chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Gout, Myalgia
Clinical narrative: Barely able to get around, difficulty getting up from chair and toilet; Aching gout pain in muscles of hip joints and shoulders; pain in his elbows and knees; Aching gout pain in shoulders, elbows, knees. muscles in his hips; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Aching gout pain in shoulders, elbows, knees. muscles in his hips), GAIT DISTURBANCE (Barely able to get around, difficulty getting up from chair and toilet), MYALGIA (Aching gout pain in muscles of hip joints and shoulders) and ARTHRALGIA (pain in his elbows and knees) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gout and Hypertension. Concomitant products included ALLOPURINOL and INDOMETHACIN [INDOMETACIN] for Gout, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced GOUT (Aching gout pain in shoulders, elbows, knees. muscles in his hips), MYALGIA (Aching gout pain in muscles of hip joints and shoulders) and ARTHRALGIA (pain in his elbows and knees). On 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Barely able to get around, difficulty getting up from chair and toilet). At the time of the report, GOUT (Aching gout pain in shoulders, elbows, knees. muscles in his hips), GAIT DISTURBANCE (Barely able to get around, difficulty getting up from chair and toilet) and MYALGIA (Aching gout pain in muscles of hip joints and shoulders) had not resolved and ARTHRALGIA (pain in his elbows and knees) had resolved.            Patient reported that she never had aches in all those locations at once, with previous gout attacks and the symptoms lasted longer than usual as well. Concomitant medication included blood pressure medicine. Treatment details included Indomethacin for his symptoms (increased use of indomethacin).   This case was linked to MOD-2021-139294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: second dose information was added
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Heard of people that gets sick from their second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Heard of people that gets sick from their second shot) 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 ILLNESS (Heard of people that gets sick from their second shot). At the time of the report, ILLNESS (Heard of people that gets sick from their second shot) outcome was unknown.            No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17year old patient received the vaccine in the left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm) had 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.   This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 003A21A) with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 003A21A) with no associated AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Myalgia
Clinical narrative: Extreme chills; Headache; Body ache; Fever; Rapid heart rate about 30 minutes after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate about 30 minutes after the vaccine), CHILLS (Extreme chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (Fever) 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 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate about 30 minutes after the vaccine). On 13-Mar-2021, the patient experienced CHILLS (Extreme chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, HEART RATE INCREASED (Rapid heart rate about 30 minutes after the vaccine) had resolved. On 14-Mar-2021, CHILLS (Extreme chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: rapid (High) Rapid heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter(declined).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme chills; Headache; Body ache; Fever; Rapid heart rate about 30 minutes after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate about 30 minutes after the vaccine), CHILLS (Extreme chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (Fever) 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 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate about 30 minutes after the vaccine). On 13-Mar-2021, the patient experienced CHILLS (Extreme chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, HEART RATE INCREASED (Rapid heart rate about 30 minutes after the vaccine) had resolved. On 14-Mar-2021, CHILLS (Extreme chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: rapid (High) Rapid heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter(declined).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Tremor
Clinical narrative: arm hurt; shakes all day long, I was freezing like I couldn't get warm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), TREMOR (shakes all day long, I was freezing like I couldn't get warm) and HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for an unknown indication.   On 13-Mar-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) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), TREMOR (shakes all day long, I was freezing like I couldn't get warm) and HEADACHE (headache). On 14-Mar-2021, TREMOR (shakes all day long, I was freezing like I couldn't get warm) and HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.            Treatment details included Ibuprofen.  Action taken with the mRNA-1273 in response to the event is not applicable.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Little hard to touch swelling on left side of face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Little hard to touch swelling on left side of face) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) and TRAZODONE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING FACE (Little hard to touch swelling on left side of face). At the time of the report, SWELLING FACE (Little hard to touch swelling on left side of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Vit mg ca. No information about treatment was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE RASH (Rash at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: Vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Vivid dreams) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ABNORMAL DREAMS (Vivid dreams). On 14-Mar-2021, ABNORMAL DREAMS (Vivid dreams) had resolved.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I have been feeling light headed since I got the vaccine/I wouldn't call it dizzy but it feels like I could be dizzy; I wouldn't call it dizzy but it feels like I could be dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I have been feeling light headed since I got the vaccine/I wouldn't call it dizzy but it feels like I could be dizzy) and DIZZINESS (I wouldn't call it dizzy but it feels like I could be dizzy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included DICLOFENAC, ALLOPURINOL, POTASSIUM CHLORIDE, INDAPAMIDE, AMLODIPINE, DEXLANSOPRAZOLE (DEXILANT) and ESCITALOPRAM for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I have been feeling light headed since I got the vaccine/I wouldn't call it dizzy but it feels like I could be dizzy) and DIZZINESS (I wouldn't call it dizzy but it feels like I could be dizzy). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (I have been feeling light headed since I got the vaccine/I wouldn't call it dizzy but it feels like I could be dizzy) had not resolved and DIZZINESS (I wouldn't call it dizzy but it feels like I could be dizzy) outcome was unknown. Not Provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site discomfort, Vaccination site pain, Vaccination site rash
Clinical narrative: Had a little bit of discomfort; Developed a really funny rash under her left arm that was wide, dark and hurting; Developed a really funny rash under her left arm that was wide, dark and hurting; Developed a really funny rash under her left arm that was wide, dark and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Had a little bit of discomfort), VACCINATION SITE DISCOLOURATION (Developed a really funny rash under her left arm that was wide, dark and hurting), VACCINATION SITE PAIN (Developed a really funny rash under her left arm that was wide, dark and hurting) and VACCINATION SITE RASH (Developed a really funny rash under her left arm that was wide, dark and hurting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Had a little bit of discomfort), VACCINATION SITE DISCOLOURATION (Developed a really funny rash under her left arm that was wide, dark and hurting), VACCINATION SITE PAIN (Developed a really funny rash under her left arm that was wide, dark and hurting) and VACCINATION SITE RASH (Developed a really funny rash under her left arm that was wide, dark and hurting). At the time of the report, VACCINATION SITE DISCOMFORT (Had a little bit of discomfort), VACCINATION SITE DISCOLOURATION (Developed a really funny rash under her left arm that was wide, dark and hurting), VACCINATION SITE PAIN (Developed a really funny rash under her left arm that was wide, dark and hurting) and VACCINATION SITE RASH (Developed a really funny rash under her left arm that was wide, dark and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (Arm Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-106996 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: sore arm after the first shot; raised, red welt at the site of the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the first shot) and VACCINATION SITE MASS (raised, red welt at the site of the shot) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE MASS (raised, red welt at the site of the shot). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after the first shot). At the time of the report, PAIN IN EXTREMITY (sore arm after the first shot) and VACCINATION SITE MASS (raised, red welt at the site of the shot) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD-2021-135806 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient denied further follow up.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right leg was swollen from her hip to the toes; Soreness of arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and PERIPHERAL SWELLING (Right leg was swollen from her hip to the toes) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     No medical history was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right leg was swollen from her hip to the toes). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown and PERIPHERAL SWELLING (Right leg was swollen from her hip to the toes) had not resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.      Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No significant information was received.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Incorrect route of product administration, Muscle tightness, Pain
Clinical narrative: she was told by her physician he thinks the first vaccine may have been inject too low on the arm; site of injection there were two red spots that looked like a bee had stung; feeling really really bad; muscle was tight; pain; swelling in the arm; itch under my attire, in the shoulder area, very itchy; slight headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm) and PRURITUS (itch under my attire, in the shoulder area, very itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Headache.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (slight headache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm), PRURITUS (itch under my attire, in the shoulder area, very itchy) and VACCINATION SITE ERYTHEMA (site of injection there were two red spots that looked like a bee had stung). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she was told by her physician he thinks the first vaccine may have been inject too low on the arm). At the time of the report, FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm), PRURITUS (itch under my attire, in the shoulder area, very itchy), VACCINATION SITE ERYTHEMA (site of injection there were two red spots that looked like a bee had stung) and HEADACHE (slight headache) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she was told by her physician he thinks the first vaccine may have been inject too low on the arm) had resolved.            No concomitant medications reported by reporter.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information was received from the initial reporter: New event, second dose details and reporter comments were added. The patient received the second dose of the Moderna vaccine and did not have any problems with that dose.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: she was told by her physician he thinks the first vaccine may have been inject too low on the arm; site of injection there were two red spots that looked like a bee had stung; feeling really really bad; muscle was tight; pain; swelling in the arm; itch under my attire, in the shoulder area, very itchy; slight headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm) and PRURITUS (itch under my attire, in the shoulder area, very itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Headache.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (slight headache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm), PRURITUS (itch under my attire, in the shoulder area, very itchy) and VACCINATION SITE ERYTHEMA (site of injection there were two red spots that looked like a bee had stung). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she was told by her physician he thinks the first vaccine may have been inject too low on the arm). At the time of the report, FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm), PRURITUS (itch under my attire, in the shoulder area, very itchy), VACCINATION SITE ERYTHEMA (site of injection there were two red spots that looked like a bee had stung) and HEADACHE (slight headache) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she was told by her physician he thinks the first vaccine may have been inject too low on the arm) had resolved.            No concomitant medications reported by reporter.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information was received from the initial reporter: New event, second dose details and reporter comments were added. The patient received the second dose of the Moderna vaccine and did not have any problems with that dose.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Mass, Paraesthesia, Vaccination site lymphadenopathy
Clinical narrative: Arms felt like pins and needle; cant sleep; my arm felt heavy; lump below left armpit,5 inches,like golf ball; Swelling of lymph node under arm she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arms felt like pins and needle), INSOMNIA (cant sleep), LIMB DISCOMFORT (my arm felt heavy), MASS (lump below left armpit,5 inches,like golf ball) and VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph node under arm she received the vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10202) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE (TOPROL) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph node under arm she received the vaccine). On an unknown date, the patient experienced PARAESTHESIA (Arms felt like pins and needle), INSOMNIA (cant sleep), LIMB DISCOMFORT (my arm felt heavy) and MASS (lump below left armpit,5 inches,like golf ball). At the time of the report, PARAESTHESIA (Arms felt like pins and needle), INSOMNIA (cant sleep), LIMB DISCOMFORT (my arm felt heavy), MASS (lump below left armpit,5 inches,like golf ball) and VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph node under arm she received the vaccine) outcome was unknown.            No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up SD received on 02-JUn-2021 in which concomitant medications and events are updated
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node swollen; 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 LYMPHADENOPATHY (lymph node swollen) 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 (lymph node swollen). At the time of the report, LYMPHADENOPATHY (lymph node swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17year old patient received the vaccine in the right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the right arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the right arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medication reported  No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea
Clinical narrative: Light headed; Nauseous; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), NAUSEA (Nauseous) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headed), NAUSEA (Nauseous) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Light headed), NAUSEA (Nauseous) and MYALGIA (Body aches) outcome was unknown.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Hard lump; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (Redness) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (Redness). On 23-Jan-2021, VACCINATION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication information was provided.  Treatment information were not provided.   This case was linked.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pain
Clinical narrative: Soreness; Pain in the body; shivering; nausea; Temperature was 101.4 slight low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering), NAUSEA (nausea) and PYREXIA (Temperature was 101.4 slight low grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering), NAUSEA (nausea) and PYREXIA (Temperature was 101.4 slight low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown and PYREXIA (Temperature was 101.4 slight low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101.4 (High) 101.4. On an unknown date, Body temperature: 99.5 (High) 99.5 and 97.5 (High) 97.5.         The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Soreness; Pain in the body; shivering; nausea; Temperature was 101.4 slight low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering), NAUSEA (nausea) and PYREXIA (Temperature was 101.4 slight low grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering), NAUSEA (nausea) and PYREXIA (Temperature was 101.4 slight low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown and PYREXIA (Temperature was 101.4 slight low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101.4 (High) 101.4. On an unknown date, Body temperature: 99.5 (High) 99.5 and 97.5 (High) 97.5.         The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: Eyes puffy; Feet puffy/Hands puffy; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes puffy) and PERIPHERAL SWELLING (Feet puffy/Hands puffy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eyes puffy) and PERIPHERAL SWELLING (Feet puffy/Hands puffy). At the time of the report, EYE SWELLING (Eyes puffy) and PERIPHERAL SWELLING (Feet puffy/Hands puffy) 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.  On 04-Mar-2021, the patient had their first dose of vaccine. The patient reported that their eyes, hands and feet were puffy.  Reportedly, it was getting better.  No Concomitant product use was reported. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site rash
Clinical narrative: changing colors from red, to greed, to dark and it is now purplish; Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (changing colors from red, to greed, to dark and it is now purplish) and VACCINATION SITE RASH (Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and POTASSIUM for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (changing colors from red, to greed, to dark and it is now purplish) and VACCINATION SITE RASH (Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored). At the time of the report, VACCINATION SITE DISCOLOURATION (changing colors from red, to greed, to dark and it is now purplish) and VACCINATION SITE RASH (Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included fluid pill triamterene.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Pain in leg; Nausea; fatigue; headache; Pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in leg), NAUSEA (Nausea), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (Pain in hip ) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, 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 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in leg), NAUSEA (Nausea), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (Pain in hip ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in leg), NAUSEA (Nausea), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (Pain in hip ) 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 16-Jul-2021: Significant follow-up is  received , patient reported she took 2nd dose and she is fine and   Events outcome for 1st dose  were updated from unknown to recovered , and Reporter declined further follow-up.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Pain in upper left arm and in fore finger; Back pain; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper left arm and in fore finger), BACK PAIN (Back pain) and ARTHRALGIA (Pain in shoulder) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042722) for COVID-19 vaccination.     Concomitant products included ENALAPRIL and TERAZOSIN for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in upper left arm and in fore finger), BACK PAIN (Back pain) and ARTHRALGIA (Pain in shoulder). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in upper left arm and in fore finger), BACK PAIN (Back pain) and ARTHRALGIA (Pain in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: upper upper arm is red; my arm is still sore; my arm swollen; my arm feels stiff; still get chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper upper arm is red), VACCINATION SITE PAIN (my arm is still sore), VACCINATION SITE SWELLING (my arm swollen), VACCINATION SITE INDURATION (my arm feels stiff) and CHILLS (still get chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ERYTHEMA (upper upper arm is red), VACCINATION SITE PAIN (my arm is still sore), VACCINATION SITE SWELLING (my arm swollen), VACCINATION SITE INDURATION (my arm feels stiff) and CHILLS (still get chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of tid. At the time of the report, ERYTHEMA (upper upper arm is red), VACCINATION SITE PAIN (my arm is still sore), VACCINATION SITE SWELLING (my arm swollen), VACCINATION SITE INDURATION (my arm feels stiff) and CHILLS (still get chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment details also include ice the area.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: swollen; like someone punched her; hard; medium red; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (like someone punched her), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (medium red) and VACCINATION SITE SWELLING (swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ra05798) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (like someone punched her), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (medium red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen). At the time of the report, MALAISE (like someone punched her), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (medium red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Bladder pain, Haematuria, Pain
Clinical narrative: Bladder spasms; Pain; Peeing blood; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Peeing blood), BLADDER PAIN (Bladder spasms) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HAEMATURIA (Peeing blood). On an unknown date, the patient experienced BLADDER PAIN (Bladder spasms) and PAIN (Pain). The patient was treated with PHENAZOPYRIDINE for Bladder spasm and Pain, at an unspecified dose and frequency and NITROFURANTOIN (NITROFURANTOIN MONO/MAC) at an unspecified dose and frequency. At the time of the report, HAEMATURIA (Peeing blood), BLADDER PAIN (Bladder spasms) and PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N concomitant medications reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Pyrexia, Vomiting
Clinical narrative: Got very very sick; Diarrhea; Vomiting; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very very sick), DIARRHOEA (Diarrhea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced ILLNESS (Got very very sick), DIARRHOEA (Diarrhea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Got very very sick), DIARRHOEA (Diarrhea), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported