chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea, Sneezing
Clinical narrative: Headache; Runny nose; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RHINORRHOEA (Runny nose) and SNEEZING (Sneezing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inflammation and Iron high.    On 03-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 HEADACHE (Headache), RHINORRHOEA (Runny nose) and SNEEZING (Sneezing). At the time of the report, HEADACHE (Headache), RHINORRHOEA (Runny nose) and SNEEZING (Sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Ibuprofen for headache.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: hot to touch; hardness underneath the injection site; shoulder felt like a lot of itching underneath the skin where the shot was at; Injection site is also bright pink/Pink moving from side of arm to the front of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (hot to touch), INJECTION SITE INDURATION (hardness underneath the injection site), INJECTION SITE PRURITUS (shoulder felt like a lot of itching underneath the skin where the shot was at) and INJECTION SITE ERYTHEMA (Injection site is also bright pink/Pink moving from side of arm to the front of arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot to touch), INJECTION SITE INDURATION (hardness underneath the injection site), INJECTION SITE PRURITUS (shoulder felt like a lot of itching underneath the skin where the shot was at) and INJECTION SITE ERYTHEMA (Injection site is also bright pink/Pink moving from side of arm to the front of arm).   At the time of the report, INJECTION SITE WARMTH (hot to touch), INJECTION SITE INDURATION (hardness underneath the injection site), INJECTION SITE PRURITUS (shoulder felt like a lot of itching underneath the skin where the shot was at) and INJECTION SITE ERYTHEMA (Injection site is also bright pink/Pink moving from side of arm to the front of 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 product use was not provided by the reporter. No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Has no energy; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Has no energy) and FATIGUE (Exhaustion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced ASTHENIA (Has no energy) and FATIGUE (Exhaustion). At the time of the report, ASTHENIA (Has no energy) and FATIGUE (Exhaustion) had not resolved.       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.   Reporter did not allow further contact.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash, Pyrexia
Clinical narrative: 99.2 degree fever; Rash; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (99.2 degree fever), INJECTION SITE RASH (Rash) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced PYREXIA (99.2 degree fever), INJECTION SITE RASH (Rash) and FATIGUE (Tired).   At the time of the report, PYREXIA (99.2 degree fever), INJECTION SITE RASH (Rash) and FATIGUE (Tired) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Erythema
Clinical narrative: Tested positive for Covid; Dry cough; Red mark on arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), COUGH (Dry cough), CHILLS (chills) and ERYTHEMA (Red mark on arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (Dry cough), CHILLS (chills) and ERYTHEMA (Red mark on arm). On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid), COUGH (Dry cough), CHILLS (chills) and ERYTHEMA (Red mark on arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Decreased appetite, Dysstasia, Feeling hot
Clinical narrative: Arm bad pain; Couldn't Eat; Arm burning; Couldn't get out of bed; Fever 101.4; Headache; Body Locking; Arm a little hot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Body Locking), FEELING HOT (Arm a little hot), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat) and BURNING SENSATION (Arm burning) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Body Locking), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat), BURNING SENSATION (Arm burning), DYSSTASIA (Couldn't get out of bed), PYREXIA (Fever 101.4) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING HOT (Arm a little hot). At the time of the report, MUSCULOSKELETAL STIFFNESS (Body Locking), FEELING HOT (Arm a little hot), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat), BURNING SENSATION (Arm burning) and DYSSTASIA (Couldn't get out of bed) had resolved and PYREXIA (Fever 101.4) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.4 (High) Patient had 101.4 temperature.         Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Arm bad pain; Couldn't Eat; Arm burning; Couldn't get out of bed; Fever 101.4; Headache; Body Locking; Arm a little hot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Body Locking), FEELING HOT (Arm a little hot), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat) and BURNING SENSATION (Arm burning) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Body Locking), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat), BURNING SENSATION (Arm burning), DYSSTASIA (Couldn't get out of bed), PYREXIA (Fever 101.4) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING HOT (Arm a little hot). At the time of the report, MUSCULOSKELETAL STIFFNESS (Body Locking), FEELING HOT (Arm a little hot), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat), BURNING SENSATION (Arm burning) and DYSSTASIA (Couldn't get out of bed) had resolved and PYREXIA (Fever 101.4) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.4 (High) Patient had 101.4 temperature.         Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: Weakness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and PAIN (Aches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On 27-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 ASTHENIA (Weakness) and PAIN (Aches). At the time of the report, ASTHENIA (Weakness) and PAIN (Aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR received on 15 JULY 2021 and event outcome updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Facial pain, Limb discomfort, Neck pain
Clinical narrative: Arm discomfort; pain on the neck; Pain on cheeks; pain in shoulder of left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm discomfort), NECK PAIN (pain on the neck), FACIAL PAIN (Pain on cheeks) and ARTHRALGIA (pain in shoulder of left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Diabetes, Hypertension and High cholesterol.    On 13-Feb-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 LIMB DISCOMFORT (Arm discomfort), NECK PAIN (pain on the neck), FACIAL PAIN (Pain on cheeks) and ARTHRALGIA (pain in shoulder of left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Arm discomfort), NECK PAIN (pain on the neck), FACIAL PAIN (Pain on cheeks) and ARTHRALGIA (pain in shoulder of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included diabetes medicine,cholesterol medicine, blood pressure medicine.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Rash came back; chills; itching on same side of injection; rash on same side of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on same side of injection), RASH (Rash came back), INJECTION SITE RASH (rash on same side of injection) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching on same side of injection) and INJECTION SITE RASH (rash on same side of injection). On 22-Feb-2021, the patient experienced RASH (Rash came back) and CHILLS (chills). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (itching on same side of injection), RASH (Rash came back), INJECTION SITE RASH (rash on same side of injection) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received on 27-APR-2021 contains non-significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: arm little sore; headache; severe chills; felt nauseated and at the verge of throwing up but never did,; felt sick/ got very sick about 24 hours after both vaccinations; major body aches like shooting pain; major arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick/ got very sick about 24 hours after both vaccinations), PAIN (major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain), VACCINATION SITE PAIN (arm little sore) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCT ACTAVIS) for Blood pressure high, METFORMIN for Diabetic, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (major arm pain). On 28-Feb-2021, the patient experienced MALAISE (felt sick/ got very sick about 24 hours after both vaccinations), PAIN (major body aches like shooting pain), VACCINATION SITE PAIN (arm little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did,). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, MALAISE (felt sick/ got very sick about 24 hours after both vaccinations), PAIN (major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain), VACCINATION SITE PAIN (arm little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-259463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Reporter information updated. Updated patient demographics. Added Dose-2 information. Added concomitant medications. Added new event -patient got very sick about 24 hours after both vaccinations. All Event outcome was updated as recovered/resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: arm little sore; headache; severe chills; felt nauseated and at the verge of throwing up but never did,; felt sick/ got very sick about 24 hours after both vaccinations; major body aches like shooting pain; major arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick/ got very sick about 24 hours after both vaccinations), PAIN (major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain), VACCINATION SITE PAIN (arm little sore) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCT ACTAVIS) for Blood pressure high, METFORMIN for Diabetic, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (major arm pain). On 28-Feb-2021, the patient experienced MALAISE (felt sick/ got very sick about 24 hours after both vaccinations), PAIN (major body aches like shooting pain), VACCINATION SITE PAIN (arm little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did,). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, MALAISE (felt sick/ got very sick about 24 hours after both vaccinations), PAIN (major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain), VACCINATION SITE PAIN (arm little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-259463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Reporter information updated. Updated patient demographics. Added Dose-2 information. Added concomitant medications. Added new event -patient got very sick about 24 hours after both vaccinations. All Event outcome was updated as recovered/resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; A spontaneous report was received from a consumer concerning a 27-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event tested positive for covid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event tested positive for covid was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Vaccination site pain
Clinical narrative: Nasal congestion; Soreness in left arm; Extremely tired; A spontaneous report was received from a consumer concerning a 21-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in left arm, extremely tired and nasal congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown) in left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the events soreness in left arm and extremely tired. On 26 Jan 2021, the patient experienced the events nasal congestion. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, soreness in left arm, extremely tired and nasal congestion was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: On 13 Feb2021 I got tested for covid and on 14Feb2021 result came covid Positive; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and on 13 Feb 2021 I got tested for covid and on 14 Feb 2021 result came covid positive,  The patient's medical history was not provided. Concomitant medications reported were Rosuvastatin, Synthroid, Viagra(as needed), Vitamins for drug use for unknown indication.  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K209) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced covid positive.  Treatment details included infusion of Bamlanivimab and Saline to flush lines in Emergency Room.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Right arm hot, red and itching at the injection site; Right arm hot, red and itching at the injection site; Right arm hot, red and itching at the injection site; A spontaneous report  was received from a consumer concerning a 82-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right arm hot, red and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events right arm hot, red and itching at the injection site.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events right arm hot, red and itching at the injection site was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: rash at injection site; itchiness at injection site; hot to touch at injection site; soreness at injection site; stomach pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at injection site, itchiness at injection site, hot to touch at injection site, soreness at injection site, and stomach pain.  The patient's medical history was not provided. Concomitant medications reported were doxycycline, xarelto, atenolol, and hydrochlorothiazide for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the events rash at injection site, itchiness at injection site, hot to touch at injection site, soreness at injection site, and stomach pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 12 Feb 2021 the outcome of event(s), stomach pain was resolved. The outcome of event(s), rash at injection site, itchiness at injection site, hot to touch at injection site, and soreness at injection site was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Muscle strain
Clinical narrative: Fatigue in waves; headaches; muscle strain in neck and head; occasional metallic taste in mouth; A spontaneous report  was received from a healthcare professional dear concerning a 53-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue in waves, headaches, muscle strain in neck and head, and occasional metallic taste in mouth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events fatigue in waves, headaches, muscle strain in neck and head, and occasional metallic taste in mouth.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fatigue in waves, headaches, muscle strain in neck and head, and occasional metallic taste in mouth was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their unknown dose of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Warm to touch; Redness; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to touch), INJECTION SITE ERYTHEMA (Redness) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to touch), INJECTION SITE ERYTHEMA (Redness) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to touch), INJECTION SITE ERYTHEMA (Redness) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) fever of 100.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   This case was linked .   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received on 27-APR-2021 contains non-significant information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck; A spontaneous report was received from a consumer  concerning herself a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen lymph node in neck.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the event(s) swollen lymph node in neck.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen lymph node in neck was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Candida infection, Chills, Coating in mouth, Headache
Clinical narrative: Felt like little thrush; White stringy sort of in mouth; Black hairy spot on back center of tongue; Very bad taste in mouth; Joint sensitivity; Headaches; Fever; Pain; Chills; Aches; Elevated heart rate of about 120; A spontaneous report  was received from a consumer concerning a 59-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events elevated heart rate of about 120, fever, headaches, pain, joint sensitivity, very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly on left non-dominant arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event, elevated heart rate of about 120, fever, headaches, pain, joint sensitivity. On 22 Feb 2021, the patient experienced the events very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills.Consent to follow up with safety.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, elevated heart rate of about 120, fever, headaches, pain, joint sensitivity, very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills were unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Pyrexia, Taste disorder, Trichoglossia
Clinical narrative: Felt like little thrush; White stringy sort of in mouth; Black hairy spot on back center of tongue; Very bad taste in mouth; Joint sensitivity; Headaches; Fever; Pain; Chills; Aches; Elevated heart rate of about 120; A spontaneous report  was received from a consumer concerning a 59-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events elevated heart rate of about 120, fever, headaches, pain, joint sensitivity, very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly on left non-dominant arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event, elevated heart rate of about 120, fever, headaches, pain, joint sensitivity. On 22 Feb 2021, the patient experienced the events very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills.Consent to follow up with safety.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, elevated heart rate of about 120, fever, headaches, pain, joint sensitivity, very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills were unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Diarrhea; Major headache; Nausea; Body aches; low grade ever; Chills; A spontaneous report was received from a healthcare professional concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events major headache, nausea, body aches, low grade ever, diarrhea, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 42L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events major headache, nausea, body aches, low grade ever, diarrhea, chills.  Treatment information include,She did not take anything for her symptoms.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, major headache, nausea, body aches, low grade ever, diarrhea, chills was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; Major headache; Nausea; Body aches; low grade ever; Chills; A spontaneous report was received from a healthcare professional concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events major headache, nausea, body aches, low grade ever, diarrhea, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 42L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events major headache, nausea, body aches, low grade ever, diarrhea, chills.  Treatment information include,She did not take anything for her symptoms.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, major headache, nausea, body aches, low grade ever, diarrhea, chills was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Her fingers were extremely painful hands; Complete loss of appetite; Had a lump about the size of the tennis ball; Redness; Headaches; Muscle ache; Fatigue; Vomitting; Nausea; A spontaneous report  was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events her fingers were extremely painful hands, had a lump about the size of the tennis ball, redness, headaches, muscle ache, complete loss of appetite, fatigue, nausea, vomiting.  The patient's medical history include positive test to covid -19 in November 2020. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events, her fingers were extremely painful hands, had a lump about the size of the tennis ball, redness, headaches, muscle ache, complete loss of appetite, fatigue, nausea, vomiting.Consent received for follow up.Would she have the same reaction to the second vaccine. No further information provided at this time.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Feb 2021 the outcome of events, her fingers were extremely painful hands, had a lump about the size of the tennis ball, redness, headaches, muscle ache, complete loss of appetite, fatigue, nausea, vomiting was resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Her fingers were extremely painful hands; Complete loss of appetite; Had a lump about the size of the tennis ball; Redness; Headaches; Muscle ache; Fatigue; Vomitting; Nausea; A spontaneous report  was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events her fingers were extremely painful hands, had a lump about the size of the tennis ball, redness, headaches, muscle ache, complete loss of appetite, fatigue, nausea, vomiting.  The patient's medical history include positive test to covid -19 in November 2020. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events, her fingers were extremely painful hands, had a lump about the size of the tennis ball, redness, headaches, muscle ache, complete loss of appetite, fatigue, nausea, vomiting.Consent received for follow up.Would she have the same reaction to the second vaccine. No further information provided at this time.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Feb 2021 the outcome of events, her fingers were extremely painful hands, had a lump about the size of the tennis ball, redness, headaches, muscle ache, complete loss of appetite, fatigue, nausea, vomiting was resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Influenza like illness, Injection site swelling
Clinical narrative: flu-like symptoms; Extreme fatigue; heart palpitations of and on; Smooth bright red area on arm; Swelling at injection site; Swollen lymph nodes under arm; Arm felt hot; Bumpy 6x3 inch red circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm felt hot), PILOERECTION (Bumpy 6x3 inch red circle on arm), PALPITATIONS (heart palpitations of and on), INFLUENZA LIKE ILLNESS (flu-like symptoms) and ERYTHEMA (Smooth bright red area on arm) in a 73-year-old female 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 reported by the reporter.  Concurrent medical conditions included Insect bite allergy (Insect bites: Swollen and red for days/even weeks). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (Arm felt hot) and PILOERECTION (Bumpy 6x3 inch red circle on arm). On 13-Feb-2021, the patient experienced PALPITATIONS (heart palpitations of and on), ERYTHEMA (Smooth bright red area on arm), INJECTION SITE SWELLING (Swelling at injection site) and LYMPHADENOPATHY (Swollen lymph nodes under arm). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (Extreme fatigue). At the time of the report, FEELING HOT (Arm felt hot), PILOERECTION (Bumpy 6x3 inch red circle on arm), PALPITATIONS (heart palpitations of and on), INFLUENZA LIKE ILLNESS (flu-like symptoms), ERYTHEMA (Smooth bright red area on arm), INJECTION SITE SWELLING (Swelling at injection site), LYMPHADENOPATHY (Swollen lymph nodes under arm) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received on 15-Jul-2021 contains significant information. Other relevant history added, dose information updated, Patient demographics updated, Events updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Palpitations, Piloerection
Clinical narrative: flu-like symptoms; Extreme fatigue; heart palpitations of and on; Smooth bright red area on arm; Swelling at injection site; Swollen lymph nodes under arm; Arm felt hot; Bumpy 6x3 inch red circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm felt hot), PILOERECTION (Bumpy 6x3 inch red circle on arm), PALPITATIONS (heart palpitations of and on), INFLUENZA LIKE ILLNESS (flu-like symptoms) and ERYTHEMA (Smooth bright red area on arm) in a 73-year-old female 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 reported by the reporter.  Concurrent medical conditions included Insect bite allergy (Insect bites: Swollen and red for days/even weeks). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (Arm felt hot) and PILOERECTION (Bumpy 6x3 inch red circle on arm). On 13-Feb-2021, the patient experienced PALPITATIONS (heart palpitations of and on), ERYTHEMA (Smooth bright red area on arm), INJECTION SITE SWELLING (Swelling at injection site) and LYMPHADENOPATHY (Swollen lymph nodes under arm). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (Extreme fatigue). At the time of the report, FEELING HOT (Arm felt hot), PILOERECTION (Bumpy 6x3 inch red circle on arm), PALPITATIONS (heart palpitations of and on), INFLUENZA LIKE ILLNESS (flu-like symptoms), ERYTHEMA (Smooth bright red area on arm), INJECTION SITE SWELLING (Swelling at injection site), LYMPHADENOPATHY (Swollen lymph nodes under arm) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received on 15-Jul-2021 contains significant information. Other relevant history added, dose information updated, Patient demographics updated, Events updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Lip swelling, Oropharyngeal pain, Pruritus
Clinical narrative: On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events itching on fingers and arm, sore throat, swollen lips, warm to the touch at the injection site. Consent for follow-up given. Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching on fingers and arm, sore throat, swollen lips, warm to the touch at the injection site were unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Injection site erythema, Injection site rash, Urticaria
Clinical narrative: chest was heavy with voice like smoker; hives; Injection site was red almost like bruise turned purplish red rash; Purplish red rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (chest was heavy with voice like smoker), URTICARIA (hives), INJECTION SITE RASH (Purplish red rash at injection site) and INJECTION SITE ERYTHEMA (Injection site was red almost like bruise turned purplish red rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE RASH (Purplish red rash at injection site). On 18-Feb-2021, the patient experienced URTICARIA (hives) and INJECTION SITE ERYTHEMA (Injection site was red almost like bruise turned purplish red rash). On 22-Feb-2021, the patient experienced CHEST DISCOMFORT (chest was heavy with voice like smoker). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (chest was heavy with voice like smoker), URTICARIA (hives), INJECTION SITE RASH (Purplish red rash at injection site) and INJECTION SITE ERYTHEMA (Injection site was red almost like bruise turned purplish red rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Woke up in the middle of the night thinking that my arm was asleep; Numbness; on my left arm down to my fingers/tingling; A spontaneous report was received from a healthcare professional concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events woke up in the middle of the night thinking that my arm was asleep, numbness, tingling, on my left arm down to my fingers.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unavailable) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unavailable) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the events woke up in the middle of the night thinking that my arm was asleep, numbness, tingling. On my left arm down to my fingers.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events woke up in the middle of the night thinking that my arm was asleep, numbness, tingling, on my left arm down to my fingers was unknown.