chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Sleep disorder, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site area remains warm to the touch; Vaccination site pain; hard to sleep on the left side; red patches; There were red patches that were kind of itchy.; injection site area remains swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site area remains warm to the touch), VACCINATION SITE PAIN (Vaccination site pain), SLEEP DISORDER (hard to sleep on the left side), ERYTHEMA (red patches) and PRURITUS (There were red patches that were kind of itchy.) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (amoxicillin) and Allergy to antibiotic (cefzil). Concomitant products included MINERALS NOS, VITAMINS NOS (EQUATE ONE DAILY WOMEN'S HEALTH) from 01-Jan-2017 to an unknown date for an unknown indication.    On 28-Mar-2021 at 7:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site area remains warm to the touch), VACCINATION SITE PAIN (Vaccination site pain), SLEEP DISORDER (hard to sleep on the left side) and VACCINATION SITE SWELLING (injection site area remains swollen). 28-Mar-2021, the patient experienced ERYTHEMA (red patches) and PRURITUS (There were red patches that were kind of itchy.). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain), PRURITUS (There were red patches that were kind of itchy.) and VACCINATION SITE SWELLING (injection site area remains swollen) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site area remains warm to the touch), SLEEP DISORDER (hard to sleep on the left side) and ERYTHEMA (red patches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was recommended to take ibuprofen and antihistamines for treatment. Symptoms lasted a total of eleven days.   This case was linked to MOD-2021-244797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up: events added, event outcomes, treatment and concomitant medications, and medical history.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site area remains warm to the touch; Vaccination site pain; hard to sleep on the left side; red patches; There were red patches that were kind of itchy.; injection site area remains swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site area remains warm to the touch), VACCINATION SITE PAIN (Vaccination site pain), SLEEP DISORDER (hard to sleep on the left side), ERYTHEMA (red patches) and PRURITUS (There were red patches that were kind of itchy.) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (amoxicillin) and Allergy to antibiotic (cefzil). Concomitant products included MINERALS NOS, VITAMINS NOS (EQUATE ONE DAILY WOMEN'S HEALTH) from 01-Jan-2017 to an unknown date for an unknown indication.    On 28-Mar-2021 at 7:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site area remains warm to the touch), VACCINATION SITE PAIN (Vaccination site pain), SLEEP DISORDER (hard to sleep on the left side) and VACCINATION SITE SWELLING (injection site area remains swollen). 28-Mar-2021, the patient experienced ERYTHEMA (red patches) and PRURITUS (There were red patches that were kind of itchy.). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain), PRURITUS (There were red patches that were kind of itchy.) and VACCINATION SITE SWELLING (injection site area remains swollen) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site area remains warm to the touch), SLEEP DISORDER (hard to sleep on the left side) and ERYTHEMA (red patches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was recommended to take ibuprofen and antihistamines for treatment. Symptoms lasted a total of eleven days.   This case was linked to MOD-2021-244797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up: events added, event outcomes, treatment and concomitant medications, and medical history.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pyrexia, Somnolence
Clinical narrative: Slept most of the weekend; Spiked a fever of 102.5F; Shortness of breath; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Shortness of breath), PAIN (Achy all over), SOMNOLENCE (Slept most of the weekend) and PYREXIA (Spiked a fever of 102.5F) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNEA (Shortness of breath), PAIN (Achy all over) and PYREXIA (Spiked a fever of 102.5F). On 02-Apr-2021, the patient experienced SOMNOLENCE (Slept most of the weekend). On 05-Apr-2021, DYSPNEA (Shortness of breath), PAIN (Achy all over), SOMNOLENCE (Slept most of the weekend) and PYREXIA (Spiked a fever of 102.5F) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-067289 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067289:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain, Vaccination site rash, Vomiting
Clinical narrative: right arm site pain; Extreme nausea; Vomiting; Fatigue; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm site pain), NAUSEA (Extreme nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 06-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. On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (right arm site pain), NAUSEA (Extreme nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (right arm site pain), NAUSEA (Extreme nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.            Patient could not keep anything such as water & could not keep pain killers down. She experienced fatigue & it carried over on the 2nd day and got worse on 3rd day and stated that nausea was discouraging. She stated that her rash was not intense but felt hurt afterwards.  Concomitant products were not provided.could not keep anything down   This case was linked to MOD-2021-067374 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains No new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pruritus
Clinical narrative: On day 3 it started itching; stiff muscle/3 x 4 inches south of vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching) in a 72-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 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) had resolved and VACCINATION SITE PRURITUS (On day 3 it started itching) outcome was unknown. Not Provided          No Concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021: Contain No new information
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; Severe, terrible sweating; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe, terrible sweating), VERTIGO (Vertigo), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced HYPERHIDROSIS (Severe, terrible sweating), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced VERTIGO (Vertigo) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Severe, terrible sweating), VERTIGO (Vertigo), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-106494, MOD-2021-209386 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow-up information received on 16-May-2021, updated reporter address. On 05-Jun-2021: Follow-up information received on 05-Jun-2021, added new events and updated outcome of the events.; Sender's Comments:  MOD-2021-106494:2nd dose case MOD-2021-209386:Same reporter (wife case)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Throat tightness, Urticaria
Clinical narrative: Throat closing up; Hives; terrible allergic reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of THROAT TIGHTNESS (Throat closing up), URTICARIA (Hives) and ALLERGY TO VACCINE (terrible allergic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat closing up), URTICARIA (Hives) and ALLERGY TO VACCINE (terrible allergic reaction). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Throat closing up), URTICARIA (Hives) and ALLERGY TO VACCINE (terrible allergic reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Benadryl as a Treatment Medication Patient used Another medication she has to take as a taper.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site reaction
Clinical narrative: I started breaking out 3 - 4 hours after the vaccine; itching; Hives; I started breaking out 3 - 4 hours after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I started breaking out 3 - 4 hours after the vaccine), PRURITUS (itching), URTICARIA (Hives) and RASH (I started breaking out 3 - 4 hours after the vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE REACTION (I started breaking out 3 - 4 hours after the vaccine), PRURITUS (itching), URTICARIA (Hives) and RASH (I started breaking out 3 - 4 hours after the vaccine). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (I started breaking out 3 - 4 hours after the vaccine), PRURITUS (itching), URTICARIA (Hives) and RASH (I started breaking out 3 - 4 hours after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Headache
Clinical narrative: Thought I couldn't walk because my body hurt bad; Every joint in my body hurt; Really bad headache; Had chills like I never had before; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Thought I couldn't walk because my body hurt bad), ARTHRALGIA (Every joint in my body hurt), HEADACHE (Really bad headache) and CHILLS (Had chills like I never had before) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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) (Intramuscular) dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced GAIT DISTURBANCE (Thought I couldn't walk because my body hurt bad), ARTHRALGIA (Every joint in my body hurt), HEADACHE (Really bad headache) and CHILLS (Had chills like I never had before). On 04-Apr-2021, GAIT DISTURBANCE (Thought I couldn't walk because my body hurt bad), ARTHRALGIA (Every joint in my body hurt), HEADACHE (Really bad headache) and CHILLS (Had chills like I never had before) had resolved.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Dizziness, Dysuria
Clinical narrative: dizzy; low energy; I think my immune system is weak; scared a little bit; it was worse; shoulder hurt bad and burning; shoulder hurt bad and burning; fever; burned urinary tract; dizzy; lost energy; couldn't generate any heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract) and URINARY TRACT INJURY (burned urinary tract) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract), the first episode of DIZZINESS (dizzy), ASTHENIA (lost energy) and FEELING COLD (couldn't generate any heat). On 09-Mar-2021, the patient experienced the second episode of DIZZINESS (dizzy), ASTHENIA (low energy), IMMUNE SYSTEM DISORDER (I think my immune system is weak), ANXIETY (scared a little bit) and FEELING ABNORMAL (it was worse). On an unknown date, the patient experienced URINARY TRACT INJURY (burned urinary tract). At the time of the report, VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract), ASTHENIA (lost energy), FEELING COLD (couldn't generate any heat), the last episode of DIZZINESS (dizzy), ASTHENIA (low energy), IMMUNE SYSTEM DISORDER (I think my immune system is weak), ANXIETY (scared a little bit) and FEELING ABNORMAL (it was worse) outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Immune system disorder, Pyrexia, Vaccination site pain
Clinical narrative: dizzy; low energy; I think my immune system is weak; scared a little bit; it was worse; shoulder hurt bad and burning; shoulder hurt bad and burning; fever; burned urinary tract; dizzy; lost energy; couldn't generate any heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract) and URINARY TRACT INJURY (burned urinary tract) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract), the first episode of DIZZINESS (dizzy), ASTHENIA (lost energy) and FEELING COLD (couldn't generate any heat). On 09-Mar-2021, the patient experienced the second episode of DIZZINESS (dizzy), ASTHENIA (low energy), IMMUNE SYSTEM DISORDER (I think my immune system is weak), ANXIETY (scared a little bit) and FEELING ABNORMAL (it was worse). On an unknown date, the patient experienced URINARY TRACT INJURY (burned urinary tract). At the time of the report, VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract), ASTHENIA (lost energy), FEELING COLD (couldn't generate any heat), the last episode of DIZZINESS (dizzy), ASTHENIA (low energy), IMMUNE SYSTEM DISORDER (I think my immune system is weak), ANXIETY (scared a little bit) and FEELING ABNORMAL (it was worse) outcome was unknown.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: strange looking rash in left armpit; a little tender and swollen lymph node under her left armpit; a little tender and swollen lymph node under her left armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (strange looking rash in left armpit), LYMPHADENOPATHY (a little tender and swollen lymph node under her left armpit) and LYMPH NODE PAIN (a little tender and swollen lymph node under her left armpit) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunization (Tdap vaccine administered into that same arm one month earlier than the first dose of the Moderna Covid-19 vaccine.). Concomitant products included ASCORBIC ACID (VITAMIN C ACID), MAGNESIUM, SELENIUM, TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) and CENTRUM B for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH (strange looking rash in left armpit), LYMPHADENOPATHY (a little tender and swollen lymph node under her left armpit) and LYMPH NODE PAIN (a little tender and swollen lymph node under her left armpit). At the time of the report, RASH (strange looking rash in left armpit), LYMPHADENOPATHY (a little tender and swollen lymph node under her left armpit) and LYMPH NODE PAIN (a little tender and swollen lymph node under her left armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Swelling in the face; redness in the face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in the face) and ERYTHEMA (redness in the face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SWELLING (Swelling in the face) and ERYTHEMA (redness in the face). At the time of the report, SWELLING (Swelling in the face) and ERYTHEMA (redness in the face) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: MD told patient to hold off on second shot due to prednisone tapering; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (MD told patient to hold off on second shot due to prednisone tapering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder since October 2020. Concomitant products included PREDNISONE for Autoimmune disorder.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced OFF LABEL USE (MD told patient to hold off on second shot due to prednisone tapering). On 21-Feb-2021, OFF LABEL USE (MD told patient to hold off on second shot due to prednisone tapering) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: shoulder, hip and butt is itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (shoulder, hip and butt is itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunization.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (shoulder, hip and butt is itchy). At the time of the report, PRURITUS (shoulder, hip and butt is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Sluggishness
Clinical narrative: The day after vaccination patient couldn't lift her arm because of soreness in her arm.; soreness in her arm; slowness; injection site warm; strong headaches; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.), PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm) and HEADACHE (strong headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS for Nutritional supplement, IRON for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm), HEADACHE (strong headaches), FATIGUE (Fatigue) and MYALGIA (Body aches). On 01-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 02-Apr-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.), PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm), HEADACHE (strong headaches), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site warmth
Clinical narrative: The day after vaccination patient couldn't lift her arm because of soreness in her arm.; soreness in her arm; slowness; injection site warm; strong headaches; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.), PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm) and HEADACHE (strong headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS for Nutritional supplement, IRON for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm), HEADACHE (strong headaches), FATIGUE (Fatigue) and MYALGIA (Body aches). On 01-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 02-Apr-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.), PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm), HEADACHE (strong headaches), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of Loss of taste in a 41-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced Loss of taste. At the time of the report, Loss of taste outcome was unknown.            This case was linked to US MODERNATX, INC MOD-2021-067136. Sender's Comments:  US MODERNATX, INC MOD-2021-067136 reporter's case
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Chills, Dizziness
Clinical narrative: Could not lift her arm; So dizzy they could not stand up; Chest pain for 31 hours; nausea; headache; Muscle pain; Joint pain; Chills; Tired; fever; Really bad lower back pain on left and right side/Like something was ripping out kidneys; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours) and NAUSEA (nausea) in a 47-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 Cancer and Cardiomyopathy. Concomitant products included METOPROLOL and GABAPENTIN for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not lift her arm). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever) outcome was unknown. Not Provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Myalgia, Nausea
Clinical narrative: Could not lift her arm; So dizzy they could not stand up; Chest pain for 31 hours; nausea; headache; Muscle pain; Joint pain; Chills; Tired; fever; Really bad lower back pain on left and right side/Like something was ripping out kidneys; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours) and NAUSEA (nausea) in a 47-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 Cancer and Cardiomyopathy. Concomitant products included METOPROLOL and GABAPENTIN for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not lift her arm). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever) outcome was unknown. Not Provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Could not lift her arm; So dizzy they could not stand up; Chest pain for 31 hours; nausea; headache; Muscle pain; Joint pain; Chills; Tired; fever; Really bad lower back pain on left and right side/Like something was ripping out kidneys; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours) and NAUSEA (nausea) in a 47-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 Cancer and Cardiomyopathy. Concomitant products included METOPROLOL and GABAPENTIN for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not lift her arm). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side/Like something was ripping out kidneys), LIMB DISCOMFORT (Could not lift her arm), DIZZINESS (So dizzy they could not stand up), CHEST PAIN (Chest pain for 31 hours), NAUSEA (nausea), HEADACHE (headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (fever) outcome was unknown. Not Provided
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (soreness in the arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 HEADACHE (Headache) and VACCINATION SITE PAIN (soreness in the arm). On 06-Mar-2021, VACCINATION SITE PAIN (soreness in the arm) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to US-MODERNATX, INC.-MOD-2021-067311 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067311:Original Case : MOD-2021-067311
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness; injection site Swelling; Injection site itching; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site Swelling), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (injection site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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. On 04-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site Swelling), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (injection site pain). At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site Swelling), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site feels hot; injection site is getting really swollen and red and feels hot; injection site is getting really red and feels hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE SWELLING (injection site is getting really swollen and red and feels hot) and VACCINATION SITE ERYTHEMA (injection site is getting really red and feels hot) 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 25-Mar-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 VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE SWELLING (injection site is getting really swollen and red and feels hot) and VACCINATION SITE ERYTHEMA (injection site is getting really red and feels hot). At the time of the report, VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE SWELLING (injection site is getting really swollen and red and feels hot) and VACCINATION SITE ERYTHEMA (injection site is getting really red and feels hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash all over body; itchiness all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body) and PRURITUS (itchiness all over her body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body) and PRURITUS (itchiness all over her body). At the time of the report, RASH (rash all over body) and PRURITUS (itchiness all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain
Clinical narrative: A few days later it started bruising/ It is round and streaky; She also has pain; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION and PAIN in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VERAPAMIL, METOPROLOL, VALSARTAN, GLIPIZIDE, ATORVASTATIN, VITAMIN D and ASPIRIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION and PAIN. At the time of the report, CONTUSION and PAIN outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site rash
Clinical narrative: Mild fatigue; Rash at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mild fatigue), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Mild fatigue), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") for Pain, at an unspecified dose and frequency. On 10-Mar-2021, FATIGUE (Mild fatigue) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.        Treatment medcation included Arnica. No concomitant medications were reported   This case was linked to MOD-2021-067351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received  including Email address provided
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching at injection site; Red bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red bump at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red bump at injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red bump at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Therapeutic product ineffective
Clinical narrative: Lack of efficacy: no antibodies after vaccinations; SARS-CoV-2 antibody test negative; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (Lack of efficacy: no antibodies after vaccinations) and SARS-COV-2 ANTIBODY TEST NEGATIVE (SARS-CoV-2 antibody test negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Taking immunosuppressants).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (Lack of efficacy: no antibodies after vaccinations) and SARS-COV-2 ANTIBODY TEST NEGATIVE (SARS-CoV-2 antibody test negative). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (Lack of efficacy: no antibodies after vaccinations) and SARS-COV-2 ANTIBODY TEST NEGATIVE (SARS-CoV-2 antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative antibodies for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taking unspecified immunosuppressants. Doctor believed her negative test results were due to the fact that she is on immunosuppressants. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added contact Email; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment for the event was not provided.