chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Nasopharyngitis, Pruritus
Clinical narrative: faint, cold/clammy, and sweating.; dizziness; blood pressure changes; chills; fatigue that would come and go; severe itching on both her forearms.; lips on the inside of her mouth swelled up on one side; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (lips on the inside of her mouth swelled up on one side), PRURITUS (severe itching on both her forearms.), FATIGUE (fatigue that would come and go), CHILLS (chills) and DIZZINESS (dizziness) in a 69-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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MOUTH SWELLING (lips on the inside of her mouth swelled up on one side). On 22-Jan-2021, the patient experienced PRURITUS (severe itching on both her forearms.). On 23-Jan-2021, the patient experienced FATIGUE (fatigue that would come and go). On 31-Jan-2021, the patient experienced CHILLS (chills). On 02-Feb-2021, the patient experienced DIZZINESS (dizziness) and BLOOD PRESSURE ABNORMAL (blood pressure changes). On an unknown date, the patient experienced NASOPHARYNGITIS (faint, cold/clammy, and sweating.). The patient was treated with CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC PLUS) for Itching, at an unspecified dose and frequency. At the time of the report, MOUTH SWELLING (lips on the inside of her mouth swelled up on one side), PRURITUS (severe itching on both her forearms.), FATIGUE (fatigue that would come and go), CHILLS (chills), DIZZINESS (dizziness), BLOOD PRESSURE ABNORMAL (blood pressure changes) and NASOPHARYNGITIS (faint, cold/clammy, and sweating.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Blood pressure measurement: 61/45, 71/49, 107/64, 109/65, 82/53, 71/53.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration
Clinical narrative: large pink circle at the injection site; Discoloration at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Discoloration at the injection site) and INJECTION SITE DISCOLOURATION (large pink circle at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (Discoloration at the injection site). On 28-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (large pink circle at the injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Discoloration at the injection site) and INJECTION SITE DISCOLOURATION (large pink circle at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided.  Treatment Medications were not taken by the patient.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Vaccination site swelling
Clinical narrative: redness at injection site; itchy; arm swelling; circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swelling), INJECTION SITE REACTION (circle at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PRURITUS (itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (contraindicated to take oral Benadryl because of her Glaucoma).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm swelling), INJECTION SITE REACTION (circle at injection site) and INJECTION SITE PRURITUS (itchy). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (arm swelling), INJECTION SITE REACTION (circle at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pneumonitis, Pulmonary pain
Clinical narrative: sharp pain in the right side of her body on the lung and bra line; ache left arm; fatigue; muscle pain; joint pain; inflammation on the lungs and ribs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (sharp pain in the right side of her body on the lung and bra line), PNEUMONITIS (inflammation on the lungs and ribs), VACCINATION SITE PAIN (ache left arm), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for Vitamin supplementation.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced PNEUMONITIS (inflammation on the lungs and ribs). On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (ache left arm), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 31-Jan-2021, the patient experienced PULMONARY PAIN (sharp pain in the right side of her body on the lung and bra line). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PULMONARY PAIN (sharp pain in the right side of her body on the lung and bra line), PNEUMONITIS (inflammation on the lungs and ribs), VACCINATION SITE PAIN (ache left arm), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sharp pain in the right side of her body on the lung and bra line; ache left arm; fatigue; muscle pain; joint pain; inflammation on the lungs and ribs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (sharp pain in the right side of her body on the lung and bra line), PNEUMONITIS (inflammation on the lungs and ribs), VACCINATION SITE PAIN (ache left arm), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for Vitamin supplementation.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced PNEUMONITIS (inflammation on the lungs and ribs). On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (ache left arm), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 31-Jan-2021, the patient experienced PULMONARY PAIN (sharp pain in the right side of her body on the lung and bra line). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PULMONARY PAIN (sharp pain in the right side of her body on the lung and bra line), PNEUMONITIS (inflammation on the lungs and ribs), VACCINATION SITE PAIN (ache left arm), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site discolouration, Vaccination site pain
Clinical narrative: where he got the injection, is yellow; Sore arm where they gave him the injection; His armpit started swelling up; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE DISCOLOURATION (where he got the injection, is yellow), LYMPHADENOPATHY (His armpit started swelling up) and VACCINATION SITE PAIN (Sore arm where they gave him the injection) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced LYMPHADENOPATHY (His armpit started swelling up). On 26-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (where he got the injection, is yellow) and VACCINATION SITE PAIN (Sore arm where they gave him the injection). At the time of the report, VACCINATION SITE DISCOLOURATION (where he got the injection, is yellow), LYMPHADENOPATHY (His armpit started swelling up) and VACCINATION SITE PAIN (Sore arm where they gave him the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I've got some reactions through the day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I've got some reactions through the day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (I've got some reactions through the day). At the time of the report, VACCINATION COMPLICATION (I've got some reactions through the day) outcome was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on left palm of hand) and URTICARIA (hives on thighs, butt, and lower chest) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, LOSARTAN, DEXLANSOPRAZOLE (DEXILANT), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOLTERODINE TARTRATE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-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 PRURITUS (itching on left palm of hand) and URTICARIA (hives on thighs, butt, and lower chest). At the time of the report, PRURITUS (itching on left palm of hand) and URTICARIA (hives on thighs, butt, and lower chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: RED AT INJECTION SITE; SWOLLEN AT INJECTION SITE; ITCHING AT INJECTION SITE; HOT AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), INJECTION SITE SWELLING (SWOLLEN AT INJECTION SITE), INJECTION SITE PRURITUS (ITCHING AT INJECTION SITE) and INJECTION SITE WARMTH (HOT AT INJECTION SITE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), INJECTION SITE SWELLING (SWOLLEN AT INJECTION SITE), INJECTION SITE PRURITUS (ITCHING AT INJECTION SITE) and INJECTION SITE WARMTH (HOT AT INJECTION SITE). At the time of the report, INJECTION SITE ERYTHEMA (RED AT INJECTION SITE), INJECTION SITE SWELLING (SWOLLEN AT INJECTION SITE), INJECTION SITE PRURITUS (ITCHING AT INJECTION SITE) and INJECTION SITE WARMTH (HOT AT INJECTION SITE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Headache
Clinical narrative: chills; head felt heavy and achy; head felt heavy and achy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEAD DISCOMFORT (head felt heavy and achy) and HEADACHE (head felt heavy and achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills), HEAD DISCOMFORT (head felt heavy and achy) and HEADACHE (head felt heavy and achy). At the time of the report, CHILLS (chills), HEAD DISCOMFORT (head felt heavy and achy) and HEADACHE (head felt heavy and achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyschromatopsia, Fatigue, Headache, Injection site erythema, Vaccination site pain
Clinical narrative: broke up redness/ still red; swollen; still soreness; extremely tired and weak for a few days; recovering color seems to go away but comes back, it's weird; chronic headache and after the shot became worse; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days) and HEADACHE (chronic headache and after the shot became worse) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A Not sure) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, GABAPENTIN and CALCIUM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (chronic headache and after the shot became worse). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days) and DYSCHROMATOPSIA (recovering color seems to go away but comes back, it's weird). At the time of the report, INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days), HEADACHE (chronic headache and after the shot became worse) and DYSCHROMATOPSIA (recovering color seems to go away but comes back, it's weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information information reported was Ibuprofen but only the first day.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: broke up redness/ still red; swollen; still soreness; extremely tired and weak for a few days; recovering color seems to go away but comes back, it's weird; chronic headache and after the shot became worse; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days) and HEADACHE (chronic headache and after the shot became worse) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A Not sure) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, GABAPENTIN and CALCIUM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (chronic headache and after the shot became worse). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days) and DYSCHROMATOPSIA (recovering color seems to go away but comes back, it's weird). At the time of the report, INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days), HEADACHE (chronic headache and after the shot became worse) and DYSCHROMATOPSIA (recovering color seems to go away but comes back, it's weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information information reported was Ibuprofen but only the first day.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Blackness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Blackness at the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Blackness at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Blackness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Soreness in the right arm; Itching; Redness; Swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in the right arm), PRURITUS (Itching), ERYTHEMA (Redness) and SWELLING (Swelling) in a 74-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 No adverse event (No medical history reported.). Concomitant products included VITAMIN 15 for Vitamin supplementation, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness) and SWELLING (Swelling). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the right arm). The patient was treated with ACETAMINOPHEN for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in the right arm), PRURITUS (Itching), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Rash, Swelling
Clinical narrative: Rash; swelling; small bruise; itch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), SWELLING (swelling), CONTUSION (small bruise) and PRURITUS (itch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LOSARTAN, AMLODIPINE, FENOFIBRATE, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM), ACYCLOVIR [ACICLOVIR], ESTRADIOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D) and BUSPIRONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (Rash), SWELLING (swelling), CONTUSION (small bruise) and PRURITUS (itch). At the time of the report, RASH (Rash), SWELLING (swelling), CONTUSION (small bruise) and PRURITUS (itch) 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: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Swelling, Vaccination site mass
Clinical narrative: RED RING 1INCH AROUND INJECTION SITE; Redness at injection site; ITCHING IN INJECTION SITE; Swelling; knot the size of a walnut; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SWELLING (Swelling), VACCINATION SITE MASS (knot the size of a walnut), INJECTION SITE ERYTHEMA (RED RING 1INCH AROUND INJECTION SITE), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (ITCHING IN INJECTION SITE) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE MASS (knot the size of a walnut). On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (ITCHING IN INJECTION SITE). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (RED RING 1INCH AROUND INJECTION SITE). At the time of the report, SWELLING (Swelling), VACCINATION SITE MASS (knot the size of a walnut), INJECTION SITE ERYTHEMA (RED RING 1INCH AROUND INJECTION SITE), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (ITCHING IN INJECTION SITE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: swelling of her face; numbness in arms; numbness in hands; tingling in her feet; some throat issue, voice hoarse, tight, but not like closing; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling of her face), HYPOAESTHESIA (numbness in arms), HYPOAESTHESIA (numbness in hands), PARAESTHESIA (tingling in her feet) and DYSPHONIA (some throat issue, voice hoarse, tight, but not like closing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced SWELLING FACE (swelling of her face), HYPOAESTHESIA (numbness in arms), HYPOAESTHESIA (numbness in hands), PARAESTHESIA (tingling in her feet) and DYSPHONIA (some throat issue, voice hoarse, tight, but not like closing). On 26-Jan-2021, SWELLING FACE (swelling of her face), HYPOAESTHESIA (numbness in arms), HYPOAESTHESIA (numbness in hands), PARAESTHESIA (tingling in her feet) and DYSPHONIA (some throat issue, voice hoarse, tight, but not like closing) 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.   Treatment details steroids and EPI-Pen.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: Sore arm; Flu symptoms (cough); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INFLUENZA (Flu symptoms (cough)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INFLUENZA (Flu symptoms (cough)). On 24-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, INFLUENZA (Flu symptoms (cough)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. No treatment details was provided.   This case was linked to MOD21-034179, US-MODERNATX, INC.-MOD-2021-018287 (Linked Report).; Sender's Comments:  MOD21-034179: US-MODERNATX, INC.-MOD-2021-018287:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Nausea, Pain
Clinical narrative: Headache; Nausea; Fatigue; Soreness; BP higher than normal; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), PAIN (Soreness) and HYPERTENSION (BP higher than normal) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), PAIN (Soreness) and HYPERTENSION (BP higher than normal). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), PAIN (Soreness) and HYPERTENSION (BP higher than normal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 21-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Birth control, multi vitamins.  Treatment information was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache; Nausea; Fatigue; Soreness; BP higher than normal; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), PAIN (Soreness) and HYPERTENSION (BP higher than normal) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), PAIN (Soreness) and HYPERTENSION (BP higher than normal). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), PAIN (Soreness) and HYPERTENSION (BP higher than normal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 21-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Birth control, multi vitamins.  Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Pyrexia
Clinical narrative: Burning up; Shivering; Feverish 104.6; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up), CHILLS (Shivering) and PYREXIA (Feverish 104.6) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BURNING SENSATION (Burning up), CHILLS (Shivering) and PYREXIA (Feverish 104.6). At the time of the report, BURNING SENSATION (Burning up), CHILLS (Shivering) and PYREXIA (Feverish 104.6) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), DIARRHOEA (Diarrhea), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced DIARRHEA (Diarrhea) and PYREXIA (Fever). On 17-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm), DIARRHEA (Diarrhea), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   This case was linked to MOD-2021-091059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Information regarding the Email Address was updated.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Sore(at the injection site); Redness (at the injection site); pain at injection site; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), MYALGIA (Sore(at the injection site)), INJECTION SITE ERYTHEMA (Redness (at the injection site)) and INJECTION SITE PAIN (pain at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (Itchiness), INJECTION SITE ERYTHEMA (Redness (at the injection site)) and INJECTION SITE PAIN (pain at injection site). On an unknown date, the patient experienced MYALGIA (Sore(at the injection site)). At the time of the report, PRURITUS (Itchiness), MYALGIA (Sore(at the injection site)), INJECTION SITE ERYTHEMA (Redness (at the injection site)) and INJECTION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Somnolence, Tremor
Clinical narrative: shakes; slept a lot; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), SOMNOLENCE (slept a lot) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 0101A21A) for COVID-19 vaccination.     The patient's past medical history included Clot blood and Gout. Concurrent medical conditions included Deep vein thrombosis, Atrial fibrillation and High cholesterol. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, ALOPURINOL for Gout, ALIROCUMAB (PRALUENT) for High cholesterol, UBIDECARENONE (COQ10 [UBIDECARENONE]) and VITAMIN D3 for an unknown indication.   On 01-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TREMOR (shakes), SOMNOLENCE (slept a lot) and CHILLS (chills). On 02-Feb-2021, TREMOR (shakes), SOMNOLENCE (slept a lot) and CHILLS (chills) had resolved.            Treatment medication was not reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received, patient medical history, product details. On 07-Aug-2021: Non Significant Follow-up
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Hips and back began to hurt after the vaccine; Hips and back began to hurt after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Hips and back began to hurt after the vaccine) and ARTHRALGIA (Hips and back began to hurt after the vaccine) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     Concurrent medical conditions included Arthritis.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced BACK PAIN (Hips and back began to hurt after the vaccine) and ARTHRALGIA (Hips and back began to hurt after the vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hips and back began to hurt after the vaccine) and ARTHRALGIA (Hips and back began to hurt after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Ear pain, Facial pain, Headache
Clinical narrative: nose hurts; ear hurts; temple hurts; white flashes on the side of her head; loose stools; shoulder pain; bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head) and DIARRHOEA (loose stools) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (Ocular migraines). Concomitant products included PARACETAMOL (TYLENOL) and CAFFEINE for Migraine.    On 21-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 NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head), DIARRHOEA (loose stools), ARTHRALGIA (shoulder pain), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head), DIARRHOEA (loose stools), ARTHRALGIA (shoulder pain), HEADACHE (bad headache) and NAUSEA (nausea) 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.   Treatment details were not reported by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nasal injury, Nausea
Clinical narrative: nose hurts; ear hurts; temple hurts; white flashes on the side of her head; loose stools; shoulder pain; bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head) and DIARRHOEA (loose stools) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (Ocular migraines). Concomitant products included PARACETAMOL (TYLENOL) and CAFFEINE for Migraine.    On 21-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 NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head), DIARRHOEA (loose stools), ARTHRALGIA (shoulder pain), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head), DIARRHOEA (loose stools), ARTHRALGIA (shoulder pain), HEADACHE (bad headache) and NAUSEA (nausea) 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.   Treatment details were not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever on and off all day for quite a while; 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 PYREXIA (fever on and off all day for quite a while) 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 22-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 PYREXIA (fever on and off all day for quite a while). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (fever on and off all day for quite a while) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Hot to the touch Injection Site; Redness (3" around Injection Site); Borderline Diarrhea; Fever 100 F; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Borderline Diarrhea), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)), PYREXIA (Fever 100 F) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever 100 F), NAUSEA (Nausea) and VOMITING (Vomiting). On 18-Feb-2021, the patient experienced DIARRHOEA (Borderline Diarrhea). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)). At the time of the report, DIARRHOEA (Borderline Diarrhea), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)) and VOMITING (Vomiting) outcome was unknown and PYREXIA (Fever 100 F) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hot to the touch Injection Site; Redness (3" around Injection Site); Borderline Diarrhea; Fever 100 F; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Borderline Diarrhea), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)), PYREXIA (Fever 100 F) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever 100 F), NAUSEA (Nausea) and VOMITING (Vomiting). On 18-Feb-2021, the patient experienced DIARRHOEA (Borderline Diarrhea). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)). At the time of the report, DIARRHOEA (Borderline Diarrhea), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Redness (3" around Injection Site)) and VOMITING (Vomiting) outcome was unknown and PYREXIA (Fever 100 F) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTION; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (ADVERSE REACTION) 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 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 ADVERSE REACTION (ADVERSE REACTION). At the time of the report, ADVERSE REACTION (ADVERSE REACTION) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Poor quality sleep
Clinical narrative: Headache; Chills; Poor sleep; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Poor sleep), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement. Concurrent medical conditions included Hypertension and Thyroid disorder.    On 27-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 POOR QUALITY SLEEP (Poor sleep) and FATIGUE (Fatigue). On 28-Jan-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, POOR QUALITY SLEEP (Poor sleep), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment was reported.   Reporter did not allow further contact; Sender's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, fatigue and chills are consistent with the known safety profile of the vaccine