chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feels dizzy; feeling really bad; freezer; Very sick; nauseous; throwing; A spontaneous report was received from a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels dizzy/ dizziness ,nauseous/ nausea, felt like she was going to pass out/loss of consciousness, throwing up/vomiting, feeling really bad/feeling abnormal, freezer and cold /nasopharyngitis and very sick/illness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 18 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On  19  Mar 2021, after receiving mRNA-1273, the patient felt dizzy ,nauseous and felt like she was going to pass out. She tried to talk on the phone but she was throwing up and feeling really bad. She was freezer and cold. Very sick. She's going to the ER right then.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, dizziness, nausea, loss of consciousness , vomiting ,feeling abnormal, nasopharyngitis and illness were not considered to be resolved at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever 100.1; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.1) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030214) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever 100.1) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever 100.1) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 100.1 (High) fever 100.1.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Vaccination site erythema, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot and throbbing spot at injection site), RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now) and VACCINATION SITE ERYTHEMA (red spot at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot and throbbing spot at injection site) and VACCINATION SITE ERYTHEMA (red spot at injection site). On an unknown date, the patient experienced RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot and throbbing spot at injection site), RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now) and VACCINATION SITE ERYTHEMA (red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching around the site of injection; Sore arm around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included TRAMADOL, PREDNISONE and TORSEMIDE for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection) outcome was unknown.            No treatment drug reported.  Patient asked if she should put and ice pack on it or use cortisone cream. Patient mentioned she has only one lot and she was not sure whether its from the first vaccine or the second vaccine
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given the second dose 19 days after the first dose; A spontaneous report  was received from a pharmacist concerning a 76-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and was given the second dose 19 days after the first dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.     On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Mar 2021, the patient was given the second dose 19 days after the first dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was given the second dose 19 days after the first dose was considered recovered on 19 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Passed the 37 days mark for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had some pain in the arm in that area of the injection, it was sore; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Had some pain in the arm in that area of the injection, it was sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had some pain in the arm in that area of the injection, it was sore). On 18-Mar-2021, VACCINATION SITE PAIN (Had some pain in the arm in that area of the injection, it was sore) had resolved.        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.   Patient was scheduled to get the second dose on 15Apr2021 but has a brain surgery for epilepsy scheduled for the 14Apr2021 from before, so they inquire if they should advance the second dose or delay it, because they won't be able to attend the appointment since they will be in the hospital.  Concomitant medication and treatment drug not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Erythema, Swelling face
Clinical narrative: severe diarrhea; diffuse abdominal pain; swollen lump in face; face redness; migratory arthralgia in right foot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness), ARTHRALGIA (migratory arthralgia in right foot) and DIARRHOEA (severe diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Ammoniacal dermatitis (Allergic to ammonia (hair dye).), Myasthenia gravis and Lymphoma.   On 01-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness) and ARTHRALGIA (migratory arthralgia in right foot). On an unknown date, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness) and ARTHRALGIA (migratory arthralgia in right foot) outcome was unknown and DIARRHOEA (severe diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Feeling hot, Pain in extremity, Vaccination site pain
Clinical narrative: pain and soreness on the injection side; pain on the other side near her pacemaker; legs sore; ankles are sore; Her legs, ankles, and toes are sore as well / Fingers are sore too; She feels a little warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain and soreness on the injection side), CHEST PAIN (pain on the other side near her pacemaker), PAIN IN EXTREMITY (legs sore), ARTHRALGIA (ankles are sore) and PAIN IN EXTREMITY (Her legs, ankles, and toes are sore as well / Fingers are sore too) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pacemaker insertion (cardiac).    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain and soreness on the injection side), CHEST PAIN (pain on the other side near her pacemaker), PAIN IN EXTREMITY (legs sore), ARTHRALGIA (ankles are sore), PAIN IN EXTREMITY (Her legs, ankles, and toes are sore as well / Fingers are sore too) and FEELING HOT (She feels a little warm). At the time of the report, VACCINATION SITE PAIN (pain and soreness on the injection side), CHEST PAIN (pain on the other side near her pacemaker), PAIN IN EXTREMITY (legs sore), ARTHRALGIA (ankles are sore), PAIN IN EXTREMITY (Her legs, ankles, and toes are sore as well / Fingers are sore too) and FEELING HOT (She feels a little warm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken for the  mRNA-1273 (Moderna COVID-19 Vaccine) not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pruritus, Pyrexia, Swelling
Clinical narrative: swelling; arm pain; itch; developed a rash at injection site; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-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 SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: swelling; arm pain; itch; developed a rash at injection site; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-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 SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough after 1st dose) in a male 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 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 COUGH (Cough after 1st dose). At the time of the report, COUGH (Cough after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant  concomitant medications provided. No relevant treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: No newinformation
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pruritus, Rash pruritic
Clinical narrative: bottom had rash and was itchy; Itchy; Fatigue; Ached all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (bottom had rash and was itchy), PRURITUS (Itchy), FATIGUE (Fatigue) and MYALGIA (Ached all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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 12-Mar-2021, the patient experienced RASH PRURITIC (bottom had rash and was itchy), PRURITUS (Itchy), FATIGUE (Fatigue) and MYALGIA (Ached all over). At the time of the report, RASH PRURITIC (bottom had rash and was itchy), PRURITUS (Itchy), FATIGUE (Fatigue) and MYALGIA (Ached all over) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 with respect to events was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Erythema, Face oedema
Clinical narrative: face itching; face swelling; face was red from my neck up; chills; joint aches; body aches; Fever; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills) and ARTHRALGIA (joint aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever). On 19-Mar-2021, the patient experienced FACE OEDEMA (face swelling) and ERYTHEMA (face was red from my neck up). On 20-Mar-2021, the patient experienced PRURITUS (face itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form and HYDROCORTISONE (topical) for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.8 (High) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Pyrexia
Clinical narrative: face itching; face swelling; face was red from my neck up; chills; joint aches; body aches; Fever; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills) and ARTHRALGIA (joint aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever). On 19-Mar-2021, the patient experienced FACE OEDEMA (face swelling) and ERYTHEMA (face was red from my neck up). On 20-Mar-2021, the patient experienced PRURITUS (face itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form and HYDROCORTISONE (topical) for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.8 (High) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oropharyngeal discomfort, Paraesthesia
Clinical narrative: discomfort in throat/Arm Paresthesia; Numbness in right side of the arm/Numbness in right side of the face; Facial Paresthesia/Arm Paresthesia; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (Numbness in right side of the arm/Numbness in right side of the face), PARAESTHESIA (Facial Paresthesia/Arm Paresthesia) and OROPHARYNGEAL DISCOMFORT (discomfort in throat/Arm Paresthesia) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    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 HYPOAESTHESIA (Numbness in right side of the arm/Numbness in right side of the face), PARAESTHESIA (Facial Paresthesia/Arm Paresthesia) and OROPHARYNGEAL DISCOMFORT (discomfort in throat/Arm Paresthesia). At the time of the report, HYPOAESTHESIA (Numbness in right side of the arm/Numbness in right side of the face), PARAESTHESIA (Facial Paresthesia/Arm Paresthesia) and OROPHARYNGEAL DISCOMFORT (discomfort in throat/Arm Paresthesia) had resolved. 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 treatment products reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Limb mass, Peripheral swelling
Clinical narrative: Redness; Swelling; Knot; Heat generating; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot), FEELING HOT (Heat generating) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included METFORMIN, LOSARTAN, SPIRONOLACTONE, SERTRALINE, CALCIUM CITRATE, SIMVASTATIN, HYDROCHLOROTHIAZIDE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and DIPHENHYDRAMINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Tiredness). On 19-Mar-2021, the patient experienced ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot) and FEELING HOT (Heat generating). At the time of the report, ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot), FEELING HOT (Heat generating) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19-Mar-2021, the patient observed her left arm was swollen, red and had a knot in it. The skin is also generating heat. These side effects had not subsided and are still present at this time.  No treatment medication was reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: left calf hot; left calf painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful). At the time of the report, FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful) outcome was unknown.            No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness in right arm; swelling in right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in right arm) and PERIPHERAL SWELLING (swelling in right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048H21H) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ERYTHEMA (redness in right arm) and PERIPHERAL SWELLING (swelling in right arm). At the time of the report, ERYTHEMA (redness in right arm) and PERIPHERAL SWELLING (swelling in right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in left knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in left knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRALGIA (pain in left knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (pain in left knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Headache; Sore arm; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PAIN (Body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Heart disorder. Concomitant products included GLIPIZIDE, Metoprolol SUCCER, FUROSEMIDE, ALLOPURINOL, SIMVASTATIN, LISINOPRIL, DIGOXIN and METFORMIN HCL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PAIN (Body aches). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown and PAIN (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included GABAPENTIN for an unknown indication.   On 15-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) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache and Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (body ache) and PYREXIA (fever) outcome was unknown. Not Provided          Additional concomitant medication included unspecified hypertension medication.  Action taken with mRNA-1273 with respect to events was not applicable.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Constipation, Feeling abnormal
Clinical narrative: Constipation; Felt awful; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful). At the time of the report, CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment products reported.   It was reported that the patient received the vaccine about 10 days before the date of reporting.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; chills; body aches; fever that ranged from 100.5 degrees to 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004AZ1A) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (abnormal) ranged from 100.5 degrees to 99 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated fever had continued to decline as well as some of the other symptoms. Some side effects were still present but were improving.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle). On 18-Mar-2021, INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.; Reporter's Comments: This report refers to a case of incorrect dose administered, and device connection issue for mRNA-1273, lot # 040A21A with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Vaccination site erythema, Vaccination site oedema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: covid arm; very very red, hot, itching and burning; red circle got really red and started burning and itching; big red bulls eye; swollen; hot area/hot; red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (big red bulls eye), VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE PRURITUS (very very red, hot, itching and burning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot) and VACCINATION SITE ERYTHEMA (red). On 18-Mar-2021, the patient experienced OCULAR HYPERAEMIA (big red bulls eye), VACCINATION SITE PRURITUS (very very red, hot, itching and burning) and VACCINATION SITE PAIN (red circle got really red and started burning and itching). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). On 12-Mar-2021, VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot) and VACCINATION SITE ERYTHEMA (red) had resolved. On 19-Mar-2021, OCULAR HYPERAEMIA (big red bulls eye) had resolved. At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (very very red, hot, itching and burning) and VACCINATION SITE PAIN (red circle got really red and started burning and itching) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-267388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone contact report received on 28-JUL-2021. Added New events big red bulls eye and covid arm. Updated action taken from unknown to no change.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: covid arm; very very red, hot, itching and burning; red circle got really red and started burning and itching; big red bulls eye; swollen; hot area/hot; red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (big red bulls eye), VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE PRURITUS (very very red, hot, itching and burning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot) and VACCINATION SITE ERYTHEMA (red). On 18-Mar-2021, the patient experienced OCULAR HYPERAEMIA (big red bulls eye), VACCINATION SITE PRURITUS (very very red, hot, itching and burning) and VACCINATION SITE PAIN (red circle got really red and started burning and itching). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). On 12-Mar-2021, VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot) and VACCINATION SITE ERYTHEMA (red) had resolved. On 19-Mar-2021, OCULAR HYPERAEMIA (big red bulls eye) had resolved. At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (very very red, hot, itching and burning) and VACCINATION SITE PAIN (red circle got really red and started burning and itching) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-267388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone contact report received on 28-JUL-2021. Added New events big red bulls eye and covid arm. Updated action taken from unknown to no change.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Nausea
Clinical narrative: Swelling; Headache; Sore Injection Site; Vomiting; Body Aches; Joint pain; Fever 100.9F; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting) and MYALGIA (Body Aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), MYALGIA (Body Aches), ARTHRALGIA (Joint pain), PYREXIA (Fever 100.9F) and NAUSEA (Nausea). On 13-Feb-2021, SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), PYREXIA (Fever 100.9F) and NAUSEA (Nausea) had resolved. On 16-Feb-2021, MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.9 (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site pain, Vomiting
Clinical narrative: Swelling; Headache; Sore Injection Site; Vomiting; Body Aches; Joint pain; Fever 100.9F; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting) and MYALGIA (Body Aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), MYALGIA (Body Aches), ARTHRALGIA (Joint pain), PYREXIA (Fever 100.9F) and NAUSEA (Nausea). On 13-Feb-2021, SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), PYREXIA (Fever 100.9F) and NAUSEA (Nausea) had resolved. On 16-Feb-2021, MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.9 (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Fatigue, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain) and PARAESTHESIA ORAL (tongue was tingling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Diabetes, Hypertension, Hypercholesterolemia and Allergy (Allergy, Unspecified).    On 01-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 VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling), PARAESTHESIA (tingling on her cheek on the left side), VACCINATION SITE PRURITUS (extreme itching on the injection site) and FATIGUE (slight fatigue). At the time of the report, VACCINATION SITE REACTION (covid arm), ADVERSE DRUG REACTION (feeling like it's nerve related), PARAESTHESIA (tingling on her cheek on the left side) and VACCINATION SITE PRURITUS (extreme itching on the injection site) outcome was unknown and HYPOAESTHESIA (arm numbness), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling) and FATIGUE (slight fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain) and PARAESTHESIA ORAL (tongue was tingling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Diabetes, Hypertension, Hypercholesterolemia and Allergy (Allergy, Unspecified).    On 01-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 VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling), PARAESTHESIA (tingling on her cheek on the left side), VACCINATION SITE PRURITUS (extreme itching on the injection site) and FATIGUE (slight fatigue). At the time of the report, VACCINATION SITE REACTION (covid arm), ADVERSE DRUG REACTION (feeling like it's nerve related), PARAESTHESIA (tingling on her cheek on the left side) and VACCINATION SITE PRURITUS (extreme itching on the injection site) outcome was unknown and HYPOAESTHESIA (arm numbness), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling) and FATIGUE (slight fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Neck pain; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain) and BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 NECK PAIN (Neck pain) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Back pain and Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain) and BACK PAIN (Back pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to her doctor on 17-Mar-2021 and she was prescribed pain medication but the pharmacy did not had the medication available. She had taken Advil (ibuprofen) but the pain was still present at the time of reporting. She said she cannot sleep on her side but had to sleep on her back. She was not on any medication.