chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm around injection site after 1st dose; circle and knot around injection site; Itchy around injection site after 1st dose; red around injection site after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm around injection site after 1st dose), VACCINATION SITE MASS (circle and knot around injection site), VACCINATION SITE PRURITUS (Itchy around injection site after 1st dose) and VACCINATION SITE ERYTHEMA (red around injection site after 1st dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 21-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 VACCINATION SITE WARMTH (Warm around injection site after 1st dose), VACCINATION SITE MASS (circle and knot around injection site), VACCINATION SITE PRURITUS (Itchy around injection site after 1st dose) and VACCINATION SITE ERYTHEMA (red around injection site after 1st dose). At the time of the report, VACCINATION SITE WARMTH (Warm around injection site after 1st dose), VACCINATION SITE MASS (circle and knot around injection site), VACCINATION SITE PRURITUS (Itchy around injection site after 1st dose) and VACCINATION SITE ERYTHEMA (red around injection site after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included thyroid medication.  Treatment medication for event was not provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Nausea, Pain, Vaccination site erythema
Clinical narrative: side of injection feels worm to the touch; redness spread to the elbow; site of injection is itching; Redness of injection site; body aches; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (side of injection feels worm to the touch), ERYTHEMA (redness spread to the elbow), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (Redness of injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (side of injection feels worm to the touch) and ERYTHEMA (redness spread to the elbow). On 02-Mar-2021, PAIN (body aches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE WARMTH (side of injection feels worm to the touch), ERYTHEMA (redness spread to the elbow), VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (Redness of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth, Vomiting
Clinical narrative: side of injection feels worm to the touch; redness spread to the elbow; site of injection is itching; Redness of injection site; body aches; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (side of injection feels worm to the touch), ERYTHEMA (redness spread to the elbow), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (Redness of injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (side of injection feels worm to the touch) and ERYTHEMA (redness spread to the elbow). On 02-Mar-2021, PAIN (body aches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE WARMTH (side of injection feels worm to the touch), ERYTHEMA (redness spread to the elbow), VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (Redness of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: A little more short of breath than usual; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (A little more short of breath than usual) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA (A little more short of breath than usual). At the time of the report, DYSPNOEA (A little more short of breath than usual) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: has yet to receive the second dose passed 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has yet to receive the second dose passed 42 days) had resolved.            Treatment and concomitant medications were provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273, Lot #: 042l20A with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on his back that is itching a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash on his back that is itching a lot). At the time of the report, RASH PRURITIC (rash on his back that is itching a lot) had not resolved.            No concomitant medications reported. No treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included LOSARTAN, PANTOPRAZOLE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ROSUVASTATIN, BACLOFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-044170 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044170:Husband case
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm was sore at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (arm was sore at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site warmth, Mass excision, Rash pruritic
Clinical narrative: bump at the injection site; bump warm; bump is hard; bump itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy). At the time of the report, INJECTION SITE MASS (bump at the injection site), INJECTION SITE WARMTH (bump warm), MASS EXCISION (bump is hard) and RASH PRURITIC (bump itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: NNI TCR attached.
Sex: M
Vaccine: COVID19
Symptoms: Infection, Vaccination site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: possible infection; redness left arm (injection site); itchy it was 4 inches wide 5 inches long; inflamed (injection site); hot to touch (injection site); hard to touch (injection site); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long), VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)) and INFECTION (possible infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long), VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)) and VACCINATION SITE ERYTHEMA (redness left arm (injection site)). On 02-Mar-2021, the patient experienced INFECTION (possible infection). On 01-Mar-2021, VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)), INFECTION (possible infection) and VACCINATION SITE ERYTHEMA (redness left arm (injection site)) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was antibiotics due to possible infection. doctor said to get the 2nd shot the other arm, we are scheduled to get the 2nd dose on the 18th of March.  Concomitant information not provided
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: possible infection; redness left arm (injection site); itchy it was 4 inches wide 5 inches long; inflamed (injection site); hot to touch (injection site); hard to touch (injection site); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long), VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)) and INFECTION (possible infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long), VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)) and VACCINATION SITE ERYTHEMA (redness left arm (injection site)). On 02-Mar-2021, the patient experienced INFECTION (possible infection). On 01-Mar-2021, VACCINATION SITE PRURITUS (itchy it was 4 inches wide 5 inches long) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflamed (injection site)), VACCINATION SITE WARMTH (hot to touch (injection site)), VACCINATION SITE INDURATION (hard to touch (injection site)), INFECTION (possible infection) and VACCINATION SITE ERYTHEMA (redness left arm (injection site)) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was antibiotics due to possible infection. doctor said to get the 2nd shot the other arm, we are scheduled to get the 2nd dose on the 18th of March.  Concomitant information not provided
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion, Pain, Pyrexia
Clinical narrative: congestion; blotchiness kind of like hives but they stay instead of come and go like hives.; terrible aches; immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose; severe chills; chronic fatigue; fever; floaters in the left eye after 2nd dose; visual disturbances; blurry left eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion) and URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances) and VISION BLURRED (blurry left eye). On an unknown date, the patient experienced NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever). At the time of the report, VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever) outcome was unknown.            Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: congestion; blotchiness kind of like hives but they stay instead of come and go like hives.; terrible aches; immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose; severe chills; chronic fatigue; fever; floaters in the left eye after 2nd dose; visual disturbances; blurry left eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion) and URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances) and VISION BLURRED (blurry left eye). On an unknown date, the patient experienced NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever). At the time of the report, VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever) outcome was unknown.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnant patient received vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus since October 2004 and Penicillin allergy. Concomitant products included INSULIN LISPRO (HUMALOG), ACETYLSALICYLIC ACID (ASPIRIN 81), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM SLEEPMELTS) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. On 27-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound foetal: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Lethargy; I have a hard time getting her out of bed /she seems knocked out; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01SM264) for COVID-19 vaccination.     The patient's past medical history included Dementia.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out). At the time of the report, LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out) had not resolved.            Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: Brain fog/felt like she was poisoned; Dizziness; Not feeling well; uneasiness; 99 Temp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well) and DISCOMFORT (uneasiness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-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 PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f (Low) temperature-99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Brain fog/felt like she was poisoned; Dizziness; Not feeling well; uneasiness; 99 Temp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well) and DISCOMFORT (uneasiness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-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 PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f (Low) temperature-99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: warm; arm felt sore again; itching; hard; the injection site is red; sore arm; hard spot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot) and INJECTION SITE INDURATION (hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced INJECTION SITE INDURATION (hard spot) and INJECTION SITE PAIN (sore arm).   On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (the injection site is red). At the time of the report, INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot), INJECTION SITE INDURATION (hard), INJECTION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (the injection site is red) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment medications reported. Patient is fully vaccinated.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR attached -Events outcome updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: warm; arm felt sore again; itching; hard; the injection site is red; sore arm; hard spot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot) and INJECTION SITE INDURATION (hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced INJECTION SITE INDURATION (hard spot) and INJECTION SITE PAIN (sore arm).   On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (the injection site is red). At the time of the report, INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot), INJECTION SITE INDURATION (hard), INJECTION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (the injection site is red) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment medications reported. Patient is fully vaccinated.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR attached -Events outcome updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Outbreak of genital herpes; A spontaneous report was received from a consumer concerning a 64-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced outbreak of genital herpes.  The patient's medical history included Genital Herpes(2011). Concomitant medication reported included paracetamol.  On 1 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced something going on, outbreak of genital herpes.  Treatment details included Valacyclovir.  Action taken with mRNA-1273 in response to the event outbreak of genital herpes was not reported.   The outcome of event outbreak of genital herpes was not reported.; Reporter's Comments: Although a temporal association exist, there is not enough information based on the information provided to assess a causal relationship between the reported event and the product use.  Critical details such as the patient's frequency of outbreaks and if prophylactic treatment was ongoing at the time of vaccine administration cannot be ascertained.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: a red and warm spot around the injection site, with a size of a baseball ball; a red and warm spot around the injection site, with a size of a baseball ball; with a size of a baseball ball; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (a red and warm spot around the injection site, with a size of a baseball ball), INJECTION SITE WARMTH (a red and warm spot around the injection site, with a size of a baseball ball) and INJECTION SITE SWELLING (with a size of a baseball ball) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (a red and warm spot around the injection site, with a size of a baseball ball), INJECTION SITE WARMTH (a red and warm spot around the injection site, with a size of a baseball ball) and INJECTION SITE SWELLING (with a size of a baseball ball). At the time of the report, INJECTION SITE ERYTHEMA (a red and warm spot around the injection site, with a size of a baseball ball), INJECTION SITE WARMTH (a red and warm spot around the injection site, with a size of a baseball ball) and INJECTION SITE SWELLING (with a size of a baseball ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Memory impairment, Palpitations, Speech disorder, Vaccination site pain
Clinical narrative: Heart was beating a little heavier than usual, racing heart skips a beat; memory issues; arm sore; warm in her chest and back and up through her neck and the back of her head; trouble talking; A spontaneous report was received from a consumer concerning an 82-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hot, warm in her chest and back and up through her neck and the back of her head, trouble talking, heart beating a little heavier, arm aches, arm sore, heart condition-racing heart-skips a beat, memory issues.  The patient's medical history included transient ischemic attacks (TIAs), vertigo, and heart condition-racing heart-skips a beat since she was 36 years old.  Concomitant medications reported were clopidogrel, levothyroxine, atorvastatin for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the patient experienced the event(s) hot, warm in her chest and back and up through her neck and the back of her head, trouble talking, heart beating a little heavier. On 05 Mar 2021, the patient experienced the event(s) arm aches. arm sore. On an unknown date, the patient experienced the event(s) heart condition-racing heart-skips a beat. 2 TIA's, vertigo, memory issues.  Treatment details included  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hot was unknown, warm in her chest and back and up through her neck and the back of her headtrouble talkingheart beating a little heavier arm achesarm sore heart condition-racing heart-skips a beat2 tia's vertigo memory issues was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dyspnoea, Insomnia, Lethargy
Clinical narrative: Arm Soreness; Sharp Pain; Numbness/Tingling in Hand; Shortness of Breath; Restlessness; Lethargic; Loss of Sleep; Increased Body Heat; Fever; Chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath) and RESTLESSNESS (Restlessness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia, Restlessness
Clinical narrative: Arm Soreness; Sharp Pain; Numbness/Tingling in Hand; Shortness of Breath; Restlessness; Lethargic; Loss of Sleep; Increased Body Heat; Fever; Chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath) and RESTLESSNESS (Restlessness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Baseball-size red lump at the injection site; Tennis-ball-size red lump at the injection site/Baseball-size red lump at the injection site; A spontaneous report was received from a type concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tennis-ball-size red lump at the injection site, baseball-size red lump at the injection site.  The patient's medical history was not provided. Concomitant medications reported were Prozac, Estradiol, Furosemide, Omeprazole, Somatostatin, vitamins for drug use for unknown indication.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 033M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event(s) tennis-ball-size red lump at the injection site . On 3 Mar 2021, the patient experienced the event(s) baseball-size red lump at the injection site.  Treatment details included Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event,  tennis-ball-size red lump at the injection site was considered resolved on 26 Feb 2021. The outcome of event, baseball-size red lump at the injection site,  was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Administered far up his upper arm almost on his shoulder; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder). On 20-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered far up his upper arm almost on his shoulder) to be not applicable.    Concomitant medications were not provided. Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; severe headache; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea) 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 03-Mar-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) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea). At the time of the report, CHILLS (Chills), HEADACHE (severe headache) and NAUSEA (nausea) outcome was unknown. Not Provided          No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiffness on right arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on right arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BROMELAINS (BROMELAIN), CALCIUM CITRATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DOXAZOSIN, BISACODYL (DULCOLAX [BISACODYL]), FLUTICASONE PROPIONATE (FLOVENT), FLUOROURACIL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEUCOVORIN CALCIUM, LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], OMEGA-3 FATTY ACIDS, OXALIPLATIN, POLICOSANOL, DABIGATRAN ETEXILATE MESILATE (PRADAXA), PROCHLORPERAZINE (COMPAZINE SPANSULE), TIOTROPIUM BROMIDE (SPIRIVA), CURCUMIN, VITAMIN C [ASCORBIC ACID] and VITAMIN D3 for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on right arm). The patient was treated with CORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness on right arm) outcome was unknown.            This case was linked to MOD-2021-222946 (Patient Link).