXIA (fever), DYSPNOEA (out of breath), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (Headache) and LYMPHADENITIS (swelling under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment products included Tylenol, Advil.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: fever; out of breath; chills; fatigue; body aches; Headache; swelling under the armpit; Patient experienced arm pain 30 minutes after receiving the dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain 30 minutes after receiving the dose), PYREXIA (fever), DYSPNOEA (out of breath), CHILLS (chills) and FATIGUE (fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C18B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 PAIN IN EXTREMITY (Patient experienced arm pain 30 minutes after receiving the dose). On 26-Mar-2021, the patient experienced PYREXIA (fever), DYSPNOEA (out of breath), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (Headache) and LYMPHADENITIS (swelling under the armpit). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain 30 minutes after receiving the dose), PYREXIA (fever), DYSPNOEA (out of breath), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (Headache) and LYMPHADENITIS (swelling under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment products included Tylenol, Advil.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use) on 27-Feb-2021 and Eczema. Concomitant products included LEVOTHYROXINE from 29-Jan-2021 to an unknown date for Thyroid disorder NOS.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Feb-2021 and the estimated date of delivery was 13-Nov-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications was provided by the reporter.  Past pregnancy: Live full term birth on 17-Nov-2019   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Dysstasia, Feeling abnormal
Clinical narrative: felt bad; didn't feel like getting up; back hurt really bad; Diarrhea; across her hips hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ARTHRALGIA (across her hips hurt really bad), FEELING ABNORMAL (felt bad), DYSSTASIA (didn't feel like getting up) and BACK PAIN (back hurt really bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Reflux gastritis and Arthritis. Concomitant products included MELOXICAM for Arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ARTHRALGIA (across her hips hurt really bad) and BACK PAIN (back hurt really bad). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad) and DYSSTASIA (didn't feel like getting up). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 29-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ARTHRALGIA (across her hips hurt really bad), FEELING ABNORMAL (felt bad), DYSSTASIA (didn't feel like getting up) and BACK PAIN (back hurt really bad) was resolving.            Concomitant medications included blood pressure, reflux and preservation eye medication. Treatment information included Imodium.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non-significant follow up. Patient declined to give email address and any further FU, states she believes she had a virus instead of adverse events to vaccine
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity, Pyrexia, Rash, Rash pruritic
Clinical narrative: Pinkish rash around injection site; Itchy sensation on rash about 2 inches by 2 inches; fever; Rash subside and come back again; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INJECTION SITE RASH (Pinkish rash around injection site), RASH PRURITIC (Itchy sensation on rash about 2 inches by 2 inches), PYREXIA (fever) and RASH (Rash subside and come back again) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 13-Mar-2021, the patient experienced INJECTION SITE RASH (Pinkish rash around injection site), RASH PRURITIC (Itchy sensation on rash about 2 inches by 2 inches), PYREXIA (fever) and RASH (Rash subside and come back again). On 06-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, INJECTION SITE RASH (Pinkish rash around injection site), RASH PRURITIC (Itchy sensation on rash about 2 inches by 2 inches), PYREXIA (fever) and RASH (Rash subside and come back again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypokinesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (it felt like the pain moved), hypokinesia (I could barely move my arm) and arthralgia (whole shoulder itself was hurting) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044A21A) for COVID-19 immunization. No medical history reported. On Mar 23, 2021, the patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient experienced arthralgia (whole shoulder itself was hurting). On Mar 24, 2021, patient experienced back pain (it felt like the pain moved) and hypokinesia (I could barely move my arm). At the time of the report, back pain (it felt like the pain moved), hypokinesia (I could barely move my arm) and arthralgia (whole shoulder itself was hurting): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact. Most recent follow-up information incorporated above included: On Jun 25, 2021: Telephone contact report received. The outcome of events updated to recovered. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of severe tinnitus in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced severe tinnitus. At the time of the report, severe tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 27, 2021, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine): unknown. Concomitant medication and treatment information not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; felt "little tired"; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (felt "little tired"), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue),in right eye "blinding white aura for 15 minutes",seems like migraine lost vision" in right eye, in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse events were reported).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (felt "little tired") and CHILLS (chills). On 27-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Migraine, at an unspecified dose and frequency. On 28-Feb-2021, HEADACHE (Headache) and FATIGUE (felt "little tired") had resolved. On 28-Mar-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. At the time of the report, CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-061190 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061190:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: once syringe was out, the needle retracted; a drop of vaccine, dropped out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (once syringe was out, the needle retracted) and UNDERDOSE (a drop of vaccine, dropped out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event were reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (once syringe was out, the needle retracted) and UNDERDOSE (a drop of vaccine, dropped out). On 29-Mar-2021, DEVICE CONNECTION ISSUE (once syringe was out, the needle retracted) and UNDERDOSE (a drop of vaccine, dropped out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History was provided by Reporter.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 22-Mar-2021, PAIN (Pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatments details was not provided. The primary healthcare professional advised the patient to take acetaminophen prior to second dose.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added TCR, NNI
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: got shingles about a little less than a week ago; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (got shingles about a little less than a week ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (got shingles about a little less than a week ago). At the time of the report, HERPES ZOSTER (got shingles about a little less than a week ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Caller received his second dose of the vaccine on 27MAR2021; tenderness at shot site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received his second dose of the vaccine on 27MAR2021) and VACCINATION SITE PAIN (tenderness at shot site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included TETANUS VACCINE from 12-Mar-2021 to an unknown date for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received his second dose of the vaccine on 27MAR2021) and VACCINATION SITE PAIN (tenderness at shot site). On 27-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received his second dose of the vaccine on 27MAR2021) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness at shot site) outcome was unknown.            Concomitant medications included tetanus shot on 12 Mar 2021. No treatment information was provided.  This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 031A21A  with associated AE vaccination site pain.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 031A21A  with associated AE vaccination site pain.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: she did not receive the full 0.5mL.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (she did not receive the full 0.5mL.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SPIRONOLACTONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]) and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (she did not receive the full 0.5mL.). At the time of the report, ACCIDENTAL UNDERDOSE (she did not receive the full 0.5mL.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shakiness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. PFIZER) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shakiness). At the time of the report, TREMOR (shakiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.