chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Spinal pain
Clinical narrative: She experienced swelling of her arm; Achiness; Slight fever; Headache; Heavy fatigue; She experienced lymph node swelling under her left arm for about ten days; Pain in spine; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (She experienced swelling of her arm), SPINAL PAIN (Pain in spine), FEELING ABNORMAL (Brain fog), PAIN (Achiness) and LYMPHADENOPATHY (She experienced lymph node swelling under her left arm for about ten days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event). Concomitant products included METHOTREXATE, GABAPENTIN and ACICLOVIR SODIUM (ACYCLOVIR VIAL) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SPINAL PAIN (Pain in spine), FEELING ABNORMAL (Brain fog) and LYMPHADENOPATHY (She experienced lymph node swelling under her left arm for about ten days). On an unknown date, the patient experienced PERIPHERAL SWELLING (She experienced swelling of her arm), PAIN (Achiness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Heavy fatigue). At the time of the report, PERIPHERAL SWELLING (She experienced swelling of her arm), SPINAL PAIN (Pain in spine), FEELING ABNORMAL (Brain fog), PAIN (Achiness), LYMPHADENOPATHY (She experienced lymph node swelling under her left arm for about ten days), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Heavy fatigue) outcome was unknown.            Treatment medication include ibuprofen
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Vaccination site discolouration, Vaccination site erythema, Vaccination site mass
Clinical narrative: vaccination site lump; Vaccination site erythema; vaccination site warmth; vaccination site discoloration; It just slammed me; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It just slammed me), MALAISE (Feeling unwell), VACCINATION SITE MASS (vaccination site lump), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE WARMTH (vaccination site warmth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatty liver.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (It just slammed me) and MALAISE (Feeling unwell). On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (vaccination site lump), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE DISCOLOURATION (vaccination site discoloration). On 22-Mar-2021, VACCINATION SITE MASS (vaccination site lump), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE DISCOLOURATION (vaccination site discoloration) had resolved. At the time of the report, FEELING ABNORMAL (It just slammed me) and MALAISE (Feeling unwell) 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.  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.   This case was linked to MOD-2021-054458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR was received Contains no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: vaccination site lump; Vaccination site erythema; vaccination site warmth; vaccination site discoloration; It just slammed me; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It just slammed me), MALAISE (Feeling unwell), VACCINATION SITE MASS (vaccination site lump), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE WARMTH (vaccination site warmth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatty liver.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (It just slammed me) and MALAISE (Feeling unwell). On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (vaccination site lump), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE DISCOLOURATION (vaccination site discoloration). On 22-Mar-2021, VACCINATION SITE MASS (vaccination site lump), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE DISCOLOURATION (vaccination site discoloration) had resolved. At the time of the report, FEELING ABNORMAL (It just slammed me) and MALAISE (Feeling unwell) 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.  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.   This case was linked to MOD-2021-054458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR was received Contains no new information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (tiredness/fatigue). At the time of the report, FATIGUE (tiredness/fatigue) had not resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to event was not applicable.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Feeling cold, Headache
Clinical narrative: not eating right; not hungry; always cold; get real hot and start sweating; feeling weak; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DECREASED APPETITE (not eating right), DECREASED APPETITE (not hungry), FEELING COLD (always cold) and HYPERHIDROSIS (get real hot and start sweating) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (not eating right), DECREASED APPETITE (not hungry), FEELING COLD (always cold), HYPERHIDROSIS (get real hot and start sweating), ASTHENIA (feeling weak) and CHILLS (chills). At the time of the report, HEADACHE (headache), DECREASED APPETITE (not hungry), FEELING COLD (always cold), HYPERHIDROSIS (get real hot and start sweating), ASTHENIA (feeling weak) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: not eating right; not hungry; always cold; get real hot and start sweating; feeling weak; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DECREASED APPETITE (not eating right), DECREASED APPETITE (not hungry), FEELING COLD (always cold) and HYPERHIDROSIS (get real hot and start sweating) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (not eating right), DECREASED APPETITE (not hungry), FEELING COLD (always cold), HYPERHIDROSIS (get real hot and start sweating), ASTHENIA (feeling weak) and CHILLS (chills). At the time of the report, HEADACHE (headache), DECREASED APPETITE (not hungry), FEELING COLD (always cold), HYPERHIDROSIS (get real hot and start sweating), ASTHENIA (feeling weak) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (I felt my throat start swelling), VACCINATION SITE INDURATION (forming a knot), VACCINATION SITE PRURITUS (then began itching), VACCINATION SITE SWELLING (had swelling at the injection site) and VACCINATION SITE ERYTHEMA (red all around the injection site/the center is dark) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PHARYNGEAL SWELLING (I felt my throat start swelling) and VACCINATION SITE SWELLING (had swelling at the injection site). On 12-Mar-2021, the patient experienced VACCINATION SITE INDURATION (forming a knot) and VACCINATION SITE PRURITUS (then began itching). On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red all around the injection site/the center is dark). On 11-Mar-2021, PHARYNGEAL SWELLING (I felt my throat start swelling) had resolved. At the time of the report, VACCINATION SITE INDURATION (forming a knot), VACCINATION SITE PRURITUS (then began itching) and VACCINATION SITE SWELLING (had swelling at the injection site) had resolved and VACCINATION SITE ERYTHEMA (red all around the injection site/the center is dark) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient was advised by her doctor to take Benadryl before getting her second dose. No treatment information was provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypertension, Nausea, Pyrexia
Clinical narrative: blood pressure is high; nausea; headache; fever; chills; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she had covid virus in March 2020 and December 2020). Concurrent medical conditions included Blood pressure high and Allergy. Concomitant products included VERAPAMIL for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-1 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Allergy medication. Treatment information included tylenol pm for headache and fever.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Vaccination site pain
Clinical narrative: blood pressure is high; nausea; headache; fever; chills; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she had covid virus in March 2020 and December 2020). Concurrent medical conditions included Blood pressure high and Allergy. Concomitant products included VERAPAMIL for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-1 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Allergy medication. Treatment information included tylenol pm for headache and fever.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Hypertension, Tachycardia
Clinical narrative: Severe High Blood Pressure (170/90 mmHg); Tachycardia (HR 116 BPM); This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Severe High Blood Pressure (170/90 mmHg)) and TACHYCARDIA (Tachycardia (HR 116 BPM)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Slightly HBP Controlled by medicine).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERTENSION (Severe High Blood Pressure (170/90 mmHg)) and TACHYCARDIA (Tachycardia (HR 116 BPM)). On 18-Mar-2021, HYPERTENSION (Severe High Blood Pressure (170/90 mmHg)) and TACHYCARDIA (Tachycardia (HR 116 BPM)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 170/90 (High) 170/90 mmHg. On 17-Mar-2021, Heart rate: 116 (High) 116 BPM. On 18-Mar-2021, Electrocardiogram: abnormal (abnormal) Showed Tachycardia.         Concomitant medications reported included unspecified medicine to control slightly high blood pressure.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received on 15-July-2021 and contains no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours), ASTHENIA (lack of energy), FATIGUE (fatigue) and PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Guillain-Barre syndrome in 1996. Concomitant products included ROSUVASTATIN for Cholesterol, LISINOPRIL for Hypertension.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours) and ASTHENIA (lack of energy). 27-Feb-2021, the patient experienced FATIGUE (fatigue), PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees), HEADACHE (occasional headache) and NAUSEA (Sometimes nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours), ASTHENIA (lack of energy), FATIGUE (fatigue), PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees), HEADACHE (occasional headache) and NAUSEA (Sometimes nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 104.4 degree Celsius High. On 23-Mar-2021, Pyrexia: 99-101 degree Celsius High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As reported treatment medications included tylenol, ibuprofen and ice packs.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054505 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Followup information was received on 8-apr-2021. Events and concomitant information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054505:1st dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours), ASTHENIA (lack of energy), FATIGUE (fatigue) and PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Guillain-Barre syndrome in 1996. Concomitant products included ROSUVASTATIN for Cholesterol, LISINOPRIL for Hypertension.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours) and ASTHENIA (lack of energy). 27-Feb-2021, the patient experienced FATIGUE (fatigue), PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees), HEADACHE (occasional headache) and NAUSEA (Sometimes nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), SOMNOLENCE (Sleeping long hours), ASTHENIA (lack of energy), FATIGUE (fatigue), PYREXIA (Fever continued to increase up to 104.4 degrees Fahrenheit /  ranging between 99 - 101 degrees), HEADACHE (occasional headache) and NAUSEA (Sometimes nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 104.4 degree Celsius High. On 23-Mar-2021, Pyrexia: 99-101 degree Celsius High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As reported treatment medications included tylenol, ibuprofen and ice packs.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054505 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Followup information was received on 8-apr-2021. Events and concomitant information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054505:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: bad itching feeling; red; warm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad itching feeling), ERYTHEMA (red) and FEELING HOT (warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 PRURITUS (bad itching feeling), ERYTHEMA (red) and FEELING HOT (warm). At the time of the report, PRURITUS (bad itching feeling), ERYTHEMA (red) and FEELING HOT (warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: little tiredness; little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tiredness) and VACCINATION SITE PAIN (little soreness at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (little tiredness) and VACCINATION SITE PAIN (little soreness at the injection site). At the time of the report, FATIGUE (little tiredness) and VACCINATION SITE PAIN (little soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Skin swelling, Swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site reaction a few days after the shot; warm to the touch at the injection site; bump sensation; swollen; hot; itching at the injection site; red at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction a few days after the shot), VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen) and FEELING HOT (hot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen), FEELING HOT (hot), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction a few days after the shot). At the time of the report, VACCINATION SITE REACTION (Injection site reaction a few days after the shot), VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen), FEELING HOT (hot), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: Injection site reaction a few days after the shot; warm to the touch at the injection site; bump sensation; swollen; hot; itching at the injection site; red at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction a few days after the shot), VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen) and FEELING HOT (hot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen), FEELING HOT (hot), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction a few days after the shot). At the time of the report, VACCINATION SITE REACTION (Injection site reaction a few days after the shot), VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen), FEELING HOT (hot), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm excruciating; swelling arm; Hot to touch; Redness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (sore arm excruciating), PERIPHERAL SWELLING (swelling arm), FEELING HOT (Hot to touch) and ERYTHEMA (Redness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm excruciating), PERIPHERAL SWELLING (swelling arm), FEELING HOT (Hot to touch) and ERYTHEMA (Redness). On 17-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm excruciating), PERIPHERAL SWELLING (swelling arm), FEELING HOT (Hot to touch) and ERYTHEMA (Redness) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypotension, Malaise, Pharyngeal swelling, Tremor
Clinical narrative: Feeling unwell; Shaking; Throat swollen shut; Low Blood Pressure; Weak Knees; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), TREMOR (Shaking), PHARYNGEAL SWELLING (Throat swollen shut), HYPOTENSION (Low Blood Pressure) and ARTHRALGIA (Weak Knees) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History reported.  Concomitant products included PREGABALIN (LYRICA), TYROSINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), POTASSIUM CHLORIDE (KLOR-CON), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CELECOXIB (CELEBREX), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CLONAZEPAM, LINAGLIPTIN (TRADJENTA) and CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (Feeling unwell), TREMOR (Shaking), PHARYNGEAL SWELLING (Throat swollen shut), HYPOTENSION (Low Blood Pressure) and ARTHRALGIA (Weak Knees). On 11-Mar-2021, TREMOR (Shaking), PHARYNGEAL SWELLING (Throat swollen shut) and ARTHRALGIA (Weak Knees) had resolved. On 17-Mar-2021, MALAISE (Feeling unwell) and HYPOTENSION (Low Blood Pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: dizziness; headache; joint pain; body ache; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A12A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included COVID-19 (was exposed a year ago ) since an unknown date.    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 DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) had a year ago, her antigen test showed that she still had antibodies..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were birth control pills with estrogen.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Physical address updated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: dizziness; headache; joint pain; body ache; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A12A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included COVID-19 (was exposed a year ago ) since an unknown date.    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 DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) had a year ago, her antigen test showed that she still had antibodies..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were birth control pills with estrogen.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Physical address updated
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypersomnia, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (also had sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERSOMNIA (just slept), PYREXIA (fever 103degF) and MYALGIA (body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (also had sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERSOMNIA (just slept), PYREXIA (fever 103degF) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (also had sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERSOMNIA (just slept), PYREXIA (fever 103degF) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103degF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient had the symptoms for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR was received and  reporter said that it was their son who has symptoms and requested to call back later.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (also had sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERSOMNIA (just slept), PYREXIA (fever 103degF) and MYALGIA (body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (also had sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERSOMNIA (just slept), PYREXIA (fever 103degF) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (also had sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERSOMNIA (just slept), PYREXIA (fever 103degF) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103degF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient had the symptoms for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR was received and  reporter said that it was their son who has symptoms and requested to call back later.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Missed second dose appointment which was scheduled for four weeks after first dose; sick; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment which was scheduled for four weeks after first dose) and ILLNESS (sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2L120A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment which was scheduled for four weeks after first dose) and ILLNESS (sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment which was scheduled for four weeks after first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter. No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: TCR: event added
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Chills, Dizziness, Eye disorder, Nodule
Clinical narrative: It felt like a moth was ifluttering in my left eye; A big nodule/ blueish lump in my left eye near the nose also a small nodule/ blueish lump in the right eye; "felt like a bug had flown into my eye"; Dizziness; Teeth were chattering; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER ("felt like a bug had flown into my eye"), BLEPHAROSPASM (It felt like a moth was ifluttering in my left eye), NODULE (A big nodule/ blueish lump in my left eye near the nose also a small nodule/ blueish lump in the right eye), DIZZINESS (Dizziness) and CHILLS (Teeth were chattering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included MEDROXYPROGESTERONE and ESTRADIOL for Estrogen replacement therapy.   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 DIZZINESS (Dizziness) and CHILLS (Teeth were chattering). On 13-Mar-2021, the patient experienced EYE DISORDER ("felt like a bug had flown into my eye"). 13-Mar-2021, the patient experienced NODULE (A big nodule/ blueish lump in my left eye near the nose also a small nodule/ blueish lump in the right eye). On an unknown date, the patient experienced BLEPHAROSPASM (It felt like a moth was ifluttering in my left eye). At the time of the report, EYE DISORDER ("felt like a bug had flown into my eye") and NODULE (A big nodule/ blueish lump in my left eye near the nose also a small nodule/ blueish lump in the right eye) had not resolved and BLEPHAROSPASM (It felt like a moth was ifluttering in my left eye), DIZZINESS (Dizziness) and CHILLS (Teeth were chattering) outcome was unknown.              Treatment medications were unknown.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient demographics added, event added and updated
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Just a little runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Just a little runny nose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 RHINORRHOEA (Just a little runny nose). At the time of the report, RHINORRHOEA (Just a little runny nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-117032 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Events resolved and consumer declined further follow up
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: achiness; sore arm; small headache; spikes a low grade fever every night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), PAIN IN EXTREMITY (sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), PAIN IN EXTREMITY (sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night). At the time of the report, PAIN (achiness), PAIN IN EXTREMITY (sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 (High) 99-100F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-054620, MOD21-088814 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: AE contact information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054620:for second dose MOD21-088814:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: achiness; really sore arm; small headache; spikes a low grade fever every night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), VACCINATION SITE PAIN (really sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-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 PAIN (achiness), VACCINATION SITE PAIN (really sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night). At the time of the report, PAIN (achiness), VACCINATION SITE PAIN (really sore arm), HEADACHE (small headache) and PYREXIA (spikes a low grade fever every night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 F.         Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054611 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054611:for first dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm - left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm - left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm - left arm). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm - left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.