chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives/rashes started to appear first on the head; hives/rashes started to appear over the back; hives/rashes started to appear on the chest; hives/rashes started to appear first on the head; hives/rashes started to appear over the back; hives/rashes started to appear on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives/rashes started to appear first on the head), URTICARIA (hives/rashes started to appear over the back), URTICARIA (hives/rashes started to appear on the chest), RASH (hives/rashes started to appear first on the head) and RASH (hives/rashes started to appear over the back) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACLIDINIUM for COPD, HYDROXYCHLOROQUINE, ACETAMINOPHEN, SALBUTAMOL (ALBUTEROL HFA), AMLODIPINE, CARVEDILOL, FINASTERIDE, FUROSEMIDE, LISINOPRIL, PRAVASTATIN, SERTRALINE, TAMSULOSIN and WARFARIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (hives/rashes started to appear first on the head), URTICARIA (hives/rashes started to appear over the back), URTICARIA (hives/rashes started to appear on the chest), RASH (hives/rashes started to appear first on the head), RASH (hives/rashes started to appear over the back) and RASH (hives/rashes started to appear on the chest). At the time of the report, URTICARIA (hives/rashes started to appear first on the head), URTICARIA (hives/rashes started to appear over the back), URTICARIA (hives/rashes started to appear on the chest), RASH (hives/rashes started to appear first on the head), RASH (hives/rashes started to appear over the back) and RASH (hives/rashes started to appear on the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medications included Betamethasone 0.5% cream and Augmenter cream oral Prednisone treatment for 10 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of extremities; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs), the second episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs) and HYPOAESTHESIA (Numbness of extremities) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028-A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced the first episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs), the second episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs) and HYPOAESTHESIA (Numbness of extremities). At the time of the report, last episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs) had not resolved and HYPOAESTHESIA (Numbness of extremities) 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Excessive eye blinking, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of excessive eye blinking (couldn't stop blinking), myalgia (mild body aches) and pyrexia (mild fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A and 032L20A) for COVID-19 immunization. Concurrent medical conditions included high blood pressure. On Jan 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 22, 2021, patient experienced excessive eye blinking (couldn't stop blinking). On Feb 23, 2021, patient experienced myalgia (mild body aches) and pyrexia (mild fever). At the time of the report, excessive eye blinking (couldn't stop blinking), myalgia (mild body aches) and pyrexia (mild fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant products included high blood pressure medication for an unknown indication. Treatment provided: Benadryl. This case linked to MOD-2021-026210 (patient link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Myalgia
Clinical narrative: hair fall; little body aches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) and MYALGIA (little body aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 042B212A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ALOPECIA (hair fall) and MYALGIA (little body aches). At the time of the report, ALOPECIA (hair fall) and MYALGIA (little body aches) outcome was unknown.            The concomitants include blood pressure medication, cholesterol medication and nature's brown hair, skin, nail vitamins. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-may-2021 contains no new information.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Arm After the First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm After the First Vaccine) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm After the First Vaccine). On 12-Mar-2021, VACCINATION SITE PAIN (Sore Arm After the First Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090334, US-MODERNATX, INC.-MOD-2021-090629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090334:Cross linked US-MODERNATX, INC.-MOD-2021-090629:cross linked dose 1
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling
Clinical narrative: sore arms; Red swollen patch on the vaccination site; vacination  site pain; Bleeding upon injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), VACCINATION SITE HAEMORRHAGE (Bleeding upon injection), VACCINATION SITE SWELLING (Red swollen patch on the vaccination site) and VACCINATION SITE PAIN (vacination  site pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding upon injection) and VACCINATION SITE PAIN (vacination  site pain). On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arms) and VACCINATION SITE SWELLING (Red swollen patch on the vaccination site). At the time of the report, PAIN IN EXTREMITY (sore arms), VACCINATION SITE HAEMORRHAGE (Bleeding upon injection), VACCINATION SITE SWELLING (Red swollen patch on the vaccination site) and VACCINATION SITE PAIN (vacination  site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: fever; chills; fatigue; nausea; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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 26-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache). At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain in extremity
Clinical narrative: hair fall; little body aches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 042B212A) for COVID-19 vaccination.     No concomitant medication reported.  Concurrent medical conditions included Hypertension and Cholesterol.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches). At the time of the report, ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches) outcome was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: accidentally administered 1ml of the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (accidentally administered 1ml of the vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (accidentally administered 1ml of the vaccine). At the time of the report, ACCIDENTAL OVERDOSE (accidentally administered 1ml of the vaccine) outcome was unknown. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-090611, US-MODERNATX, INC.-MOD-2021-090426, US-MODERNATX, INC.-MOD-2021-090288 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090611: US-MODERNATX, INC.-MOD-2021-090426: US-MODERNATX, INC.-MOD-2021-090288:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on her face and neck / broke into hives this morning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her face and neck / broke into hives this morning) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021 at 8:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives on her face and neck / broke into hives this morning). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her face and neck / broke into hives this morning) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-090576 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Tongue discolouration
Clinical narrative: Body aches; Tongue turned white; Headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027T21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-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 14-Apr-2021, the patient experienced PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 17-Apr-2021, PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever) had resolved.            No concomitant information provided. Treatment details included  extra Strength Tylenol
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaccination site pain
Clinical narrative: Menstrual Period is Late Because of the Vaccine; Sore Arm After the Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine) and VACCINATION SITE PAIN (Sore Arm After the Second Shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm After the Second Shot). On 26-Apr-2021, the patient experienced MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine). On 08-Apr-2021, VACCINATION SITE PAIN (Sore Arm After the Second Shot) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090334 (E2B Linked Report). This case was linked to MOD-2021-090621 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090334:Cross linked
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Head discomfort, Headache, Myalgia
Clinical narrative: pressure in her head; fever; nausea; chills; body aches and muscle pain; joint pain; bad intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches and muscle pain) in a 38-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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches). On an unknown date, the patient experienced MYALGIA (body aches and muscle pain). At the time of the report, HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to INC.-MOD-2021-090357 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-090357:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: pressure in her head; fever; nausea; chills; body aches and muscle pain; joint pain; bad intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches and muscle pain) in a 38-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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches). On an unknown date, the patient experienced MYALGIA (body aches and muscle pain). At the time of the report, HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to INC.-MOD-2021-090357 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-090357:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Blodd pressure elevated upto 154/99; 1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 028L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LORAZEPAM, SERTRALINE HCL, ATORVASTATIN, ESZOPICLONE (LUNESTA), MULTIVITAMIN [VITAMINS NOS], FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL] and FISH OIL for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021). On 16-Apr-2021 at 10:00 AM, the patient experienced BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021) had resolved. On 17-Apr-2021, BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: 154/99 (High) 154/99. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-033069 (E2B Linked Report). This case was linked to MOD-2021-033069 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033069:Dose 1
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Rash macular
Clinical narrative: Tired now; flu like symptoms; red splotches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH MACULAR (red splotches) and FATIGUE (Tired now) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 641L20A and N4017294) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) for Blood pressure high, SERTRALINE HYDROCHLORIDE (SERTRALINE A) for Depression, TOPIRAMATE for Headache, CEFIXIME (FLEXERIL [CEFIXIME]) for Muscle relaxant and rest, TRAMADOL for Pain.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and RASH MACULAR (red splotches). On 26-Apr-2021, the patient experienced FATIGUE (Tired now). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved, RASH MACULAR (red splotches) had not resolved and FATIGUE (Tired now) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitants included thyroid and cholesterol medication, Treatment medication included Dermand cream.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave the first dose to 6 patients between the ages of 16 - 17 years old; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave the first dose to 6 patients between the ages of 16 - 17 years old) in an adolescent patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave the first dose to 6 patients between the ages of 16 - 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave the first dose to 6 patients between the ages of 16 - 17 years old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The reporter was a Chief Clinical Officer (MD).  No patient details available.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Thawed in refrigerator then placed in freezer; removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Thawed in refrigerator then placed in freezer ) and PRODUCT STORAGE ERROR (removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) 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 26-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Thawed in refrigerator then placed in freezer ) and PRODUCT STORAGE ERROR (removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,). On 26-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Thawed in refrigerator then placed in freezer ) and PRODUCT STORAGE ERROR (removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the Reporter. No Treatment medications were provided by the Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non Significant follow up  and It was contain no new information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza like illness, Pruritus, Rash, Rash erythematous
Clinical narrative: skin was itchy both arms, arms to waist, back, legs; like sting sunburn, kept on scratching; could not think clearly; rash over the trunk, under breasts; a lot of red dots on upper arms and upper legs; bad flu; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over the trunk, under breasts), ERYTHEMA (a lot of red dots on upper arms and upper legs), PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly) in a 55-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.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (bad flu). On 24-Apr-2021, the patient experienced RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs). On 26-Apr-2021, the patient experienced PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly). On 25-Apr-2021, RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs) had resolved. At the time of the report, PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching), THINKING ABNORMAL (could not think clearly) and INFLUENZA LIKE ILLNESS (bad flu) outcome was unknown.            Other concomitant medications include Hormone Replacement gel from France and Hormone Replacement take daily.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to MOD-2021-090646 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: skin was itchy both arms, arms to waist, back, legs; like sting sunburn, kept on scratching; could not think clearly; rash over the trunk, under breasts; a lot of red dots on upper arms and upper legs; bad flu; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over the trunk, under breasts), ERYTHEMA (a lot of red dots on upper arms and upper legs), PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly) in a 55-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.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (bad flu). On 24-Apr-2021, the patient experienced RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs). On 26-Apr-2021, the patient experienced PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly). On 25-Apr-2021, RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs) had resolved. At the time of the report, PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching), THINKING ABNORMAL (could not think clearly) and INFLUENZA LIKE ILLNESS (bad flu) outcome was unknown.            Other concomitant medications include Hormone Replacement gel from France and Hormone Replacement take daily.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to MOD-2021-090646 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gait inability, Pruritus, Testicular swelling, Testis discomfort
Clinical narrative: can not move; itchy arm; right testicle was swollen; painful testicle; red testicle; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle), ERYTHEMA (red testicle), GAIT INABILITY (can not move) and PRURITUS (itchy arm) 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 21-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 21-Apr-2021, the patient experienced TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle) and ERYTHEMA (red testicle). On an unknown date, the patient experienced GAIT INABILITY (can not move) and PRURITUS (itchy arm). At the time of the report, TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle), ERYTHEMA (red testicle), GAIT INABILITY (can not move) and PRURITUS (itchy arm) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Vaccination site swelling
Clinical narrative: was unable to raise my arm; itchiness; injection site swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (was unable to raise my arm), PRURITUS (itchiness) and VACCINATION SITE SWELLING (injection site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 042L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3 and VITAMIN B12 NOS for an unknown indication.   On 09-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling). On an unknown date, the patient experienced LIMB DISCOMFORT (was unable to raise my arm) and PRURITUS (itchiness). On 20-Feb-2021, VACCINATION SITE SWELLING (injection site swelling) had resolved. At the time of the report, LIMB DISCOMFORT (was unable to raise my arm) and PRURITUS (itchiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-027305 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Erythema, Fatigue, Influenza
Clinical narrative: Red dots on upper arms and upper legs; Skin was itchy on both arms / waist / back / leg; Sting sunburn; Patient could not think / sharpness was gone; red dots on arm; Rash on trunk / under breast; Bad flu; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Bad flu), PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn), MEMORY IMPAIRMENT (Patient could not think / sharpness was gone) and ERYTHEMA (Red dots on upper arms and upper legs) in a 55-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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 22-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). On 22-Apr-2021, the patient experienced INFLUENZA (Bad flu). On 24-Apr-2021, the patient experienced RASH (Rash on trunk / under breast) and ALLERGY TO VACCINE (red dots on arm). On 26-Apr-2021, the patient experienced PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn) and MEMORY IMPAIRMENT (Patient could not think / sharpness was gone). On an unknown date, the patient experienced ERYTHEMA (Red dots on upper arms and upper legs). On 24-Mar-2021, CHILLS (Chills) outcome was unknown. On 29-Mar-2021, FATIGUE (fatigue) outcome was unknown. On 25-Apr-2021, ALLERGY TO VACCINE (red dots on arm) outcome was unknown. At the time of the report, INFLUENZA (Bad flu), PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn), MEMORY IMPAIRMENT (Patient could not think / sharpness was gone), ERYTHEMA (Red dots on upper arms and upper legs) and RASH (Rash on trunk / under breast) 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.       Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pruritus, Rash, Sunburn
Clinical narrative: Red dots on upper arms and upper legs; Skin was itchy on both arms / waist / back / leg; Sting sunburn; Patient could not think / sharpness was gone; red dots on arm; Rash on trunk / under breast; Bad flu; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Bad flu), PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn), MEMORY IMPAIRMENT (Patient could not think / sharpness was gone) and ERYTHEMA (Red dots on upper arms and upper legs) in a 55-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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 22-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). On 22-Apr-2021, the patient experienced INFLUENZA (Bad flu). On 24-Apr-2021, the patient experienced RASH (Rash on trunk / under breast) and ALLERGY TO VACCINE (red dots on arm). On 26-Apr-2021, the patient experienced PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn) and MEMORY IMPAIRMENT (Patient could not think / sharpness was gone). On an unknown date, the patient experienced ERYTHEMA (Red dots on upper arms and upper legs). On 24-Mar-2021, CHILLS (Chills) outcome was unknown. On 29-Mar-2021, FATIGUE (fatigue) outcome was unknown. On 25-Apr-2021, ALLERGY TO VACCINE (red dots on arm) outcome was unknown. At the time of the report, INFLUENZA (Bad flu), PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn), MEMORY IMPAIRMENT (Patient could not think / sharpness was gone), ERYTHEMA (Red dots on upper arms and upper legs) and RASH (Rash on trunk / under breast) 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.       Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: being tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (being tired and fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOFLOXACIN, RIVAROXABAN (XARELTO), LISINOPRIL, HYDROCHLOROTHIAZIDE, OXYCODONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (being tired and fatigued). On 14-Feb-2021, FATIGUE (being tired and fatigued) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.   This case was linked to MOD-2021-090660 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: facial redness; some tingling; numbing in the front of her face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face) 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 ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face). At the time of the report, ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face) outcome was unknown. 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.   No concomitant medication details were provided. Benadryl was used as treatment medication.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain two weeks after; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain two weeks after) in a 76-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 NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), VITAMIN D NOS, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (lower back pain two weeks after). The patient was treated with NAPROXEN for Pain, at a dose of UNK dosage form. At the time of the report, BACK PAIN (lower back pain two weeks after) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-090652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021. Patient stated that two weeks after 1st shot, lower back pain not bad, she stated that she ignored became worse after 2nd shot with other events.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: some contractors at their site got second doses for an interval gap of 50+ days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days) outcome was unknown. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-090613 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090613:Case for patient
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: brainf fog; The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left; can hardly walk , can't get out of bed, has a hard time getting off the toilet.; fatigue; chills; fever; back pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN, FEELING ABNORMAL (brains fog), MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left) and FATIGUE (fatigue) in a 76-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 was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Flax Seed Oil, POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (back pain). On 25-Mar-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN (back pain), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-090649 (Patient Link).