chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her arm since then only been spreading and getting worst. Over her full body.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm since then only been spreading and getting worst. Over her full body.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (Rash on her arm since then only been spreading and getting worst. Over her full body.). At the time of the report, RASH (Rash on her arm since then only been spreading and getting worst. Over her full body.) 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.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Injection site pain, Myalgia, Pyrexia
Clinical narrative: weakness; muscle pain; sore at the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (pain) and VACCINATION SITE PAIN (sore at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-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 ASTHENIA (weakness), MYALGIA (pain) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, ASTHENIA (weakness), MYALGIA (pain) and VACCINATION SITE PAIN (sore at 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.   This case was linked to MOD-2021-017165 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cold urticaria
Clinical narrative: feels a little warmth on the face; This spontaneous case was reported by a consumer and describes the occurrence of COLD URTICARIA (feels a little warmth on the face) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 COLD URTICARIA (feels a little warmth on the face). At the time of the report, COLD URTICARIA (feels a little warmth on the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Co-suspect included an unspecified allergy pills.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However the allergy medication the patient has been taking is a co-suspect
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Swelling
Clinical narrative: sweating; Body aches; swelling; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN (Body aches), SWELLING (swelling), CHILLS (Chills) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00045124) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN (Body aches), SWELLING (swelling), CHILLS (Chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), PAIN (Body aches), SWELLING (swelling), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment of these events were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Non significant follow up- Patient first name updated. No new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Hives; Pain in the same arm of injection; Fatigue; Headache; Nausea; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the same arm of injection), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 reported medical history).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the same arm of injection), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Aches). On 03-Feb-2021, the patient experienced URTICARIA (Hives). On 28-Jan-2021, INJECTION SITE PAIN (Pain in the same arm of injection), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Aches) had resolved. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included none.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Pain in the same arm of injection; Fatigue; Headache; Nausea; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the same arm of injection), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 reported medical history).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the same arm of injection), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Aches). On 03-Feb-2021, the patient experienced URTICARIA (Hives). On 28-Jan-2021, INJECTION SITE PAIN (Pain in the same arm of injection), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PAIN (Aches) had resolved. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included none.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Diarrhoea, Headache
Clinical narrative: little touch of loose stools; stomach that makes noise; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (little touch of loose stools), ABDOMINAL DISCOMFORT (stomach that makes noise) and HEADACHE (dull headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (dull headache). On an unknown date, the patient experienced DIARRHOEA (little touch of loose stools) and ABDOMINAL DISCOMFORT (stomach that makes noise). At the time of the report, DIARRHOEA (little touch of loose stools), ABDOMINAL DISCOMFORT (stomach that makes noise) and HEADACHE (dull headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 99 (High) 99F. On an unknown date, Body temperature: 97 (normal) always normal temperature was 97F and 98.4 (Inconclusive) week later temperature was 98.4F.         No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Reporter Contact details updated. On 05-Aug-2021: Source document has no new information. On 09-Aug-2021: NNI Follow up received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red warm to the touch knot at the injection site; Red knot at the injection site,Itchy knot at the site of injection; itchiness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red warm to the touch knot at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Red knot at the injection site,Itchy knot at the site of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history provided).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (red warm to the touch knot at the injection site) and VACCINATION SITE SWELLING (Red knot at the injection site,Itchy knot at the site of injection). At the time of the report, VACCINATION SITE WARMTH (red warm to the touch knot at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Red knot at the injection site,Itchy knot at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   Treatment using acetaminophen was reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Positive COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19 Test) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced COVID-19 (Positive COVID-19 Test). At the time of the report, COVID-19 (Positive COVID-19 Test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided  Patient tested Positive for COVID-19 after vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nasopharyngitis, Neck pain, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Is feeling cold.; lots of pain in the legs; lots of pain in the hips; lots of pain in the neck; cannot move the arm where they got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lots of pain in the legs), MUSCULOSKELETAL DISCOMFORT (lots of pain in the hips), NECK PAIN (lots of pain in the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move the arm where they got the vaccine) and NASOPHARYNGITIS (Is feeling cold.) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (lots of pain in the legs), MUSCULOSKELETAL DISCOMFORT (lots of pain in the hips), NECK PAIN (lots of pain in the neck) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move the arm where they got the vaccine). On an unknown date, the patient experienced NASOPHARYNGITIS (Is feeling cold.). At the time of the report, PAIN IN EXTREMITY (lots of pain in the legs), MUSCULOSKELETAL DISCOMFORT (lots of pain in the hips), NECK PAIN (lots of pain in the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move the arm where they got the vaccine) and NASOPHARYNGITIS (Is feeling cold.) had not resolved. Not Provided  No treatment information was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bite, Erythema, Rash, Vaccination site erythema
Clinical narrative: red big bite; changed to a medium red color but then went back to a dark color; Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple; Redness at the site; This spontaneous case was reported by a consumer and describes the occurrence of BITE (red big bite), ERYTHEMA (changed to a medium red color but then went back to a dark color), RASH (Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple) and VACCINATION SITE ERYTHEMA (Redness at the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the site). On an unknown date, the patient experienced BITE (red big bite), ERYTHEMA (changed to a medium red color but then went back to a dark color) and RASH (Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple). At the time of the report, BITE (red big bite), ERYTHEMA (changed to a medium red color but then went back to a dark color), RASH (Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple) and VACCINATION SITE ERYTHEMA (Redness at the site) outcome was unknown. not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No specific follow-up information recorded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: My arm was sore; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), CHILLS (Chills) and MYALGIA (Achiness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore), CHILLS (Chills) and MYALGIA (Achiness). At the time of the report, PAIN IN EXTREMITY (My arm was sore), CHILLS (Chills) and MYALGIA (Achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling and soreness on the injection site; swelling and soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling and soreness on the injection site) and INJECTION SITE PAIN (swelling and soreness on the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling and soreness on the injection site) and INJECTION SITE PAIN (swelling and soreness on the injection site). At the time of the report, INJECTION SITE SWELLING (swelling and soreness on the injection site) and INJECTION SITE PAIN (swelling and soreness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm (injection site) was a little bumpy and sore; Arm (injection site) was a little bumpy and sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Arm (injection site) was a little bumpy and sore) and INJECTION SITE PAIN (Arm (injection site) was a little bumpy and sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE SWELLING (Arm (injection site) was a little bumpy and sore) and INJECTION SITE PAIN (Arm (injection site) was a little bumpy and sore). At the time of the report, INJECTION SITE SWELLING (Arm (injection site) was a little bumpy and sore) and INJECTION SITE PAIN (Arm (injection site) was a little bumpy and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Injection Site is RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection Site is RED) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection Site is RED). At the time of the report, VACCINATION SITE ERYTHEMA (Injection Site is RED) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Redness on the arm when the shot was given; slightly swollen; A kind of rash; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on the arm when the shot was given, slightly swollen, a kind of rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, patient experienced redness on the arm when the shot was given, Slightly swollen, and rash.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Cough, Fatigue, Headache
Clinical narrative: cough; nausea; tiredness; chills; headache; leg cramps; elevated blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (elevated blood pressure), MUSCLE SPASMS (leg cramps), COUGH (cough), NAUSEA (nausea) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ankylosing spondylitis and Drug allergy (Remicade allergy). Concomitant products included LOSARTAN for Blood pressure management, ETANERCEPT (ENBREL) for Spondylosis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Jan-2021, the patient experienced HYPERTENSION (elevated blood pressure). On 24-Jan-2021, the patient experienced MUSCLE SPASMS (leg cramps). On 26-Jan-2021, the patient experienced COUGH (cough), NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and HEADACHE (headache). On 24-Jan-2021, MUSCLE SPASMS (leg cramps) had resolved. At the time of the report, HYPERTENSION (elevated blood pressure), COUGH (cough), NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 153/84 mmHg (High) elevated and 162/91 mmHg (High) elevated. On 23-Jan-2021, Blood pressure measurement: elevated mmHg (High) elevated blood pressure persisted.. On 25-Jan-2021, Blood pressure measurement: 157/83 mmHg (High) elevated. On 26-Jan-2021, Blood pressure measurement: 144/75 mmHg (High) elevated. On 27-Jan-2021, Blood pressure measurement: 158/71 mmHg (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Muscle spasms, Nausea
Clinical narrative: cough; nausea; tiredness; chills; headache; leg cramps; elevated blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (elevated blood pressure), MUSCLE SPASMS (leg cramps), COUGH (cough), NAUSEA (nausea) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ankylosing spondylitis and Drug allergy (Remicade allergy). Concomitant products included LOSARTAN for Blood pressure management, ETANERCEPT (ENBREL) for Spondylosis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Jan-2021, the patient experienced HYPERTENSION (elevated blood pressure). On 24-Jan-2021, the patient experienced MUSCLE SPASMS (leg cramps). On 26-Jan-2021, the patient experienced COUGH (cough), NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and HEADACHE (headache). On 24-Jan-2021, MUSCLE SPASMS (leg cramps) had resolved. At the time of the report, HYPERTENSION (elevated blood pressure), COUGH (cough), NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 153/84 mmHg (High) elevated and 162/91 mmHg (High) elevated. On 23-Jan-2021, Blood pressure measurement: elevated mmHg (High) elevated blood pressure persisted.. On 25-Jan-2021, Blood pressure measurement: 157/83 mmHg (High) elevated. On 26-Jan-2021, Blood pressure measurement: 144/75 mmHg (High) elevated. On 27-Jan-2021, Blood pressure measurement: 158/71 mmHg (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site pain, Ocular hyperaemia
Clinical narrative: Severe Sweating; Eyes were bloodshot red; headache; injection arm burning; Felt really fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia.    On 14-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 HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue). At the time of the report, HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: A red strip across the left arm , which was the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A red strip across the left arm , which was the injection site) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (A red strip across the left arm , which was the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (A red strip across the left arm , which was the injection site) 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Nausea, Vaccination site pain
Clinical narrative: Strong metal taste in the mouth; Nauseated; very chilled; Hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metal taste in the mouth), NAUSEA (Nauseated), CHILLS (very chilled) and VACCINATION SITE PAIN (Hurting arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DYSGEUSIA (Strong metal taste in the mouth), NAUSEA (Nauseated), CHILLS (very chilled) and VACCINATION SITE PAIN (Hurting arm). At the time of the report, DYSGEUSIA (Strong metal taste in the mouth), NAUSEA (Nauseated), CHILLS (very chilled) and VACCINATION SITE PAIN (Hurting arm) 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 medications were not provided. No treatment medications were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Eye swelling, Feeling abnormal, Headache
Clinical narrative: adverse events to the vaccine similar to what she had when she actually had Covid; felt horrible; panicking a bit; felt as bad as she did at the peak with she had Covid; left eye was very swollen underneath her eye socke; Swollen lymph nodes at the base of her skull that were inflamed; chills; fever of 102; pains; aches; nausea; head hurt so bad she could not move it; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid) and EYE SWELLING (left eye was very swollen underneath her eye socke) in a 55-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.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure, ALPRAZOLAM (XANAX) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid), EYE SWELLING (left eye was very swollen underneath her eye socke), LYMPHADENOPATHY (Swollen lymph nodes at the base of her skull that were inflamed), CHILLS (chills), PYREXIA (fever of 102), PAIN (pains), MYALGIA (aches), NAUSEA (nausea) and HEADACHE (head hurt so bad she could not move it). On 26-Jan-2021, ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid), EYE SWELLING (left eye was very swollen underneath her eye socke), CHILLS (chills), PYREXIA (fever of 102), PAIN (pains), MYALGIA (aches), NAUSEA (nausea) and HEADACHE (head hurt so bad she could not move it) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes at the base of her skull that were inflamed) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Nausea, Pain
Clinical narrative: adverse events to the vaccine similar to what she had when she actually had Covid; felt horrible; panicking a bit; felt as bad as she did at the peak with she had Covid; left eye was very swollen underneath her eye socke; Swollen lymph nodes at the base of her skull that were inflamed; chills; fever of 102; pains; aches; nausea; head hurt so bad she could not move it; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid) and EYE SWELLING (left eye was very swollen underneath her eye socke) in a 55-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.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure, ALPRAZOLAM (XANAX) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid), EYE SWELLING (left eye was very swollen underneath her eye socke), LYMPHADENOPATHY (Swollen lymph nodes at the base of her skull that were inflamed), CHILLS (chills), PYREXIA (fever of 102), PAIN (pains), MYALGIA (aches), NAUSEA (nausea) and HEADACHE (head hurt so bad she could not move it). On 26-Jan-2021, ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid), EYE SWELLING (left eye was very swollen underneath her eye socke), CHILLS (chills), PYREXIA (fever of 102), PAIN (pains), MYALGIA (aches), NAUSEA (nausea) and HEADACHE (head hurt so bad she could not move it) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes at the base of her skull that were inflamed) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Pyrexia
Clinical narrative: adverse events to the vaccine similar to what she had when she actually had Covid; felt horrible; panicking a bit; felt as bad as she did at the peak with she had Covid; left eye was very swollen underneath her eye socke; Swollen lymph nodes at the base of her skull that were inflamed; chills; fever of 102; pains; aches; nausea; head hurt so bad she could not move it; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid) and EYE SWELLING (left eye was very swollen underneath her eye socke) in a 55-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.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure, ALPRAZOLAM (XANAX) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid), EYE SWELLING (left eye was very swollen underneath her eye socke), LYMPHADENOPATHY (Swollen lymph nodes at the base of her skull that were inflamed), CHILLS (chills), PYREXIA (fever of 102), PAIN (pains), MYALGIA (aches), NAUSEA (nausea) and HEADACHE (head hurt so bad she could not move it). On 26-Jan-2021, ADVERSE EVENT (adverse events to the vaccine similar to what she had when she actually had Covid), MALAISE (felt horrible), PANIC ATTACK (panicking a bit), FEELING ABNORMAL (felt as bad as she did at the peak with she had Covid), EYE SWELLING (left eye was very swollen underneath her eye socke), CHILLS (chills), PYREXIA (fever of 102), PAIN (pains), MYALGIA (aches), NAUSEA (nausea) and HEADACHE (head hurt so bad she could not move it) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes at the base of her skull that were inflamed) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: decreased visual acuity; felt knocked off feet; significant left arm pain; low grade fever of 100.5; chills; headache; joint pain; This spontaneous case was reported by a physician and describes the occurrence of VISUAL ACUITY REDUCED (decreased visual acuity), FEELING ABNORMAL (felt knocked off feet), PAIN IN EXTREMITY (significant left arm pain), PYREXIA (low grade fever of 100.5) and CHILLS (chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), FLUOXETINE HYDROCHLORIDE (PROZAC), QUETIAPINE FUMARATE (SEROQUEL), ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, CETIRIZINE, MELOXICAM, PANTOPRAZOLE SODIUM SESQUIHYDRATE (TOPRAZOLE), ALPRAZOLAM, GABAPENTIN and FLUOXETINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VISUAL ACUITY REDUCED (decreased visual acuity), FEELING ABNORMAL (felt knocked off feet), PAIN IN EXTREMITY (significant left arm pain), PYREXIA (low grade fever of 100.5), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain). On 04-Feb-2021, VISUAL ACUITY REDUCED (decreased visual acuity), PAIN IN EXTREMITY (significant left arm pain), PYREXIA (low grade fever of 100.5), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain) had resolved and FEELING ABNORMAL (felt knocked off feet) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 100.5 (abnormal) low grade fever of 100.5.     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.   04-feb-2021 Reporter states still a bit of discomfort, but feels better and back to work.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Visual acuity reduced
Clinical narrative: decreased visual acuity; felt knocked off feet; significant left arm pain; low grade fever of 100.5; chills; headache; joint pain; This spontaneous case was reported by a physician and describes the occurrence of VISUAL ACUITY REDUCED (decreased visual acuity), FEELING ABNORMAL (felt knocked off feet), PAIN IN EXTREMITY (significant left arm pain), PYREXIA (low grade fever of 100.5) and CHILLS (chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), FLUOXETINE HYDROCHLORIDE (PROZAC), QUETIAPINE FUMARATE (SEROQUEL), ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, CETIRIZINE, MELOXICAM, PANTOPRAZOLE SODIUM SESQUIHYDRATE (TOPRAZOLE), ALPRAZOLAM, GABAPENTIN and FLUOXETINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VISUAL ACUITY REDUCED (decreased visual acuity), FEELING ABNORMAL (felt knocked off feet), PAIN IN EXTREMITY (significant left arm pain), PYREXIA (low grade fever of 100.5), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain). On 04-Feb-2021, VISUAL ACUITY REDUCED (decreased visual acuity), PAIN IN EXTREMITY (significant left arm pain), PYREXIA (low grade fever of 100.5), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain) had resolved and FEELING ABNORMAL (felt knocked off feet) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 100.5 (abnormal) low grade fever of 100.5.     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.   04-feb-2021 Reporter states still a bit of discomfort, but feels better and back to work.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Chills, Dyspnoea
Clinical narrative: Could barely breathe for 35-45 minutes; Inability to speak; Chills, violent shaking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Could barely breathe for 35-45 minutes), APHASIA (Inability to speak) and CHILLS (Chills, violent shaking) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DYSPNOEA (Could barely breathe for 35-45 minutes), APHASIA (Inability to speak) and CHILLS (Chills, violent shaking). In January 2021, DYSPNOEA (Could barely breathe for 35-45 minutes), APHASIA (Inability to speak) and CHILLS (Chills, violent shaking) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination complication
Clinical narrative: fever; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION COMPLICATION (feel bad) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION COMPLICATION (feel bad). At the time of the report, PYREXIA (fever) and VACCINATION COMPLICATION (feel bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Mobility decreased, Pyrexia
Clinical narrative: Rapid heartbeat; Fever; Chills; Mobility decreased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), PYREXIA (Fever), CHILLS (Chills) and MOBILITY DECREASED (Mobility decreased) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heartbeat), PYREXIA (Fever), CHILLS (Chills) and MOBILITY DECREASED (Mobility decreased). At the time of the report, HEART RATE INCREASED (Rapid heartbeat), PYREXIA (Fever), CHILLS (Chills) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm on the injection site got hot; arm on the injection site got red; arm on the injection site got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm on the injection site got hot), VACCINATION SITE ERYTHEMA (arm on the injection site got red) and VACCINATION SITE SWELLING (arm on the injection site got swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm on the injection site got hot), VACCINATION SITE ERYTHEMA (arm on the injection site got red) and VACCINATION SITE SWELLING (arm on the injection site got swollen). At the time of the report, VACCINATION SITE WARMTH (arm on the injection site got hot), VACCINATION SITE ERYTHEMA (arm on the injection site got red) and VACCINATION SITE SWELLING (arm on the injection site got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information reported. No relevant concomitant medications were reported.   Reporter did not allow further contact