chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Influenza like illness, Nausea
Clinical narrative: Throw up; Nausea/"feeling like I wanted to throw up"; Body ache similarly to the flu; Feels like I am sleeping more; Chills; Fever (102 degrees); Fatigue set in; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Body ache similarly to the flu), SOMNOLENCE (Feels like I am sleeping more), NAUSEA (Nausea/"feeling like I wanted to throw up"), VOMITING (Throw up) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LIRAGLUTIDE (VICTOZA), PHENTERMINE, ROSUVASTATIN, FAMOTIDINE, IBUPROFEN (DUEXIS) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Body ache similarly to the flu), SOMNOLENCE (Feels like I am sleeping more), CHILLS (Chills), PYREXIA (Fever (102 degrees)) and FATIGUE (Fatigue set in). On an unknown date, the patient experienced NAUSEA (Nausea/"feeling like I wanted to throw up") and VOMITING (Throw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Body ache similarly to the flu) had resolved. On 04-Apr-2021, PYREXIA (Fever (102 degrees)) had resolved. At the time of the report, SOMNOLENCE (Feels like I am sleeping more), NAUSEA (Nausea/"feeling like I wanted to throw up"), VOMITING (Throw up) and CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue set in) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever went up to 102 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: No new information was received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: Throw up; Nausea/"feeling like I wanted to throw up"; Body ache similarly to the flu; Feels like I am sleeping more; Chills; Fever (102 degrees); Fatigue set in; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Body ache similarly to the flu), SOMNOLENCE (Feels like I am sleeping more), NAUSEA (Nausea/"feeling like I wanted to throw up"), VOMITING (Throw up) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LIRAGLUTIDE (VICTOZA), PHENTERMINE, ROSUVASTATIN, FAMOTIDINE, IBUPROFEN (DUEXIS) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Body ache similarly to the flu), SOMNOLENCE (Feels like I am sleeping more), CHILLS (Chills), PYREXIA (Fever (102 degrees)) and FATIGUE (Fatigue set in). On an unknown date, the patient experienced NAUSEA (Nausea/"feeling like I wanted to throw up") and VOMITING (Throw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Body ache similarly to the flu) had resolved. On 04-Apr-2021, PYREXIA (Fever (102 degrees)) had resolved. At the time of the report, SOMNOLENCE (Feels like I am sleeping more), NAUSEA (Nausea/"feeling like I wanted to throw up"), VOMITING (Throw up) and CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue set in) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever went up to 102 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: No new information was received.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Body ache; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-184845, MOD-2021-184845 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Feeling like I wanted to throw up; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea) and VOMITING (Feeling like I wanted to throw up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LIRAGLUTIDE (VICTOZA), PHENTERMINE, ROSUVASTATIN, FAMOTIDINE, IBUPROFEN (DUEXIS) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Feeling like I wanted to throw up). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and VOMITING (Feeling like I wanted to throw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-184719 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Body ache; Chills; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, MYALGIA (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-184726 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ALLERGY TO VACCINE (Allergic reaction to the first dose). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: arm hurt; couldnt sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and INSOMNIA (couldnt sleep) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Blood sugar abnormal and High cholesterol.    On 17-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 hurt) and INSOMNIA (couldnt sleep). At the time of the report, PAIN IN EXTREMITY (arm hurt) and INSOMNIA (couldnt sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for  the management of high blood pressure, blood sugar, high cholesterol.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Arm soreness; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and DIZZINESS (Light headed) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included CHOLESTYRAMINE and ADALIMUMAB (HUMIRA) for Ulcerative colitis, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), SERTRALINE HYDROCHLORIDE (ZOLOFT), CETIRIZINE HYDROCHLORIDE (CITIRIZINE [CETIRIZINE HYDROCHLORIDE]), VITAMIN D [VITAMIN D NOS] and MELATONIN for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and DIZZINESS (Light headed). On 04-Apr-2021, DIZZINESS (Light headed) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.   This case was linked to MOD-2021-163987 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Allergy to intravenous contrast media (IVP dye).    On 12-Jan-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 ARTHRALGIA (Sore arm). At the time of the report, ARTHRALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-060659 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, SARS-CoV-2 test
Clinical narrative: SORE ARM; NASAL CONGESTION/RUNNY NOSE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM) and NASAL CONGESTION (NASAL CONGESTION/RUNNY NOSE) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 16-Mar-2021. Concurrent medical conditions included Iodine contrast media allergy (IVP dye), Penicillin allergy and Allergy to antibiotic (Amoxicillin).   On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 9:30 AM, 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 PAIN IN EXTREMITY (SORE ARM) and NASAL CONGESTION (NASAL CONGESTION/RUNNY NOSE). At the time of the report, PAIN IN EXTREMITY (SORE ARM) and NASAL CONGESTION (NASAL CONGESTION/RUNNY NOSE) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product details was not reported.  Treatment details was not reported .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: red around injection site; swollen around injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE ERYTHEMA (red around injection site) and VACCINATION SITE SWELLING (swollen around injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Oral thrush from 01-Feb-2021 to 06-Feb-2021. Concurrent medical conditions included Allergy to antibiotic (Macrodantin) and Hypothyroidism since 1992. Concomitant products included TIMOLOL and LATANOPROST for Glaucoma, LEVOTHYROXINE for Hypothyroidism.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red around injection site) and VACCINATION SITE SWELLING (swollen around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red around injection site) and VACCINATION SITE SWELLING (swollen around injection site) had resolved.            Medical History of oral thrush -was prescribed clotrimazole tablets Treatment medication not provided.   This case was linked to MOD-2021-025395 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore left arm; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Fatigued) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Cataract in April 2021, Cataract operation (The patient had Cataract surgery on left eye on 06-MAY-2021) on 06-May-2021 and Cataract operation (The patient had Cataract surgery on right eyeon 21-MAY-2021) on 21-May-2021.    On 29-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 VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Fatigued). At the time of the report, VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-185661, MOD-2021-182328, MOD-2021-182328 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Slept most of the day; Had little to no desire to eat; Ache; Fever; Very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever) and FATIGUE (Very tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Food allergy and Food allergy. Concomitant products included LEVOTHYROXINE, OLMESARTAN MEDOXOMIL and ESTRADIOL, PROGESTERONE (BIJUVA) for an unknown indication.   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 SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever), FATIGUE (Very tired) and CHILLS (Chills). On 24-Apr-2021, SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever), FATIGUE (Very tired) and CHILLS (Chills) had resolved.            Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073793 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073793:First dose case
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Slept most of the day; Had little to no desire to eat; Ache; Fever; Very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever) and FATIGUE (Very tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Food allergy and Food allergy. Concomitant products included LEVOTHYROXINE, OLMESARTAN MEDOXOMIL and ESTRADIOL, PROGESTERONE (BIJUVA) for an unknown indication.   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 SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever), FATIGUE (Very tired) and CHILLS (Chills). On 24-Apr-2021, SOMNOLENCE (Slept most of the day), DECREASED APPETITE (Had little to no desire to eat), MYALGIA (Ache), PYREXIA (Fever), FATIGUE (Very tired) and CHILLS (Chills) had resolved.            Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073793 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073793:First dose case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Severe reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 VACCINATION COMPLICATION (Severe reactions). At the time of the report, VACCINATION COMPLICATION (Severe reactions) outcome was unknown.            Concomitant product use was not reported Treatment information was not provided Reporter's 2 of his Co-workers have experienced severe reaction to the 2 nd dose. Action taken with mRNA-1273 in response to the events is not applicable.   This case was linked to MOD-2021-130413 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was reported by the provider.  Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of erythema (redness), swelling, warm skin (heat of the rash) and rash in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included for an unreported indication: Rubella vaccine in 1984. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced erythema (redness), swelling, warm skin (heat of the rash) and rash. The patient treated with Bactine (benzalkonium chloride/lidocaine hydrochloride), 1 dosage form; twice a day. On May 12, 2021, erythema (redness), swelling, warm skin (heat of the rash) and rash resolved. No concomitant medications reported. This case linked to MOD-2021-090407 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Neck pain, Pain in jaw, Vaccination site erythema
Clinical narrative: Red bump at the injection site; Shooting pain in the jaw; Shooting pain on the neck that extended to the left side of her jaws up and down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Shooting pain in the jaw), NECK PAIN (Shooting pain on the neck that extended to the left side of her jaws up and down) and VACCINATION SITE ERYTHEMA (Red bump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Macrobid allergy).   On 15-Feb-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Feb-2021, the patient experienced PAIN IN JAW (Shooting pain in the jaw) and NECK PAIN (Shooting pain on the neck that extended to the left side of her jaws up and down). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red bump at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PAIN IN JAW (Shooting pain in the jaw) and NECK PAIN (Shooting pain on the neck that extended to the left side of her jaws up and down) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red bump at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other (Inconclusive) Went up and down for 36 hours and reached 99.87F.         Concomitant medication included Elquiis
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: SORE ARM; BODY ACHES; HEADACHE; FEVER; NAUSEA; INCREASED FATIGUE; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (SORE ARM), MYALGIA (BODY ACHES), HEADACHE (HEADACHE), PYREXIA (FEVER) and NAUSEA (NAUSEA) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM), MYALGIA (BODY ACHES), HEADACHE (HEADACHE), PYREXIA (FEVER), NAUSEA (NAUSEA) and FATIGUE (INCREASED FATIGUE). At the time of the report, VACCINATION SITE PAIN (SORE ARM), MYALGIA (BODY ACHES), HEADACHE (HEADACHE), PYREXIA (FEVER), NAUSEA (NAUSEA) and FATIGUE (INCREASED FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported Treatment medication was not provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM; BODY ACHES; HEADACHE; FEVER; NAUSEA; INCREASED FATIGUE; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (SORE ARM), MYALGIA (BODY ACHES), HEADACHE (HEADACHE), PYREXIA (FEVER) and NAUSEA (NAUSEA) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM), MYALGIA (BODY ACHES), HEADACHE (HEADACHE), PYREXIA (FEVER), NAUSEA (NAUSEA) and FATIGUE (INCREASED FATIGUE). At the time of the report, VACCINATION SITE PAIN (SORE ARM), MYALGIA (BODY ACHES), HEADACHE (HEADACHE), PYREXIA (FEVER), NAUSEA (NAUSEA) and FATIGUE (INCREASED FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported Treatment medication was not provided by the reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (itchiness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Tobacco user (Five cigarette sticks a day) from 1979 to 2015, Rash (resolved) in January 2021 and Blood blister (resolved) in January 2021. Concurrent medical conditions included Penicillin allergy (manifested by hives and anaphylactic shock), Drug allergy (ENBREL and KEVZARA - hives and red rash on injection site; PLAQUENIL - big red rash on right arm; CYMBALTA - more pain, a lot of swelling) and Alcohol use (Hard liquor, occassionally) since 1979. Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRURITUS (itchiness). The patient was treated with BETAMETHASONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness) had not resolved.        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.   The patient's past medications include PLAQUENIL, CYMBALTA, KEVZARA, HUMIRA, ENBREL for an unknown indication   This case was linked to MOD-2021-185971 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Dermatitis, Pruritus, Rash, Skin irritation
Clinical narrative: recurrent blood blisters; Skin Irritation; Pruritus; Dermatitis; recurrent rash/breakout; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (recurrent blood blisters), SKIN IRRITATION (Skin Irritation), PRURITUS (Pruritus), DERMATITIS (Dermatitis) and RASH (recurrent rash/breakout) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tobacco user in 1979. Concurrent medical conditions included Alcoholism since 1979, Penicillin allergy (MANIFESTED BY HIVES AND ANAPHYLACTIC SHOCK), Drug hypersensitivity (MANIFESTED BY HIVES AND RED RASH ON INJECTION SITE), Drug hypersensitivity (Plaquenil), Drug hypersensitivity (Cymbalta allergy, MANIFESTED BY MORE PAIN, A LOT OF SWELLING) and Drug hypersensitivity (Kevzara allergy, MANIFESTED BY HIVES AND RED RASH ON INJECTION SITE). Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), DULOXETINE HYDROCHLORIDE (CYMBALTA), SARILUMAB (KEVZARA), ADALIMUMAB (HUMIRA) and ETANERCEPT (ENBREL) for an unknown indication.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD BLISTER (recurrent blood blisters), SKIN IRRITATION (Skin Irritation), PRURITUS (Pruritus), DERMATITIS (Dermatitis) and RASH (recurrent rash/breakout). The patient was treated with BETAMETHASONE (intramuscular) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, BLOOD BLISTER (recurrent blood blisters) and RASH (recurrent rash/breakout) had resolved, SKIN IRRITATION (Skin Irritation) outcome was unknown and PRURITUS (Pruritus) and DERMATITIS (Dermatitis) had not resolved.            The patient had skin irritation and wondered if it was from using RINVOQ. Patient stopped taking RINVOQ because it took couple of months to get approved and secure supplies for RINVOQ. When the patient started taking RINVO, the skin became darker and the symptoms returned on a regular basis. HCP considered it as dermatitis. During the call, patient was not willing to give the concomitant medication. Before at least one symptom happened, the patient received Covid-19 vaccination and considered as co-suspect product. The expiration date of the covid-19 vaccination was not mentioned in the vaccination card. It was unclear whether the patient enrolled in covid-19 vaccination trial.   This case was linked to MOD-2021-185939, MOD-2021-185939 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pruritus
Clinical narrative: Memory impaired; Hand itching; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impaired) and PRURITUS (Hand itching) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free pen. In April 2021, the patient experienced PRURITUS (Hand itching). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impaired). In April 2021, PRURITUS (Hand itching) had resolved. At the time of the report, MEMORY IMPAIRMENT (Memory impaired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-186011 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Myalgia
Clinical narrative: Got really sick and sore; Got really sick and sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick and sore) and MYALGIA (Got really sick and sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Arthritis.    No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free pen. In May 2021, the patient experienced ILLNESS (Got really sick and sore) and MYALGIA (Got really sick and sore). In May 2021, ILLNESS (Got really sick and sore) and MYALGIA (Got really sick and sore) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-185994 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of the whole left armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of LYMPHADENOPATHY (swelling of the whole left armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling of the whole left armpit). At the time of the report, LYMPHADENOPATHY (swelling of the whole left armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dysphonia, Flushing, Limb discomfort
Clinical narrative: Itchy; Chills; Rash; protruding chest pain; sore arm one week later after moderna vaccine; Flushing; HOARSENESS; Left breast is hurting and has noticeable lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (protruding chest pain), LIMB DISCOMFORT (sore arm one week later after moderna vaccine), PRURITUS (Itchy), FLUSHING (Flushing) and DYSPHONIA (HOARSENESS) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM, TRIAMTERENE and RABEPRAZOLE SODIUM (ACIPHEX) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CHEST PAIN (protruding chest pain), LIMB DISCOMFORT (sore arm one week later after moderna vaccine), FLUSHING (Flushing), DYSPHONIA (HOARSENESS) and LYMPH NODE PAIN (Left breast is hurting and has noticeable lymph nodes). On 24-Apr-2021, the patient experienced PRURITUS (Itchy), CHILLS (Chills) and RASH (Rash). The patient was treated with HYDROCORTISONE ongoing from 19-May-2021 for Adverse event, at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; MOMETASONE ongoing from 19-May-2021 for Adverse event, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHEST PAIN (protruding chest pain), LIMB DISCOMFORT (sore arm one week later after moderna vaccine), FLUSHING (Flushing), DYSPHONIA (HOARSENESS) and LYMPH NODE PAIN (Left breast is hurting and has noticeable lymph nodes) outcome was unknown and PRURITUS (Itchy), CHILLS (Chills) and RASH (Rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication include Benadryl and Clotran. Other Medications Include Vdtex.   This case was linked to MOD-2021-075107, MOD-2021-075107 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Followup received and treatment medications were added. On 01-Jul-2021: Follow up received and patient demograpics were added. Concomitant medications were added. Events were added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pruritus, Rash
Clinical narrative: Itchy; Chills; Rash; protruding chest pain; sore arm one week later after moderna vaccine; Flushing; HOARSENESS; Left breast is hurting and has noticeable lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (protruding chest pain), LIMB DISCOMFORT (sore arm one week later after moderna vaccine), PRURITUS (Itchy), FLUSHING (Flushing) and DYSPHONIA (HOARSENESS) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM, TRIAMTERENE and RABEPRAZOLE SODIUM (ACIPHEX) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CHEST PAIN (protruding chest pain), LIMB DISCOMFORT (sore arm one week later after moderna vaccine), FLUSHING (Flushing), DYSPHONIA (HOARSENESS) and LYMPH NODE PAIN (Left breast is hurting and has noticeable lymph nodes). On 24-Apr-2021, the patient experienced PRURITUS (Itchy), CHILLS (Chills) and RASH (Rash). The patient was treated with HYDROCORTISONE ongoing from 19-May-2021 for Adverse event, at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; MOMETASONE ongoing from 19-May-2021 for Adverse event, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHEST PAIN (protruding chest pain), LIMB DISCOMFORT (sore arm one week later after moderna vaccine), FLUSHING (Flushing), DYSPHONIA (HOARSENESS) and LYMPH NODE PAIN (Left breast is hurting and has noticeable lymph nodes) outcome was unknown and PRURITUS (Itchy), CHILLS (Chills) and RASH (Rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication include Benadryl and Clotran. Other Medications Include Vdtex.   This case was linked to MOD-2021-075107, MOD-2021-075107 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Followup received and treatment medications were added. On 01-Jul-2021: Follow up received and patient demograpics were added. Concomitant medications were added. Events were added.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Connective tissue disorder, Drug ineffective, Nausea, Pain in extremity
Clinical narrative: Reaction to COVID vaccine; Drug does not help joint pain; Sore arm; Connected tissue disease; Nauseous; Vomitting; Joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reaction to COVID vaccine), DRUG INEFFECTIVE (Drug does not help joint pain), PAIN IN EXTREMITY (Sore arm), CONNECTIVE TISSUE DISORDER (Connected tissue disease) and NAUSEA (Nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to COVID vaccine), DRUG INEFFECTIVE (Drug does not help joint pain), PAIN IN EXTREMITY (Sore arm), CONNECTIVE TISSUE DISORDER (Connected tissue disease), NAUSEA (Nauseous), VOMITING (Vomitting) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION COMPLICATION (Reaction to COVID vaccine), NAUSEA (Nauseous) and VOMITING (Vomitting) had resolved, DRUG INEFFECTIVE (Drug does not help joint pain) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and CONNECTIVE TISSUE DISORDER (Connected tissue disease) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION COMPLICATION (Reaction to COVID vaccine), PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseous) and VOMITING (Vomitting) to be probably related. No further causality assessments were provided for DRUG INEFFECTIVE (Drug does not help joint pain), CONNECTIVE TISSUE DISORDER (Connected tissue disease) and ARTHRALGIA (Joint pain).    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 event of vaccination complication, pain in extremity, connective tissue disorder and nausea, a causal relationship cannot be excluded, humira was also a confounder. Causality for the event of drug ineffective is not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Reaction to COVID vaccine; Drug does not help joint pain; Sore arm; Connected tissue disease; Nauseous; Vomitting; Joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reaction to COVID vaccine), DRUG INEFFECTIVE (Drug does not help joint pain), PAIN IN EXTREMITY (Sore arm), CONNECTIVE TISSUE DISORDER (Connected tissue disease) and NAUSEA (Nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to COVID vaccine), DRUG INEFFECTIVE (Drug does not help joint pain), PAIN IN EXTREMITY (Sore arm), CONNECTIVE TISSUE DISORDER (Connected tissue disease), NAUSEA (Nauseous), VOMITING (Vomitting) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION COMPLICATION (Reaction to COVID vaccine), NAUSEA (Nauseous) and VOMITING (Vomitting) had resolved, DRUG INEFFECTIVE (Drug does not help joint pain) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and CONNECTIVE TISSUE DISORDER (Connected tissue disease) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION COMPLICATION (Reaction to COVID vaccine), PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseous) and VOMITING (Vomitting) to be probably related. No further causality assessments were provided for DRUG INEFFECTIVE (Drug does not help joint pain), CONNECTIVE TISSUE DISORDER (Connected tissue disease) and ARTHRALGIA (Joint pain).    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 event of vaccination complication, pain in extremity, connective tissue disorder and nausea, a causal relationship cannot be excluded, humira was also a confounder. Causality for the event of drug ineffective is not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Injection site bruising, Psoriasis
Clinical narrative: Back Pain; Knee pain; psoriasis; Injection Site Bruising; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE BRUISING (Injection Site Bruising), BACK PAIN (Back Pain), ARTHRALGIA (Knee pain) and PSORIASIS (psoriasis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 29-May-2021 at 10:55 AM, the patient experienced INJECTION SITE BRUISING (Injection Site Bruising). On an unknown date, the patient experienced BACK PAIN (Back Pain), ARTHRALGIA (Knee pain) and PSORIASIS (psoriasis). At the time of the report, INJECTION SITE BRUISING (Injection Site Bruising), BACK PAIN (Back Pain), ARTHRALGIA (Knee pain) and PSORIASIS (psoriasis) 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 medications  were reported     Reporter did not allow further contact