chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypertension, Tremor
Clinical narrative: Chills; shivering; shaking; very high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), CHILLS (shivering), TREMOR (shaking) and HYPERTENSION (very high blood pressure) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CHILLS (Chills), CHILLS (shivering), TREMOR (shaking) and HYPERTENSION (very high blood pressure). At the time of the report, CHILLS (Chills), CHILLS (shivering), TREMOR (shaking) and HYPERTENSION (very high blood pressure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-076620 (Linked Report).  Treatment products included metoprolol 50 mg.; Sender's Comments:  MOD21-076620:MOD-2021-078027 -1st dose of vaccine
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: lump the size of golf ball in the arm of the injection; arm was sore last night and all day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump the size of golf ball in the arm of the injection) and PAIN IN EXTREMITY (arm was sore last night and all day) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (Patient completed series of vaccination on 14 Apr 2021 and details about previous vaccine not provided.).    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE MASS (lump the size of golf ball in the arm of the injection) and PAIN IN EXTREMITY (arm was sore last night and all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump the size of golf ball in the arm of the injection) and PAIN IN EXTREMITY (arm was sore last night and all day) outcome was unknown. Not Provided          No concomitant medication were provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after 48 hours of a punctured vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) 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 09-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial). On 09-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-077668, US-MODERNATX, INC.-MOD-2021-077928, US-MODERNATX, INC.-MOD-2021-078057 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 01-JUN-2021 and patient details, product details was updated.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 006821A)  with no associated AEs. US-MODERNATX, INC.-MOD-2021-077668: US-MODERNATX, INC.-MOD-2021-077928: US-MODERNATX, INC.-MOD-2021-078057:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting projectile
Clinical narrative: "throwing up non-stop"; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING PROJECTILE ("throwing up non-stop") in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN for Cholesterol, ATENOLOL for Hypertension.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VOMITING PROJECTILE ("throwing up non-stop"). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of unknown. At the time of the report, VOMITING PROJECTILE ("throwing up non-stop") outcome was unknown.            Treatment ZOFRAN   This case was linked to MOD-2021-078029 (E2B Linked Report).; Sender's Comments:  MOD-2021-078029:First dose case
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint swelling
Clinical narrative: Ankles are swollen; Can't walk properly; Pain in left ankle; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankles are swollen), GAIT DISTURBANCE (Can't walk properly) and ARTHRALGIA (Pain in left ankle) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21N and 044A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CHLORTHALIDONE and SIMVASTATINE 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 12-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 JOINT SWELLING (Ankles are swollen), GAIT DISTURBANCE (Can't walk properly) and ARTHRALGIA (Pain in left ankle). At the time of the report, JOINT SWELLING (Ankles are swollen), GAIT DISTURBANCE (Can't walk properly) and ARTHRALGIA (Pain in left ankle) outcome was unknown.            This case was linked to MOD-2021-078036 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nasal congestion
Clinical narrative: Period came a week and a half earlier than normal; nose virus before and still has the virus after the vaccination; Vaccination caused early periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period came a week and a half earlier than normal), NASAL CONGESTION (nose virus before and still has the virus after the vaccination) and MENSTRUATION IRREGULAR (Vaccination caused early periods) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Nasal congestion. Concomitant products included Nasal Spray for Nose Virus for an unknown indication.    On 13-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 MENSTRUATION IRREGULAR (Period came a week and a half earlier than normal), NASAL CONGESTION (nose virus before and still has the virus after the vaccination) and MENSTRUATION IRREGULAR (Vaccination caused early periods). At the time of the report, MENSTRUATION IRREGULAR (Period came a week and a half earlier than normal), NASAL CONGESTION (nose virus before and still has the virus after the vaccination) and MENSTRUATION IRREGULAR (Vaccination caused early periods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia, Pain in extremity
Clinical narrative: 3-4 days after receiving his 2nd dose, both of his arms have been aching; inability of hardly being able to lift them in the morning; pain more of a muscle pain than joint; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (3-4 days after receiving his 2nd dose, both of his arms have been aching), MOVEMENT DISORDER (inability of hardly being able to lift them in the morning) and MYALGIA (pain more of a muscle pain than joint) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Nov-2020. Concomitant products included VALSARTAN, SIMVASTATIN and VENLAFAXINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (3-4 days after receiving his 2nd dose, both of his arms have been aching), MOVEMENT DISORDER (inability of hardly being able to lift them in the morning) and MYALGIA (pain more of a muscle pain than joint). At the time of the report, PAIN IN EXTREMITY (3-4 days after receiving his 2nd dose, both of his arms have been aching), MOVEMENT DISORDER (inability of hardly being able to lift them in the morning) and MYALGIA (pain more of a muscle pain than joint) outcome was unknown. Not Provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: fever; headache; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA), ATORVASTATIN CALCIUM (LIPITOR) and FINASTERIDE for an unknown indication.   On 14-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 14-Apr-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drainage, Oropharyngeal pain
Clinical narrative: sore throat; drainage; coughing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and COUGH (coughing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and COUGH (coughing). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and COUGH (coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine given after 48 hours of a punctured vial; Vaccine given after 48 hours of a punctured vial; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) 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 09-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial). At the time of the report, PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-077668, US-MODERNATX, INC.-MOD-2021-078047, US-MODERNATX, INC.-MOD-2021-077928 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non Significant follow up received on 21 JUL 2021, no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077668: US-MODERNATX, INC.-MOD-2021-078047: US-MODERNATX, INC.-MOD-2021-077928:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: More than Half the vaccine dose leaked (Second Dose) per patient; More than Half the vaccine dose leaked (Second Dose) per patient; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (More than Half the vaccine dose leaked (Second Dose) per patient) and DEVICE CONNECTION ISSUE (More than Half the vaccine dose leaked (Second Dose) per patient) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021 at 5:15 PM, 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 DEVICE CONNECTION ISSUE (More than Half the vaccine dose leaked (Second Dose) per patient). On 15-Apr-2021 at 5:15 PM, the patient experienced UNDERDOSE (More than Half the vaccine dose leaked (Second Dose) per patient). On 15-Apr-2021 at 5:15 PM, UNDERDOSE (More than Half the vaccine dose leaked (Second Dose) per patient) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (More than Half the vaccine dose leaked (Second Dose) per patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Per report, during vaccine administration, the needle dislocated from the syringe and one drip was lost on the floor. Therefore the patient requests for the dose to be repeated.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Moderna vaccine first dose information updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN for Cholesterol blood excessive, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and PIOGLITAZONE for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) and NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (B-100 COMPLEX) for an unknown indication.    On 16-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 PAIN (Soreness). On 19-Mar-2021, PAIN (Soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Tremor
Clinical narrative: Shakes; A lot of fatigue; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), FATIGUE (A lot of fatigue) and NAUSEA (Nauseas) 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 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced TREMOR (Shakes), FATIGUE (A lot of fatigue) and NAUSEA (Nauseas). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 13 milligram. At the time of the report, TREMOR (Shakes), FATIGUE (A lot of fatigue) and NAUSEA (Nauseas) outcome was unknown.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     Reporter did not allow further contact
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Immediate swelling at the injection site after administration; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Immediate swelling at the injection site after administration) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Immediate swelling at the injection site after administration). At the time of the report, VACCINATION SITE SWELLING (Immediate swelling at the injection site after administration) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient was monitored for 30 minutes in the waiting area and the reaction was subsided by then.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Underdose
Clinical narrative: most of the vaccine ran down outside; one of the needle was not completely tight; one of the needle was not completely tight; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (most of the vaccine ran down outside), UNDERDOSE (one of the needle was not completely tight) and DEVICE CONNECTION ISSUE (one of the needle was not completely tight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (most of the vaccine ran down outside) and UNDERDOSE (one of the needle was not completely tight). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (one of the needle was not completely tight). At the time of the report, INCORRECT DOSE ADMINISTERED (most of the vaccine ran down outside) and UNDERDOSE (one of the needle was not completely tight) 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.
Sex: M
Vaccine: COVID19
Symptoms: Tooth loss
Clinical narrative: crown fell out; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH LOSS (crown fell out) 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 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced TOOTH LOSS (crown fell out). At the time of the report, TOOTH LOSS (crown fell out) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment details were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache
Clinical narrative: Coughing; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and HEADACHE (Headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headaches cluster on 13-Apr-2021 and Coughing on 13-Apr-2021.    On 13-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 COUGH (Coughing) and HEADACHE (Headaches). At the time of the report, COUGH (Coughing) and HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatments were not reported. Treatment include bed rest. Patient undergone an unknown surgery.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received and contains significant information. Updated Non drug treatment and surgery.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FARXIGA                                                      and PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZON) for Diabetes mellitus, ATORVASTATIN for Hypercholesteraemia, LOSARTAN for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CYANOCOBALAMIN (B-12) for an unknown indication.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-078059 (E2B Linked Report).; Sender's Comments:  MOD-2021-078059:First dose case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dyspnoea, Fatigue
Clinical narrative: joint pain; muscle pain; fatigue; chills; nausea; chest pain; difficulty breathing; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, WARFARIN and FENTANYL (FENTANYL PATCH) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing) and SWELLING (Swelling). At the time of the report, ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing) and SWELLING (Swelling) outcome was unknown. Not Provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Swelling
Clinical narrative: joint pain; muscle pain; fatigue; chills; nausea; chest pain; difficulty breathing; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM, WARFARIN and FENTANYL (FENTANYL PATCH) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing) and SWELLING (Swelling). At the time of the report, ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing) and SWELLING (Swelling) outcome was unknown. Not Provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Sneezing
Clinical narrative: left eye kept watering; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (left eye kept watering) and SNEEZING (sneezing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LORATADINE for an unknown indication.    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 LACRIMATION INCREASED (left eye kept watering) and SNEEZING (sneezing). At the time of the report, LACRIMATION INCREASED (left eye kept watering) and SNEEZING (sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided          No concomitant medications were reported. No corrective treatment was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past due for his second Moderna Covid-19 shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past due for his second Moderna Covid-19 shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (past due for his second Moderna Covid-19 shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past due for his second Moderna Covid-19 shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information and treatment details provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: TCR
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: and tenderness; her fever spiked a fever of over 102; She also had redness; and swelling; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (and tenderness), OXYGEN SATURATION DECREASED (her pulse O2 dropped to 95%), PYREXIA (her fever spiked a fever of over 102), VACCINATION SITE ERYTHEMA (She also had redness) and VACCINATION SITE SWELLING (and swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-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 TENDERNESS (and tenderness), OXYGEN SATURATION DECREASED (her pulse O2 dropped to 95%), PYREXIA (her fever spiked a fever of over 102), VACCINATION SITE ERYTHEMA (She also had redness) and VACCINATION SITE SWELLING (and swelling). At the time of the report, TENDERNESS (and tenderness), OXYGEN SATURATION DECREASED (her pulse O2 dropped to 95%), PYREXIA (her fever spiked a fever of over 102), VACCINATION SITE ERYTHEMA (She also had redness) and VACCINATION SITE SWELLING (and swelling) 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.   RN called and said last year in March prior to masking and she had a patient that was sick and was diagnosed with double pneumonia The nurse also got sick. But neither tested positive for COVID. Recently she received the second dose of the vaccine and her fever spiked a fever of over 102 and her pulse O2 dropped to 95% She is wondering if she had this reaction due to her contact with the patient a year ago. If she had gained antibodies and this is why she had a severe reaction. She also had redness and swelling and tenderness on injection site No further information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site rash
Clinical narrative: Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder) and VACCINATION SITE RASH (Rash around the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder) and VACCINATION SITE RASH (Rash around the injection site). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was not administered properly in the deltoid muscle but rather halfway between her elbowand shoulder) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dry mouth, Feeling abnormal, Insomnia
Clinical narrative: whole body was weak; heavy mucus cough; hideous dry mouth; body felt like it had no bones; really really terrible; fell asleep in a stupor for 24 hours; felt like she was a snake; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (whole body was weak), COUGH (heavy mucus cough), DRY MOUTH (hideous dry mouth), FEELING ABNORMAL (body felt like it had no bones) and FEELING ABNORMAL (really really terrible) 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 12-Jan-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 an unknown date, the patient experienced ASTHENIA (whole body was weak), COUGH (heavy mucus cough), DRY MOUTH (hideous dry mouth), FEELING ABNORMAL (body felt like it had no bones), FEELING ABNORMAL (really really terrible), INSOMNIA (fell asleep in a stupor for 24 hours) and FEELING ABNORMAL (felt like she was a snake). At the time of the report, ASTHENIA (whole body was weak), COUGH (heavy mucus cough), DRY MOUTH (hideous dry mouth), FEELING ABNORMAL (body felt like it had no bones), FEELING ABNORMAL (really really terrible), INSOMNIA (fell asleep in a stupor for 24 hours) and FEELING ABNORMAL (felt like she was a snake) outcome was unknown. Not Provided          No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Huge rash; grape size swollen lymph node; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Huge rash) and LYMPHADENOPATHY (grape size swollen lymph node) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced RASH (Huge rash) and LYMPHADENOPATHY (grape size swollen lymph node). At the time of the report, RASH (Huge rash) and LYMPHADENOPATHY (grape size swollen lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non significant follow up received on 18-MAY-2021, no new information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Fatigue, Myalgia, Vertigo
Clinical narrative: spinning feeling upon rapid movements or rising up; dizziness; vertigo; tired and achy; tired and achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (spinning feeling upon rapid movements or rising up), DIZZINESS (dizziness), VERTIGO (vertigo), FATIGUE (tired and achy) and MYALGIA (tired and achy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit disorder, GLATIRAMER ACETATE (COPAXONE) for Multiple sclerosis, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000).   On 06-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 07-Apr-2021, the patient experienced FATIGUE (tired and achy) and MYALGIA (tired and achy). On 11-Apr-2021, the patient experienced DIZZINESS POSTURAL (spinning feeling upon rapid movements or rising up), DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS POSTURAL (spinning feeling upon rapid movements or rising up), DIZZINESS (dizziness), VERTIGO (vertigo), FATIGUE (tired and achy) and MYALGIA (tired and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: I am positive for covid at this time; Dizziness; I feel sick; Did not feel good; Patient stated that she didnot feel normal; Felling fatigued; Headache; Seeing spots; Felt was like having motion sickness; Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), VISUAL IMPAIRMENT (Seeing spots) and MOTION SICKNESS (Felt was like having motion sickness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-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 15-Apr-2021, the patient experienced VISUAL IMPAIRMENT (Seeing spots), MOTION SICKNESS (Felt was like having motion sickness) and FEELING ABNORMAL (Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good). On an unknown date, the patient experienced COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), ILLNESS (Did not feel good), FEELING ABNORMAL (Patient stated that she didnot feel normal), FATIGUE (Felling fatigued) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), VISUAL IMPAIRMENT (Seeing spots), MOTION SICKNESS (Felt was like having motion sickness), FEELING ABNORMAL (Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good), ILLNESS (Did not feel good), FEELING ABNORMAL (Patient stated that she didnot feel normal), FATIGUE (Felling fatigued) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicines were not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow-up as event added
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Motion sickness, Visual impairment
Clinical narrative: I am positive for covid at this time; Dizziness; I feel sick; Did not feel good; Patient stated that she didnot feel normal; Felling fatigued; Headache; Seeing spots; Felt was like having motion sickness; Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), VISUAL IMPAIRMENT (Seeing spots) and MOTION SICKNESS (Felt was like having motion sickness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-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 15-Apr-2021, the patient experienced VISUAL IMPAIRMENT (Seeing spots), MOTION SICKNESS (Felt was like having motion sickness) and FEELING ABNORMAL (Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good). On an unknown date, the patient experienced COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), ILLNESS (Did not feel good), FEELING ABNORMAL (Patient stated that she didnot feel normal), FATIGUE (Felling fatigued) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COVID-19 (I am positive for covid at this time), DIZZINESS (Dizziness), ILLNESS (I feel sick), VISUAL IMPAIRMENT (Seeing spots), MOTION SICKNESS (Felt was like having motion sickness), FEELING ABNORMAL (Scary feeling because she couldn't feel herself/Patient stated that she didn't feel normal/Didn't feel good), ILLNESS (Did not feel good), FEELING ABNORMAL (Patient stated that she didnot feel normal), FATIGUE (Felling fatigued) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicines were not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow-up as event added
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included RIVAROXABAN (XARELTO) for Blood disorder, PRAVASTATIN for Cholesterol, VALSARTAN and AMLODIPINE for Hypertension, MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Mar-2021, the patient experienced MYALGIA (Soreness). On 19-Mar-2021, MYALGIA (Soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.    This case was linked to MOD-2021-078059, MOD-2021-078068, MOD-2021-078029, MOD-2021-078048 (E2B Linked Report).; Sender's Comments:  MOD-2021-078059:Wife first dose case MOD-2021-078068:Wife second dose case MOD-2021-078029:Son first dose case MOD-2021-078048:Son second dose case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Emotional distress, Erythema
Clinical narrative: Wanted to jump out a window; In "agony"; Couldn't sleep for 36 hours; Intense chest pain (felt like an Myocardial infarction); Had to crawl back to bed on hands and knees; Chest pain resolved in 10 minutes; Dizzy; Bilateral redness on cheeks; Pain "unbearable"; Head started pounding; Chills (not too bad); Felt like knives were going into her head through both eyes; Sore injected arm; Felt as if she could unzip her head, and let the pressure out she would feel better; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)) and GAIT DISTURBANCE (Had to crawl back to bed on hands and knees) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included multivitamin, Emer-GN-cee   This case was linked to US-MODERNATX, INC.-MOD-2021-078099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078099: