chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Hives all over the body; Arm is swollen; Hurts badly; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), PERIPHERAL SWELLING (Arm is swollen) and PAIN IN EXTREMITY (Hurts badly) 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 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives all over the body), PERIPHERAL SWELLING (Arm is swollen) and PAIN IN EXTREMITY (Hurts badly). The patient was treated with TRIAMCINOLONE (topical) for Hives, at a dose of 1 percent. At the time of the report, URTICARIA (Hives all over the body) had not resolved and PERIPHERAL SWELLING (Arm is swollen) and PAIN IN EXTREMITY (Hurts badly) 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Live follow up received on 11-Jun-2021 and contains updated event outcome to not recovered
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Pain in extremity
Clinical narrative: Sore arm; Irregular heartbeat; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEART RATE IRREGULAR (Irregular heartbeat) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321B21H) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 14-Apr-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 PAIN IN EXTREMITY (Sore arm), HEART RATE IRREGULAR (Irregular heartbeat) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEART RATE IRREGULAR (Irregular heartbeat) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Symptom recurrence, Vaccination site pain
Clinical narrative: redness on left arm; warm on left arm; Symptoms reemerged with sore right arm again; sore arm right; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on left arm), FEELING HOT (warm on left arm), SYMPTOM RECURRENCE (Symptoms reemerged with sore right arm again) and VACCINATION SITE PAIN (sore arm right) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm right). On 07-May-2021, the patient experienced SYMPTOM RECURRENCE (Symptoms reemerged with sore right arm again). On 08-May-2021, the patient experienced ERYTHEMA (redness on left arm) and FEELING HOT (warm on left arm). On 01-May-2021, VACCINATION SITE PAIN (sore arm right) had resolved. On 08-May-2021, SYMPTOM RECURRENCE (Symptoms reemerged with sore right arm again) had resolved. At the time of the report, ERYTHEMA (redness on left arm) and FEELING HOT (warm on left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-JUL-2021 contains updated contact information - email address and phone number.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Chills, Deafness unilateral, Ear discomfort, Magnetic resonance imaging
Clinical narrative: Sudden loss of hearing in left ear; Pressure in ear; Aches/Pains; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Sudden loss of hearing in left ear), EAR DISCOMFORT (Pressure in ear), PAIN (Aches/Pains) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Interstitial lung disease since 26-Dec-2019. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) from 1965 to an unknown date for Hypothyroidism, CALCIUM from 2010 to an unknown date and VITAMIN D3 from 2010 to an unknown date for Osteoporosis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Aches/Pains) and CHILLS (Chills). On 26-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Sudden loss of hearing in left ear) and EAR DISCOMFORT (Pressure in ear). The patient was treated with PREDNISONE on 26-Apr-2021 for Partial hearing loss, at a dose of 50 mg once a day. On 07-May-2021, DEAFNESS UNILATERAL (Sudden loss of hearing in left ear) and EAR DISCOMFORT (Pressure in ear) had resolved. At the time of the report, PAIN (Aches/Pains) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Acoustic stimulation tests: (Inconclusive) confirmed partial hearing loss in left ear.. On 05-May-2021, Magnetic resonance imaging: unknown (Inconclusive) showed no tumor or other abnormality.. On 07-May-2021, Acoustic stimulation tests: (Inconclusive) showed hearing restored..         Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-117984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Updated the reporters details, patient past medical history, laboratory data, concomitant medications and treatment drug added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sudden loss of hearing in left ear; Pressure in ear; Aches/Pains; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Sudden loss of hearing in left ear), EAR DISCOMFORT (Pressure in ear), PAIN (Aches/Pains) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Interstitial lung disease since 26-Dec-2019. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) from 1965 to an unknown date for Hypothyroidism, CALCIUM from 2010 to an unknown date and VITAMIN D3 from 2010 to an unknown date for Osteoporosis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Aches/Pains) and CHILLS (Chills). On 26-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Sudden loss of hearing in left ear) and EAR DISCOMFORT (Pressure in ear). The patient was treated with PREDNISONE on 26-Apr-2021 for Partial hearing loss, at a dose of 50 mg once a day. On 07-May-2021, DEAFNESS UNILATERAL (Sudden loss of hearing in left ear) and EAR DISCOMFORT (Pressure in ear) had resolved. At the time of the report, PAIN (Aches/Pains) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Acoustic stimulation tests: (Inconclusive) confirmed partial hearing loss in left ear.. On 05-May-2021, Magnetic resonance imaging: unknown (Inconclusive) showed no tumor or other abnormality.. On 07-May-2021, Acoustic stimulation tests: (Inconclusive) showed hearing restored..         Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-117984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Updated the reporters details, patient past medical history, laboratory data, concomitant medications and treatment drug added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Menstruation delayed, Myalgia
Clinical narrative: sweat through fleece; hands aches; missed her menstrual cycle last month which was supposed to be on April 18; body aches; headache on left side; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches) and HEADACHE (headache on left side) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DHEA, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), UBIDECARENONE (COQ-10) and FISH OIL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches), HEADACHE (headache on left side) and CHILLS (cold chills). At the time of the report, HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches), HEADACHE (headache on left side) and CHILLS (cold chills) outcome was unknown.            Concomitant included vitamins for fertility. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient is not sure if she is pregnant but have not seen doctor yet. patient also mentions of having a negative covid test
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sweat through fleece; hands aches; missed her menstrual cycle last month which was supposed to be on April 18; body aches; headache on left side; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches) and HEADACHE (headache on left side) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DHEA, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), UBIDECARENONE (COQ-10) and FISH OIL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches), HEADACHE (headache on left side) and CHILLS (cold chills). At the time of the report, HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches), HEADACHE (headache on left side) and CHILLS (cold chills) outcome was unknown.            Concomitant included vitamins for fertility. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient is not sure if she is pregnant but have not seen doctor yet. patient also mentions of having a negative covid test
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: peeling of the skin; swelling area was warm to the touch; injection site is still swelling; redness of the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (peeling of the skin), VACCINATION SITE WARMTH (swelling area was warm to the touch), VACCINATION SITE SWELLING (injection site is still swelling) and VACCINATION SITE ERYTHEMA (redness of the skin) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (swelling area was warm to the touch), VACCINATION SITE SWELLING (injection site is still swelling) and VACCINATION SITE ERYTHEMA (redness of the skin). On 08-May-2021, the patient experienced SKIN EXFOLIATION (peeling of the skin). At the time of the report, SKIN EXFOLIATION (peeling of the skin) and VACCINATION SITE SWELLING (injection site is still swelling) had not resolved and VACCINATION SITE WARMTH (swelling area was warm to the touch) and VACCINATION SITE ERYTHEMA (redness of the skin) had resolved.            No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received a double dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received a double dose of the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included ADD and Anxiety.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a double dose of the vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received a double dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications included an unspecified ADD (Attention deficit disorder) medication and an anxiety medication.  No treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and event treatment information was not provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red injection site; Sore right arm; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red injection site), PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE SWELLING (Swollen injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site), PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE SWELLING (Swollen injection site). On 08-May-2021, VACCINATION SITE ERYTHEMA (Red injection site), PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE SWELLING (Swollen injection site) had resolved. Not Provided   Treatment information was provided i.e., Tylenol for pain     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073215 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: more than half the dose didn't make it into the arm; 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 INCORRECT DOSE ADMINISTERED (more than half the dose didn't make it into the arm) 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (more than half the dose didn't make it into the arm). At the time of the report, INCORRECT DOSE ADMINISTERED (more than half the dose didn't make it into the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided.  No treatment information provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received.Second dose info received
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of sense of taste a week after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of sense of taste a week after vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, CELECOXIB (CELEXA [CELECOXIB]) and PREDNISONE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-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 AGEUSIA (Loss of sense of taste a week after vaccination). At the time of the report, AGEUSIA (Loss of sense of taste a week after vaccination) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 10-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Myalgia
Clinical narrative: 2nd dose was due but was out of town and still has not receive the 2nd Moderna vaccine; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (2nd dose was due on but was out of town and still has not receive the 2nd Moderna) and MYALGIA (arm was sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy (Contrast Dye).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (arm was sore). On 11-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (2nd dose was due on but was out of town and still has not receive the 2nd Moderna). On 10-Mar-2021, MYALGIA (arm was sore) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (2nd dose was due on but was out of town and still has not receive the 2nd Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter. Patient did not use any treatment medications.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: Cracked her left bottom third tooth from back; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Cracked her left bottom third tooth from back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Patient had 2 knee replacement surgeries) and Back surgery since an unknown date.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced TOOTH FRACTURE (Cracked her left bottom third tooth from back). At the time of the report, TOOTH FRACTURE (Cracked her left bottom third tooth from back) 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 information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site anaesthesia
Clinical narrative: loss of feeling in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (loss of feeling in right arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L208) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE ANAESTHESIA (loss of feeling in right arm). On 18-Jan-2021, VACCINATION SITE ANAESTHESIA (loss of feeling in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-118044 (Patient Link).
Age: 72.0
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 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for Blood pressure and Thyroiditis, unspecified, Zanax for Product used for unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Blood pressure and Thyroiditis medicines.  Treatment medications were not used   This case was linked to MOD21-073436 (E2B Linked Report).; Sender's Comments:  MOD21-073436:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) 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 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 PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided          No concomitant medication were reported. The reporter did not mention any treatment information.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Rash erythematous
Clinical narrative: red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose; red and tingling; red and tingling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose), RASH ERYTHEMATOUS (red and tingling) and PARAESTHESIA (red and tingling) 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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced RASH (red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose), RASH ERYTHEMATOUS (red and tingling) and PARAESTHESIA (red and tingling). At the time of the report, RASH (red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose), RASH ERYTHEMATOUS (red and tingling) and PARAESTHESIA (red and tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Anger, Headache, Insomnia, Nightmare, Vaccination site anaesthesia
Clinical narrative: nightmares; lack of sleep; severe loss of feeling in right arm; gets angry really quick; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), INSOMNIA (lack of sleep), VACCINATION SITE ANAESTHESIA (severe loss of feeling in right arm), ANGER (gets angry really quick) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M208 and 027L208) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 15-Feb-2021, the patient experienced NIGHTMARE (nightmares), INSOMNIA (lack of sleep), VACCINATION SITE ANAESTHESIA (severe loss of feeling in right arm), ANGER (gets angry really quick) and HEADACHE (headaches). At the time of the report, NIGHTMARE (nightmares), INSOMNIA (lack of sleep), VACCINATION SITE ANAESTHESIA (severe loss of feeling in right arm), ANGER (gets angry really quick) and HEADACHE (headaches) outcome was unknown.      Patient received 2nd shot on 15-FEB-2021 in the right arm (Lot: 024M208, Expiration date: 01JAN1900). Patient experienced loss of feeling in the right arm to where they were let go from their job. The patient also had lack of sleep, gets angry really quick, headaches and nightmares. Patient refused to give out date of birth. Patient took Ibuprofen once in a while (unknown strength and amount). Patient gave consent for safety to follow up.     No concomitant information was provided.  Treatment information included ibuprofen once in a while (unknown strength and amount).   This case was linked to MOD-2021-118014 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Heart rate, Heart rate increased, Myalgia
Clinical narrative: some allergic reaction; Difficulty breathing; Fast heart beat; blurry eyes; felt sick/Not feeling well; Sore in left arm; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (some allergic reaction), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heart beat), VISION BLURRED (blurry eyes) and VACCINATION COMPLICATION (felt sick/Not feeling well) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ALLERGY TO VACCINE (some allergic reaction), HEART RATE INCREASED (Fast heart beat) and VISION BLURRED (blurry eyes). 23-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), VACCINATION COMPLICATION (felt sick/Not feeling well), PAIN IN EXTREMITY (Sore in left arm) and MYALGIA (body ache). On 23-Apr-2021, ALLERGY TO VACCINE (some allergic reaction), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heart beat) and VISION BLURRED (blurry eyes) had resolved. On 24-Apr-2021, VACCINATION COMPLICATION (felt sick/Not feeling well), PAIN IN EXTREMITY (Sore in left arm) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.  The patient took Tylenol (acetaminophen) as advised by the pharmacy.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication, Vision blurred
Clinical narrative: some allergic reaction; Difficulty breathing; Fast heart beat; blurry eyes; felt sick/Not feeling well; Sore in left arm; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (some allergic reaction), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heart beat), VISION BLURRED (blurry eyes) and VACCINATION COMPLICATION (felt sick/Not feeling well) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ALLERGY TO VACCINE (some allergic reaction), HEART RATE INCREASED (Fast heart beat) and VISION BLURRED (blurry eyes). 23-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), VACCINATION COMPLICATION (felt sick/Not feeling well), PAIN IN EXTREMITY (Sore in left arm) and MYALGIA (body ache). On 23-Apr-2021, ALLERGY TO VACCINE (some allergic reaction), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heart beat) and VISION BLURRED (blurry eyes) had resolved. On 24-Apr-2021, VACCINATION COMPLICATION (felt sick/Not feeling well), PAIN IN EXTREMITY (Sore in left arm) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.  The patient took Tylenol (acetaminophen) as advised by the pharmacy.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Pain
Clinical narrative: Headache; pains; occasional dizziness; aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (pains), DIZZINESS (occasional dizziness) and MYALGIA (aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. refused) 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 HEADACHE (Headache), PAIN (pains), DIZZINESS (occasional dizziness) and MYALGIA (aches). At the time of the report, HEADACHE (Headache), PAIN (pains), DIZZINESS (occasional dizziness) and MYALGIA (aches) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant and treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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) (Intramuscular) 1 dosage form. On an unknown date, 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 PRURITUS (Itching). At the time of the report, PRURITUS (Itching) had resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: TCR : AE details and outcome.Patient's gender was added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; Myalgia; This spontaneous case was reported by a physician assistant and describes the occurrence of PYREXIA (Fever), MYALGIA (Myalgia) and NAUSEA (Nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINOCYCLINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Myalgia). On an unknown date, the patient experienced NAUSEA (Nausea). On 11-May-2021, PYREXIA (Fever), MYALGIA (Myalgia) and NAUSEA (Nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Total reduction in ankle swelling/Complete reduction in ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Total reduction in ankle swelling/Complete reduction in ankle pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B04A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high. Concomitant products included ENALAPRIL for Blood pressure management, LEVOTHYROXINE for Thyroid disorder, CALCIUM, MAGNESIUM, VITAMINS NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Total reduction in ankle swelling/Complete reduction in ankle pain). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Total reduction in ankle swelling/Complete reduction in ankle pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Throat tightness
Clinical narrative: Did not receive 2nd dose on due date; Felt like throat was closed; This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Felt like throat was closed) and INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose on due date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT TIGHTNESS (Felt like throat was closed). On 11-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose on due date). On 11-May-2021, INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose on due date) had resolved. At the time of the report, THROAT TIGHTNESS (Felt like throat was closed) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.  The patient felt like his throat was closed when he was on his way home, 30 minutes after the 1st dose. He was due for his second dose on day of this report but they declined to give the patient due his side effects after the first dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: redness in arm; soreness in arm; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), PERIPHERAL SWELLING (swelling in arm) and ERYTHEMA (redness in arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #003621A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm) and PERIPHERAL SWELLING (swelling in arm). On 11-May-2021, the patient experienced ERYTHEMA (redness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm), PERIPHERAL SWELLING (swelling in arm) and ERYTHEMA (redness in arm) outcome was unknown.            No concomitant medication and treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in both arms; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash in both arms) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced RASH (Rash in both arms). On 01-May-2021, RASH (Rash in both arms) 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.   patient did not taken any treatment for the event.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19
Clinical narrative: Getting COVID-19 after receiving the first dose of Moderna COVID-19 vaccine; Feels really weak two weeks after contracting COVID -19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting COVID-19 after receiving the first dose of Moderna COVID-19 vaccine) and ASTHENIA (Feels really weak two weeks after contracting COVID -19 infection) 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 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 COVID-19 (Getting COVID-19 after receiving the first dose of Moderna COVID-19 vaccine) and ASTHENIA (Feels really weak two weeks after contracting COVID -19 infection). At the time of the report, COVID-19 (Getting COVID-19 after receiving the first dose of Moderna COVID-19 vaccine) and ASTHENIA (Feels really weak two weeks after contracting COVID -19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 50-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Slept for 15 hours straight; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERSOMNIA (Slept for 15 hours straight) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERSOMNIA (Slept for 15 hours straight). On 09-Apr-2021, HYPERSOMNIA (Slept for 15 hours straight) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported     This case was linked to MOD-2021-118235 (Patient Link).