chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms, back and chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash on arms, back and chest) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN, LEVOTHYROXINE, VALACICLOVIR, ZOLPIDEM, ESTRADIOL (VIVELLE-DOT), HYDROCODONE, GABAPENTIN, OMEPRAZOLE, VITAMIN D NOS and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on arms, back and chest). At the time of the report, RASH (Rash on arms, back and chest) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Benadryl pill, Benadryl cream, and triamcinolone acetonide cream.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Oropharyngeal pain, Pain in extremity
Clinical narrative: Just abnormal symptoms for few days; Tiredness; Arm is really sore; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore), OROPHARYNGEAL PAIN (Sore throat), FEELING ABNORMAL (Just abnormal symptoms for few days) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tiredness). On an unknown date, the patient experienced FEELING ABNORMAL (Just abnormal symptoms for few days). At the time of the report, PAIN IN EXTREMITY (Arm is really sore), OROPHARYNGEAL PAIN (Sore throat), FEELING ABNORMAL (Just abnormal symptoms for few days) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow up received on 2-jun-2021 :new event was added
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Secretion discharge
Clinical narrative: Heavy mucous production; Low grade fever; Felt achy; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Heavy mucous production), PYREXIA (Low grade fever) and MYALGIA (Felt achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Hypertension.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Felt achy). On 14-Feb-2021, the patient experienced SECRETION DISCHARGE (Heavy mucous production) and PYREXIA (Low grade fever). At the time of the report, SECRETION DISCHARGE (Heavy mucous production) and PYREXIA (Low grade fever) outcome was unknown and MYALGIA (Felt achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were high blood pressure medicine, inhaler for seasonal allergies. Treatment details included paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary infection). At the time of the report, URINARY TRACT INFECTION (Urinary infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (Hives all over the body). At the time of the report, URTICARIA (Hives all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included cortisone injection.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: horrible headaches;pain on the top left side of the head and Pressure in the head; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headaches;pain on the top left side of the head and Pressure in the head) and LIMB DISCOMFORT (pain in the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (horrible headaches;pain on the top left side of the head and Pressure in the head) and LIMB DISCOMFORT (pain in the arm). On 14-Feb-2021, LIMB DISCOMFORT (pain in the arm) had resolved. At the time of the report, HEADACHE (horrible headaches;pain on the top left side of the head and Pressure in the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included Reflux medication. Treatment details included Excedrin.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Achy across the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Achy across the shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 03-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) (unknown route) 1 dosage form(s). On 03-Feb-2021, the patient experienced ARTHRALGIA (Achy across the shoulder). At the time of the report, ARTHRALGIA (Achy across the shoulder) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful lymph node; Swollen lymph node same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Painful lymph node) and LYMPHADENOPATHY (Swollen lymph node same arm of injection) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node same arm of injection). On an unknown date, the patient experienced LYMPH NODE PAIN (Painful lymph node). At the time of the report, LYMPH NODE PAIN (Painful lymph node) and LYMPHADENOPATHY (Swollen lymph node same arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red, painful, bump at injection site; Red, painful, bump at injection site; Red, painful, bump at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red, painful, bump at injection site), VACCINATION SITE PAIN (Red, painful, bump at injection site) and VACCINATION SITE SWELLING (Red, painful, bump at injection site) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, painful, bump at injection site), VACCINATION SITE PAIN (Red, painful, bump at injection site) and VACCINATION SITE SWELLING (Red, painful, bump at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red, painful, bump at injection site), VACCINATION SITE PAIN (Red, painful, bump at injection site) and VACCINATION SITE SWELLING (Red, painful, bump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: swollen at injection site; injection site red; injection site hot; headache; achiness on body; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swollen at injection site), INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site hot), HEADACHE (headache) and MYALGIA (achiness on body) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 immunization.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swollen at injection site), INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site hot), HEADACHE (headache) and MYALGIA (achiness on body). At the time of the report, INJECTION SITE SWELLING (swollen at injection site), INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site hot), HEADACHE (headache) and MYALGIA (achiness on body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included took Advil and Tylenol. No relevant concomitant medications were reported.   This case was linked to MOD-2021-020775 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Oropharyngeal pain
Clinical narrative: sore throat; Pain in the left upper arm at the injection site; Mild Headache; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (Mild Headache) and INJECTION SITE PAIN (Pain in the left upper arm at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Mild Headache). On 23-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and INJECTION SITE PAIN (Pain in the left upper arm at the injection site). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (Mild Headache) and INJECTION SITE PAIN (Pain in the left upper arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for UTI, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (UTI) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains significant information. The event outcome was updated from unknown to recovered/resolved.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 102.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.) 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-Feb-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 PYREXIA (fever of 102.). At the time of the report, PYREXIA (fever of 102.) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Influenza, Lymphadenopathy
Clinical narrative: 2 swollen lymph nodes in her neck; chills; stayed in bed all day; like the flu; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (stayed in bed all day), INFLUENZA (like the flu), LYMPHADENOPATHY (2 swollen lymph nodes in her neck) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced BED REST (stayed in bed all day), INFLUENZA (like the flu) and CHILLS (chills). On 18-Feb-2021, the patient experienced LYMPHADENOPATHY (2 swollen lymph nodes in her neck). At the time of the report, BED REST (stayed in bed all day), INFLUENZA (like the flu), LYMPHADENOPATHY (2 swollen lymph nodes in her neck) and CHILLS (chills) outcome was unknown.            Treatment details included Tylenol(paracetamol) and motrin (Ibuprofen).
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tension
Clinical narrative: arm hurts; worried about second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) and TENSION (worried about second shot) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 (arm hurts) and TENSION (worried about second shot). At the time of the report, PAIN IN EXTREMITY (arm hurts) and TENSION (worried about second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Post 1st vaccine Left Arm Hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Post 1st vaccine Left Arm Hurt a little) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013M20A) for COVID-19 vaccination. The patient's past medical history included Fibromyalgia and Irritable bowel syndrome.On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Post 1st vaccine Left Arm Hurt a little). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Jan-2021, PAIN IN EXTREMITY (Post 1st vaccine Left Arm Hurt a little) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Treatment details also include Ice.
Age: 77.0
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 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 11-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after the first dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after the first dose). At the time of the report, COVID-19 (Tested positive for COVID-19 after the first dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear infection
Clinical narrative: diagnosed with ear infection in both ears; both ears starting bothering her; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (diagnosed with ear infection in both ears) and EAR DISCOMFORT (both ears starting bothering her) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy (allergic to sulfa.).   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced EAR DISCOMFORT (both ears starting bothering her). On 22-Feb-2021, the patient experienced EAR INFECTION (diagnosed with ear infection in both ears). At the time of the report, EAR INFECTION (diagnosed with ear infection in both ears) and EAR DISCOMFORT (both ears starting bothering her) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment medications included unknown antibiotics.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes; LYMPH NODE PAIN; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (LYMPH NODE PAIN) and LYMPHADENOPATHY (Swollen Lymph Nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced LYMPH NODE PAIN (LYMPH NODE PAIN). On 20-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes). At the time of the report, LYMPH NODE PAIN (LYMPH NODE PAIN) and LYMPHADENOPATHY (Swollen Lymph Nodes) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Aches; Lingering headache; Have a fever which was up and down up to 100.3F / went away and came back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PYREXIA (Have a fever which was up and down up to 100.3F / went away and came back) and HEADACHE (Lingering headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (Have a fever which was up and down up to 100.3F / went away and came back). On an unknown date, the patient experienced PAIN (Aches) and HEADACHE (Lingering headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Aches), PYREXIA (Have a fever which was up and down up to 100.3F / went away and came back) and HEADACHE (Lingering headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Contains non-significant information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Headache, Myalgia
Clinical narrative: Swelling arm; swelling and redness in his arm; headache; chills; joint and muscle pain; joint and muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (swelling and redness in his arm), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint and muscle pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (swelling and redness in his arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint and muscle pain) and MYALGIA (joint and muscle pain). At the time of the report, PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (swelling and redness in his arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint and muscle pain) and MYALGIA (joint and muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Laboratory details were provided. No Treatment information reported.      Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling arm; swelling and redness in his arm; headache; chills; joint and muscle pain; joint and muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (swelling and redness in his arm), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint and muscle pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (swelling and redness in his arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint and muscle pain) and MYALGIA (joint and muscle pain). At the time of the report, PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (swelling and redness in his arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint and muscle pain) and MYALGIA (joint and muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Laboratory details were provided. No Treatment information reported.      Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: Neck felt stiff; Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck felt stiff) and RASH (Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX on 19-Jan-2021.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck felt stiff) and RASH (Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest). On 22-Feb-2021, MUSCULOSKELETAL STIFFNESS (Neck felt stiff) outcome was unknown. At the time of the report, RASH (Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-098966 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Lot number, Treatment meds
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: delayed transient numbness in his face; delayed transient numbness in his hands; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (delayed transient numbness in his face) and HYPOAESTHESIA (delayed transient numbness in his hands) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced HYPOAESTHESIA (delayed transient numbness in his face) and HYPOAESTHESIA (delayed transient numbness in his hands). At the time of the report, HYPOAESTHESIA (delayed transient numbness in his face) and HYPOAESTHESIA (delayed transient numbness in his hands) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hypersomnia, Illness, Pain
Clinical narrative: Extremely sick; Kept falling asleep; Vertigo; Swelling and redness spreading down arm; Swelling and redness spreading down arm; Fever; Head was pounding; Pain on the side like was hit by a bowling ball; Redness seems to be getting worse; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), HYPERSOMNIA (Kept falling asleep), VERTIGO (Vertigo), SWELLING (Swelling and redness spreading down arm) and ERYTHEMA (Swelling and redness spreading down arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 ILLNESS (Extremely sick), HYPERSOMNIA (Kept falling asleep), VERTIGO (Vertigo), SWELLING (Swelling and redness spreading down arm), ERYTHEMA (Swelling and redness spreading down arm), PYREXIA (Fever), HEADACHE (Head was pounding), PAIN (Pain on the side like was hit by a bowling ball) and ERYTHEMA (Redness seems to be getting worse). At the time of the report, ILLNESS (Extremely sick), HYPERSOMNIA (Kept falling asleep), VERTIGO (Vertigo), SWELLING (Swelling and redness spreading down arm), ERYTHEMA (Swelling and redness spreading down arm), PYREXIA (Fever), HEADACHE (Head was pounding), PAIN (Pain on the side like was hit by a bowling ball) and ERYTHEMA (Redness seems to be getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vertigo
Clinical narrative: Extremely sick; Kept falling asleep; Vertigo; Swelling and redness spreading down arm; Swelling and redness spreading down arm; Fever; Head was pounding; Pain on the side like was hit by a bowling ball; Redness seems to be getting worse; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), HYPERSOMNIA (Kept falling asleep), VERTIGO (Vertigo), SWELLING (Swelling and redness spreading down arm) and ERYTHEMA (Swelling and redness spreading down arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 ILLNESS (Extremely sick), HYPERSOMNIA (Kept falling asleep), VERTIGO (Vertigo), SWELLING (Swelling and redness spreading down arm), ERYTHEMA (Swelling and redness spreading down arm), PYREXIA (Fever), HEADACHE (Head was pounding), PAIN (Pain on the side like was hit by a bowling ball) and ERYTHEMA (Redness seems to be getting worse). At the time of the report, ILLNESS (Extremely sick), HYPERSOMNIA (Kept falling asleep), VERTIGO (Vertigo), SWELLING (Swelling and redness spreading down arm), ERYTHEMA (Swelling and redness spreading down arm), PYREXIA (Fever), HEADACHE (Head was pounding), PAIN (Pain on the side like was hit by a bowling ball) and ERYTHEMA (Redness seems to be getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Soreness at arm of injetion; Itching at the site of injection; Headache; tired; Rash at the site of injection,rash moved down to arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness at arm of injetion), VACCINATION SITE PRURITUS (Itching at the site of injection), HEADACHE (Headache), FATIGUE (tired) and VACCINATION SITE RASH (Rash at the site of injection,rash moved down to arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 PAIN IN EXTREMITY (Soreness at arm of injetion), VACCINATION SITE PRURITUS (Itching at the site of injection), HEADACHE (Headache), FATIGUE (tired) and VACCINATION SITE RASH (Rash at the site of injection,rash moved down to arm). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (Soreness at arm of injetion), VACCINATION SITE PRURITUS (Itching at the site of injection), HEADACHE (Headache), FATIGUE (tired) and VACCINATION SITE RASH (Rash at the site of injection,rash moved down to arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Erythema, Mouth swelling, Peripheral swelling, Pruritus
Clinical narrative: Itching; Hands had become red; Hands became swollen to the point where couldn't make a fist; Swelling on face; Swelling on back; Swelling on legs; Swelling on chest; Swelling on mouth; Swelling on stomach; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back) and PERIPHERAL SWELLING (Swelling on legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back), PERIPHERAL SWELLING (Swelling on legs), SWELLING (Swelling on chest), MOUTH SWELLING (Swelling on mouth) and ABDOMINAL DISTENSION (Swelling on stomach). On 06-Feb-2021, the patient experienced PRURITUS (Itching). At the time of the report, ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back), PERIPHERAL SWELLING (Swelling on legs), SWELLING (Swelling on chest), MOUTH SWELLING (Swelling on mouth), ABDOMINAL DISTENSION (Swelling on stomach) and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitants were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 JULY 2021 and added patient demography. added 2nd dose details. added new event.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Itching; Hands had become red; Hands became swollen to the point where couldn't make a fist; Swelling on face; Swelling on back; Swelling on legs; Swelling on chest; Swelling on mouth; Swelling on stomach; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back) and PERIPHERAL SWELLING (Swelling on legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back), PERIPHERAL SWELLING (Swelling on legs), SWELLING (Swelling on chest), MOUTH SWELLING (Swelling on mouth) and ABDOMINAL DISTENSION (Swelling on stomach). On 06-Feb-2021, the patient experienced PRURITUS (Itching). At the time of the report, ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back), PERIPHERAL SWELLING (Swelling on legs), SWELLING (Swelling on chest), MOUTH SWELLING (Swelling on mouth), ABDOMINAL DISTENSION (Swelling on stomach) and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitants were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 JULY 2021 and added patient demography. added 2nd dose details. added new event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) in a 64-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.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided; Sender'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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Rash, Rash erythematous
Clinical narrative: small red bumps covering her body; headache; nausea; aches and pains; rash on legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (small red bumps covering her body), HEADACHE (headache), NAUSEA (nausea), PAIN (aches and pains) and RASH (rash on legs) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 RASH ERYTHEMATOUS (small red bumps covering her body), HEADACHE (headache), NAUSEA (nausea), PAIN (aches and pains) and RASH (rash on legs). At the time of the report, RASH ERYTHEMATOUS (small red bumps covering her body), HEADACHE (headache), NAUSEA (nausea), PAIN (aches and pains) and RASH (rash on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Sunburn
Clinical narrative: felt and looked like an itchy sunburn/Patient's rib cage on up, both in back and front were itchy and slightly red; felt and looked like an itchy sunburn; Patient's rib cage on up, both in back and front were slightly red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (felt and looked like an itchy sunburn/Patient's rib cage on up, both in back and front were itchy and slightly red), SUNBURN (felt and looked like an itchy sunburn) and ERYTHEMA (Patient's rib cage on up, both in back and front were slightly red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (felt and looked like an itchy sunburn/Patient's rib cage on up, both in back and front were itchy and slightly red), SUNBURN (felt and looked like an itchy sunburn) and ERYTHEMA (Patient's rib cage on up, both in back and front were slightly red). At the time of the report, PRURITUS (felt and looked like an itchy sunburn/Patient's rib cage on up, both in back and front were itchy and slightly red), SUNBURN (felt and looked like an itchy sunburn) and ERYTHEMA (Patient's rib cage on up, both in back and front were slightly red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl. No concomitant medications were provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 102.4; Started with Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Started with Fever) and PYREXIA (Fever of 102.4) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Jan-2021, the patient experienced PYREXIA (Started with Fever). On 21-Feb-2021, the patient experienced PYREXIA (Fever of 102.4). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 3 dosage form. On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PYREXIA (Started with Fever) and PYREXIA (Fever of 102.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Pyrexia: 102.4 (High) 102.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Swelling
Clinical narrative: slightly swollen and itchy; slightly swollen and itchy; redness at the injection site of the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slightly swollen and itchy), SWELLING (slightly swollen and itchy) and INJECTION SITE ERYTHEMA (redness at the injection site of the size of a golf ball) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and CITALOPRAM for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (slightly swollen and itchy), SWELLING (slightly swollen and itchy) and INJECTION SITE ERYTHEMA (redness at the injection site of the size of a golf ball). At the time of the report, PRURITUS (slightly swollen and itchy), SWELLING (slightly swollen and itchy) and INJECTION SITE ERYTHEMA (redness at the injection site of the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.