chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: it itches; arm is swollen; a very delayed injection site reaction; arm was getting hard on the deltoid; it was red, redness like in a crescent moon shape, settled down in the lower deltoid; it was hot; Am getting sore in deltoid at injection site; A spontaneous report was received from reporters ( HCP and Consumer) concerning a 47 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events such as Injection site pain,Injection site swelling,Musculoskeletal stiffness ,Injection site reaction ,Injection site erythema , injection site warmth and pruritus.  The patient's medical history was not provided. The relevant concomitant medications were amitriptyline 25 mg ,Xiidra,Aimovig 70 mg,Duloxetine 30 mg , Armour Thyroid ,Cyclobenzaprine,spironolactone 50 mg ,esomeprazole, Ubrelvy,celecoxib 250 mg, clonazepam 0.5 mg, biot-E testosterone and progesterone, Vitamin D3 and  Omega 3 200 mg .  On 6-Jan-2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (batch number:  027L20A ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 6-Jan-2021, the patient experienced a non- serious ,sore injection site. On 15-Jan-2021, the patient experienced non serious,a very delayed injection site reaction, arm was getting hard on the deltoid,started getting sore , it was swollen , it was hard , it was red , it was hot ,redness like in a crescent moon shape, settled down in the lower deltoid . On 16-Jan-2021 the patient experienced non serious event such as arm is hot, swollen and it hurts. On 20-Jan-2021 the patient experienced non serious events it itches.  No laboratory details was provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 8-Jan -2021 the outcome of the event (sore injection site) was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pruritus
Clinical narrative: it itches; arm is swollen; a very delayed injection site reaction; arm was getting hard on the deltoid; it was red, redness like in a crescent moon shape, settled down in the lower deltoid; it was hot; Am getting sore in deltoid at injection site; A spontaneous report was received from reporters ( HCP and Consumer) concerning a 47 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events such as Injection site pain,Injection site swelling,Musculoskeletal stiffness ,Injection site reaction ,Injection site erythema , injection site warmth and pruritus.  The patient's medical history was not provided. The relevant concomitant medications were amitriptyline 25 mg ,Xiidra,Aimovig 70 mg,Duloxetine 30 mg , Armour Thyroid ,Cyclobenzaprine,spironolactone 50 mg ,esomeprazole, Ubrelvy,celecoxib 250 mg, clonazepam 0.5 mg, biot-E testosterone and progesterone, Vitamin D3 and  Omega 3 200 mg .  On 6-Jan-2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (batch number:  027L20A ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 6-Jan-2021, the patient experienced a non- serious ,sore injection site. On 15-Jan-2021, the patient experienced non serious,a very delayed injection site reaction, arm was getting hard on the deltoid,started getting sore , it was swollen , it was hard , it was red , it was hot ,redness like in a crescent moon shape, settled down in the lower deltoid . On 16-Jan-2021 the patient experienced non serious event such as arm is hot, swollen and it hurts. On 20-Jan-2021 the patient experienced non serious events it itches.  No laboratory details was provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 8-Jan -2021 the outcome of the event (sore injection site) was resolved.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; bad headache; chills; muscle pain; joint pain; nausea; fever - 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Joint pain on 15-Jan-2021, Nausea on 15-Jan-2021 and Fever on 15-Jan-2021. Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees). On 17-Jan-2021, FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Excedrin
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fatigue; bad headache; chills; muscle pain; joint pain; nausea; fever - 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Joint pain on 15-Jan-2021, Nausea on 15-Jan-2021 and Fever on 15-Jan-2021. Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees). On 17-Jan-2021, FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Excedrin
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm  hurt a lot; Body aches; Temperature of 100.3 going to 100.7; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  hurt a lot), PAIN (Body aches) and PYREXIA (Temperature of 100.3 going to 100.7) in a 55-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 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 PAIN IN EXTREMITY (Arm  hurt a lot), PAIN (Body aches) and PYREXIA (Temperature of 100.3 going to 100.7). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at a dose of unknown. At the time of the report, PAIN IN EXTREMITY (Arm  hurt a lot), PAIN (Body aches) and PYREXIA (Temperature of 100.3 going to 100.7) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction to the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (a reaction to the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Injection site erythema, Injection site paraesthesia, Injection site warmth, Pyrexia
Clinical narrative: red arm; zone had fever; fever; red area at the injection site; tingling on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and INJECTION SITE ERYTHEMA (red area at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced PYREXIA (fever) and INJECTION SITE ERYTHEMA (red area at the injection site). At the time of the report, PYREXIA (fever) and INJECTION SITE ERYTHEMA (red area at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Rash pruritic
Clinical narrative: rash on head, It's kind of itchy; bumps on forehead got worse; injection arm "hurt"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with FLUOROURACIL SODIUM (FLUOROURACIL 5) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was sore for 1 or 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was sore for 1 or 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was sore for 1 or 2 days). At the time of the report, PAIN IN EXTREMITY (her arm was sore for 1 or 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site area became hot; Injection site area became swollen; Discoloration was 2.5-3 inches in size; Injection site area became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site area became hot), VACCINATION SITE SWELLING (Injection site area became swollen), SKIN DISCOLOURATION (Discoloration was 2.5-3 inches in size) and VACCINATION SITE ERYTHEMA (Injection site area became red) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site area became hot), VACCINATION SITE SWELLING (Injection site area became swollen), SKIN DISCOLOURATION (Discoloration was 2.5-3 inches in size) and VACCINATION SITE ERYTHEMA (Injection site area became red). At the time of the report, VACCINATION SITE WARMTH (Injection site area became hot), VACCINATION SITE SWELLING (Injection site area became swollen), SKIN DISCOLOURATION (Discoloration was 2.5-3 inches in size) and VACCINATION SITE ERYTHEMA (Injection site area became red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance impaired, Maternal exposure during pregnancy, Pain in extremity, Pregnancy test, Ultrasound foetal
Clinical narrative: Sore Arm; Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Sore Arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis A (Hepatitis A treated in 2007.) on 31-Jul-2007. Concurrent medical conditions included Asthma since 14-Nov-1990 and Placenta previa. Concomitant products included FAMOTIDINE from 01-Jan-2021 to an unknown date for Heartburn, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 20-Oct-2020 to an unknown date for an unknown indication.    On 14-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 22-Jun-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 14-Jan-2021 at 1:00 PM, the patient experienced PAIN IN EXTREMITY (Sore Arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2020, Pregnancy test: positive (Positive) positive. On 11-Nov-2020, Ultrasound foetal: 1 fetus 1 fetus. On 17-Dec-2020, Ultrasound foetal: placenta previa Placenta previa. On 26-Jan-2021, Ultrasound foetal: low line placenta (Low) low line placenta. On 28-Mar-2021, Glucose tolerance impaired: passed- 1 hour test Passed- 1 hour test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Sore Arm) to be possibly related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy).    On 14jan2021, post vaccination, the patient reported that she experienced symptoms of pain in extremity and exposure during pregnancy.  No treatment information was provided   Follow-up information on 16 APR 2021, included concomitant medications and event for second dose.   This case was linked to MOD-2021-086690 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Internal review on 20jul2021 resulted in updates to pregnancy information On 16-Apr-2021: No specific follow-up information recorded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Feeling hot, Heart rate increased, Myalgia
Clinical narrative: Fast Heart Beat; Muscle pain; Joint pain; Felt Warm; Nausea; Difficulty Breathing; Lymph Node by ear on same side as vaccine site is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (Fast Heart Beat), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING HOT (Felt Warm) and NAUSEA (Nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U1120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast Heart Beat), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING HOT (Felt Warm), NAUSEA (Nausea), DYSPNOEA (Difficulty Breathing) and VACCINATION SITE LYMPHADENOPATHY (Lymph Node by ear on same side as vaccine site is swollen). At the time of the report, HEART RATE INCREASED (Fast Heart Beat), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING HOT (Felt Warm), NAUSEA (Nausea), DYSPNOEA (Difficulty Breathing) and VACCINATION SITE LYMPHADENOPATHY (Lymph Node by ear on same side as vaccine site is swollen) outcome was unknown. Not Provided      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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site lymphadenopathy
Clinical narrative: Fast Heart Beat; Muscle pain; Joint pain; Felt Warm; Nausea; Difficulty Breathing; Lymph Node by ear on same side as vaccine site is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (Fast Heart Beat), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING HOT (Felt Warm) and NAUSEA (Nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U1120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast Heart Beat), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING HOT (Felt Warm), NAUSEA (Nausea), DYSPNOEA (Difficulty Breathing) and VACCINATION SITE LYMPHADENOPATHY (Lymph Node by ear on same side as vaccine site is swollen). At the time of the report, HEART RATE INCREASED (Fast Heart Beat), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FEELING HOT (Felt Warm), NAUSEA (Nausea), DYSPNOEA (Difficulty Breathing) and VACCINATION SITE LYMPHADENOPATHY (Lymph Node by ear on same side as vaccine site is swollen) outcome was unknown. Not Provided      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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (pain in both side of her lower back), pain in extremity (little sore arm), arthralgia (joint pain), pain in extremity (pain in her right shoulder and goes down to her hand and fingers) and myalgia (muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011J20A) for COVID-19 immunization. No medical history reported. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 13, 2021, patient experienced pain in extremity (little sore arm). On Jan 15, 2021, patient experienced back pain (pain in both side of her lower back). On Jan 17, 2021, patient experienced arthralgia (joint pain) and myalgia (muscle pain). On Jan 18, 2021, patient experienced pain in extremity (pain in her right shoulder and goes down to her hand and fingers). The patient treated with ibuprofen on Jan 17, 2021 for adverse event, unknown dosage form. On Jan 17, 2021, pain in extremity (little sore arm) had resolved. At the time of the report, back pain (pain in both side of her lower back), arthralgia (joint pain), pain in extremity (pain in her right shoulder and goes down to her hand and fingers) and myalgia (muscle pain): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication included blood pressure pills. On Wednesday and Thursday, patient was fine only with little sore arm. On Friday, patient felt pain in both side of her lower back. This continued on Saturday morning. The day prior to report experienced join pain and muscle pain. On the day of report she felt pain in her right shoulder that goes down to her hand and fingers, she put a heating pad. On the day of report, the symptoms was still ongoing in her right-side, lower back. She could not stand up and was difficult to move. Reporter did not allow further contact. Sender's comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: Felt like she had the flu; pain in arm; headache; A spontaneous report was received from a consumer concerning a 69-year-old, female patient who developed pain in arm/ pain in extremity, headache and felt like she had the flu/ influenza like illness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.      On 14 Jan 2021, patient received first dose of vaccine and experienced events, pain in arm/ pain in extremity, headache and felt like she had the flu/ influenza like illness.     Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Head discomfort, Headache
Clinical narrative: body aches (all over); stuff nose; Chills; Headaches; Weakness; Tiredness; Heavy head; A spontaneous report was received from a consumer concerning a 69-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed body aches (all over), stuff nose, chills, headaches, weakness, tiredness, and heavy head.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not provided.  On 11 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient developed body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head.  Treatment for the event included 3 baby Aspirin tablet.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head, was considered unknown  Follow-up  On 18 Jan 2021 ,the outcome of the event,date body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head, was considered not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: body aches (all over); stuff nose; Chills; Headaches; Weakness; Tiredness; Heavy head; A spontaneous report was received from a consumer concerning a 69-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed body aches (all over), stuff nose, chills, headaches, weakness, tiredness, and heavy head.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not provided.  On 11 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient developed body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head.  Treatment for the event included 3 baby Aspirin tablet.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head, was considered unknown  Follow-up  On 18 Jan 2021 ,the outcome of the event,date body aches (all over), stuff nose, chills,headaches, weakness, tiredness, and heavy head, was considered not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site cellulitis, Injection site warmth
Clinical narrative: Cellulitis; Weakness during walk; Hot and warm at site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE CELLULITIS (Cellulitis), ASTHENIA (Weakness during walk) and INJECTION SITE WARMTH (Hot and warm at site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE CELLULITIS (Cellulitis), ASTHENIA (Weakness during walk) and INJECTION SITE WARMTH (Hot and warm at site). At the time of the report, INJECTION SITE CELLULITIS (Cellulitis), ASTHENIA (Weakness during walk) and INJECTION SITE WARMTH (Hot and warm at site) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: injection site red and swollen; has a temperature; The injection site started itching (like a mosquito bite); injection site red and swollen; nausea; vomiting; diarrhea; elevated temperature of 99.3 F; heavy fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2O-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: injection site red and swollen; has a temperature; The injection site started itching (like a mosquito bite); injection site red and swollen; nausea; vomiting; diarrhea; elevated temperature of 99.3 F; heavy fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2O-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: itching in their right upper deltoid; it was really red, kind of swelling, a little bit hot to the touch; down the arm, around their wrist area, hurt to turn; Now the arm is only a bit red as large as an orange; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itching in their right upper deltoid), SWELLING (it was really red, kind of swelling, a little bit hot to the touch), PAIN (down the arm, around their wrist area, hurt to turn) and ERYTHEMA (Now the arm is only a bit red as large as an orange) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historic conditions.) and Mastectomy (27 years ago patient had left mastectomy).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PRURITUS (itching in their right upper deltoid), SWELLING (it was really red, kind of swelling, a little bit hot to the touch), PAIN (down the arm, around their wrist area, hurt to turn) and ERYTHEMA (Now the arm is only a bit red as large as an orange). At the time of the report, PRURITUS (itching in their right upper deltoid), SWELLING (it was really red, kind of swelling, a little bit hot to the touch), PAIN (down the arm, around their wrist area, hurt to turn) and ERYTHEMA (Now the arm is only a bit red as large as an orange) outcome was unknown. Not Provided      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.   No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Back pain, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: eyesight blurry; irritated; agitated; I didn't feel confident to stand up; lightheaded; got very hot; sweating everywhere; felt like I was going to faint; nauseous; headache; back muscle hurt; sore; blood pressure really high (it spiked); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint) and NAUSEA (nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt), BACK PAIN (sore), HYPERTENSION (blood pressure really high (it spiked)) and FEELING ABNORMAL (I didn't feel confident to stand up). On 17-Jan-2021, the patient experienced IRRITABILITY (irritated) and AGITATION (agitated). On 18-Jan-2021, the patient experienced VISION BLURRED (eyesight blurry). On 15-Jan-2021, FEELING ABNORMAL (I didn't feel confident to stand up) had resolved. On 18-Jan-2021, FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt) and BACK PAIN (sore) had resolved. At the time of the report, DIZZINESS (lightheaded), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HYPERTENSION (blood pressure really high (it spiked)), VISION BLURRED (eyesight blurry), IRRITABILITY (irritated) and AGITATION (agitated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypertension, Irritability, Muscle spasms
Clinical narrative: eyesight blurry; irritated; agitated; I didn't feel confident to stand up; lightheaded; got very hot; sweating everywhere; felt like I was going to faint; nauseous; headache; back muscle hurt; sore; blood pressure really high (it spiked); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint) and NAUSEA (nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt), BACK PAIN (sore), HYPERTENSION (blood pressure really high (it spiked)) and FEELING ABNORMAL (I didn't feel confident to stand up). On 17-Jan-2021, the patient experienced IRRITABILITY (irritated) and AGITATION (agitated). On 18-Jan-2021, the patient experienced VISION BLURRED (eyesight blurry). On 15-Jan-2021, FEELING ABNORMAL (I didn't feel confident to stand up) had resolved. On 18-Jan-2021, FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt) and BACK PAIN (sore) had resolved. At the time of the report, DIZZINESS (lightheaded), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HYPERTENSION (blood pressure really high (it spiked)), VISION BLURRED (eyesight blurry), IRRITABILITY (irritated) and AGITATION (agitated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Vision blurred
Clinical narrative: eyesight blurry; irritated; agitated; I didn't feel confident to stand up; lightheaded; got very hot; sweating everywhere; felt like I was going to faint; nauseous; headache; back muscle hurt; sore; blood pressure really high (it spiked); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint) and NAUSEA (nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (lightheaded), FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt), BACK PAIN (sore), HYPERTENSION (blood pressure really high (it spiked)) and FEELING ABNORMAL (I didn't feel confident to stand up). On 17-Jan-2021, the patient experienced IRRITABILITY (irritated) and AGITATION (agitated). On 18-Jan-2021, the patient experienced VISION BLURRED (eyesight blurry). On 15-Jan-2021, FEELING ABNORMAL (I didn't feel confident to stand up) had resolved. On 18-Jan-2021, FEELING HOT (got very hot), HYPERHIDROSIS (sweating everywhere), HEADACHE (headache), MUSCLE SPASMS (back muscle hurt) and BACK PAIN (sore) had resolved. At the time of the report, DIZZINESS (lightheaded), PRESYNCOPE (felt like I was going to faint), NAUSEA (nauseous), HYPERTENSION (blood pressure really high (it spiked)), VISION BLURRED (eyesight blurry), IRRITABILITY (irritated) and AGITATION (agitated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling, redness and pain in the arm of injection; swelling, redness and pain in the arm of injection; swelling, redness and pain in the arm of injection; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling, redness and pain in the arm of injection), VACCINATION SITE ERYTHEMA (swelling, redness and pain in the arm of injection), VACCINATION SITE PAIN (swelling, redness and pain in the arm of injection) and VACCINATION SITE PRURITUS (itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling, redness and pain in the arm of injection), VACCINATION SITE ERYTHEMA (swelling, redness and pain in the arm of injection), VACCINATION SITE PAIN (swelling, redness and pain in the arm of injection) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE SWELLING (swelling, redness and pain in the arm of injection), VACCINATION SITE ERYTHEMA (swelling, redness and pain in the arm of injection), VACCINATION SITE PAIN (swelling, redness and pain in the arm of injection) and VACCINATION SITE PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: arm has been hurting so much; difficulty sleeping; tingly and numb in arm; severe headache in her forehead and eyes; This spontaneous case was reported by a pharmacist and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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. Treatment included Pain Killers
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Couldn't eat; Nauseous; Arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), DECREASED APPETITE (Couldn't eat), NAUSEA (Nauseous) and PERIPHERAL SWELLING (Arm swelled up) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), DECREASED APPETITE (Couldn't eat), NAUSEA (Nauseous) and PERIPHERAL SWELLING (Arm swelled up). At the time of the report, PYREXIA (Fever), DECREASED APPETITE (Couldn't eat), NAUSEA (Nauseous) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: Nasal congestion; Mild headache; Fatigue; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal congestion), HEADACHE (Mild headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced RHINORRHOEA (Runny nose). On 18-Jan-2021, the patient experienced NASAL CONGESTION (Nasal congestion), HEADACHE (Mild headache) and FATIGUE (Fatigue). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal congestion), HEADACHE (Mild headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site warmth
Clinical narrative: injection site warm to the touch; flu like symptoms; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE WARMTH (injection site warm to the touch) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced INJECTION SITE WARMTH (injection site warm to the touch). At the time of the report, INJECTION SITE WARMTH (injection site warm to the touch) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis in left foot; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (arthritis in left foot) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced ARTHRITIS (arthritis in left foot). The patient was treated with PREDNISONE ongoing since an unknown date for Arthritis, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (arthritis in left foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment included Prednisone
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Breast feeding, Burning sensation, Chest pain, Hyperhidrosis
Clinical narrative: Chest pain; Arm pit was burning; Felt tingling; Sweaty; Color of face went white; When lying down BP was higher than standing up; panic attack; Breast feeding; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty) and PALLOR (Color of face went white) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DULOXETINE from 06-Jan-2021 to an unknown date for Depression.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty), PALLOR (Color of face went white), BLOOD PRESSURE FLUCTUATION (When lying down BP was higher than standing up), PANIC ATTACK (panic attack) and BREAST FEEDING (Breast feeding). At the time of the report, CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty), PALLOR (Color of face went white), BLOOD PRESSURE FLUCTUATION (When lying down BP was higher than standing up), PANIC ATTACK (panic attack) and BREAST FEEDING (Breast feeding) 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 treatment information provided.