chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under his arm as big as a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under his arm as big as a golf ball) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under his arm as big as a golf ball). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under his arm as big as a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-092212 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092212:for 2nd dose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: the second dose after 36th day; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (the second dose after 36th day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (MVI [VITAMINS NOS]) for Supplementation therapy.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (the second dose after 36th day). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (the second dose after 36th day) outcome was unknown. Not Provided          Concomitant medications includes Asthma medications (spouse does not remember) along with above mentioned medications. No treatment drugs were reported.   This case was linked to MOD21-082878, US-MODERNATX, INC.-MOD-2021-092255 (E2B Linked Report).; Sender's Comments:  MOD21-082878:Spouse case US-MODERNATX, INC.-MOD-2021-092255:spouse case
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Little headache; Arm was a little sore; Slight chills; General aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), CHILLS (Slight chills), MYALGIA (General aches and pains) and HEADACHE (Little headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), CHILLS (Slight chills) and MYALGIA (General aches and pains). On 27-Apr-2021, the patient experienced HEADACHE (Little headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), CHILLS (Slight chills), MYALGIA (General aches and pains) and HEADACHE (Little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information include Tylenol and ice pack. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: red or pink circle at injection site 8 days later; sore left arm for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm for two days) and VACCINATION SITE ERYTHEMA (red or pink circle at injection site 8 days later) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Dermatitis.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm for two days). On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red or pink circle at injection site 8 days later). On 14-Apr-2021, VACCINATION SITE PAIN (sore left arm for two days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red or pink circle at injection site 8 days later) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Dermatitis. Concomitant products included steriod injection  for dematitis
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hectic Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (hectic Tinnitus) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (hectic Tinnitus). At the time of the report, TINNITUS (hectic Tinnitus) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-092173 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in ear) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus in ear). At the time of the report, TINNITUS (tinnitus in ear) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Constipation, Fatigue, Lymphadenopathy
Clinical narrative: constipation; swollen lymph nodes; abdominal pain; vasculitis; fever of a 103 degrees; fatigue; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), VASCULITIS (vasculitis), PYREXIA (fever of a 103 degrees) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced PYREXIA (fever of a 103 degrees), FATIGUE (fatigue) and CHILLS (chills). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain) and VASCULITIS (vasculitis). On an unknown date, the patient experienced CONSTIPATION (constipation) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), VASCULITIS (vasculitis), PYREXIA (fever of a 103 degrees), FATIGUE (fatigue), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.    This case was linked to MOD-2021-092196 (E2B Linked Report).; Sender's Comments:  MOD-2021-092196:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vasculitis
Clinical narrative: constipation; swollen lymph nodes; abdominal pain; vasculitis; fever of a 103 degrees; fatigue; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), VASCULITIS (vasculitis), PYREXIA (fever of a 103 degrees) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced PYREXIA (fever of a 103 degrees), FATIGUE (fatigue) and CHILLS (chills). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain) and VASCULITIS (vasculitis). On an unknown date, the patient experienced CONSTIPATION (constipation) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), VASCULITIS (vasculitis), PYREXIA (fever of a 103 degrees), FATIGUE (fatigue), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.    This case was linked to MOD-2021-092196 (E2B Linked Report).; Sender's Comments:  MOD-2021-092196:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Nasopharyngitis, Pruritus, Swelling
Clinical narrative: Allergy / allergic reaction to vaccine; Itchiness on his body; hives; swelling; chills; cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), PRURITUS (Itchiness on his body), URTICARIA (hives), SWELLING (swelling) and ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031B21A or 4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced NASOPHARYNGITIS (cold) and CHILLS (chills). On 25-Apr-2021, the patient experienced PRURITUS (Itchiness on his body), URTICARIA (hives) and SWELLING (swelling). On 27-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine). At the time of the report, NASOPHARYNGITIS (cold), URTICARIA (hives), ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine) and CHILLS (chills) outcome was unknown and PRURITUS (Itchiness on his body) and SWELLING (swelling) was resolving. Not Provided          No concomitant medication reported.  Treatment for the event include loratadine, an allergy pill and an steroid pill for the swelling ( caller does not remember the names of the pills, maybe ¨efedrin or something like that¨)..   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergy / allergic reaction to vaccine; Itchiness on his body; hives; swelling; chills; cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), PRURITUS (Itchiness on his body), URTICARIA (hives), SWELLING (swelling) and ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031B21A or 4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced NASOPHARYNGITIS (cold) and CHILLS (chills). On 25-Apr-2021, the patient experienced PRURITUS (Itchiness on his body), URTICARIA (hives) and SWELLING (swelling). On 27-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine). At the time of the report, NASOPHARYNGITIS (cold), URTICARIA (hives), ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine) and CHILLS (chills) outcome was unknown and PRURITUS (Itchiness on his body) and SWELLING (swelling) was resolving. Not Provided          No concomitant medication reported.  Treatment for the event include loratadine, an allergy pill and an steroid pill for the swelling ( caller does not remember the names of the pills, maybe ¨efedrin or something like that¨)..   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Might miss the 2nd Dose of vaccine; Soreness of Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Arm) and PRODUCT DOSE OMISSION ISSUE (Might miss the 2nd Dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Arm). On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Might miss the 2nd Dose of vaccine). At the time of the report, PAIN IN EXTREMITY (Soreness of Arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Might miss the 2nd Dose of vaccine) had resolved. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  Treatment information was not provided. Additional information was provided that patient had received steroids. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Decreased appetite, Head discomfort, Musculoskeletal discomfort, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (she was still having issues neck), HEAD DISCOMFORT (she woke up and could not lift her head again), BALANCE DISORDER, SOMNOLENCE, and DECREASED APPETITE (Did not want to eat anything which is unusual for her) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Allergy to chemicals (Dye).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HEAD DISCOMFORT (she woke up and could not lift her head again), SOMNOLENCE, and DECREASED APPETITE (Did not want to eat anything which is unusual for her). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (she was still having issues neck) and BALANCE DISORDER (she feels unbalance). The patient was treated with PREDNISONE for Muscle relaxation, at a dose of 1 dosage form and DIAZEPAM for Muscle relaxation, at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL DISCOMFORT (she was still having issues neck), HEAD DISCOMFORT (she woke up and could not lift her head again), and BALANCE DISORDER (she feels unbalance) had not resolved and SOMNOLENCE (she slept all day) and DECREASED APPETITE outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information also included Cold compress and Hot compress.  Action taken with respect to mRNA-1273 was not applicable.  Additional information included that the patient was under regular medication as blood thinner, heart medication and other medications.   This case was linked to MOD-2021-092355.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Little bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little bit of soreness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (Little bit of soreness). At the time of the report, MYALGIA (Little bit of soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Little bit sick; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little bit sick) and VACCINATION SITE PAIN (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis since December 1994, Fibromyalgia since 2000 and Allergy to chemicals (Gadolinium). Concomitant products included DIMETHYL FUMARATE (TECFIDERA), PANTOPRAZOLE, AMANTADINE, CLONAZEPAM, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CYANOCOBALAMIN (B 12), VITAMIN B3 and VITAMIN D3 for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Little bit sick). an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION COMPLICATION (Little bit sick) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.            Treatment for the event included ice on arm. Action taken with mRNA-1273 in response to the events was not applicable.  The patient reported that she was not taking Amantadine a few days before the shot and stated that she should not have stopped the Amantadine at all.   This case was linked to MOD-2021-019087 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Added HCP contact information, patient demographics, start date of current medical condition, new concomitant drugs (Clonazapam, Protonix, Vitamin D3)
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: temperature went up to 103.8degF; headache; feeling fatigue, tiredness; nauseous; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temperature went up to 103.8degF), HEADACHE (headache), FATIGUE (feeling fatigue, tiredness) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 028L20A) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (temperature went up to 103.8degF), HEADACHE (headache), FATIGUE (feeling fatigue, tiredness) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. In March 2021, PYREXIA (temperature went up to 103.8degF), HEADACHE (headache), FATIGUE (feeling fatigue, tiredness) and NAUSEA (nauseous) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103.8degf (High) 103.8degF.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.   This case was linked to MOD-2021-017478, MOD-2021-017391 (E2B Linked Report).; Sender's Comments:  MOD-2021-017478: MOD-2021-017391:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site discolouration
Clinical narrative: knew his shoulder was going to be sore; at the injection site he has a line the size of little finger and it looks jaundice - yellow/green color; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (at the injection site he has a line the size of little finger and it looks jaundice - yellow/green color) and ARTHRALGIA (knew his shoulder was going to be sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (at the injection site he has a line the size of little finger and it looks jaundice - yellow/green color). On an unknown date, the patient experienced ARTHRALGIA (knew his shoulder was going to be sore). At the time of the report, VACCINATION SITE DISCOLOURATION (at the injection site he has a line the size of little finger and it looks jaundice - yellow/green color) and ARTHRALGIA (knew his shoulder was going to be sore) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-092495 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092495:Same reporter, different patient
Sex: F
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 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 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          Treatment information were not provide.   This case was linked to US-MODERNATX, INC.-MOD-2021-091772, US-MODERNATX, INC.-MOD-2021-092438 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091772: US-MODERNATX, INC.-MOD-2021-092438:Case for son.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: The rash is a bump looks like a welt; got a rash on the arm; rash came back hard; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (The rash is a bump looks like a welt), RASH (got a rash on the arm) and INJECTION SITE URTICARIA (rash came back hard) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced URTICARIA (The rash is a bump looks like a welt), RASH (got a rash on the arm) and INJECTION SITE URTICARIA (rash came back hard). At the time of the report, URTICARIA (The rash is a bump looks like a welt), RASH (got a rash on the arm) and INJECTION SITE URTICARIA (rash came back hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking Thyroid medications concomitantly. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Ataxia, Chills, Confusional state, Fatigue
Clinical narrative: Slight ataxia; Fluish (under the weather); Developed sensitivity to the medications that she has been using for years without any prior incidence; Her body is turned on itself; confusion; increased tinnitus; Severe Chills/ Chills sporadically; TIredness; Headaches / top of head and back of the head/Mild headache/Unbearable headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe Chills/ Chills sporadically), PYREXIA (Fever), FATIGUE (TIredness), HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache) and TINNITUS (increased tinnitus) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), EZETIMIBE and TRAVOPROST (TRAVATAN Z) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache). On 21-Mar-2021, the patient experienced CHILLS (Severe Chills/ Chills sporadically), FATIGUE (TIredness) and TINNITUS (increased tinnitus). On 26-Mar-2021, the patient experienced CONFUSIONAL STATE (confusion), INFLUENZA LIKE ILLNESS (Fluish (under the weather)), ADVERSE REACTION (Developed sensitivity to the medications that she has been using for years without any prior incidence) and FEELING ABNORMAL (Her body is turned on itself). On 26-Apr-2021, the patient experienced ATAXIA (Slight ataxia). At the time of the report, CHILLS (Severe Chills/ Chills sporadically), PYREXIA (Fever), FATIGUE (TIredness), HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache), TINNITUS (increased tinnitus), CONFUSIONAL STATE (confusion), ATAXIA (Slight ataxia), INFLUENZA LIKE ILLNESS (Fluish (under the weather)), ADVERSE REACTION (Developed sensitivity to the medications that she has been using for years without any prior incidence) and FEELING ABNORMAL (Her body is turned on itself) outcome was unknown.            No treatment details were provided   This case was linked to MOD-2021-092195 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness, Pyrexia, Tinnitus
Clinical narrative: Slight ataxia; Fluish (under the weather); Developed sensitivity to the medications that she has been using for years without any prior incidence; Her body is turned on itself; confusion; increased tinnitus; Severe Chills/ Chills sporadically; TIredness; Headaches / top of head and back of the head/Mild headache/Unbearable headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe Chills/ Chills sporadically), PYREXIA (Fever), FATIGUE (TIredness), HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache) and TINNITUS (increased tinnitus) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), EZETIMIBE and TRAVOPROST (TRAVATAN Z) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache). On 21-Mar-2021, the patient experienced CHILLS (Severe Chills/ Chills sporadically), FATIGUE (TIredness) and TINNITUS (increased tinnitus). On 26-Mar-2021, the patient experienced CONFUSIONAL STATE (confusion), INFLUENZA LIKE ILLNESS (Fluish (under the weather)), ADVERSE REACTION (Developed sensitivity to the medications that she has been using for years without any prior incidence) and FEELING ABNORMAL (Her body is turned on itself). On 26-Apr-2021, the patient experienced ATAXIA (Slight ataxia). At the time of the report, CHILLS (Severe Chills/ Chills sporadically), PYREXIA (Fever), FATIGUE (TIredness), HEADACHE (Headaches / top of head and back of the head/Mild headache/Unbearable headache), TINNITUS (increased tinnitus), CONFUSIONAL STATE (confusion), ATAXIA (Slight ataxia), INFLUENZA LIKE ILLNESS (Fluish (under the weather)), ADVERSE REACTION (Developed sensitivity to the medications that she has been using for years without any prior incidence) and FEELING ABNORMAL (Her body is turned on itself) outcome was unknown.            No treatment details were provided   This case was linked to MOD-2021-092195 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Paraesthesia
Clinical narrative: Nerve damage on back and neck; Tingling that goes up and down her back; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve damage on back and neck) and PARAESTHESIA (Tingling that goes up and down her back) 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 NERVE INJURY (Nerve damage on back and neck) and PARAESTHESIA (Tingling that goes up and down her back). At the time of the report, NERVE INJURY (Nerve damage on back and neck) and PARAESTHESIA (Tingling that goes up and down her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Unbearable pain 2-3 hours after vaccination on his arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Unbearable pain 2-3 hours after vaccination on his arm of injection) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Patient had arthritis on his shoulder for the last 5 years.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Unbearable pain 2-3 hours after vaccination on his arm of injection). On 09-Apr-2021, PAIN IN EXTREMITY (Unbearable pain 2-3 hours after vaccination on his arm of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported. The patient stated that he had a positive reaction as his arthritis went away.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27 May 2021 contains non-significant information.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD21-082687, MOD-2021-092714, MOD-2021-092653 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: The second dose after day 36th; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (The second dose after day 36th) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension, VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (The second dose after day 36th). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (The second dose after day 36th) outcome was unknown. Not Provided          The time between the 1st dose and 2nd dose is 79 days.  Other Concomitant Medication provided Centrum Silver 1 tablet daily (Supplements).  The action taken with the drug was Not applicable.  No treatment  was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092201 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092201:spouse case
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm; difficulty raising his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (difficulty raising his arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003811A and 0114C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (difficulty raising his arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (difficulty raising his arm) outcome was unknown. Not Provided          No concomitant medications and treatment information were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: Infectious mononucleosis; This spontaneous case was reported by a pharmacist and describes the occurrence of INFECTIOUS MONONUCLEOSIS (Infectious mononucleosis) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced INFECTIOUS MONONUCLEOSIS (Infectious mononucleosis). At the time of the report, INFECTIOUS MONONUCLEOSIS (Infectious mononucleosis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Diabetic complication, Intentional dose omission, SARS-CoV-2 test positive
Clinical narrative: More than 36 days after the first dose without receiving the second dose; Went to emergency Room for diabetes; Covid-19 positive but not experiencing symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETIC COMPLICATION (Went to emergency Room for diabetes), ASYMPTOMATIC COVID-19 (Covid-19 positive but not experiencing symptoms) and INTENTIONAL DOSE OMISSION (More than 36 days after the first dose without receiving the second dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure, CLOPIDOGREL for Blood thrombin, MAGNESIUM, ASA, VITAMIN D [VITAMIN D NOS], AMLODIPINE BESILATE, METFORMIN, GLIPIZIDE, VENLAFAXINE, TAMSULOSIN, MULTIVITAMINS [VITAMINS NOS] and CYANOCOBALAMIN (B12 1000 SR) for an unknown indication.    On 25-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 DIABETIC COMPLICATION (Went to emergency Room for diabetes) and ASYMPTOMATIC COVID-19 (Covid-19 positive but not experiencing symptoms). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (More than 36 days after the first dose without receiving the second dose). At the time of the report, DIABETIC COMPLICATION (Went to emergency Room for diabetes), ASYMPTOMATIC COVID-19 (Covid-19 positive but not experiencing symptoms) and INTENTIONAL DOSE OMISSION (More than 36 days after the first dose without receiving the second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Aura, Chromatopsia
Clinical narrative: similar aura in left eye; aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye; color blotches in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATOPSIA (color blotches in both eyes), AURA (aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye) and AURA (similar aura in left eye) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Kidney function abnormal, Enlarged prostate since 2019, Arthritis and Sinus pressure (from allergies). Concomitant products included CLARITIN for Allergy, COLCHICINE for Arthritis, MAXFLO for Enlarged prostate, CALCIUM CITRATE for Osteopenia, D3 for an unknown indication.    On 25-Feb-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHROMATOPSIA (color blotches in both eyes). On 05-Mar-2021 at 8:00 AM, the patient experienced AURA (aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye). On 06-Mar-2021 at 8:15 AM, the patient experienced AURA (similar aura in left eye). On 07-Mar-2021, CHROMATOPSIA (color blotches in both eyes) had resolved. At the time of the report, AURA (aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye) and AURA (similar aura in left eye) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021 Follow up received contains significant information outcome of events updated, concomitant medication added, medical history of the patient, and patient initials.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Vaccination site paraesthesia
Clinical narrative: From the injection site to her fingers, she feels tingling; Thumb and index fingers were numb; Tingling; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HYPOAESTHESIA (Thumb and index fingers were numb), PARAESTHESIA (Tingling) and VACCINATION SITE PARAESTHESIA (From the injection site to her fingers, she feels tingling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2(Z)1A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included LOSARTAN, ATORVASTATIN and FENOFIBRATE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 06-Apr-2021, the patient experienced HYPOAESTHESIA (Thumb and index fingers were numb) and PARAESTHESIA (Tingling). On 25-Apr-2021, the patient experienced VACCINATION SITE PARAESTHESIA (From the injection site to her fingers, she feels tingling). At the time of the report, PAIN IN EXTREMITY (Pain in arm), HYPOAESTHESIA (Thumb and index fingers were numb), PARAESTHESIA (Tingling) and VACCINATION SITE PARAESTHESIA (From the injection site to her fingers, she feels tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR received  No new information reported. reporter hung up the phone.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Swollen tongue
Clinical narrative: Stiff left arm; Swollen tongue for 2 days; This spontaneous case was reported by a nurse and describes the occurrence of SWOLLEN TONGUE (2 days) and MUSCULOSKELETAL STIFFNESS (Stiff left arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWOLLEN TONGUE (2 days). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff left arm). At the time of the report, SWOLLEN TONGUE (2 days) and MUSCULOSKELETAL STIFFNESS (Stiff left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above included on 28-Jun-2021 F/U received on 28-jun-2021, document received reporter updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: sore throat; no sense of taste; no sense of smell; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment medication includes Excederin extra strength.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore throat; no sense of taste; no sense of smell; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment medication includes Excederin extra strength.