chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site streaking
Clinical narrative: Indentation - Near Injection Site; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (Indentation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 307K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE STREAKING (Indentation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). At the time of the report, VACCINATION SITE STREAKING (Indentation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash pruritic
Clinical narrative: itchy; rash on her arm; swelling on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her arm), RASH PRURITIC (itchy) and RASH (rash on her arm) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling on her arm). On 26-Feb-2021, the patient experienced RASH PRURITIC (itchy) and RASH (rash on her arm). At the time of the report, PERIPHERAL SWELLING (swelling on her arm), RASH PRURITIC (itchy) and RASH (rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Nasal dryness, Throat tightness
Clinical narrative: Throat Closing; Trouble Swallowing; Dry nose; Slight Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Throat Closing), DYSPHAGIA (Trouble Swallowing), NASAL DRYNESS (Dry nose) and HEADACHE (Slight Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included LOSARTAN POTASSIUM (COZAAR), AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and NICOTINAMIDE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat Closing), DYSPHAGIA (Trouble Swallowing), NASAL DRYNESS (Dry nose) and HEADACHE (Slight Headache). At the time of the report, THROAT TIGHTNESS (Throat Closing), DYSPHAGIA (Trouble Swallowing), NASAL DRYNESS (Dry nose) and HEADACHE (Slight Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Sinusitis
Clinical narrative: Sinus Infection and it was hurting; Myalgia; Sore Arm; A spontaneous report was received from a consumer concerning a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus infection and it was hurting/sinusitis, body ache/pain, sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021 prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date the patient experienced the events sinus infection and it was hurting, body ache and sore arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events sinus infection and it was hurting, body ache and sore arm was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy
Clinical narrative: Lethargic; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), FATIGUE (Fatigue) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced LETHARGY (Lethargic), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, LETHARGY (Lethargic) and HEADACHE (Headache) had not resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: High heart rate; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (High heart rate), CHILLS (Chills) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (High heart rate), CHILLS (Chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (High heart rate), CHILLS (Chills) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Headache; fever; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection; It was swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE ERYTHEMA (red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE RASH (she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE RASH (she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information was received on 29-Apr-2021 content no new information.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site warmth, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Arm Pain; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INJECTION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, INJECTION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), PAIN IN EXTREMITY (Arm Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Red Mark (Injection Site); Itchiness (Injection Site); chills; body aches; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (Red Mark (Injection Site)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (headache). On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Mark (Injection Site)) and VACCINATION SITE PRURITUS (Itchiness (Injection Site)). At the time of the report, CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headache), VACCINATION SITE ERYTHEMA (Red Mark (Injection Site)) and VACCINATION SITE PRURITUS (Itchiness (Injection Site)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 102 (High) 102.         No concomitant medication were reported No treatment medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red Mark (Injection Site); Itchiness (Injection Site); chills; body aches; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (Red Mark (Injection Site)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (headache). On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Mark (Injection Site)) and VACCINATION SITE PRURITUS (Itchiness (Injection Site)). At the time of the report, CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headache), VACCINATION SITE ERYTHEMA (Red Mark (Injection Site)) and VACCINATION SITE PRURITUS (Itchiness (Injection Site)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 102 (High) 102.         No concomitant medication were reported No treatment medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red circle about 4 inches in diameter at the injection site; A spontaneous report was received from a nurse concerning a 23-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red circle about 4 inches in diameter at the injection site/vaccination site erythema.  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: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, ten days after receiving the vaccine the patient experienced the event red circle about 4 inches in diameter at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event red circle about 4 inches in diameter at the injection site was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness; Shortness of breath; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (Shortness of breath) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (Shortness of breath). At the time of the report, CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: On her arm where she got vaccine, she had red spot; it's really hot; sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (On her arm where she got vaccine, she had red spot), VACCINATION SITE PAIN (sore arm for a day) and VACCINATION SITE WARMTH (it's really hot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M020A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm for a day). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (On her arm where she got vaccine, she had red spot) and VACCINATION SITE WARMTH (it's really hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (On her arm where she got vaccine, she had red spot), VACCINATION SITE PAIN (sore arm for a day) and VACCINATION SITE WARMTH (it's really hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: can hardly raise right arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (can hardly raise right arm), HEADACHE (headache) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Allergy (ibuprofen allergy) and Allergy (tylenol allergy).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (can hardly raise right arm). At the time of the report, PAIN IN EXTREMITY (can hardly raise right arm), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Left Shoulder pain; Neck pain; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left Shoulder pain), NECK PAIN (Neck pain) and PAIN IN EXTREMITY (Arm soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ARTHRALGIA (Left Shoulder pain), NECK PAIN (Neck pain) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, ARTHRALGIA (Left Shoulder pain), NECK PAIN (Neck pain) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Rash
Clinical narrative: experienced warm feeling in the chest; Big bumps on left arm and red; Arm soreness; Itch; left arm broke out with rash; Redness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itch) and RASH (left arm broke out with rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itch), RASH (left arm broke out with rash) and ERYTHEMA (Redness on the arm). On 25-Jan-2021, FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PRURITUS (Itch), RASH (left arm broke out with rash) and ERYTHEMA (Redness on the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Benadryl
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: experienced warm feeling in the chest; Big bumps on left arm and red; Arm soreness; Itch; left arm broke out with rash; Redness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itch) and RASH (left arm broke out with rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itch), RASH (left arm broke out with rash) and ERYTHEMA (Redness on the arm). On 25-Jan-2021, FEELING HOT (experienced warm feeling in the chest), RASH MACULAR (Big bumps on left arm and red), PRURITUS (Itch), RASH (left arm broke out with rash) and ERYTHEMA (Redness on the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Benadryl
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever - Temperature of 99.8F; Body Aches; Headache; Fatigue; Diarrhea; Chills; Arm Pain; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, arm pain, body aches, fever - temperature of 99.8f, headache, diarrhea, fatigue.  The patient's medical history included aspergillosis. Concomitant medications reported were antihistamines for aspergillosis.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) Intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced the events chills and  arm pain. On 30 Jan 2021, the patient experienced body aches, fever, headache, diarrhea, fatigue. On the same day the lab test performed included body temperature: 99.9 F(high). On an unknown date covid test was conducted thrice which was negative.Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  On 25 Jan 2021 the outcome of events chills, arm pain were resolved.The outcome of events body aches, fever - temperature of 99, 8f, headache, diarrhea and  fatigue were unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever - Temperature of 99.8F; Body Aches; Headache; Fatigue; Diarrhea; Chills; Arm Pain; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, arm pain, body aches, fever - temperature of 99.8f, headache, diarrhea, fatigue.  The patient's medical history included aspergillosis. Concomitant medications reported were antihistamines for aspergillosis.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) Intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced the events chills and  arm pain. On 30 Jan 2021, the patient experienced body aches, fever, headache, diarrhea, fatigue. On the same day the lab test performed included body temperature: 99.9 F(high). On an unknown date covid test was conducted thrice which was negative.Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  On 25 Jan 2021 the outcome of events chills, arm pain were resolved.The outcome of events body aches, fever - temperature of 99, 8f, headache, diarrhea and  fatigue were unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at Injection Site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat at Injection Site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Heat at Injection Site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dizziness, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: blisters itching quite a bit on legs and arms/marked swelling and rise on skin surface and theres a head; dime sized red swelling on torso; just don't feel right; blisters itching quite a bit on arms; red welts with blisters that had clear fluid; nausea; fatigue; muscle aches; lightheadedness/dizziness; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle aches, fatigue, headaches, lightheadedness, dizziness, nausea, red welts with blisters that had clear fluid, blisters itching quite a bit on legs, dime sized red swelling on torso, marked swelling and rise on skin surface and theres a head, just didn't feel right, blisters itching quite a bit on arms.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 057G20A) for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the event(s) muscle aches, fatigue, headaches, lightheadedness, dizziness, nausea.  On an unknown date, the patient experienced the event(s) red welts with blisters that had clear fluid, blisters itching quite a bit on legs, dime sized red swelling on torso, marked swelling and rise on skin surface and theres a head, just didn't feel right, blisters itching quite a bit on arms.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  On 7 Feb 2021 the outcome of event(s), dizziness, nausea was resolved. The outcome of event(s), muscle aches, fatigue, headaches, lightheadedness, red welts with blisters that had clear fluid, blisters itching quite a bit on legs, dime sized red swelling on torso, marked swelling and rise on skin surface and theres a head, just didn't  feel right, blisters itching quite a bit on arms was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Swelling, Urticaria
Clinical narrative: blisters itching quite a bit on legs and arms/marked swelling and rise on skin surface and theres a head; dime sized red swelling on torso; just don't feel right; blisters itching quite a bit on arms; red welts with blisters that had clear fluid; nausea; fatigue; muscle aches; lightheadedness/dizziness; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle aches, fatigue, headaches, lightheadedness, dizziness, nausea, red welts with blisters that had clear fluid, blisters itching quite a bit on legs, dime sized red swelling on torso, marked swelling and rise on skin surface and theres a head, just didn't feel right, blisters itching quite a bit on arms.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 057G20A) for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the event(s) muscle aches, fatigue, headaches, lightheadedness, dizziness, nausea.  On an unknown date, the patient experienced the event(s) red welts with blisters that had clear fluid, blisters itching quite a bit on legs, dime sized red swelling on torso, marked swelling and rise on skin surface and theres a head, just didn't feel right, blisters itching quite a bit on arms.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  On 7 Feb 2021 the outcome of event(s), dizziness, nausea was resolved. The outcome of event(s), muscle aches, fatigue, headaches, lightheadedness, red welts with blisters that had clear fluid, blisters itching quite a bit on legs, dime sized red swelling on torso, marked swelling and rise on skin surface and theres a head, just didn't  feel right, blisters itching quite a bit on arms was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Type IV hypersensitivity reaction, Vaccination complication, Vaccination site erythema
Clinical narrative: covid arm; red spot; itchy; warm; hot to touch; has gotten a lot larger; pain to the touch; armed turned red about an egg size; the redness has gotten bigger and it is a deep red; it feels like something is traveling up to the side of her neck; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (red spot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (warm) and VACCINATION SITE WARMTH (hot to touch) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history  is provided and concomitant drugs are provided.  Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and MELOXICAM as needed for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (red spot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (warm), VACCINATION SITE WARMTH (hot to touch), VACCINATION COMPLICATION (has gotten a lot larger), VACCINATION SITE PAIN (pain to the touch), ERYTHEMA (armed turned red about an egg size), VACCINATION COMPLICATION (the redness has gotten bigger and it is a deep red), VACCINATION COMPLICATION (it feels like something is traveling up to the side of her neck) and FEELING HOT (warm to touch). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (red spot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (warm), VACCINATION SITE WARMTH (hot to touch), VACCINATION COMPLICATION (has gotten a lot larger), VACCINATION SITE PAIN (pain to the touch), ERYTHEMA (armed turned red about an egg size), VACCINATION COMPLICATION (the redness has gotten bigger and it is a deep red), VACCINATION COMPLICATION (it feels like something is traveling up to the side of her neck) and FEELING HOT (warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: covid arm; red spot; itchy; warm; hot to touch; has gotten a lot larger; pain to the touch; armed turned red about an egg size; the redness has gotten bigger and it is a deep red; it feels like something is traveling up to the side of her neck; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (red spot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (warm) and VACCINATION SITE WARMTH (hot to touch) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history  is provided and concomitant drugs are provided.  Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and MELOXICAM as needed for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (red spot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (warm), VACCINATION SITE WARMTH (hot to touch), VACCINATION COMPLICATION (has gotten a lot larger), VACCINATION SITE PAIN (pain to the touch), ERYTHEMA (armed turned red about an egg size), VACCINATION COMPLICATION (the redness has gotten bigger and it is a deep red), VACCINATION COMPLICATION (it feels like something is traveling up to the side of her neck) and FEELING HOT (warm to touch). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (red spot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (warm), VACCINATION SITE WARMTH (hot to touch), VACCINATION COMPLICATION (has gotten a lot larger), VACCINATION SITE PAIN (pain to the touch), ERYTHEMA (armed turned red about an egg size), VACCINATION COMPLICATION (the redness has gotten bigger and it is a deep red), VACCINATION COMPLICATION (it feels like something is traveling up to the side of her neck) and FEELING HOT (warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Both his feet and ankles are swollen as if it is water retention; Both his feet and ankles are swollen as if it is water retention; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both his feet and ankles are swollen as if it is water retention) and JOINT SWELLING (Both his feet and ankles are swollen as if it is water retention) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Peripheral neuropathy (Legs and feet).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (Both his feet and ankles are swollen as if it is water retention) and JOINT SWELLING (Both his feet and ankles are swollen as if it is water retention). At the time of the report, PERIPHERAL SWELLING (Both his feet and ankles are swollen as if it is water retention) and JOINT SWELLING (Both his feet and ankles are swollen as if it is water retention) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: red round circle around the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red round circle around the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red round circle around the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved and VACCINATION SITE ERYTHEMA (red round circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Products includes Cholesterol Meds.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site itchy; injection site rashy; injection site raised; she had a red circle about size of half dollar at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (she had a red circle about size of half dollar at the injection site), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE RASH (injection site rashy) and INJECTION SITE SWELLING (injection site raised) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (she had a red circle about size of half dollar at the injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE RASH (injection site rashy) and INJECTION SITE SWELLING (injection site raised). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (she had a red circle about size of half dollar at the injection site), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE RASH (injection site rashy) and INJECTION SITE SWELLING (injection site raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of ANTIBODY TEST NEGATIVE (Got the antibody test and it came back negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Got the antibody test and it came back negative). At the time of the report, ANTIBODY TEST NEGATIVE (Got the antibody test and it came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: Negative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: Face swelling; Itchiness all over her body; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Face swelling) and PRURITUS (Itchiness all over her body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced SWELLING FACE (Face swelling) and PRURITUS (Itchiness all over her body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face swelling) and PRURITUS (Itchiness all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: swelling under eyes; This spontaneous case was reported by a health care professional and describes the occurrence of EYE SWELLING (swelling under eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (swelling under eyes). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, EYE SWELLING (swelling under eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   patient took ibuprofen as treatment and with in one week the event is resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pain
Clinical narrative: Chest pain left side; Tightness in the chest 2 nights; Pain on the side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain left side), CHEST DISCOMFORT (Tightness in the chest 2 nights) and PAIN (Pain on the side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHEST PAIN (Chest pain left side), CHEST DISCOMFORT (Tightness in the chest 2 nights) and PAIN (Pain on the side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain left side), CHEST DISCOMFORT (Tightness in the chest 2 nights) and PAIN (Pain on the side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided; 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.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: decrease sensation to the left side of my face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (decrease sensation to the left side of my face) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced HYPOAESTHESIA (decrease sensation to the left side of my face). At the time of the report, HYPOAESTHESIA (decrease sensation to the left side of my face) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment information was not provided.