chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Pain in extremity, Pruritus
Clinical narrative: Itching all over; Injection site redness; Injection site itching; Injection site induration; Pain in arm; A spontaneous report was received from a consumer concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was little sore/pain in extremity, last week there was a knot there/injection site induration, arm started itching/injection site pruritus, red circle where shot was administered/injection site erythema, whole body feels itching/itching all over.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, Aldactone a, carvedilol, metformin, atorvastatin, omeprazole, hydrochlorothiazide.  On 5 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscular in left arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient experienced arm was little sore/pain in extremity. On 7 Feb 2021, the patient experienced last week there was a knot there/injection site induration. On 14 Feb 2021, the patient experienced arm started itching/injection site pruritus. On 19 Feb 2021, the patient experienced red circle where shot was administered/injection site erythema, whole body feels itching/itching all over. Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm was little sore/pain in extremity, last week there was a knot there/injection site induration were considered resolved on 13 Feb 2021. The outcome of events arm started itching/injection site pruritus, red circle where shot was administered/injection site erythema, whole body feels itching/itching all over was considered not resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Myalgia
Clinical narrative: sore arm; bruise on the site of the injection; A spontaneous report was received from a healthcare professional concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, bruise on the site of the injection,  The patient's medical history was not provided. Concomitant medications reported were Aleve for knee pain occasionally, vitamins for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) sore arm. On an unknown date, the patient experienced the event(s) bruise on the site of the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, bruise on the site of the injection was unknown.; Sender's Comments:  MOD21-034490:patient 2
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site infection, Injection site pain, Injection site pruritus, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE INDURATION (Induration that is getting bigger) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Induration that is getting bigger) and INJECTION SITE PAIN (Soreness at the injection site). The patient was treated with DOXYCYCLINE at a dose of UNK, bid. At the time of the report, VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Induration that is getting bigger) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received and Patient provided email and confirmed that she is a physician.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE INDURATION (Induration that is getting bigger) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Induration that is getting bigger) and INJECTION SITE PAIN (Soreness at the injection site). The patient was treated with DOXYCYCLINE at a dose of UNK, bid. At the time of the report, VACCINATION SITE MASS (Developed two lumps), ERYTHEMA (Redness), INJECTION SITE INFECTION (Infected), INJECTION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Induration that is getting bigger) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received and Patient provided email and confirmed that she is a physician.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Nausea
Clinical narrative: redness; swollen arm; rash; a little nauseous; A spontaneous report was received from a consumer concerning a 86-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea,injection site erythema,injection site swelling and injection site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Immediately after the first dose patient felt nauseous.On 20 Feb 2021,patient felt the events injection site erythema,injection site swelling and injection site rash.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events nausea,injection site erythema,injection site swelling and injection site rash was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Significant fatigue; Muscle aches; A spontaneous report was received a nurse concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/pain in extremity, significant fatigue/fatigue, muscle aches/myalgia.  The patient's medical history was not provided. Concomitant product use was not provided.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the event(s) sore arm, significant fatigue, muscle aches which lasted for 6 days.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   On 4 Feb 2021, the outcome of event(s), sore arm, significant fatigue, muscle aches was resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: Shaking uncontrollably; body and head aches; chills; Fever; body and headaches; A spontaneous report was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shaking uncontrollably, body and head aches, chills, 100.7â°f fever,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) shaking uncontrollably, body and head aches, chills, 100.7â°f fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shaking uncontrollably, body and head aches, chills, 100, 7â°f fever was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin reaction, Soft tissue mass, Vaccination site erythema, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (Injection site induration/firmness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) 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 medical history reported.).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 04-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE INDURATION (Injection site induration/firmness) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE INDURATION (Injection site induration/firmness) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (Injection site induration/firmness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) 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 medical history reported.).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 04-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE INDURATION (Injection site induration/firmness) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, SKIN REACTION (Delayed injection site reaction), SOFT TISSUE MASS (Soft mobile lumb at left clavicle), PAIN (Painful to touch), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE INDURATION (Injection site induration/firmness) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swelling in both ankles all the way up to her knees; Swollen Feet; Worst Swelling in the left leg; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling in both ankles all the way up to her knees, swollen feet, worst swelling in the left leg.  The patient's procedural history included lung surgery. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) swelling in both ankles all the way up to her knees, swollen feet, worst swelling in the left leg.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swelling in both ankles all the way up to her knees, swollen feet, worst swelling in the left leg was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 100.2F; Headache; Body ache; A spontaneous report was received from a consumer concerning a 74-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced pyrexia/ fever of 100.2F, Headache and bodyache/ myalgia.  The patient's medical history was not reported. No relevant concomitant medication were reported  On 12 feb 2021 approximately 6 days prior to the onset of events the patient received their first planned dose of mRNA-1273 (Lot number: 030M20A) via unknown route in left arm for prophylaxis of COVID-19 infection.   On 15 feb 2021, approximately 6 days prior to receiving  mRNA-1273  the patient experienced pyrexia/ fever of 100.2F, Headache and Myalgia. Treatment for the events included paracetamol  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events, Pyrexia/ fever of 100.2F, Headche and myalgia were resolved
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Illness, Pruritus, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very Ill), DYSPNOEA (Difficulty Breathing), TACHYCARDIA (Fast Heart Beat), DIZZINESS (Dizziness) and PRURITUS (Itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 ILLNESS (Very Ill), DYSPNOEA (Difficulty Breathing), TACHYCARDIA (Fast Heart Beat), DIZZINESS (Dizziness) and PRURITUS (Itching). On 20-Feb-2021, ILLNESS (Very Ill), DYSPNOEA (Difficulty Breathing), TACHYCARDIA (Fast Heart Beat), DIZZINESS (Dizziness) and PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: Soreness on left arm; Left arm feels heavy to lift; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness on left arm, left arm feels heavy to lift.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) soreness on left arm, left arm feels heavy to lift.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness on left arm, left arm feels heavy to lift was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Vaccination complication
Clinical narrative: having side affect; hot; tired; flushed in his face; A spontaneous report was received from a  concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events having side affect, hot, tired, flushed in his face.  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 an unknown date, the patient experienced the event(s) having side affect, hot, tired, flushed in his face.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), having side affect, hot, tired, flushed in his face was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeding disorder, Gastrointestinal tract irritation, Nausea
Clinical narrative: unable to hold down any food; severe nausea; vomitting; lost 25 pounds since then; feels very weak; dealing with GI periodically since then; unable to hold down any food; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then) and ASTHENIA (feels very weak) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then), ASTHENIA (feels very weak), GASTROINTESTINAL TRACT IRRITATION (dealing with GI periodically since then) and FEEDING DISORDER (unable to hold down any food). At the time of the report, DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then), ASTHENIA (feels very weak), GASTROINTESTINAL TRACT IRRITATION (dealing with GI periodically since then) and FEEDING DISORDER (unable to hold down any food) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment included Phenergan and Zofran.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: unable to hold down any food; severe nausea; vomitting; lost 25 pounds since then; feels very weak; dealing with GI periodically since then; unable to hold down any food; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then) and ASTHENIA (feels very weak) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then), ASTHENIA (feels very weak), GASTROINTESTINAL TRACT IRRITATION (dealing with GI periodically since then) and FEEDING DISORDER (unable to hold down any food). At the time of the report, DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then), ASTHENIA (feels very weak), GASTROINTESTINAL TRACT IRRITATION (dealing with GI periodically since then) and FEEDING DISORDER (unable to hold down any food) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment included Phenergan and Zofran.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site warmth
Clinical narrative: rash the size of his palm of his hand; itchy; warm to the touch; A spontaneous report was received from a consumer concerning a 81-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash the size of his palm of his hand, itchy, warm to the touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the event(s) rash the size of his palm of his hand, itchy, warm to the touch.  Treatment for the events were unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash the size of his palm of his hand, itchy, warm to the touch was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Injection site reaction, Injection site swelling, Lymph node pain
Clinical narrative: Little bump at the injection site; Bump turned more circler; Bump covered the deltoid; Bump was red; Bump was painful; Lymph nodes under arm painful; Lymph nodes under arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red) and PAIN (Bump was painful) in a female patient of an unknown age 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 (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red), PAIN (Bump was painful), LYMPH NODE PAIN (Lymph nodes under arm painful) and LYMPHADENOPATHY (Lymph nodes under arm swollen). At the time of the report, INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red), PAIN (Bump was painful), LYMPH NODE PAIN (Lymph nodes under arm painful) and LYMPHADENOPATHY (Lymph nodes under arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include allergy medicine.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Little bump at the injection site; Bump turned more circler; Bump covered the deltoid; Bump was red; Bump was painful; Lymph nodes under arm painful; Lymph nodes under arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red) and PAIN (Bump was painful) in a female patient of an unknown age 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 (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red), PAIN (Bump was painful), LYMPH NODE PAIN (Lymph nodes under arm painful) and LYMPHADENOPATHY (Lymph nodes under arm swollen). At the time of the report, INJECTION SITE SWELLING (Little bump at the injection site), INJECTION SITE MASS (Bump turned more circler), INJECTION SITE REACTION (Bump covered the deltoid), ERYTHEMA (Bump was red), PAIN (Bump was painful), LYMPH NODE PAIN (Lymph nodes under arm painful) and LYMPHADENOPATHY (Lymph nodes under arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include allergy medicine.  Treatment information was not provided.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Chills; Episode with teeth chattering; 100.2 degree fever; back of her neck was dripping with water; Episode with shaking; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), CHILLS (Episode with teeth chattering), PYREXIA (100.2 degree fever) and HYPERHIDROSIS (back of her neck was dripping with water) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (Fatigue). On 18-Feb-2021, the patient experienced CHILLS (Episode with teeth chattering), PYREXIA (100.2 degree fever), HYPERHIDROSIS (back of her neck was dripping with water) and TREMOR (Episode with shaking). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), CHILLS (Episode with teeth chattering), PYREXIA (100.2 degree fever), HYPERHIDROSIS (back of her neck was dripping with water) and TREMOR (Episode with shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Pyrexia
Clinical narrative: A spontaneous report was received from a consumer, a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, muscle pain/myalgia, fever/pyrexia and difficulty breathing/dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided the reporter. On 17 Feb 2021, prior to the onset of the events, the patient received second of two planned doses of mRNA-1273 (lot/batch number: 016m20a) via unknown route for prophylaxis of COVID-19 infection. On 17 Feb 2021, a couple hours later the second dose of mRNA-1273, the patient experienced the events headache, muscle pain, fever with difficulty breathing. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events headache, muscle pain, fever with difficulty breathing was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Freezing phenomenon, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: didn't want to eat; her whole body was wet with sweat; headache; felt sore all over. Her body was as sore as her arm; a nauseous feeling and she wanted to throw up, but she didn't; freezing to death, shivering, shaking, and couldn't get warm; had a restless night in bed; her arm was very sore; a sore arm for four or five days; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm for four or five days, her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed, headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat, her whole body was wet with sweat.  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 first of two planned doses of mRNA-1273 (lot/batch: 02L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the event(s) a sore arm for four or five days. On 17 Feb 2021, the patient experienced the event(s) her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed. On 18 Feb 2021, the patient experienced the event(s) headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat. On 19 Feb 2021, the patient experienced the event(s) her whole body was wet with sweat.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event(s), her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed was resolved. On18 Feb 2021 the outcome of event(s), headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat was resolved. On19 Feb 2021 the outcome of event(s), her whole body was wet with sweat was resolved. The outcome of event(s), a sore arm for four or five days was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Restlessness
Clinical narrative: didn't want to eat; her whole body was wet with sweat; headache; felt sore all over. Her body was as sore as her arm; a nauseous feeling and she wanted to throw up, but she didn't; freezing to death, shivering, shaking, and couldn't get warm; had a restless night in bed; her arm was very sore; a sore arm for four or five days; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm for four or five days, her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed, headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat, her whole body was wet with sweat.  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 first of two planned doses of mRNA-1273 (lot/batch: 02L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the event(s) a sore arm for four or five days. On 17 Feb 2021, the patient experienced the event(s) her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed. On 18 Feb 2021, the patient experienced the event(s) headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat. On 19 Feb 2021, the patient experienced the event(s) her whole body was wet with sweat.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event(s), her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed was resolved. On18 Feb 2021 the outcome of event(s), headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat was resolved. On19 Feb 2021 the outcome of event(s), her whole body was wet with sweat was resolved. The outcome of event(s), a sore arm for four or five days was unknown.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: A spontaneous report was received from a consumer concerning a 95 years old, female patient who experienced injection site redness/vaccination site erythema, injection site itchy/vaccination site pruritus and injection site round rash/vaccination site rash. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date in Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. On an unknown date in 2021, the patient experienced red itchy and round rash at the injection site. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events red itchy and round rash at the injection site were unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: COVID-19; Vaccination site erythema; left arm stayed swollen; left arm stayed itchy; A spontaneous report was received from a consumer concerning herself, a 70 year old  white female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, COVID-19 , Vaccination site erythema, swollen left arm, and  left arm stayed itchy.  The patient's medical history included mild high blood pressure and allergy to statins and Ambien.  The patient was on concomitant medications but refused to report and list them.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced severe left arm reaction after the vaccination that stayed red, swollen and itchy for one week. Next day, on 07 Jan 2021, the patient was also diagnosed with Covid-19.  Laboratory details included COVID-19 positive on 07 Jan 2021.   No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.    The events, Vaccination site erythema, swollen left arm, and left arm stayed itchy were considered resolved on 13 Jan 2021; while the event Covid-19 was considered resolved on 17 Jan 2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: The rash was itchy; Rash here and there on her body; feet were stinging; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (The rash was itchy), RASH (Rash here and there on her body) and PAIN (feet were stinging) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041220A) 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) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRURITUS (The rash was itchy), RASH (Rash here and there on her body) and PAIN (feet were stinging). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 4 pills a day. On 19-Jan-2021, PAIN (feet were stinging) outcome was unknown. At the time of the report, PRURITUS (The rash was itchy) and RASH (Rash here and there on her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Benadryl upto 4 pills a day and Benadryl creams. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 20-JUN-2021 contains No new information.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial pain, Hypoacusis, Suspected COVID-19
Clinical narrative: pain in the left side of her face; pain traveled to her ear; hard for her to hear; suspected COVID-19 symptoms; A spontaneous report was received from a consumer concerning a 48-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced symptoms of covid/ suspected COVID-19 symptoms, pain in the left side of her face/ facial pain, pain traveled to her ear/ ear pain and now it is hard for her to hear/ hypoacusis  The patient's medical history was not reported. No relevant concomitant medication were reported  On 15 jan 2021, the patient received their first planned dose of mRNA-1273 (Lot number: 037K20A) via unknown for prophylaxis of COVID-19 infection.  On 15 feb 2021, approximately 3 days prior to receiving  mRNA-1273  the patient experienced symptoms of covid/ suspected COVID-19 symptoms, pain in the left side of her face/ facial pain, pain traveled to her ear/ ear pain and now it is hard for her to hear/ hypoacusis.Treatment for the events included different antibiotics and a steroid  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events, symptoms of covid/ suspected COVID-19 symptoms, pain in the left side of her face/ facial pain, pain traveled to her ear/ ear pain and now it is hard for her to hear/ hypoacusis  were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Rash pruritic
Clinical narrative: Patches are itchy; headache; still breaking out in patches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Patches are itchy), RASH (still breaking out in patches) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041220A and 030M204) 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) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced RASH (still breaking out in patches). On 18-Feb-2021, the patient experienced RASH PRURITIC (Patches are itchy) and HEADACHE (headache). On 18-Feb-2021, HEADACHE (headache) outcome was unknown. At the time of the report, RASH PRURITIC (Patches are itchy) and RASH (still breaking out in patches) outcome was unknown.            Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient tested postive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested postive for COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Patient tested postive for COVID-19). At the time of the report, COVID-19 (Patient tested postive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided. Patient was scheduled to receive the second dose on 12-MAR-2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant followup appended
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Myalgia, Rhinorrhoea
Clinical narrative: Muscle aches; Nose was running like mad; Headaches; Felt pretty tired; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Nose was running like mad), HEADACHE (Headaches), FATIGUE (Felt pretty tired) and MYALGIA (Muscle aches) 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 Cardiac ablation in June 2020. Concurrent medical conditions included Atrial fibrillation (Ten year history of A Fib), Congestive heart failure and Rhinitis (Chronic non-allergic rhinitis for years). Concomitant products included WARFARIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHINORRHOEA (Nose was running like mad), HEADACHE (Headaches), FATIGUE (Felt pretty tired) and MYALGIA (Muscle aches). The patient was treated with GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) for Runny nose, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), RHINORRHOEA (Nose was running like mad), HEADACHE (Headaches), FATIGUE (Felt pretty tired) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Physical examination: (abnormal) Had a slightly out of normal range kidney function. On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-090588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Event detail updated, medical history updated, concomitant medication list updated, second dose details updated, and treatment details updated.; 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.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Muscle aches; Nose was running like mad; Headaches; Felt pretty tired; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Nose was running like mad), HEADACHE (Headaches), FATIGUE (Felt pretty tired) and MYALGIA (Muscle aches) 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 Cardiac ablation in June 2020. Concurrent medical conditions included Atrial fibrillation (Ten year history of A Fib), Congestive heart failure and Rhinitis (Chronic non-allergic rhinitis for years). Concomitant products included WARFARIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHINORRHOEA (Nose was running like mad), HEADACHE (Headaches), FATIGUE (Felt pretty tired) and MYALGIA (Muscle aches). The patient was treated with GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) for Runny nose, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), RHINORRHOEA (Nose was running like mad), HEADACHE (Headaches), FATIGUE (Felt pretty tired) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Physical examination: (abnormal) Had a slightly out of normal range kidney function. On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-090588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Event detail updated, medical history updated, concomitant medication list updated, second dose details updated, and treatment details updated.; 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.