chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing impaired. Concomitant products included METOPROLOL, SIMVASTATIN, PARACETAMOL (TYLENOL), ZINC, VITAMIN B3, ALLOPURINOL, OMEPRAZOLE, PROBIOTICS NOS, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), OXYBUTYNIN, VITAMIN B12 NOS, DIAZEPAM and FOLIC ACID (FOLATE) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Cold symptoms; Cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) and COUGH (Cough) in an 85-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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms) and COUGH (Cough). At the time of the report, NASOPHARYNGITIS (Cold symptoms) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: bed ridden for a day after the 2nd dose,could not go into work; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bed ridden for a day after the 2nd dose,could not go into work) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (bed ridden for a day after the 2nd dose,could not go into work). At the time of the report, BEDRIDDEN (bed ridden for a day after the 2nd dose,could not go into work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Rash
Clinical narrative: Broke out again but "not as progressive"; She had residual redness; Bumps that don't itch or burn; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (She had residual redness), MASS (Bumps that don't itch or burn) and RASH (Broke out again but "not as progressive") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 024m20a) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ERYTHEMA (She had residual redness) and MASS (Bumps that don't itch or burn). On 14-Mar-2021, the patient experienced RASH (Broke out again but "not as progressive"). The patient was treated with HYDROCORTISONE (topical) at a dose of 1 dosage form. In March 2021, RASH (Broke out again but "not as progressive") outcome was unknown. At the time of the report, ERYTHEMA (She had residual redness) and MASS (Bumps that don't itch or burn) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-073770, MOD-2021-074842 (E2B Linked Report).; Sender's Comments:  MOD-2021-073770:First dose MOD-2021-074842:Second dose
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year old daughter who received the first dose of Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old daughter who received the first dose of Moderna covid-19 vaccine) in a 17-year-old female patient 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old daughter who received the first dose of Moderna covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old daughter who received the first dose of Moderna covid-19 vaccine) had resolved. 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.   No concomitant and treatment medication information was reported. The report is from a mother regarding a 17-year old daughter who received the first dose of Moderna covid-19 vaccine three weeks ago. Her daughter went to school and enrolled for receiving the vaccine not knowing about the recommended age. The vaccine provider gave her the first shot after checking the age in the driver's license ID. As per the card she went on to receive the second shot and they denied her for the second shot based on her age. The reporter did not have the product information and hurried disconnected the call said would be calling back in some time. The reporter had question if her daughter can take the vaccine at the age 17 and if yes, reporter needed help in getting one as now her daughter is denied for her age. The case number was given to the patient. The reporter gave the facility address where the patient received the shot.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Arm was sore but not unbearable; was a little red; headache; nausea; fatigue,exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore but not unbearable), ERYTHEMA (was a little red), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue,exhausted) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Panniculitis and COVID-19 on 04-Jan-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE, HYDROCODONE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.    On 01-Apr-2021, 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 (Arm was sore but not unbearable), ERYTHEMA (was a little red), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue,exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore but not unbearable), ERYTHEMA (was a little red), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue,exhausted) 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 include half of hydrocodone.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes around both eyes, mostly under eyes/non itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes around both eyes, mostly under eyes/non itchy rash) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Allergy.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (rashes around both eyes, mostly under eyes/non itchy rash). At the time of the report, RASH (rashes around both eyes, mostly under eyes/non itchy rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information does not provided. The action taken with the drug was not applicable. Upon in internal review on 04-Aug-2021, the age was corrected to 22 years   This case was linked to MOD-2021-073782 (E2B Linked Report).; Sender's Comments:  MOD-2021-073782:First  dose case
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: Feels weak; Stiff muscles; Headache for the past 10 days; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff muscles), HEADACHE (Headache for the past 10 days), CHILLS (Chills) and ASTHENIA (Feels weak) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff muscles), HEADACHE (Headache for the past 10 days), CHILLS (Chills) and ASTHENIA (Feels weak). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff muscles), HEADACHE (Headache for the past 10 days), CHILLS (Chills) and ASTHENIA (Feels weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she is afraid to receive the 2nd dose. No concomitant medications and treatment information were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction, Vaccination site bruising, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Having a delayed reaction of a bruise, tenderness and itchiness at injection site; "Covid arm"; Having a delayed reaction of a bruise, tenderness and itchiness at injection site; Having a delayed reaction of a bruise, tenderness and itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Having a delayed reaction of a bruise, tenderness and itchiness at injection site), TYPE IV HYPERSENSITIVITY REACTION ("Covid arm"), VACCINATION SITE PAIN (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) and VACCINATION SITE PRURITUS (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Food allergy (Grapes and resins.). Concomitant products included LEVOTHYROXINE, OLMESARTAN MEDOXOMIL and ESTRADIOL, PROGESTERONE (BIJUVA) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Having a delayed reaction of a bruise, tenderness and itchiness at injection site), TYPE IV HYPERSENSITIVITY REACTION ("Covid arm"), VACCINATION SITE PAIN (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) and VACCINATION SITE PRURITUS (Having a delayed reaction of a bruise, tenderness and itchiness at injection site). At the time of the report, VACCINATION SITE BRUISING (Having a delayed reaction of a bruise, tenderness and itchiness at injection site), TYPE IV HYPERSENSITIVITY REACTION ("Covid arm"), VACCINATION SITE PAIN (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) and VACCINATION SITE PRURITUS (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-185669 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Patient demographics, Concomitant medication, allergy details, second dose information and vaccination facility information were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-185669:First dose case
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pain in jaw
Clinical narrative: Dull pain in her jaw; Sore arm; Stiffness in her neck and face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Dull pain in her jaw), PAIN IN EXTREMITY (Sore arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in her neck and face) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Dull pain in her jaw), PAIN IN EXTREMITY (Sore arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in her neck and face). At the time of the report, PAIN IN JAW (Dull pain in her jaw) and MUSCULOSKELETAL STIFFNESS (Stiffness in her neck and face) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site itchy after 1st dose; Injection site red after 1st dose; Injection site warm to the touch after 1st dose; Bumps around injection site area after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy after 1st dose), VACCINATION SITE WARMTH (Injection site warm to the touch after 1st dose), INJECTION SITE SWELLING (Bumps around injection site area after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch after 1st dose) and INJECTION SITE SWELLING (Bumps around injection site area after 1st dose). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose). On 13-Apr-2021, VACCINATION SITE WARMTH (Injection site warm to the touch after 1st dose) and INJECTION SITE SWELLING (Bumps around injection site area after 1st dose) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information  received on  19 May 2021 contains demographics, first event start date, outcome and second dose details updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: arm stiffness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm stiffness) and MYALGIA (soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002AZIA and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm stiffness) and MYALGIA (soreness). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (arm stiffness) and MYALGIA (soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: chest pain; chest tightness; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (chest pain) and CHEST DISCOMFORT (chest tightness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CHEST PAIN (chest pain) and CHEST DISCOMFORT (chest tightness). On 29-Mar-2021, CHEST PAIN (chest pain) and CHEST DISCOMFORT (chest tightness) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use
Clinical narrative: Out of the window for the second shot; Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive) and OFF LABEL USE (Out of the window for the second shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 COVID-19 (Tested positive). On an unknown date, the patient experienced OFF LABEL USE (Out of the window for the second shot). At the time of the report, COVID-19 (Tested positive) and OFF LABEL USE (Out of the window for the second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. The event outcome was not reported.   Sender's Comments: WIFE CASE
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: body swelling legs, stomach, arms; itching; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body swelling legs, stomach, arms) and PRURITUS (itching) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING (body swelling legs, stomach, arms) and PRURITUS (itching). At the time of the report, SWELLING (body swelling legs, stomach, arms) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient was consulted by a nurse to take piedmont as treatment.,No prescriptions written.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included FAMOTIDINE and PLECANATIDE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.    This case was linked to MOD-2021-073815 (Patient Link).   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cartilage injury
Clinical narrative: 4 days after receiving 1st dose, she started with burning sensations in knees; She has been hearing some noise (cartilage moving) in left knee when she bends down; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (4 days after receiving 1st dose, she started with burning sensations in knees) and CARTILAGE INJURY (She has been hearing some noise (cartilage moving) in left knee when she bends down) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (4 days after receiving 1st dose, she started with burning sensations in knees) and CARTILAGE INJURY (She has been hearing some noise (cartilage moving) in left knee when she bends down). The patient was treated with GLUCOSAMINE at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (4 days after receiving 1st dose, she started with burning sensations in knees) and CARTILAGE INJURY (She has been hearing some noise (cartilage moving) in left knee when she bends down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, 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 (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No corrective treatment was provided.  No further information provided as patient hung up the phone call.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Pain
Clinical narrative: Heartburn; Indigestion, acidity; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DYSPEPSIA (Heartburn) and DYSPEPSIA (Indigestion, acidity) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN (Body aches), DYSPEPSIA (Heartburn) and DYSPEPSIA (Indigestion, acidity). At the time of the report, PAIN (Body aches), DYSPEPSIA (Heartburn) and DYSPEPSIA (Indigestion, acidity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: She was really sick.; She was really tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was really sick.) and FATIGUE (She was really tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was really sick.) and FATIGUE (She was really tired). At the time of the report, ILLNESS (She was really sick.) and FATIGUE (She was really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Swollen tongue; allergies has flared up; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue) and HYPERSENSITIVITY (allergies has flared up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Unspecified).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue) and HYPERSENSITIVITY (allergies has flared up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swollen tongue, at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Swollen tongue) and HYPERSENSITIVITY (allergies has flared up) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient said the swollen tongue is from something she ate last night and not from the vaccine. Patient said she has had this before and it is not from the first vaccine. According to patient, she did not have any side effect from the first vaccine. Patient called to reschedule her appointment for the second dose of the Moderna COVID-19 vaccine
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03DA21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received updated event outcome and vaccine start date.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin E, Lip swelling, Urticaria
Clinical narrative: his upper lip swollen; hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs) and LIP SWELLING (his upper lip swollen) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No treatment medication was provided.  The patient's past medical history included No adverse event (No medical history reported.). Concurrent medical conditions included Crabs NOS.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs). On 16-Mar-2021, the patient experienced LIP SWELLING (his upper lip swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing from 13-May-2021 for Hives, at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing from 17-May-2021 for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on his upper leg/hives on his arm/hives on his shoulder/hives on his belly/hives on his thighs) had not resolved and LIP SWELLING (his upper lip swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin E: 92 (Low) LOW.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took cetirizine (Zyrtec) as corrective treatment. Patient preferred contact method was email. Patient wanted to know if he should receive the 2nd dose and if this is common.   This case was linked to MOD-2021-146178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: VAERS and Hypersensitivity form with significant info
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: Weak; Hot; Sweat sweat sweat; Exhausted; Fever just a little north of 102 degrees; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted) and PYREXIA (Fever just a little north of 102 degrees) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included LEVOTHYROXINE for Disorder thyroid, VITAMINS NOS for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted), PYREXIA (Fever just a little north of 102 degrees) and FATIGUE (Fatigue). On 11-Apr-2021, ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted), PYREXIA (Fever just a little north of 102 degrees) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102 (High) fever ranged between 100 to 102.8 and settled around 101.5,then down to 99.2.         Concomitant medications included unspecified statin for cholesterol.  Treatment medications included Tylenol (acetaminophen.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weak; Hot; Sweat sweat sweat; Exhausted; Fever just a little north of 102 degrees; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted) and PYREXIA (Fever just a little north of 102 degrees) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included LEVOTHYROXINE for Disorder thyroid, VITAMINS NOS for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted), PYREXIA (Fever just a little north of 102 degrees) and FATIGUE (Fatigue). On 11-Apr-2021, ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted), PYREXIA (Fever just a little north of 102 degrees) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102 (High) fever ranged between 100 to 102.8 and settled around 101.5,then down to 99.2.         Concomitant medications included unspecified statin for cholesterol.  Treatment medications included Tylenol (acetaminophen.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Sinusitis
Clinical narrative: fever; rash; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PYREXIA (fever) and RASH (rash) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced SINUSITIS (Sinus infection). On 09-Apr-2021, the patient experienced PYREXIA (fever) and RASH (rash). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection), PYREXIA (fever) and RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information included  Antibiotics with sulfa.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Sneezing
Clinical narrative: Lips started swelling; Tingling in mouth; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING, PARAESTHESIA ORAL and SNEEZING in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LIP SWELLING, PARAESTHESIA ORAL and SNEEZING. The patient was treated with BENADRYL at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, LIP SWELLING, PARAESTHESIA ORAL, and SNEEZING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient received the second dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Slight fever; Cold sweating; Stomach pain; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Slight fever), HYPERHIDROSIS (Cold sweating), ABDOMINAL PAIN UPPER (Stomach pain) and VOMITING (Vomiting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Slight fever), HYPERHIDROSIS (Cold sweating), ABDOMINAL PAIN UPPER (Stomach pain) and VOMITING (Vomiting). At the time of the report, PYREXIA (Slight fever), HYPERHIDROSIS (Cold sweating) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown and VOMITING (Vomiting) had not resolved.            No concomitant medication reported.  Treatment for the event include 500 mg ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Heart rate
Clinical narrative: dizziness; feels really warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and FEELING HOT (feels really warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (dizziness) and FEELING HOT (feels really warm). At the time of the report, DIZZINESS (dizziness) and FEELING HOT (feels really warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: 110 (High) fast heartbeat, which is normally in the 50s but was at 110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; sneezing; tired; fever 100.9; she had a terrible sore arm; she had during the night chills that she couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had a terrible sore arm), CHILLS (she had during the night chills that she couldn't sleep), PYREXIA (fever 100.9), FATIGUE (tired) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included PARACETAMOL (TYLENOL).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (she had a terrible sore arm) and CHILLS (she had during the night chills that she couldn't sleep). On 04-Apr-2021, the patient experienced PYREXIA (fever 100.9). On 05-Apr-2021, the patient experienced FATIGUE (tired). On 06-Apr-2021, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, PAIN IN EXTREMITY (she had a terrible sore arm), CHILLS (she had during the night chills that she couldn't sleep), PYREXIA (fever 100.9), FATIGUE (tired), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient does not received any treatment.   This case was linked to MOD-2021-073801 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: runny nose; sneezing; tired; fever 100.9; she had a terrible sore arm; she had during the night chills that she couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had a terrible sore arm), CHILLS (she had during the night chills that she couldn't sleep), PYREXIA (fever 100.9), FATIGUE (tired) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included PARACETAMOL (TYLENOL).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (she had a terrible sore arm) and CHILLS (she had during the night chills that she couldn't sleep). On 04-Apr-2021, the patient experienced PYREXIA (fever 100.9). On 05-Apr-2021, the patient experienced FATIGUE (tired). On 06-Apr-2021, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, PAIN IN EXTREMITY (she had a terrible sore arm), CHILLS (she had during the night chills that she couldn't sleep), PYREXIA (fever 100.9), FATIGUE (tired), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient does not received any treatment.   This case was linked to MOD-2021-073801 (Patient Link).   Reporter did not allow further contact
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Nipple swelling, Tenderness
Clinical narrative: swelling in left nipple; tenderness in left nipple; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE SWELLING (swelling in left nipple) and TENDERNESS (tenderness in left nipple) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and LOSARTAN for an unknown indication.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIPPLE SWELLING (swelling in left nipple) and TENDERNESS (tenderness in left nipple). At the time of the report, NIPPLE SWELLING (swelling in left nipple) and TENDERNESS (tenderness in left nipple) had not resolved.            Patient said the second dose of the vaccine was administered on 29-Mar-2021 or 30-Mar-2021. The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No treatment drugs were reported