chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain
Clinical narrative: cold in nose and throat; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold in nose and throat) and PAIN (soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold in nose and throat) and PAIN (soreness at injection site). At the time of the report, NASOPHARYNGITIS (cold in nose and throat) and PAIN (soreness at injection site) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.  No treatment specified.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: Hiccups; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HICCUPS (Hiccups) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HICCUPS (Hiccups). On 13-Feb-2021, HICCUPS (Hiccups) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided/unknown by the reporter.   Treatment: Not given.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Low fever; Body aches; Injection site pain; Felling tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low fever), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Felling tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021 at 8:00 PM, the patient experienced PYREXIA (Low fever), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Felling tired). At the time of the report, PYREXIA (Low fever), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Felling tired) had not resolved.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash on the arm that she got the shot in; Other arm is getting a rash as well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the arm that she got the shot in) and RASH (Other arm is getting a rash as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on the arm that she got the shot in) and RASH (Other arm is getting a rash as well). At the time of the report, VACCINATION SITE RASH (Rash on the arm that she got the shot in) and RASH (Other arm is getting a rash as well) 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 for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the arm that she got the shot in) and RASH (Other arm is getting a rash as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on the arm that she got the shot in) and RASH (Other arm is getting a rash as well). At the time of the report, VACCINATION SITE RASH (Rash on the arm that she got the shot in) and RASH (Other arm is getting a rash as well) 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 for the event was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Elbow swelling; Elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Joint pain.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) outcome was unknown.            Concomitant product use was not provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Joint pain.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Elbow swelling) and ARTHRALGIA (Elbow pain) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Lip swelling, Pruritus
Clinical narrative: rash in her mouth; swollen lips; difficulty of breathing; intense itchiness of legs and feet; occasional weakness; occasional dizziness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet) and ASTHENIA (occasional weakness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet), ASTHENIA (occasional weakness) and DIZZINESS (occasional dizziness). At the time of the report, RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet), ASTHENIA (occasional weakness) and DIZZINESS (occasional dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided No treatment medication were provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash in her mouth; swollen lips; difficulty of breathing; intense itchiness of legs and feet; occasional weakness; occasional dizziness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet) and ASTHENIA (occasional weakness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet), ASTHENIA (occasional weakness) and DIZZINESS (occasional dizziness). At the time of the report, RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet), ASTHENIA (occasional weakness) and DIZZINESS (occasional dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided No treatment medication were provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain in extremity
Clinical narrative: severe pain in her arm; Difficulty lifting arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in her arm), LIMB DISCOMFORT (Difficulty lifting arm) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031521) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her arm), LIMB DISCOMFORT (Difficulty lifting arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (severe pain in her arm), LIMB DISCOMFORT (Difficulty lifting arm) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood thinner, blood pressure medication, thyroid medication and cholesterol medication
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot #024LM20A) 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 an unknown date, the patient experienced NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Muscular weakness, Vaccination site pain
Clinical narrative: his left hand is not functioning correctly, the sensation on his fingers is not the same as always and does not grip that well, he has weakness on his left hand; feeling down; a little sore at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEPRESSED MOOD (feeling down), MUSCULAR WEAKNESS (his left hand is not functioning correctly, the sensation on his fingers is not the same as always and does not grip that well, he has weakness on his left hand) and VACCINATION SITE PAIN (a little sore at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and MONTELUKAST for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little sore at the injection site). On 15-Feb-2021, the patient experienced DEPRESSED MOOD (feeling down). On 16-Feb-2021, the patient experienced MUSCULAR WEAKNESS (his left hand is not functioning correctly, the sensation on his fingers is not the same as always and does not grip that well, he has weakness on his left hand). On 15-Feb-2021, DEPRESSED MOOD (feeling down) and VACCINATION SITE PAIN (a little sore at the injection site) had resolved. At the time of the report, MUSCULAR WEAKNESS (his left hand is not functioning correctly, the sensation on his fingers is not the same as always and does not grip that well, he has weakness on his left hand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated the outcome of event left hand not functioning for several days (from unknown to recovered)
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue
Clinical narrative: Sore Arm; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore Arm) and FATIGUE (FATIGUE) in an 82-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced AXILLARY PAIN (Sore Arm) and FATIGUE (FATIGUE). The patient was treated with Tylenol at an unspecified dose and frequency.   At the time of the report, AXILLARY PAIN (Sore Arm) and FATIGUE (FATIGUE) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Nasal congestion
Clinical narrative: it is getting worse; headache; nose congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nose congestion), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot # 007M208) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced NASAL CONGESTION (nose congestion) and HEADACHE (headache). On an unknown date, the patient experienced CONDITION AGGRAVATED (it is getting worse). At the time of the report, NASAL CONGESTION (nose congestion), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (headache) 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was tested with COVID 19 a few days post vaccination. The reporter stated that she was not aware about the concomitant medications taken by the patient. The patient was asymptomatic for the event so the details like when he was infected and when he got COVID shot were unknown. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up document was received on 09 Jul 2021 and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Midnight (12/Feb/2021) she had diarrhea until Sunday.; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Midnight (12/Feb/2021) she had diarrhea until Sunday.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medication history was provided.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIARRHOEA (Midnight (12/Feb/2021) she had diarrhea until Sunday.). On 14-Feb-2021, DIARRHOEA (Midnight (12/Feb/2021) she had diarrhea until Sunday.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Cipro 500 mg two times a day for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: TCR  received on 25-apr-2021, patient declined follow up
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chills, Hyperhidrosis, Limb discomfort
Clinical narrative: chills; could not get out of bed; I cant move my legs; Very weak; Soaking from sweats; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats), MYALGIA (Muscle pain) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL for Gout, ASA 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-Feb-2021, the patient experienced LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats) and MYALGIA (Muscle pain). On 14-Feb-2021, the patient experienced CHILLS (chills) and BEDRIDDEN (could not get out of bed). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-Feb-2021, LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats) and MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (chills) and BEDRIDDEN (could not get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Event was updated, outcome of one event was updated and  Route of administration added
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: chills; could not get out of bed; I cant move my legs; Very weak; Soaking from sweats; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats), MYALGIA (Muscle pain) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL for Gout, ASA 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-Feb-2021, the patient experienced LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats) and MYALGIA (Muscle pain). On 14-Feb-2021, the patient experienced CHILLS (chills) and BEDRIDDEN (could not get out of bed). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-Feb-2021, LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats) and MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (chills) and BEDRIDDEN (could not get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Event was updated, outcome of one event was updated and  Route of administration added
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: arm red; arm hard lump; arm itchy; A spontaneous report  was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm red(Injection site erythema), arm hard lump(Injection site mass), arm itchy(Injection site pruritus).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient experienced arm red, arm hard lump, arm itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm red, arm hard lump,arm itchy was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: body shaking; chest pain; pain in throat; muscle aches; joint aches; headache; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (COVID arm), TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat) and MYALGIA (muscle aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (COVID arm). On 15-Feb-2021, the patient experienced TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (COVID arm), TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details included Tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: body shaking; chest pain; pain in throat; muscle aches; joint aches; headache; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (COVID arm), TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat) and MYALGIA (muscle aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (COVID arm). On 15-Feb-2021, the patient experienced TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (COVID arm), TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details included Tylenol.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness
Clinical narrative: felt woozy; BP of 100/60mmHg; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt woozy(Dizziness), bp of 100 60mmhg(Blood pressure decreased).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021,at 11am prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) felt woozy. bp of 100 60mmhg.  He felt nothing until this morning, after breakfast he felt woozy. He said his BP normally measures 110 70mmHg, but it read 100 60mmHg. He noticed getting slight headache on the left quadrant of his head. Treatment given was not provided Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), felt woozy, bp of 100 60mmhg was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: spots of blood from urine but it is not frequent and not painful; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (spots of blood from urine but it is not frequent and not painful) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced BLOOD URINE PRESENT (spots of blood from urine but it is not frequent and not painful). At the time of the report, BLOOD URINE PRESENT (spots of blood from urine but it is not frequent and not painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Feeling abnormal, Heart rate increased, Hypertension
Clinical narrative: Fast heart beat; Blood pressure readings of 150/103, 140/100 and 180/113; Felt her heart moving around; Pain in her arm; A little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113), FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113), FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued). On 13-Feb-2021, HEART RATE INCREASED (Fast heart beat) and BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113) had resolved. On 16-Feb-2021, FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Hypertension: 180/113 (High) 45 minutes until her blood pressure went down to 135/80..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fast heart beat; Blood pressure readings of 150/103, 140/100 and 180/113; Felt her heart moving around; Pain in her arm; A little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113), FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113), FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued). On 13-Feb-2021, HEART RATE INCREASED (Fast heart beat) and BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113) had resolved. On 16-Feb-2021, FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Hypertension: 180/113 (High) 45 minutes until her blood pressure went down to 135/80..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Sore arm; Red arm; Itching at the injection site; A spontaneous report was received from a type consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm(Vaccination site pain), red arm(Vaccination site erythema), itching at the injection site(Injection site pruritus).  The patient's medical history was provided as arthritis,have an artificial shoulder in my left due to an infection she had some years ago . Concomitant medications reported were Tylenol .  On 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 016M20A) in the right arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) arm was pretty sore and red and it was already 5 days since she gotten the shot.    Treatment details included Ice packs 3 times a day and cortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, red arm,itching at the injection site was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: warm to the touch IS; Itch IS; Redness IS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch IS), INJECTION SITE PRURITUS (Itch IS) and INJECTION SITE ERYTHEMA (Redness IS) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch IS), INJECTION SITE PRURITUS (Itch IS) and INJECTION SITE ERYTHEMA (Redness IS). At the time of the report, INJECTION SITE WARMTH (warm to the touch IS), INJECTION SITE PRURITUS (Itch IS) and INJECTION SITE ERYTHEMA (Redness IS) outcome was unknown.            No concomitant and treatment drugs were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Headache, Hyperhidrosis, Somnolence
Clinical narrative: increase in blood sugar; grogginess; sweats; chills all night; pain at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (increase in blood sugar), SOMNOLENCE (grogginess), HYPERHIDROSIS (sweats), CHILLS (chills all night) and VACCINATION SITE PAIN (pain at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills all night), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (headache). On 13-Feb-2021, the patient experienced SOMNOLENCE (grogginess) and HYPERHIDROSIS (sweats). On 16-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (increase in blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (increase in blood sugar), SOMNOLENCE (grogginess), HYPERHIDROSIS (sweats), CHILLS (chills all night), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: increase (High) unknown.         No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: increase in blood sugar; grogginess; sweats; chills all night; pain at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (increase in blood sugar), SOMNOLENCE (grogginess), HYPERHIDROSIS (sweats), CHILLS (chills all night) and VACCINATION SITE PAIN (pain at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills all night), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (headache). On 13-Feb-2021, the patient experienced SOMNOLENCE (grogginess) and HYPERHIDROSIS (sweats). On 16-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (increase in blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (increase in blood sugar), SOMNOLENCE (grogginess), HYPERHIDROSIS (sweats), CHILLS (chills all night), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: increase (High) unknown.         No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash on her left arm injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her left arm injection site(Injection site rash).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) rash on her left arm injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on her left arm injection site,  was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: fever; lost appetite; COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), DECREASED APPETITE (lost appetite) and COVID-19 (COVID-19) in a 72-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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PYREXIA (fever) and DECREASED APPETITE (lost appetite).   At the time of the report, PYREXIA (fever), DECREASED APPETITE (lost appetite) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.   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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Hardness at injection; swelling at injection; Itching at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection), VACCINATION SITE SWELLING (swelling at injection) and VACCINATION SITE PRURITUS (Itching at injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness at injection), VACCINATION SITE SWELLING (swelling at injection) and VACCINATION SITE PRURITUS (Itching at injection).   At the time of the report, VACCINATION SITE INDURATION (Hardness at injection), VACCINATION SITE SWELLING (swelling at injection) and VACCINATION SITE PRURITUS (Itching at injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pruritus, Vaccination site erythema
Clinical narrative: sore arm; Red arm; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), VACCINATION SITE ERYTHEMA (Red arm) and INJECTION SITE PRURITUS (injection site itching) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Implantation complication (Patient had an artificial shoulder in left arm due to infection, some years ago.) since an unknown date. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Joint ache.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 14-Feb-2021, the patient experienced AXILLARY PAIN (sore arm), VACCINATION SITE ERYTHEMA (Red arm) and INJECTION SITE PRURITUS (injection site itching).   The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency.   At the time of the report, AXILLARY PAIN (sore arm), VACCINATION SITE ERYTHEMA (Red arm) and INJECTION SITE PRURITUS (injection site itching) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: upper right arm is hurting; Upper right arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of   in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.            No concomitant medications were provided.  No treatment information provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Hypertension, Injection site erythema, Pain
Clinical narrative: when I take antibiotic for urinary tract infection my blood pressure goes up; felt burning sensation while urinating; red patch; slight pain; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pain, injection site erythema, hypertension and Dysuria.      The patient's medical history included hypertension and urinary tract infection. Concomitant medications reported were Bystolic Nebivolol for HBP 10mg QD, Telmisartan Micardis 80mg QD, Cefadroxil 500mg BID for drug use for unknown indication.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event, slight pain . On 1 Feb 2021, the patient experienced the event, red patch . On 12 Feb 2021, the patient experienced the events, when i take antibiotic for urinary tract infection my blood pressure goes up. felt burning sensation while urinating. On 13 Feb 2021, the patient experienced the event, bothered with blood pressure.  Treatment details included Benadryl 2 tablets for 25mg.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, slight pain, red patch,when i take antibiotic for urinary tract infection my blood pressure goes up,felt burning sensation while urinating,bothered with blood pressure was unknown.