chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass, Vaccination site swelling
Clinical narrative: this time more painful when he moves his arm; about one inch below injection site bulging; about one inch below injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (this time more painful when he moves his arm), VACCINATION SITE MASS (about one inch below injection site bulging) and VACCINATION SITE SWELLING (about one inch below injection site swelling) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 an unknown date, the patient experienced PAIN IN EXTREMITY (this time more painful when he moves his arm), VACCINATION SITE MASS (about one inch below injection site bulging) and VACCINATION SITE SWELLING (about one inch below injection site swelling). At the time of the report, PAIN IN EXTREMITY (this time more painful when he moves his arm), VACCINATION SITE MASS (about one inch below injection site bulging) and VACCINATION SITE SWELLING (about one inch below injection site swelling) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079317 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079317:First dose case
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in the leg and arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain in the leg and arm) 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 15-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 MYALGIA (muscle pain in the leg and arm). At the time of the report, MYALGIA (muscle pain in the leg and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Vaccination site bruising; Bruise is purplish in color; Bruise a bit swollen, about a size of a nickel; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising), INJECTION SITE DISCOLOURATION (Bruise is purplish in color) and VACCINATION SITE SWELLING (Bruise a bit swollen, about a size of a nickel) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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 VACCINATION SITE BRUISING (Vaccination site bruising), INJECTION SITE DISCOLOURATION (Bruise is purplish in color) and VACCINATION SITE SWELLING (Bruise a bit swollen, about a size of a nickel). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising), INJECTION SITE DISCOLOURATION (Bruise is purplish in color) and VACCINATION SITE SWELLING (Bruise a bit swollen, about a size of a nickel) 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.   concomitant medicines was not reported by reporter   treatment information was not provided
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Oesophagitis, Pain in extremity, Somnolence
Clinical narrative: Has Eosinophilic Esophagitis. Had a flare up today; sore arm; felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (Has Eosinophilic Esophagitis. Had a flare up today), PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (felt sleepy) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Eosinophilic esophagitis.  On 09-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 OESOPHAGITIS (Has Eosinophilic Esophagitis. Had a flare up today), PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (felt sleepy). At the time of the report, OESOPHAGITIS (Has Eosinophilic Esophagitis. Had a flare up today), PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (felt sleepy) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient experienced pain and was worsened then expected. It felt like cellulitis. The patient normally took methyl prednisone and wanted to know if he can take it.  No concomitant medication reported.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash, Rash macular
Clinical narrative: Little spots in the body; Flu-like symptoms (runny nose, throat was hurting a little bit, light fever, shivers, felt tired); Rash around the eye, rash on wrists, back and face; Rash on the legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Little spots in the body), INFLUENZA LIKE ILLNESS (Flu-like symptoms (runny nose, throat was hurting a little bit, light fever, shivers, felt tired)), RASH (Rash around the eye, rash on wrists, back and face) and RASH (Rash on the legs) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced RASH MACULAR (Little spots in the body), INFLUENZA LIKE ILLNESS (Flu-like symptoms (runny nose, throat was hurting a little bit, light fever, shivers, felt tired)), RASH (Rash around the eye, rash on wrists, back and face) and RASH (Rash on the legs). On 16-Apr-2021, RASH (Rash around the eye, rash on wrists, back and face) had resolved. At the time of the report, RASH MACULAR (Little spots in the body) and INFLUENZA LIKE ILLNESS (Flu-like symptoms (runny nose, throat was hurting a little bit, light fever, shivers, felt tired)) outcome was unknown and RASH (Rash on the legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included high blood pressure and injection for the bones once every 2 years. Treatment details  included Benadryl.
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Back pain, Breast pain, Fatigue, Hypoaesthesia
Clinical narrative: neck ache; Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful; enlarged lymph nodes in her underarm, under chin, neck and breast; really sore in the breast area from nipple to back; really sore in the breast area from nipple to back; Tingling numbness under eye and cheek; Tingling numbness under eye and cheek; really tired; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), PAIN IN EXTREMITY (soreness of arm), NECK PAIN (neck ache), LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast) and BREAST PAIN (really sore in the breast area from nipple to back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (really tired) and PAIN IN EXTREMITY (soreness of arm). On 29-Mar-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast), BREAST PAIN (really sore in the breast area from nipple to back), BACK PAIN (really sore in the breast area from nipple to back), HYPOAESTHESIA (Tingling numbness under eye and cheek) and PARAESTHESIA (Tingling numbness under eye and cheek). On an unknown date, the patient experienced NECK PAIN (neck ache) and APHTHOUS ULCER (Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (really tired), PAIN IN EXTREMITY (soreness of arm), NECK PAIN (neck ache), LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast), BREAST PAIN (really sore in the breast area from nipple to back), BACK PAIN (really sore in the breast area from nipple to back), HYPOAESTHESIA (Tingling numbness under eye and cheek), PARAESTHESIA (Tingling numbness under eye and cheek) and APHTHOUS ULCER (Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: neck ache; Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful; enlarged lymph nodes in her underarm, under chin, neck and breast; really sore in the breast area from nipple to back; really sore in the breast area from nipple to back; Tingling numbness under eye and cheek; Tingling numbness under eye and cheek; really tired; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), PAIN IN EXTREMITY (soreness of arm), NECK PAIN (neck ache), LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast) and BREAST PAIN (really sore in the breast area from nipple to back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (really tired) and PAIN IN EXTREMITY (soreness of arm). On 29-Mar-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast), BREAST PAIN (really sore in the breast area from nipple to back), BACK PAIN (really sore in the breast area from nipple to back), HYPOAESTHESIA (Tingling numbness under eye and cheek) and PARAESTHESIA (Tingling numbness under eye and cheek). On an unknown date, the patient experienced NECK PAIN (neck ache) and APHTHOUS ULCER (Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (really tired), PAIN IN EXTREMITY (soreness of arm), NECK PAIN (neck ache), LYMPHADENOPATHY (enlarged lymph nodes in her underarm, under chin, neck and breast), BREAST PAIN (really sore in the breast area from nipple to back), BACK PAIN (really sore in the breast area from nipple to back), HYPOAESTHESIA (Tingling numbness under eye and cheek), PARAESTHESIA (Tingling numbness under eye and cheek) and APHTHOUS ULCER (Canker in the mouth is painful/Big canker in her mouth on left hand side/bothering in the mouth is painful) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Herpes zoster, Illness, Type IV hypersensitivity reaction
Clinical narrative: Shingles; sick for 24 hours; allergy to Moderna COVID-19 Vaccine; COVID-19 arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ILLNESS (sick for 24 hours), ALLERGY TO VACCINE (allergy to Moderna COVID-19 Vaccine) and TYPE IV HYPERSENSITIVITY REACTION (COVID-19 arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (did not specify).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles), ILLNESS (sick for 24 hours), ALLERGY TO VACCINE (allergy to Moderna COVID-19 Vaccine) and TYPE IV HYPERSENSITIVITY REACTION (COVID-19 arm). At the time of the report, HERPES ZOSTER (Shingles), ILLNESS (sick for 24 hours), ALLERGY TO VACCINE (allergy to Moderna COVID-19 Vaccine) and TYPE IV HYPERSENSITIVITY REACTION (COVID-19 arm) outcome was unknown. Not Provided          No concomitant medications were reported.  Patient was developed shingles twice in the same month despite having already received the shingles vaccine.
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.     Concurrent medical conditions included Colonoscopy.    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). At the time of the report, HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment medication not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Palpitations, Pruritus, Rash, Urticaria
Clinical narrative: heart started to beat fast; itching; lethargic; hives; rash on my back, forearm and stomach; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started to beat fast), PRURITUS (itching), LETHARGY (lethargic), URTICARIA (hives) and RASH (rash on my back, forearm and stomach) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Sulfur derived products).    On 24-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (heart started to beat fast), PRURITUS (itching), LETHARGY (lethargic), URTICARIA (hives) and RASH (rash on my back, forearm and stomach). On 25-Mar-2021, PRURITUS (itching) and RASH (rash on my back, forearm and stomach) had resolved. At the time of the report, PALPITATIONS (heart started to beat fast), LETHARGY (lethargic) and URTICARIA (hives) 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 medications were reported.  Treatment was with Benadryl.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Muscular weakness, Vaccination site pain
Clinical narrative: soreness where they gave the shot; tingling in my arm of the injection, it is sort of a pressure/It is in my shoulder and goes down my arm; It feels like my arm is going weak; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness where they gave the shot), INJECTION SITE PARAESTHESIA (tingling in my arm of the injection, it is sort of a pressure/It is in my shoulder and goes down my arm) and MUSCULAR WEAKNESS (It feels like my arm is going weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 VACCINATION SITE PAIN (soreness where they gave the shot), INJECTION SITE PARAESTHESIA (tingling in my arm of the injection, it is sort of a pressure/It is in my shoulder and goes down my arm) and MUSCULAR WEAKNESS (It feels like my arm is going weak). At the time of the report, VACCINATION SITE PAIN (soreness where they gave the shot) had resolved and INJECTION SITE PARAESTHESIA (tingling in my arm of the injection, it is sort of a pressure/It is in my shoulder and goes down my arm) and MUSCULAR WEAKNESS (It feels like my arm is going weak) had not resolved. Not Provided          No concomitant medication were provided.  Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-079325 (E2B Linked Report). This case was linked to MOD-2021-079325 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079325:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy (she was 13 weeks pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 043B21A) for COVID-19 vaccination. No medical history reported. On Apr 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was Oct 16, 2021. On Apr 16, 2021, patient experienced maternal exposure during pregnancy (she is 13 weeks pregnant). On Apr 16, 2021, maternal exposure during pregnancy (she is 13 weeks pregnant) resolved. Diagnostic results: On Feb 7, 2021, pregnancy test: positive. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchiness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity and Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's weight is given as 316 (unit unknown). No treatment medications were provided. No concomitant medications were reported. The patient stated one knot may have been from the first shot of vaccine she never noticed. She said she have been rubbing it, moving around, alleviate. At time of reporting pain has reduced but the knot still persist in pea size.   This case was linked to MOD-2021-079388 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Both doses of the vaccine raised my blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Both doses of the vaccine raised my blood pressure) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and FINASTERIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (Both doses of the vaccine raised my blood pressure). At the time of the report, HYPERTENSION (Both doses of the vaccine raised my blood pressure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 158/93 mmHg (High) 158/93. On 19-Mar-2021, Blood pressure measurement: 148/91 mmHg (High) 148/91. On an unknown date, Blood pressure measurement: 153/96 mmHg (High) 153/96.     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.   Treatment medication included Lisinopril.   This case was linked to US-MODERNATX, INC.-MOD-2021-079319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079319:First Dose
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Dizziness, Head discomfort, Hyperhidrosis, Pain in extremity
Clinical narrative: Bad vision in the left eye; Rush of pressure in the brain and head; Heart pounding; Palms of arms and hands sweating; Legs begin to quiver shake; Bowel movement; Dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Bad vision in the left eye), HEAD DISCOMFORT (Rush of pressure in the brain and head), PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating) and TREMOR (Legs begin to quiver shake) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac ablation. Concomitant products included ATORVASTATIN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Bad vision in the left eye), HEAD DISCOMFORT (Rush of pressure in the brain and head), PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating), TREMOR (Legs begin to quiver shake), BOWEL MOVEMENT IRREGULARITY (Bowel movement), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Sore arm). At the time of the report, VISUAL IMPAIRMENT (Bad vision in the left eye) and HEAD DISCOMFORT (Rush of pressure in the brain and head) had not resolved and PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating), TREMOR (Legs begin to quiver shake), BOWEL MOVEMENT IRREGULARITY (Bowel movement), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a history of rare blood IgA factor. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor, Visual impairment
Clinical narrative: Bad vision in the left eye; Rush of pressure in the brain and head; Heart pounding; Palms of arms and hands sweating; Legs begin to quiver shake; Bowel movement; Dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Bad vision in the left eye), HEAD DISCOMFORT (Rush of pressure in the brain and head), PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating) and TREMOR (Legs begin to quiver shake) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac ablation. Concomitant products included ATORVASTATIN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Bad vision in the left eye), HEAD DISCOMFORT (Rush of pressure in the brain and head), PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating), TREMOR (Legs begin to quiver shake), BOWEL MOVEMENT IRREGULARITY (Bowel movement), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Sore arm). At the time of the report, VISUAL IMPAIRMENT (Bad vision in the left eye) and HEAD DISCOMFORT (Rush of pressure in the brain and head) had not resolved and PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating), TREMOR (Legs begin to quiver shake), BOWEL MOVEMENT IRREGULARITY (Bowel movement), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a history of rare blood IgA factor. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body pain; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain), CHILLS (Chills) and HEADACHE (Headache) 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 PAIN (Body pain), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Body pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: TCR declining further FUP
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site pain (her right arm at injection site is sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 047B21A) for COVID-19 immunization. No medical history reported. On Apr 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 16, 2021, patient experienced injection site pain (her right arm at injection site is sore). At the time of the report, injection site pain (her right arm at injection site is sore): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. She called inquiring what type of treatment can she use to relieve the soreness. She wants relief before it gets any worse.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Dizziness, Emotional disorder
Clinical narrative: dizzy; bones hurt; Feels weak, Low energy; States she also feels very emotional; joint pain; Feels very achy in all her muscles, especially in her legs and arms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional) and ARTHRALGIA (joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional), ARTHRALGIA (joint pain), MYALGIA (Feels very achy in all her muscles, especially in her legs and arms) and HEADACHE (Headache). At the time of the report, DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional), ARTHRALGIA (joint pain), MYALGIA (Feels very achy in all her muscles, especially in her legs and arms) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: dizzy; bones hurt; Feels weak, Low energy; States she also feels very emotional; joint pain; Feels very achy in all her muscles, especially in her legs and arms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional) and ARTHRALGIA (joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional), ARTHRALGIA (joint pain), MYALGIA (Feels very achy in all her muscles, especially in her legs and arms) and HEADACHE (Headache). At the time of the report, DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional), ARTHRALGIA (joint pain), MYALGIA (Feels very achy in all her muscles, especially in her legs and arms) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: fatigue; headache; muscle aches; 100 earlier and 100.2 now; soreness in my left arm again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my left arm again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in my left arm again). On 16-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now). At the time of the report, PAIN IN EXTREMITY (soreness in my left arm again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature (97-99): fever of 102f and 100.2 f. (High) fever of 102F and 100.2 F..         No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; headache; muscle aches; 100 earlier and 100.2 now; soreness in my left arm again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my left arm again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in my left arm again). On 16-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now). At the time of the report, PAIN IN EXTREMITY (soreness in my left arm again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (100 earlier and 100.2 now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature (97-99): fever of 102f and 100.2 f. (High) fever of 102F and 100.2 F..         No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: migraine; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting) 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 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore left arm; Fatigue; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), FATIGUE (Fatigue) and CHILLS (Chills). On 09-Mar-2021, PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) had not resolved.            The Action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable.  Concomitant medication used were not provided.  No treatment information was provided.     This case was linked to MOD-2021-039122 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Nausea, Visual impairment
Clinical narrative: vision changes; Heavy headache with lot of pressure; nausea; Severe headache - 8/10, dull achy pain; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision changes), HEAD DISCOMFORT (Heavy headache with lot of pressure), NAUSEA (nausea) and HEADACHE (Severe headache - 8/10, dull achy pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VISUAL IMPAIRMENT (vision changes), HEAD DISCOMFORT (Heavy headache with lot of pressure), NAUSEA (nausea) and HEADACHE (Severe headache - 8/10, dull achy pain). At the time of the report, VISUAL IMPAIRMENT (vision changes), HEAD DISCOMFORT (Heavy headache with lot of pressure), NAUSEA (nausea) and HEADACHE (Severe headache - 8/10, dull achy pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient did not consult the doctor. Since 05-Apr-2021, she took Tylenol  (acetaminophen) once a day. The patient was not taking any other concomitant medication or supplements prior to vaccination. The patient had no allergies to food or medications.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Insomnia
Clinical narrative: inability to fall asleep at night; continuous headache that can't be relieved with a variety of medications; tiredness all of the time; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (inability to fall asleep at night), HEADACHE (continuous headache that can't be relieved with a variety of medications) and FATIGUE (tiredness all of the time) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested Positive for COVID) on 08-Oct-2020, Lost weight (lost 30 pounds due to COVID) on 08-Oct-2020, Vomiting on 08-Oct-2020, Oxygen consumption decreased (admitted to the hospital she needed oxygen) on 08-Oct-2020 and Hyponatraemia (sodium levels were low) on 08-Oct-2020.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INSOMNIA (inability to fall asleep at night), HEADACHE (continuous headache that can't be relieved with a variety of medications) and FATIGUE (tiredness all of the time). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MOTRIN FORTE) at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRINIL) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (inability to fall asleep at night), HEADACHE (continuous headache that can't be relieved with a variety of medications) and FATIGUE (tiredness all of the time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, COVID-19: Positive.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-079395 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079395:2nd dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Somnolence, Vaccination site erythema
Clinical narrative: Sleeping all day; dibilitating after the first vaccine; Headache; injection site redness; Injection site soreness; felt fatigue, tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Sleeping all day), ASTHENIA (dibilitating after the first vaccine), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (Injection site soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy (Sulfa).   On 06-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Apr-2021, the patient experienced SOMNOLENCE (Sleeping all day), ASTHENIA (dibilitating after the first vaccine), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (felt fatigue, tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleeping all day), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown, ASTHENIA (dibilitating after the first vaccine) and HEADACHE (Headache) had not resolved and FATIGUE (felt fatigue, tired) had resolved.            No concomitant medication information was provided.   This case was linked to MOD-2021-280145 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up information received on 06-AUG-2021. reporter address, patient demographic, Allergy history, treatment medication Vitamin and New events were updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sleeping all day; dibilitating after the first vaccine; Headache; injection site redness; Injection site soreness; felt fatigue, tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Sleeping all day), ASTHENIA (dibilitating after the first vaccine), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (Injection site soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy (Sulfa).   On 06-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Apr-2021, the patient experienced SOMNOLENCE (Sleeping all day), ASTHENIA (dibilitating after the first vaccine), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (felt fatigue, tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleeping all day), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown, ASTHENIA (dibilitating after the first vaccine) and HEADACHE (Headache) had not resolved and FATIGUE (felt fatigue, tired) had resolved.            No concomitant medication information was provided.   This case was linked to MOD-2021-280145 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up information received on 06-AUG-2021. reporter address, patient demographic, Allergy history, treatment medication Vitamin and New events were updated.