chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site induration, Pyrexia
Clinical narrative: Headache; fever; fatigue; chills; injection site bump; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue), CHILLS (chills) and INJECTION SITE INDURATION (injection site bump) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue), CHILLS (chills) and INJECTION SITE INDURATION (injection site bump).   At the time of the report, HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue), CHILLS (chills) and INJECTION SITE INDURATION (injection site bump) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain in left arm; Redness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in left arm) and VACCINATION SITE ERYTHEMA (Redness in left arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in left arm) and VACCINATION SITE ERYTHEMA (Redness in left arm).   On 18-Jan-2021, VACCINATION SITE PAIN (Pain in left arm) and VACCINATION SITE ERYTHEMA (Redness in left arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-020882 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Swelling
Clinical narrative: body pain; feels awful; swelling; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of   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 26-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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; sore arm; fever; chills; A spontaneous report was received from a nurse concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever, body aches, chills and sore arm.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 20 Jan 2021, approximately on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient experienced fever, chills, body aches and sore arm which was resolved.   Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, fever, chills, body aches and sore arm, was considered resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Swelling, Vaccination site swelling
Clinical narrative: Itchy; Swollen lymph nodes and neck; Swollen lymph nodes and neck; Swollen at the site, up the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), SWELLING (Swollen lymph nodes and neck), LYMPHADENOPATHY (Swollen lymph nodes and neck) and VACCINATION SITE SWELLING (Swollen at the site, up the arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included HYDROCHLOROTHIAZIDE.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itchy), SWELLING (Swollen lymph nodes and neck) and LYMPHADENOPATHY (Swollen lymph nodes and neck). 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at the site, up the arm). At the time of the report, PRURITUS (Itchy), SWELLING (Swollen lymph nodes and neck), LYMPHADENOPATHY (Swollen lymph nodes and neck) and VACCINATION SITE SWELLING (Swollen at the site, up the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included as Rubbing alcohol on the injection site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Headache, Pain in extremity
Clinical narrative: painful arm; redness in arm; stomach distress; diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), ERYTHEMA (redness in arm), ABDOMINAL DISCOMFORT (stomach distress), DIARRHOEA (diarrhea) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (painful arm), ERYTHEMA (redness in arm), ABDOMINAL DISCOMFORT (stomach distress), DIARRHOEA (diarrhea) and HEADACHE (headache). On 23-Jan-2021, PAIN IN EXTREMITY (painful arm), ERYTHEMA (redness in arm), ABDOMINAL DISCOMFORT (stomach distress), DIARRHOEA (diarrhea) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-020863.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling and redness at the injection; swelling and redness at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling and redness at the injection) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling and redness at the injection) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection). At the time of the report, VACCINATION SITE SWELLING (swelling and redness at the injection) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Pyrexia, Vaccination site bruising, Vaccination site erythema
Clinical narrative: looked like a bruise size of quarter at the site; would sting at site; bubbles at vaccination site; vacinnation site raised; red circle at injection site; chills; bones hurt; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt), VACCINATION SITE VESICLES (bubbles at vaccination site), VACCINATION SITE BRUISING (looked like a bruise size of quarter at the site), VACCINATION SITE PAIN (would sting at site) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteopenia. Concurrent medical conditions included Seasonal allergy. Concomitant products included DENOSUMAB (PROLIA Injection) from 15-Jan-2021 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 13-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 BONE PAIN (bones hurt), PYREXIA (Fever) and CHILLS (chills). On 21-Jan-2021, the patient experienced VACCINATION SITE VESICLES (bubbles at vaccination site), VACCINATION SITE PAIN (would sting at site), VACCINATION SITE SWELLING (vacinnation site raised) and VACCINATION SITE ERYTHEMA (red circle at injection site). On 22-Jan-2021, the patient experienced VACCINATION SITE BRUISING (looked like a bruise size of quarter at the site). At the time of the report, BONE PAIN (bones hurt), VACCINATION SITE VESICLES (bubbles at vaccination site), VACCINATION SITE BRUISING (looked like a bruise size of quarter at the site), VACCINATION SITE PAIN (would sting at site), PYREXIA (Fever), VACCINATION SITE SWELLING (vacinnation site raised), VACCINATION SITE ERYTHEMA (red circle at injection site) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: looked like a bruise size of quarter at the site; would sting at site; bubbles at vaccination site; vacinnation site raised; red circle at injection site; chills; bones hurt; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt), VACCINATION SITE VESICLES (bubbles at vaccination site), VACCINATION SITE BRUISING (looked like a bruise size of quarter at the site), VACCINATION SITE PAIN (would sting at site) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteopenia. Concurrent medical conditions included Seasonal allergy. Concomitant products included DENOSUMAB (PROLIA Injection) from 15-Jan-2021 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 13-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 BONE PAIN (bones hurt), PYREXIA (Fever) and CHILLS (chills). On 21-Jan-2021, the patient experienced VACCINATION SITE VESICLES (bubbles at vaccination site), VACCINATION SITE PAIN (would sting at site), VACCINATION SITE SWELLING (vacinnation site raised) and VACCINATION SITE ERYTHEMA (red circle at injection site). On 22-Jan-2021, the patient experienced VACCINATION SITE BRUISING (looked like a bruise size of quarter at the site). At the time of the report, BONE PAIN (bones hurt), VACCINATION SITE VESICLES (bubbles at vaccination site), VACCINATION SITE BRUISING (looked like a bruise size of quarter at the site), VACCINATION SITE PAIN (would sting at site), PYREXIA (Fever), VACCINATION SITE SWELLING (vacinnation site raised), VACCINATION SITE ERYTHEMA (red circle at injection site) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Paraesthesia, Rhinorrhoea
Clinical narrative: Runny nose; Cough; tingling in left hand; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (tingling in left hand), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 08-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 PARAESTHESIA (tingling in left hand) and OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Cough).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Antihistamine, Decongestant and Cough supressant
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Nov-2020 and the estimated date of delivery was 12-Aug-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had three previous pregnancies.  For first pregnancy, end of pregnancy was in 2004, which resulted in induced abortion.  For second pregnancy, end of pregnancy was in 2005, which resulted in induced abortion.  For third pregnancy, end of pregnancy was in 2006, which resulted in induced abortion.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Injection site erythema, Malaise
Clinical narrative: severe spine pain; felt really tired; could not get out of bed; exhausted; arm a little red; chills; arm sore; fever; slept the entire next day; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BACK PAIN (severe spine pain), MALAISE (felt really tired), FATIGUE (could not get out of bed; exhausted), INJECTION SITE ERYTHEMA (arm a little red) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ASCORBIC ACID, FOLIC ACID, IRON, RETINOL, ZINC (SUPLEMENTO DE MICRONUTRIENTES), VITAMINS NOS, LEVOTHYROXINE and ALBUTEROL SULFATE for an unknown indication.   On 24-Jan-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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced BACK PAIN (severe spine pain), MALAISE (felt really tired), FATIGUE (could not get out of bed; exhausted), INJECTION SITE ERYTHEMA (arm a little red), CHILLS (chills), PAIN IN EXTREMITY (arm sore), PYREXIA (fever) and FATIGUE (slept the entire next day). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram. At the time of the report, BACK PAIN (severe spine pain), MALAISE (felt really tired), FATIGUE (could not get out of bed; exhausted), INJECTION SITE ERYTHEMA (arm a little red), CHILLS (chills), PAIN IN EXTREMITY (arm sore), PYREXIA (fever) and FATIGUE (slept the entire next day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: severe spine pain; felt really tired; could not get out of bed; exhausted; arm a little red; chills; arm sore; fever; slept the entire next day; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BACK PAIN (severe spine pain), MALAISE (felt really tired), FATIGUE (could not get out of bed; exhausted), INJECTION SITE ERYTHEMA (arm a little red) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ASCORBIC ACID, FOLIC ACID, IRON, RETINOL, ZINC (SUPLEMENTO DE MICRONUTRIENTES), VITAMINS NOS, LEVOTHYROXINE and ALBUTEROL SULFATE for an unknown indication.   On 24-Jan-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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced BACK PAIN (severe spine pain), MALAISE (felt really tired), FATIGUE (could not get out of bed; exhausted), INJECTION SITE ERYTHEMA (arm a little red), CHILLS (chills), PAIN IN EXTREMITY (arm sore), PYREXIA (fever) and FATIGUE (slept the entire next day). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram. At the time of the report, BACK PAIN (severe spine pain), MALAISE (felt really tired), FATIGUE (could not get out of bed; exhausted), INJECTION SITE ERYTHEMA (arm a little red), CHILLS (chills), PAIN IN EXTREMITY (arm sore), PYREXIA (fever) and FATIGUE (slept the entire next day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm  swelled a little; Hot to the touch - injection site; Arm  hurt - injection site; Red - 80-90% gone - injection site; deep itching/itched severely - injection site; A little sore-injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site), VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site) and VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney disorder, Liver disorder and Heart disease, unspecified.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site), VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site), VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) and VACCINATION SITE PAIN (A little sore-injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Jan-2021, PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site) and VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site) was resolving and VACCINATION SITE PAIN (A little sore-injection site) had not 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.   No treatment information provided.   This case was linked to MOD-2021-014285, MOD-2021-017150 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm  swelled a little; Hot to the touch - injection site; Arm  hurt - injection site; Red - 80-90% gone - injection site; deep itching/itched severely - injection site; A little sore-injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site), VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site) and VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney disorder, Liver disorder and Heart disease, unspecified.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site), VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site), VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) and VACCINATION SITE PAIN (A little sore-injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Jan-2021, PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site) and VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site) was resolving and VACCINATION SITE PAIN (A little sore-injection site) had not 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.   No treatment information provided.   This case was linked to MOD-2021-014285, MOD-2021-017150 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pyrexia
Clinical narrative: her arm is sore and she has a 100.2°F fever; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (her arm is sore and she has a 100.2°F fever) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (her arm is sore and she has a 100.2°F fever) and PYREXIA (Fever). The patient was treated with ALPRAZOLAM (XANAX) for Sleep difficult, at an unspecified dose and frequency.   At the time of the report, INJECTION SITE PAIN (her arm is sore and she has a 100.2°F fever) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 100.2 (High) Patient had fever of 100.2 F.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Musculoskeletal stiffness
Clinical narrative: stiff neck; toe infection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck) and LOCALISED INFECTION (toe infection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, CEFALEXIN (CEPHALEXINE) for Infected toe.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and LOCALISED INFECTION (toe infection). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) and LOCALISED INFECTION (toe infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event include muscle cream.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Muscular weakness, Myalgia
Clinical narrative: felt like leg muscle failed; sore muscles; sore joints; Difficulty walking; This spontaneous case was reported by a physician and describes the occurrence of GAIT DISTURBANCE (Difficulty walking), MUSCULAR WEAKNESS (felt like leg muscle failed), MYALGIA (sore muscles) and ARTHRALGIA (sore joints) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history was not reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced GAIT DISTURBANCE (Difficulty walking), MYALGIA (sore muscles) and ARTHRALGIA (sore joints). On 23-Jan-2021, the patient experienced MUSCULAR WEAKNESS (felt like leg muscle failed). At the time of the report, GAIT DISTURBANCE (Difficulty walking), MUSCULAR WEAKNESS (felt like leg muscle failed), MYALGIA (sore muscles) and ARTHRALGIA (sore joints) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: warm around the injection site; puffiness around the injection site; sensitive to touch near the injection site; soreness on arm-injection site; pain on arm-injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm around the injection site), INJECTION SITE SWELLING (puffiness around the injection site), INJECTION SITE HYPERSENSITIVITY (sensitive to touch near the injection site), INJECTION SITE PAIN (soreness on arm-injection site) and INJECTION SITE PAIN (pain on arm-injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included UTI. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METFORMIN and LISINOPRIL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm around the injection site), INJECTION SITE SWELLING (puffiness around the injection site), INJECTION SITE HYPERSENSITIVITY (sensitive to touch near the injection site), INJECTION SITE PAIN (soreness on arm-injection site) and INJECTION SITE PAIN (pain on arm-injection site). At the time of the report, INJECTION SITE WARMTH (warm around the injection site), INJECTION SITE SWELLING (puffiness around the injection site), INJECTION SITE HYPERSENSITIVITY (sensitive to touch near the injection site), INJECTION SITE PAIN (soreness on arm-injection site) and INJECTION SITE PAIN (pain on arm-injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment takes antibiotics for UTI  Patient did not provide consent for safety to contact HCP or the Lot number.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Pruritus
Clinical narrative: stomach ache; itchy; chills; tired; head ache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itchy), CHILLS (chills), FATIGUE (tired) and HEADACHE (head ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 28-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itchy), CHILLS (chills), FATIGUE (tired) and HEADACHE (head ache). The patient was treated with NAPROXEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itchy), CHILLS (chills), FATIGUE (tired) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Heart rate increased, Hypoaesthesia, Limb discomfort, Muscular weakness
Clinical narrative: Lost feeling her face; Left arm went numb; Pain still in her left arm; Left arm is tired; Left arm is weak; Heart rate went high; Blotchy; Red; Itchy; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Lost feeling her face), HYPOAESTHESIA (Left arm went numb), PAIN IN EXTREMITY (Pain still in her left arm), LIMB DISCOMFORT (Left arm is tired) and MUSCULAR WEAKNESS (Left arm is weak) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HYPOAESTHESIA (Lost feeling her face), HYPOAESTHESIA (Left arm went numb), PAIN IN EXTREMITY (Pain still in her left arm), LIMB DISCOMFORT (Left arm is tired), MUSCULAR WEAKNESS (Left arm is weak), HEART RATE INCREASED (Heart rate went high), RASH MACULAR (Blotchy), ERYTHEMA (Red) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Lost feeling her face), HYPOAESTHESIA (Left arm went numb), PAIN IN EXTREMITY (Pain still in her left arm), LIMB DISCOMFORT (Left arm is tired), MUSCULAR WEAKNESS (Left arm is weak), HEART RATE INCREASED (Heart rate went high), RASH MACULAR (Blotchy), ERYTHEMA (Red) and PRURITUS (Itchy) 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.   Treatment information also included physical therapy.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash macular
Clinical narrative: Lost feeling her face; Left arm went numb; Pain still in her left arm; Left arm is tired; Left arm is weak; Heart rate went high; Blotchy; Red; Itchy; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Lost feeling her face), HYPOAESTHESIA (Left arm went numb), PAIN IN EXTREMITY (Pain still in her left arm), LIMB DISCOMFORT (Left arm is tired) and MUSCULAR WEAKNESS (Left arm is weak) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HYPOAESTHESIA (Lost feeling her face), HYPOAESTHESIA (Left arm went numb), PAIN IN EXTREMITY (Pain still in her left arm), LIMB DISCOMFORT (Left arm is tired), MUSCULAR WEAKNESS (Left arm is weak), HEART RATE INCREASED (Heart rate went high), RASH MACULAR (Blotchy), ERYTHEMA (Red) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Lost feeling her face), HYPOAESTHESIA (Left arm went numb), PAIN IN EXTREMITY (Pain still in her left arm), LIMB DISCOMFORT (Left arm is tired), MUSCULAR WEAKNESS (Left arm is weak), HEART RATE INCREASED (Heart rate went high), RASH MACULAR (Blotchy), ERYTHEMA (Red) and PRURITUS (Itchy) 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.   Treatment information also included physical therapy.  No concomitant medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Influenza like illness, Pain, Somnolence
Clinical narrative: headache; every muscle i was just aching; it was hard to walk; slept most all the day; Flu like symptoms; preety intense; A spontaneous report was received from a Consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-like symptoms, pretty intense, headache, every muscle, i was just aching, it was hard to walk, couldn't eat, slept most, all day, didn't feel hungry.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events flu-like symptoms. pretty intense, headache, every muscle, i was just aching, it was hard to walk, couldn't eat. On 23 Jan 2021, the patient experienced the events slept most. all day, didn't feel hungry.  Treatment details included Not provided  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, flu-like symptoms, pretty intense, headache, every muscle, i was just aching, it was hard to walk, couldn't eat, slept most, all day, didn't feel hungry was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: itch; swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itch) and SWELLING (swelling) in a 49-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 No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Jan-2021, the patient experienced PRURITUS (itch) and SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itch) and SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site oedema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash at the injection site; Vaccination site swollen; Warm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE OEDEMA (Vaccination site swollen) and VACCINATION SITE WARMTH (Warm injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE OEDEMA (Vaccination site swollen) and VACCINATION SITE WARMTH (Warm injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE OEDEMA (Vaccination site swollen) and VACCINATION SITE WARMTH (Warm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site joint erythema, Injection site pain, Injection site pruritus
Clinical narrative: had no reaction except for a sore arm; I find that my arm is still hot, red and itchy; I find that my arm is still hot, red and itchy; I find that my arm is still hot, red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (had no reaction except for a sore arm), FEELING HOT (I find that my arm is still hot, red and itchy), INJECTION SITE JOINT ERYTHEMA (I find that my arm is still hot, red and itchy) and INJECTION SITE PRURITUS (I find that my arm is still hot, red and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (had no reaction except for a sore arm), FEELING HOT (I find that my arm is still hot, red and itchy), INJECTION SITE JOINT ERYTHEMA (I find that my arm is still hot, red and itchy) and INJECTION SITE PRURITUS (I find that my arm is still hot, red and itchy).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: woke up in the morning with a sweat; headache; neck hurt really really bad; woke up and froze; chills; sore arm; cough on and off; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze) and CHILLS (chills) in a 75-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.     No medical history was provided by reporter.  Concomitant products included METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and COUGH (cough on and off). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and COUGH (cough on and off) 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.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: woke up in the morning with a sweat; headache; neck hurt really really bad; woke up and froze; chills; sore arm; cough on and off; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze) and CHILLS (chills) in a 75-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.     No medical history was provided by reporter.  Concomitant products included METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and COUGH (cough on and off). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (woke up in the morning with a sweat), HEADACHE (headache), NECK PAIN (neck hurt really really bad), FEELING COLD (woke up and froze), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and COUGH (cough on and off) 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Induration, Rash
Clinical narrative: been 2 weeks and still red; a little bit light, but not completely gone; rash 24 hours after shot; hardness; redness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INDURATION (hardness), ERYTHEMA (redness), RASH (rash 24 hours after shot) and ERYTHEMA (been 2 weeks and still red; a little bit light, but not completely gone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INDURATION (hardness) and ERYTHEMA (redness). On 14-Jan-2021, the patient experienced RASH (rash 24 hours after shot). On 27-Jan-2021, the patient experienced ERYTHEMA (been 2 weeks and still red; a little bit light, but not completely gone). At the time of the report, INDURATION (hardness), ERYTHEMA (redness), RASH (rash 24 hours after shot) and ERYTHEMA (been 2 weeks and still red; a little bit light, but not completely gone) 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 relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact