chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Ocular discomfort, Pyrexia, Tongue discomfort
Clinical narrative: right side of face is numb/The right side of me face is drooping; cannot close right eye all of the way; speech is slurred; excessive drooling from my mouth; Tiredness; tongue felt like I had burned it; tongue became numb; sweating; chills; fever; Sore left injection site Arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue became numb), HYPERHIDROSIS (sweating), TONGUE DISCOMFORT (tongue felt like I had burned it), HYPOAESTHESIA (right side of face is numb/The right side of me face is drooping) and OCULAR DISCOMFORT (cannot close right eye all of the way) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site Arm). On 03-Aug-2021, the patient experienced HYPOAESTHESIA ORAL (tongue became numb), HYPERHIDROSIS (sweating), CHILLS (chills) and PYREXIA (fever). On 04-Aug-2021, the patient experienced TONGUE DISCOMFORT (tongue felt like I had burned it) and FATIGUE (Tiredness). On 05-Aug-2021, the patient experienced HYPOAESTHESIA (right side of face is numb/The right side of me face is drooping), OCULAR DISCOMFORT (cannot close right eye all of the way), DYSARTHRIA (speech is slurred) and DROOLING (excessive drooling from my mouth). At the time of the report, HYPOAESTHESIA ORAL (tongue became numb), HYPERHIDROSIS (sweating), TONGUE DISCOMFORT (tongue felt like I had burned it), HYPOAESTHESIA (right side of face is numb/The right side of me face is drooping), OCULAR DISCOMFORT (cannot close right eye all of the way), DYSARTHRIA (speech is slurred), VACCINATION SITE PAIN (Sore left injection site Arm), DROOLING (excessive drooling from my mouth), FATIGUE (Tiredness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right side of face is numb/The right side of me face is drooping; cannot close right eye all of the way; speech is slurred; excessive drooling from my mouth; Tiredness; tongue felt like I had burned it; tongue became numb; sweating; chills; fever; Sore left injection site Arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue became numb), HYPERHIDROSIS (sweating), TONGUE DISCOMFORT (tongue felt like I had burned it), HYPOAESTHESIA (right side of face is numb/The right side of me face is drooping) and OCULAR DISCOMFORT (cannot close right eye all of the way) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site Arm). On 03-Aug-2021, the patient experienced HYPOAESTHESIA ORAL (tongue became numb), HYPERHIDROSIS (sweating), CHILLS (chills) and PYREXIA (fever). On 04-Aug-2021, the patient experienced TONGUE DISCOMFORT (tongue felt like I had burned it) and FATIGUE (Tiredness). On 05-Aug-2021, the patient experienced HYPOAESTHESIA (right side of face is numb/The right side of me face is drooping), OCULAR DISCOMFORT (cannot close right eye all of the way), DYSARTHRIA (speech is slurred) and DROOLING (excessive drooling from my mouth). At the time of the report, HYPOAESTHESIA ORAL (tongue became numb), HYPERHIDROSIS (sweating), TONGUE DISCOMFORT (tongue felt like I had burned it), HYPOAESTHESIA (right side of face is numb/The right side of me face is drooping), OCULAR DISCOMFORT (cannot close right eye all of the way), DYSARTHRIA (speech is slurred), VACCINATION SITE PAIN (Sore left injection site Arm), DROOLING (excessive drooling from my mouth), FATIGUE (Tiredness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: just got COVID I have been vaccinated with Moderna (both shots); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (just got COVID I have been vaccinated with Moderna (both shots)) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 COVID-19 (just got COVID I have been vaccinated with Moderna (both shots)). At the time of the report, COVID-19 (just got COVID I have been vaccinated with Moderna (both shots)) outcome was unknown.            No concomitant medications were reported. No treatment medications were provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Interchange of vaccine products, Pain in extremity
Clinical narrative: a lot of soreness in her arm; scheduled for her second dose of the Pfizer COVID19 vaccine in 4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of soreness in her arm) and INTERCHANGE OF VACCINE PRODUCTS (scheduled for her second dose of the Pfizer COVID19 vaccine in 4 weeks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (compromised immune system) and Irritable bowel (disorder). Concomitant products included IMMUNOGLOBULIN G HUMAN (GAMMA GLOBULIN) and INFLIXIMAB (REMICADE) for an unknown indication.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a lot of soreness in her arm) and INTERCHANGE OF VACCINE PRODUCTS (scheduled for her second dose of the Pfizer COVID19 vaccine in 4 weeks). At the time of the report, PAIN IN EXTREMITY (a lot of soreness in her arm) and INTERCHANGE OF VACCINE PRODUCTS (scheduled for her second dose of the Pfizer COVID19 vaccine in 4 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) the two antibodies measured.         No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was provided.  No treatment medication information was provided.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Product administered to patient of inappropriate age, Swelling of eyelid
Clinical narrative: Right eye lid of patient had swelling; Eye redness in both eyes; A 12 year old received the vaccine/1st dose administered to a 12 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING OF EYELID (Right eye lid of patient had swelling), OCULAR HYPERAEMIA (Eye redness in both eyes) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year old received the vaccine/1st dose administered to a 12 year old patient) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021, the patient experienced SWELLING OF EYELID (Right eye lid of patient had swelling), OCULAR HYPERAEMIA (Eye redness in both eyes) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year old received the vaccine/1st dose administered to a 12 year old patient). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) for Adverse event, at a dose of 50 milligram. On 04-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year old received the vaccine/1st dose administered to a 12 year old patient) had resolved. At the time of the report, SWELLING OF EYELID (Right eye lid of patient had swelling) and OCULAR HYPERAEMIA (Eye redness in both eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided  After vaccination  the patient was fine but  within 15 minutes of the vaccine had a delayed reaction where it was noticed that the  right eyelid of the patient had swelling and had eye redness in both eyes and came back to the clinic and was administered 50mg of Benadryl intramuscularly.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had the Moderna vaccine in January and February...i now have covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had the Moderna vaccine in January and February...i now have covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I had the Moderna vaccine in January and February...i now have covid). At the time of the report, COVID-19 (I had the Moderna vaccine in January and February..i now have covid) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: I have breakthrough COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (I have breakthrough COVID) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (I have breakthrough COVID). At the time of the report, DRUG INEFFECTIVE (I have breakthrough COVID) outcome was unknown.            No concomitant medication information was provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: Got first shot on 2-10-21 last shot made me sick for a day; Now I am having some nausea now have had this for several days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got first shot on 2-10-21 last shot made me sick for a day) and NAUSEA (Now I am having some nausea now have had this for several days) 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 10-Feb-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 ILLNESS (Got first shot on 2-10-21 last shot made me sick for a day) and NAUSEA (Now I am having some nausea now have had this for several days). At the time of the report, ILLNESS (Got first shot on 2-10-21 last shot made me sick for a day) had resolved and NAUSEA (Now I am having some nausea now have had this for several days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.  The patient had nausea for several days.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Product dose omission issue
Clinical narrative: it has been more than 36 days since the first dose and patient had not gotten the second dose; in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath) and PRODUCT DOSE OMISSION ISSUE (it has been more than 36 days since the first dose and patient had not gotten the second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 CHEST PAIN (in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath) and PRODUCT DOSE OMISSION ISSUE (it has been more than 36 days since the first dose and patient had not gotten the second dose). At the time of the report, CHEST PAIN (in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath) had resolved and PRODUCT DOSE OMISSION ISSUE (it has been more than 36 days since the first dose and patient had not gotten the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: She felt bad as well; Dizziness; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt bad as well), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She felt bad as well), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (She felt bad as well), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-079407 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Musculoskeletal stiffness
Clinical narrative: Spine has been stiff/stiffness in the spine; Could barley walk around; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Spine has been stiff/stiffness in the spine) and GAIT DISTURBANCE (Could barley walk around) 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 Degenerative disc disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Spine has been stiff/stiffness in the spine) and GAIT DISTURBANCE (Could barley walk around). At the time of the report, MUSCULOSKELETAL STIFFNESS (Spine has been stiff/stiffness in the spine) and GAIT DISTURBANCE (Could barley walk around) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bronchial secretion retention, Chills, Cough, Pyrexia
Clinical narrative: Cough; Great amount of mucus; Super weak; Chills; Fever went up to 102°F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BRONCHIAL SECRETION RETENTION (Great amount of mucus), ASTHENIA (Super weak), CHILLS (Chills) and PYREXIA (Fever went up to 102°F) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever went up to 102°F). On 03-Aug-2021, the patient experienced ASTHENIA (Super weak). On 04-Aug-2021, the patient experienced COUGH (Cough) and BRONCHIAL SECRETION RETENTION (Great amount of mucus). The patient was treated with DICLOFENAC (DICLO [DICLOFENAC]) ongoing from 02-Aug-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, COUGH (Cough), BRONCHIAL SECRETION RETENTION (Great amount of mucus), ASTHENIA (Super weak), CHILLS (Chills) and PYREXIA (Fever went up to 102°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received both doses of the Moderna Covid19 Vaccine while she was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of the Moderna Covid19 Vaccine while she was pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of the Moderna Covid19 Vaccine while she was pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received both doses of the Moderna Covid19 Vaccine while she was pregnant) had resolved.            Patient wanted to know if the child should be tested for antibodies once they give birth to it, and wanted to know any information related to pregnancy and the vaccine.  No Concomitant medication were reported. No treatment medication were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: stabbing pain in the back that feels like fire; chest hurts; arm is numb; arm is tingly; feels like she is hungover; heat/hotness at the injection site; arm is swollen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly) and FEELING ABNORMAL (feels like she is hungover) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly), FEELING ABNORMAL (feels like she is hungover), VACCINATION SITE WARMTH (heat/hotness at the injection site) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly), FEELING ABNORMAL (feels like she is hungover), VACCINATION SITE WARMTH (heat/hotness at the injection site) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site warmth
Clinical narrative: stabbing pain in the back that feels like fire; chest hurts; arm is numb; arm is tingly; feels like she is hungover; heat/hotness at the injection site; arm is swollen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly) and FEELING ABNORMAL (feels like she is hungover) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly), FEELING ABNORMAL (feels like she is hungover), VACCINATION SITE WARMTH (heat/hotness at the injection site) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, BACK PAIN (stabbing pain in the back that feels like fire), CHEST PAIN (chest hurts), HYPOAESTHESIA (arm is numb), PARAESTHESIA (arm is tingly), FEELING ABNORMAL (feels like she is hungover), VACCINATION SITE WARMTH (heat/hotness at the injection site) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: isolated sinus tachycardia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency WEB. Regulatory number: DE-RA-202200062676 (RA).  A 45 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Dec2021 (Lot number: SDEW9) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single, lot number 1G040A, route of administration Intramuscular), for covid-19 immunisation. The following information was reported: SINUS TACHYCARDIA (hospitalization) with onset 22Dec2021, outcome "recovered" (29Dec2021), described as "isolated sinus tachycardia". Therapeutic measures were taken as a result of sinus tachycardia. Only conditional recovery occurred with therapy.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This case received via the regulatory authority (reference number: 126746) on Aug 5, 2021, and forwarded to Moderna, reported by a consumer and describes the occurrence of product dose omission issue (second dose past 36 days) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016B21A) for COVID-19 immunization. No medical history reported. On Mar 31, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced product dose omission issue (second dose past 36 days). On Mar 31, 2021, product dose omission issue (second dose past 36 days): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 05May2021; 2nd dose 31Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05May2021; 2nd dose 31Jul2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05May2021; 2nd dose 31Jul2021). On 31-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05May2021; 2nd dose 31Jul2021) had resolved.            The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Product dose omission issue
Clinical narrative: typical flu-like symptoms; First vaccine in Apr2021, did not get second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (typical flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (First vaccine in Apr2021, did not get second) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (typical flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (First vaccine in Apr2021, did not get second). At the time of the report, INFLUENZA LIKE ILLNESS (typical flu-like symptoms) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (First vaccine in Apr2021, did not get second) 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.   No concomitant medications are provided by reporter. No treatment medications are provided by reporter.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Discomfort, Lichen sclerosus
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LICHEN SCLEROSUS (Lichen Sclerosus) and DISCOMFORT (increased until it was uncomfortable enough that I went to a doctor) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination.   No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced a regulatory authority and DISCOMFORT (increased until it was uncomfortable enough that I went to a doctor). The patient was treated with PROGESTERONE for Lichen sclerosus, at a dose of 1 dosage form and ESTRADIOL for Lichen sclerosus, at a dose of UNK dosage form. At the time of the report, LICHEN SCLEROSUS (Lichen Sclerosus) and DISCOMFORT (increased until it was uncomfortable enough that I went to a doctor) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: lichen sclerosus (Inconclusive) Lichen Sclerosus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Patient stated that the event was diagnosed around 6 weeks after the second dose, and the diagnosis was lichen sclerosus. Patient stated it was an autoimmune disease in the skin in the genital area.  Patient was treated with a steroid cream (it improved symptoms but she has to keep using it, it does not go away).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) had resolved.            No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis
Clinical narrative: Cold; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and MYALGIA (Body aches) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and MYALGIA (Body aches). At the time of the report, NASOPHARYNGITIS (Cold) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by the reporter. No concomitant medication provided by the reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: unauthorized age (16 year old received Moderna vaccine); This case was received via regulatory authority (Reference number: 126869) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age (16 year old received Moderna vaccine)) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age (16 year old received Moderna vaccine)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age (16 year old received Moderna vaccine)) 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.   Concomitant product use was not provided by the reporter. Treatment product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve discomfort in my left foot; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve discomfort in my left foot) 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 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 NEURALGIA (nerve discomfort in my left foot). At the time of the report, NEURALGIA (nerve discomfort in my left foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Have a headache; Tiredness/I feel very tired; Sore at the injection site/ my arm started hurting at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/I feel very tired), VACCINATION SITE PAIN (Sore at the injection site/ my arm started hurting at the injection site) and HEADACHE (Have a headache) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced FATIGUE (Tiredness/I feel very tired) and VACCINATION SITE PAIN (Sore at the injection site/ my arm started hurting at the injection site). On 04-Aug-2021, the patient experienced HEADACHE (Have a headache). At the time of the report, FATIGUE (Tiredness/I feel very tired), VACCINATION SITE PAIN (Sore at the injection site/ my arm started hurting at the injection site) and HEADACHE (Have a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose end of Mar-2021, second dose end of Jun-2021; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose end of Mar-2021, second dose end of Jun-2021) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose end of Mar-2021, second dose end of Jun-2021). In June 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose end of Mar-2021, second dose end of Jun-2021) had resolved.            The patient took first dose of vaccine in end of Mar-2021 and second dose in end of Jun-2021. No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nasopharyngitis
Clinical narrative: feel like i have a cold 2 days later; arm felt sore; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feel like i have a cold 2 days later), MYALGIA (arm felt sore) and FATIGUE (felt tired) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (feel like i have a cold 2 days later), MYALGIA (arm felt sore) and FATIGUE (felt tired). At the time of the report, NASOPHARYNGITIS (feel like i have a cold 2 days later), MYALGIA (arm felt sore) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Full blood count, Metabolic function test, Thyroid function test, Vitamin D
Clinical narrative: mild dizziness; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (mild dizziness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, GERD and Osteopenia.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (mild dizziness). At the time of the report, DIZZINESS (mild dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) Normal. On an unknown date, Metabolic function test: normal (normal) Normal. On an unknown date, Thyroid function test: normal (normal) Thyroid panel normal. On an unknown date, Vitamin D: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (mild dizziness) to be possibly related.    No concomitant medications were reported.  No treatment medication were reported.   This case was linked to MOD-2021-278255, MOD-2021-276754 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: follow-up information included no new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Dizziness, Full blood count, Metabolic function test
Clinical narrative: Dizziness; Symptoms worsened; Loss of balance; Tinnitus; Migraine headaches; Vertiginous symptoms; N/V; N/V; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus) and MIGRAINE (Migraine headaches) in a 75-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.     The patient's past medical history included GERD. Concurrent medical conditions included Hypothyroidism and Osteopenia.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus), MIGRAINE (Migraine headaches), VERTIGO (Vertiginous symptoms), NAUSEA (N/V) and VOMITING (N/V). The patient was treated with OXITRIPTAN (TRIPTAN [OXITRIPTAN]) for Adverse event, at an unspecified dose and frequency; OMEPRAZOLE for Adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus), MIGRAINE (Migraine headaches), VERTIGO (Vertiginous symptoms), NAUSEA (N/V) and VOMITING (N/V) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal. On an unknown date, Thyroid function test: normal (normal) normal. On an unknown date, Vitamin D: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that symptoms resolved after 3 months.   This case was linked to MOD-2021-278248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up contains No New Information. On 17-Aug-2021: Follow-up received contains NNI.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Thyroid function test, Tinnitus, Vertigo
Clinical narrative: Dizziness; Symptoms worsened; Loss of balance; Tinnitus; Migraine headaches; Vertiginous symptoms; N/V; N/V; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus) and MIGRAINE (Migraine headaches) in a 75-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.     The patient's past medical history included GERD. Concurrent medical conditions included Hypothyroidism and Osteopenia.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus), MIGRAINE (Migraine headaches), VERTIGO (Vertiginous symptoms), NAUSEA (N/V) and VOMITING (N/V). The patient was treated with OXITRIPTAN (TRIPTAN [OXITRIPTAN]) for Adverse event, at an unspecified dose and frequency; OMEPRAZOLE for Adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus), MIGRAINE (Migraine headaches), VERTIGO (Vertiginous symptoms), NAUSEA (N/V) and VOMITING (N/V) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal. On an unknown date, Thyroid function test: normal (normal) normal. On an unknown date, Vitamin D: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that symptoms resolved after 3 months.   This case was linked to MOD-2021-278248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up contains No New Information. On 17-Aug-2021: Follow-up received contains NNI.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D, Vomiting
Clinical narrative: Dizziness; Symptoms worsened; Loss of balance; Tinnitus; Migraine headaches; Vertiginous symptoms; N/V; N/V; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus) and MIGRAINE (Migraine headaches) in a 75-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.     The patient's past medical history included GERD. Concurrent medical conditions included Hypothyroidism and Osteopenia.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus), MIGRAINE (Migraine headaches), VERTIGO (Vertiginous symptoms), NAUSEA (N/V) and VOMITING (N/V). The patient was treated with OXITRIPTAN (TRIPTAN [OXITRIPTAN]) for Adverse event, at an unspecified dose and frequency; OMEPRAZOLE for Adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), CONDITION AGGRAVATED (Symptoms worsened), BALANCE DISORDER (Loss of balance), TINNITUS (Tinnitus), MIGRAINE (Migraine headaches), VERTIGO (Vertiginous symptoms), NAUSEA (N/V) and VOMITING (N/V) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal. On an unknown date, Thyroid function test: normal (normal) normal. On an unknown date, Vitamin D: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that symptoms resolved after 3 months.   This case was linked to MOD-2021-278248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up contains No New Information. On 17-Aug-2021: Follow-up received contains NNI.