chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling arm; warm on injection site; lost appetite; red spot on injection site; chills; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling arm), INJECTION SITE WARMTH (warm on injection site), DECREASED APPETITE (lost appetite), INJECTION SITE ERYTHEMA (red spot on injection site) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A. and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (NORVASC) 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 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling arm), INJECTION SITE WARMTH (warm on injection site), DECREASED APPETITE (lost appetite), INJECTION SITE ERYTHEMA (red spot on injection site), CHILLS (chills) and FATIGUE (felt tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (swelling arm), INJECTION SITE WARMTH (warm on injection site), DECREASED APPETITE (lost appetite), INJECTION SITE ERYTHEMA (red spot on injection site), CHILLS (chills) and FATIGUE (felt tired) outcome was unknown. Not Provided
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Peripheral swelling, Pruritus
Clinical narrative: fever; Chills; Headache; Swelling on upper arm; Redness of upper arm; Itching of eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm) and ERYTHEMA (Redness of upper arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy and Drug allergy (drugs like LAMOTRIGINE , SULFAMETHOXAZOLE.). Concomitant products included ATORVASTATIN, PROPRANOLOL and LISINOPRIL for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm), ERYTHEMA (Redness of upper arm) and PRURITUS (Itching of eyes). At the time of the report, PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm), ERYTHEMA (Redness of upper arm) and PRURITUS (Itching of eyes) was resolving. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Chills; Headache; Swelling on upper arm; Redness of upper arm; Itching of eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm) and ERYTHEMA (Redness of upper arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy and Drug allergy (drugs like LAMOTRIGINE , SULFAMETHOXAZOLE.). Concomitant products included ATORVASTATIN, PROPRANOLOL and LISINOPRIL for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm), ERYTHEMA (Redness of upper arm) and PRURITUS (Itching of eyes). At the time of the report, PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm), ERYTHEMA (Redness of upper arm) and PRURITUS (Itching of eyes) was resolving. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe pain in knee) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 20-Feb-2021, the patient experienced ARTHRALGIA (severe pain in knee). At the time of the report, ARTHRALGIA (severe pain in knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-044607 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR document was attached. Patient still has knee pain.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B2HA and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (diabetes is usually controlled with BG levels normally around 120). Concomitant products included INSULIN, PREGABALIN (LYRICA), ROPINIROLE HYDROCHLORIDE (REQUIP) and VITAMINS NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked; Sender's Comments:  US-MODERNATX, INC.-Case for first dose
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Condition aggravated, Headache, Muscle spasms
Clinical narrative: she feels much worse than when she had covid; really sore arm/really intense muscle pain; chills; headache; throwing up; all muscles in the body were having spasms; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), CONDITION AGGRAVATED (she feels much worse than when she had covid), MYALGIA (really sore arm/really intense muscle pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (really sore arm/really intense muscle pain), CHILLS (chills), HEADACHE (headache) and VOMITING (throwing up). On an unknown date, the patient experienced CONDITION AGGRAVATED (she feels much worse than when she had covid). At the time of the report, MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), CONDITION AGGRAVATED (she feels much worse than when she had covid), MYALGIA (really sore arm/really intense muscle pain), CHILLS (chills), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitants were not provided. Patient used heating pad for muscle pain.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-Significant Follow Up Appended- Contact Information updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: she feels much worse than when she had covid; really sore arm/really intense muscle pain; chills; headache; throwing up; all muscles in the body were having spasms; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), CONDITION AGGRAVATED (she feels much worse than when she had covid), MYALGIA (really sore arm/really intense muscle pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (really sore arm/really intense muscle pain), CHILLS (chills), HEADACHE (headache) and VOMITING (throwing up). On an unknown date, the patient experienced CONDITION AGGRAVATED (she feels much worse than when she had covid). At the time of the report, MUSCLE SPASMS (all muscles in the body were having spasms), ABDOMINAL DISCOMFORT (upset stomach), CONDITION AGGRAVATED (she feels much worse than when she had covid), MYALGIA (really sore arm/really intense muscle pain), CHILLS (chills), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitants were not provided. Patient used heating pad for muscle pain.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-Significant Follow Up Appended- Contact Information updated
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: covid arm; Arm developed a red rash; arm developed a red rash and is extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (covid arm), RASH (Arm developed a red rash) and PRURITUS (arm developed a red rash and is extremely itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025AziA and 006MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (covid arm), RASH (Arm developed a red rash) and PRURITUS (arm developed a red rash and is extremely itchy). At the time of the report, PAIN IN EXTREMITY (covid arm), RASH (Arm developed a red rash) and PRURITUS (arm developed a red rash and is extremely itchy) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment details included application of ice and anti-itch cream. Action taken with mRNA-1273 in response to events were not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: heart palpitations; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and DIZZINESS (dizziness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL 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 05-Mar-2021, the patient experienced PALPITATIONS (heart palpitations) and DIZZINESS (dizziness). On 07-Mar-2021, PALPITATIONS (heart palpitations) and DIZZINESS (dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular discomfort, Pruritus, Rash erythematous
Clinical narrative: eye itchy and tight; eye itchy and tight; itching hands on the left side; red blotchy under skin on left arm and neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching hands on the left side), RASH ERYTHEMATOUS (red blotchy under skin on left arm and neck), EYE PRURITUS (eye itchy and tight) and OCULAR DISCOMFORT (eye itchy and tight) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PRURITUS (itching hands on the left side) and RASH ERYTHEMATOUS (red blotchy under skin on left arm and neck). On an unknown date, the patient experienced EYE PRURITUS (eye itchy and tight) and OCULAR DISCOMFORT (eye itchy and tight). At the time of the report, PRURITUS (itching hands on the left side) was resolving and RASH ERYTHEMATOUS (red blotchy under skin on left arm and neck), EYE PRURITUS (eye itchy and tight) and OCULAR DISCOMFORT (eye itchy and tight) outcome was unknown.            Concomitant products included eye drops for an unknown indication.  No treatment information was reported.   This case was linked to MOD-2021-062891 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Inappropriate schedule of product administration, Lethargy, Nausea
Clinical narrative: lethargic; sweating; skin tone change; heart racing; More than 36 days difference between both doses; radiated to middle of back; fever of 100 F; Golf ball size swelling at injection site; Hardness at injection site; nauseous; Swollen Arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), HYPERHIDROSIS (sweating), SKIN DISCOLOURATION (skin tone change), PALPITATIONS (heart racing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.   On 02-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 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm) and CHILLS (chills). On 12-Mar-2021, the patient experienced LETHARGY (lethargic), HYPERHIDROSIS (sweating), SKIN DISCOLOURATION (skin tone change), PALPITATIONS (heart racing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses), PAIN (radiated to middle of back), PYREXIA (fever of 100 F), VACCINATION SITE SWELLING (Golf ball size swelling at injection site), VACCINATION SITE INDURATION (Hardness at injection site) and NAUSEA (nauseous). On 03-Feb-2021, CHILLS (chills) had resolved. On 09-Feb-2021, PERIPHERAL SWELLING (Swollen Arm) had resolved. On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses) and PAIN (radiated to middle of back) had resolved. On 13-Mar-2021, PALPITATIONS (heart racing), PYREXIA (fever of 100 F), VACCINATION SITE SWELLING (Golf ball size swelling at injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 14-Mar-2021, LETHARGY (lethargic) and NAUSEA (nauseous) had resolved. On 15-Mar-2021, HYPERHIDROSIS (sweating) and SKIN DISCOLOURATION (skin tone change) had resolved.            No treatment information was reported.  The Action Taken for mRNA-1273 (Moderna COVID-19 Vaccine) was unknown   This case was linked to MOD-2021-044073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-significant Follow-up appended
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: lethargic; sweating; skin tone change; heart racing; More than 36 days difference between both doses; radiated to middle of back; fever of 100 F; Golf ball size swelling at injection site; Hardness at injection site; nauseous; Swollen Arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), HYPERHIDROSIS (sweating), SKIN DISCOLOURATION (skin tone change), PALPITATIONS (heart racing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.   On 02-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 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm) and CHILLS (chills). On 12-Mar-2021, the patient experienced LETHARGY (lethargic), HYPERHIDROSIS (sweating), SKIN DISCOLOURATION (skin tone change), PALPITATIONS (heart racing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses), PAIN (radiated to middle of back), PYREXIA (fever of 100 F), VACCINATION SITE SWELLING (Golf ball size swelling at injection site), VACCINATION SITE INDURATION (Hardness at injection site) and NAUSEA (nauseous). On 03-Feb-2021, CHILLS (chills) had resolved. On 09-Feb-2021, PERIPHERAL SWELLING (Swollen Arm) had resolved. On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses) and PAIN (radiated to middle of back) had resolved. On 13-Mar-2021, PALPITATIONS (heart racing), PYREXIA (fever of 100 F), VACCINATION SITE SWELLING (Golf ball size swelling at injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 14-Mar-2021, LETHARGY (lethargic) and NAUSEA (nauseous) had resolved. On 15-Mar-2021, HYPERHIDROSIS (sweating) and SKIN DISCOLOURATION (skin tone change) had resolved.            No treatment information was reported.  The Action Taken for mRNA-1273 (Moderna COVID-19 Vaccine) was unknown   This case was linked to MOD-2021-044073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-significant Follow-up appended
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: lethargic; sweating; skin tone change; heart racing; More than 36 days difference between both doses; radiated to middle of back; fever of 100 F; Golf ball size swelling at injection site; Hardness at injection site; nauseous; Swollen Arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), HYPERHIDROSIS (sweating), SKIN DISCOLOURATION (skin tone change), PALPITATIONS (heart racing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.   On 02-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 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm) and CHILLS (chills). On 12-Mar-2021, the patient experienced LETHARGY (lethargic), HYPERHIDROSIS (sweating), SKIN DISCOLOURATION (skin tone change), PALPITATIONS (heart racing), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses), PAIN (radiated to middle of back), PYREXIA (fever of 100 F), VACCINATION SITE SWELLING (Golf ball size swelling at injection site), VACCINATION SITE INDURATION (Hardness at injection site) and NAUSEA (nauseous). On 03-Feb-2021, CHILLS (chills) had resolved. On 09-Feb-2021, PERIPHERAL SWELLING (Swollen Arm) had resolved. On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days difference between both doses) and PAIN (radiated to middle of back) had resolved. On 13-Mar-2021, PALPITATIONS (heart racing), PYREXIA (fever of 100 F), VACCINATION SITE SWELLING (Golf ball size swelling at injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 14-Mar-2021, LETHARGY (lethargic) and NAUSEA (nauseous) had resolved. On 15-Mar-2021, HYPERHIDROSIS (sweating) and SKIN DISCOLOURATION (skin tone change) had resolved.            No treatment information was reported.  The Action Taken for mRNA-1273 (Moderna COVID-19 Vaccine) was unknown   This case was linked to MOD-2021-044073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-significant Follow-up appended
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: coughing all through the night; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing all through the night) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A20A and 028L20A) for COVID-19 immunisation.     Concurrent medical conditions included Bronchitis (had cough and a sore throat) since 11-Mar-2021, Hypothyroidism since 2014 and Artificial sweetener intolerance (Aspartame). Concomitant products included PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE and ALBUTEROL [SALBUTAMOL] for Bronchitis, LEVOTHYROXINE SODIUM (SYNTHROID) from 2014 to an unknown date for Hypothyroidism.   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 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (coughing all through the night). At the time of the report, COUGH (coughing all through the night) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 11-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative for PCR test.         Treatment information was not provided by the reporter. Action taken with mRNA-1273 in response to event was not applicable.   This case was linked to MOD-2021-044686 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Added patient details, relevant history. Added Vaccination facility information, concomitant drug and updated the outcome of event.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: soreness, aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness, aches) and HEADACHE (headaches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (soreness, aches) and HEADACHE (headaches). At the time of the report, PAIN (soreness, aches) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 58-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 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
Sex: F
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 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 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Joint pain; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Fever) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FLUTICASONE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Mammogram
Clinical narrative: right breast cyst had lumpectomy; This spontaneous case was reported by a non-health professional and describes the occurrence of BREAST CYST (right breast cyst had lumpectomy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Lumpectomy on 24-Mar-2021. Concurrent medical conditions included Hypertension (High blood pressure) and Thyroid disorder.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CYST (right breast cyst had lumpectomy). At the time of the report, BREAST CYST (right breast cyst had lumpectomy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Mammogram: cyst in right breast (Positive) cyst in right breast.     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 medication includes high blood pressure and thyroid.  No treatment medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Pain in jaw, Toothache
Clinical narrative: tooth pain; upper right side jaw pain (bone); tooth sensitivity to hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (tooth pain), PAIN IN JAW (upper right side jaw pain (bone)) and HYPERAESTHESIA TEETH (tooth sensitivity to hot and cold) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (ANTIBIOTIC EAR) and HYDROCODONE 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 20-Mar-2021, the patient experienced TOOTHACHE (tooth pain), PAIN IN JAW (upper right side jaw pain (bone)) and HYPERAESTHESIA TEETH (tooth sensitivity to hot and cold). At the time of the report, TOOTHACHE (tooth pain), PAIN IN JAW (upper right side jaw pain (bone)) and HYPERAESTHESIA TEETH (tooth sensitivity to hot and cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also includes dentist visit, dental X-rays, physician follow-up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Developed high fever; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed high fever) and ILLNESS (Very sick) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (Had leukemia for 30 years).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Developed high fever) and ILLNESS (Very sick). At the time of the report, PYREXIA (Developed high fever) and ILLNESS (Very sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details included use of Extra strength Tylenol and Motrin Alternating The reporter was concerned if its ok for fever to rise up to 101.8 degree F
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Headache, Malaise
Clinical narrative: Vertigo; Vertigo; teeth chattering; headache; chills; tiredness, little wearied feeling; vomiting; high fever; barely able to walk; shaken; a little more anxious; body ache, achy feeling; did not feel that good; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (barely able to walk), TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling) and MALAISE (did not feel that good) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Agoraphobia. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.   On 04-Mar-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling), MALAISE (did not feel that good), PAIN IN EXTREMITY (arm is sore), HEADACHE (headache), CHILLS (chills), FATIGUE (tiredness, little wearied feeling), VOMITING (vomiting) and PYREXIA (high fever). On 27-Jan-2021, the patient experienced MOBILITY DECREASED (barely able to walk) and CHILLS (teeth chattering). On 04-Mar-2021, the patient experienced the first episode of VERTIGO (Vertigo). On 01-Apr-2021, the patient experienced the second episode of VERTIGO (Vertigo). At the time of the report, MOBILITY DECREASED (barely able to walk), TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling), MALAISE (did not feel that good), PAIN IN EXTREMITY (arm is sore), HEADACHE (headache), the last episode of VERTIGO (Vertigo), CHILLS (chills), FATIGUE (tiredness, little wearied feeling), VOMITING (vomiting), PYREXIA (high fever) and CHILLS (teeth chattering) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was taken as Advil and Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Provided Email Address On 11-May-2021: VAERS,Cocomitant medication,vaccination informations,patient details
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Vertigo; Vertigo; teeth chattering; headache; chills; tiredness, little wearied feeling; vomiting; high fever; barely able to walk; shaken; a little more anxious; body ache, achy feeling; did not feel that good; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (barely able to walk), TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling) and MALAISE (did not feel that good) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Agoraphobia. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.   On 04-Mar-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling), MALAISE (did not feel that good), PAIN IN EXTREMITY (arm is sore), HEADACHE (headache), CHILLS (chills), FATIGUE (tiredness, little wearied feeling), VOMITING (vomiting) and PYREXIA (high fever). On 27-Jan-2021, the patient experienced MOBILITY DECREASED (barely able to walk) and CHILLS (teeth chattering). On 04-Mar-2021, the patient experienced the first episode of VERTIGO (Vertigo). On 01-Apr-2021, the patient experienced the second episode of VERTIGO (Vertigo). At the time of the report, MOBILITY DECREASED (barely able to walk), TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling), MALAISE (did not feel that good), PAIN IN EXTREMITY (arm is sore), HEADACHE (headache), the last episode of VERTIGO (Vertigo), CHILLS (chills), FATIGUE (tiredness, little wearied feeling), VOMITING (vomiting), PYREXIA (high fever) and CHILLS (teeth chattering) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was taken as Advil and Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Provided Email Address On 11-May-2021: VAERS,Cocomitant medication,vaccination informations,patient details
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo; Vertigo; teeth chattering; headache; chills; tiredness, little wearied feeling; vomiting; high fever; barely able to walk; shaken; a little more anxious; body ache, achy feeling; did not feel that good; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (barely able to walk), TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling) and MALAISE (did not feel that good) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Agoraphobia. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.   On 04-Mar-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling), MALAISE (did not feel that good), PAIN IN EXTREMITY (arm is sore), HEADACHE (headache), CHILLS (chills), FATIGUE (tiredness, little wearied feeling), VOMITING (vomiting) and PYREXIA (high fever). On 27-Jan-2021, the patient experienced MOBILITY DECREASED (barely able to walk) and CHILLS (teeth chattering). On 04-Mar-2021, the patient experienced the first episode of VERTIGO (Vertigo). On 01-Apr-2021, the patient experienced the second episode of VERTIGO (Vertigo). At the time of the report, MOBILITY DECREASED (barely able to walk), TREMOR (shaken), ANXIETY (a little more anxious), PAIN (body ache, achy feeling), MALAISE (did not feel that good), PAIN IN EXTREMITY (arm is sore), HEADACHE (headache), the last episode of VERTIGO (Vertigo), CHILLS (chills), FATIGUE (tiredness, little wearied feeling), VOMITING (vomiting), PYREXIA (high fever) and CHILLS (teeth chattering) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was taken as Advil and Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Provided Email Address On 11-May-2021: VAERS,Cocomitant medication,vaccination informations,patient details
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Limb discomfort, Pain, Swelling
Clinical narrative: headache; aches and pains; chills; is experiencing swelling in her left hand; having trouble moving L arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (aches and pains), CHILLS (chills), SWELLING (is experiencing swelling in her left hand) and LIMB DISCOMFORT (having trouble moving L arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache), PAIN (aches and pains), CHILLS (chills), SWELLING (is experiencing swelling in her left hand) and LIMB DISCOMFORT (having trouble moving L arm). At the time of the report, HEADACHE (headache), PAIN (aches and pains), CHILLS (chills), SWELLING (is experiencing swelling in her left hand) and LIMB DISCOMFORT (having trouble moving L arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: vomiting; fever; Claminess; shooting pain in my arm; headache; nausea; Red Spot then got bigger and hotter; injection site was red; tender; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Claminess), PAIN IN EXTREMITY (shooting pain in my arm), VACCINATION SITE WARMTH (Red Spot then got bigger and hotter), VOMITING (vomiting) and PYREXIA (fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red Spot then got bigger and hotter), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE PAIN (tender). On 25-Mar-2021, the patient experienced HYPERHIDROSIS (Claminess), PAIN IN EXTREMITY (shooting pain in my arm), VOMITING (vomiting), PYREXIA (fever), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPERHIDROSIS (Claminess), PAIN IN EXTREMITY (shooting pain in my arm), VACCINATION SITE WARMTH (Red Spot then got bigger and hotter), VOMITING (vomiting), PYREXIA (fever), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE PAIN (tender), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: vomiting; fever; Claminess; shooting pain in my arm; headache; nausea; Red Spot then got bigger and hotter; injection site was red; tender; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Claminess), PAIN IN EXTREMITY (shooting pain in my arm), VACCINATION SITE WARMTH (Red Spot then got bigger and hotter), VOMITING (vomiting) and PYREXIA (fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red Spot then got bigger and hotter), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE PAIN (tender). On 25-Mar-2021, the patient experienced HYPERHIDROSIS (Claminess), PAIN IN EXTREMITY (shooting pain in my arm), VOMITING (vomiting), PYREXIA (fever), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPERHIDROSIS (Claminess), PAIN IN EXTREMITY (shooting pain in my arm), VACCINATION SITE WARMTH (Red Spot then got bigger and hotter), VOMITING (vomiting), PYREXIA (fever), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE PAIN (tender), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: body aches; low fever; sore left arm where injection was given; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (low fever) and INJECTION SITE PAIN (sore left arm where injection was given) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (body aches) and INJECTION SITE PAIN (sore left arm where injection was given). 09-Mar-2021, the patient experienced PYREXIA (low fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (body aches), PYREXIA (low fever) and INJECTION SITE PAIN (sore left arm where injection was given) outcome was unknown.            No concomitant medication details was reported  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-058712 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated reporter's email address