chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Nasal congestion, Palpitations
Clinical narrative: General discomfort, that lasted for 3 or 4 days; Bone pain, that lasted for 3 or 4 days; Felt like she had fever, but she had not , that lasted for 3 or 4 days; Chills, that lasted for 3 or 4 days; Headache , that is not usual for her, that are worse at night; Nasal congestion, that is worse than previous time when she had them, and are worse at night; Fast heart beat, after the vaccine is worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse), BONE PAIN (Bone pain, that lasted for 3 or 4 days) and PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ04) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, ATENOLOL, ATORVASTATIN, LOSARTAN and TRIAMTERENE for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse) and HEADACHE (Headache , that is not usual for her, that are worse at night). On an unknown date, the patient experienced VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), BONE PAIN (Bone pain, that lasted for 3 or 4 days), PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days) and CHILLS (Chills, that lasted for 3 or 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse), BONE PAIN (Bone pain, that lasted for 3 or 4 days), PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days), HEADACHE (Headache , that is not usual for her, that are worse at night) and CHILLS (Chills, that lasted for 3 or 4 days) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: General discomfort, that lasted for 3 or 4 days; Bone pain, that lasted for 3 or 4 days; Felt like she had fever, but she had not , that lasted for 3 or 4 days; Chills, that lasted for 3 or 4 days; Headache , that is not usual for her, that are worse at night; Nasal congestion, that is worse than previous time when she had them, and are worse at night; Fast heart beat, after the vaccine is worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse), BONE PAIN (Bone pain, that lasted for 3 or 4 days) and PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ04) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, ATENOLOL, ATORVASTATIN, LOSARTAN and TRIAMTERENE for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse) and HEADACHE (Headache , that is not usual for her, that are worse at night). On an unknown date, the patient experienced VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), BONE PAIN (Bone pain, that lasted for 3 or 4 days), PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days) and CHILLS (Chills, that lasted for 3 or 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse), BONE PAIN (Bone pain, that lasted for 3 or 4 days), PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days), HEADACHE (Headache , that is not usual for her, that are worse at night) and CHILLS (Chills, that lasted for 3 or 4 days) outcome was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Chilling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Chilling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING COLD (Chilling). At the time of the report, FEELING COLD (Chilling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: sore arm; Itchy ears; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (Itchy ears) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PRURITUS (Itchy ears) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (Itchy ears) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st shot administered to 16yr old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st shot administered to 16yr old) in a 16-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.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st shot administered to 16yr old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st shot administered to 16yr old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up was received. No new information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pruritus, Vaccination site erythema
Clinical narrative: Itchy; Noticed 3 or 4 faint red marks when he took a band aid off from injection site; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Noticed 3 or 4 faint red marks when he took a band aid off from injection site), MYALGIA (Body ache) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M208) for COVID-19 vaccination.     Concomitant products included QUINAPRIL, ATORVASTATIN and TAMSULOSIN for an unknown indication.   On 03-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 04-Mar-2021, the patient experienced MYALGIA (Body ache) and HEADACHE (Headache). On 05-Mar-2021, the patient experienced PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Noticed 3 or 4 faint red marks when he took a band aid off from injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, MYALGIA (Body ache) and HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Noticed 3 or 4 faint red marks when he took a band aid off from injection site) outcome was unknown.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itches at the left arm; Swelling at the left arm; Redness at the left arm; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PRURITUS (Itches at the left arm), VACCINATION SITE SWELLING (Swelling at the left arm) and VACCINATION SITE ERYTHEMA (Redness at the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itches at the left arm), VACCINATION SITE SWELLING (Swelling at the left arm) and VACCINATION SITE ERYTHEMA (Redness at the left arm). At the time of the report, VACCINATION SITE PRURITUS (Itches at the left arm), VACCINATION SITE SWELLING (Swelling at the left arm) and VACCINATION SITE ERYTHEMA (Redness at the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on back of both hands and fingers; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of both hands and fingers) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21N) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-May-2006. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 01-May-2006 to an unknown date for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (Rash on back of both hands and fingers). On 17-Apr-2021, RASH (Rash on back of both hands and fingers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used an old moisturizer evening of the day when patient received the first shot of moderna vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient demographics , medical history and concomitant medications were updated. De-challenge andre-challenge  and stop date of the event  were updated. Outcome of the event was changed from unknown to recovered.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Shivering; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, PRAZOSIN, ATORVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Shivering). On 05-Mar-2021, CHILLS (Shivering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache
Clinical narrative: Discomfort; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) and HEADACHE (Headache) 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 DISCOMFORT (Discomfort) and HEADACHE (Headache). At the time of the report, DISCOMFORT (Discomfort) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: 3 inches blisters , that were like a tennis ball , all around the injection arm (left arm); Severe hardness all around the injection arm (left arm); Redness all around the injection arm (left arm); Swelling all around the injection arm (left arm); This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE VESICLES (3 inches blisters , that were like a tennis ball , all around the injection arm (left arm)), VACCINATION SITE INDURATION (Severe hardness all around the injection arm (left arm)), VACCINATION SITE ERYTHEMA (Redness all around the injection arm (left arm)) and VACCINATION SITE SWELLING (Swelling all around the injection arm (left arm)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE VESICLES (3 inches blisters , that were like a tennis ball , all around the injection arm (left arm)), VACCINATION SITE INDURATION (Severe hardness all around the injection arm (left arm)), VACCINATION SITE ERYTHEMA (Redness all around the injection arm (left arm)) and VACCINATION SITE SWELLING (Swelling all around the injection arm (left arm)). At the time of the report, VACCINATION SITE VESICLES (3 inches blisters , that were like a tennis ball , all around the injection arm (left arm)), VACCINATION SITE INDURATION (Severe hardness all around the injection arm (left arm)), VACCINATION SITE ERYTHEMA (Redness all around the injection arm (left arm)) and VACCINATION SITE SWELLING (Swelling all around the injection arm (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: M
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 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19 vaccination, at an unspecified dose and frequency. 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 medication was provided by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: little swelling in the arm; ached and pains; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (little swelling in the arm) and PAIN (ached and pains) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 017170A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (little swelling in the arm) and PAIN (ached and pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (little swelling in the arm) and PAIN (ached and pains) had resolved.            Concomitant information not provided.   This case was linked to MOD-2021-036179 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound scan, X-ray
Clinical narrative: Hands swollen like a balloon; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hands swollen like a balloon) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Hands swollen like a balloon). At the time of the report, PERIPHERAL SWELLING (Hands swollen like a balloon) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (Inconclusive) could not find anything wrong. On an unknown date, X-ray: (Inconclusive) could not find anything wrong.         Treatment details included Pain medication.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Instead of putting it in the deltoid it went to the back of her arm  lower than where it should go /  not intramuscularly; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was observed that instead of putting it in the deltoid, it went to the back of her arm and lower than where it should go and she doesn't think she got it intramuscularly i.e. incorrect route of product administration occurred.   The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The dose number were not reported.  On an unknown date while vaccine administration it was observed that instead of putting it in the deltoid it went to the back of her arm and lower than where it should go, and she doesn't think she got it intramuscularly. The event was a medication error.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event was considered as resolved on an unknown date.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: very hot and uncomfortable ear for 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other caregiver and describes the occurrence of EAR DISCOMFORT (very hot and uncomfortable ear for 24 hours) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced EAR DISCOMFORT (very hot and uncomfortable ear for 24 hours). At the time of the report, EAR DISCOMFORT (very hot and uncomfortable ear for 24 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: TCR form - does not recall reporting this
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: sore arm; very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (very tired) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (very tired) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (very tired) and CHILLS (chills) had resolved.            No concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling hot, Headache
Clinical narrative: Dizzy; Felt hot; Blood pressure increased; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING HOT (Felt hot), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizzy), FEELING HOT (Felt hot), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizzy), FEELING HOT (Felt hot), BLOOD PRESSURE INCREASED (Blood pressure increased) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Blood pressure measurement: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chills, Fatigue
Clinical narrative: Arm was sore; Arm still hurts but nothing else; Sleeping on and of; Bone pain; Injection site was hard as rock; Muscle pain; Joint pain; Headache; So Tired; Fever 102degF; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Arm still hurts but nothing else), SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain) and VACCINATION SITE INDURATION (Injection site was hard as rock) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE, OMEPRAZOLE, AMITRIPTYLINE, ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and HYDROCHLOROTHIAZIDE for an unknown indication.    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 PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Arm still hurts but nothing else), SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain), VACCINATION SITE INDURATION (Injection site was hard as rock), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (So Tired), PYREXIA (Fever 102degF), CHILLS (Chills) and NAUSEA (Nausea). 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) and LIMB DISCOMFORT (Arm still hurts but nothing else) had not resolved and SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain), VACCINATION SITE INDURATION (Injection site was hard as rock), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (So Tired), PYREXIA (Fever 102degF), CHILLS (Chills) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.     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 21-Jul-2021: Non significant followup added. TCR form appended.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Myalgia, Nausea, Pain in extremity
Clinical narrative: Arm was sore; Arm still hurts but nothing else; Sleeping on and of; Bone pain; Injection site was hard as rock; Muscle pain; Joint pain; Headache; So Tired; Fever 102degF; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Arm still hurts but nothing else), SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain) and VACCINATION SITE INDURATION (Injection site was hard as rock) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE, OMEPRAZOLE, AMITRIPTYLINE, ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and HYDROCHLOROTHIAZIDE for an unknown indication.    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 PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Arm still hurts but nothing else), SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain), VACCINATION SITE INDURATION (Injection site was hard as rock), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (So Tired), PYREXIA (Fever 102degF), CHILLS (Chills) and NAUSEA (Nausea). 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) and LIMB DISCOMFORT (Arm still hurts but nothing else) had not resolved and SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain), VACCINATION SITE INDURATION (Injection site was hard as rock), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (So Tired), PYREXIA (Fever 102degF), CHILLS (Chills) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.     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 21-Jul-2021: Non significant followup added. TCR form appended.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Vaccination site induration
Clinical narrative: Arm was sore; Arm still hurts but nothing else; Sleeping on and of; Bone pain; Injection site was hard as rock; Muscle pain; Joint pain; Headache; So Tired; Fever 102degF; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Arm still hurts but nothing else), SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain) and VACCINATION SITE INDURATION (Injection site was hard as rock) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE, OMEPRAZOLE, AMITRIPTYLINE, ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and HYDROCHLOROTHIAZIDE for an unknown indication.    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 PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Arm still hurts but nothing else), SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain), VACCINATION SITE INDURATION (Injection site was hard as rock), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (So Tired), PYREXIA (Fever 102degF), CHILLS (Chills) and NAUSEA (Nausea). 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) and LIMB DISCOMFORT (Arm still hurts but nothing else) had not resolved and SLEEP DISORDER (Sleeping on and of), BONE PAIN (Bone pain), VACCINATION SITE INDURATION (Injection site was hard as rock), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (So Tired), PYREXIA (Fever 102degF), CHILLS (Chills) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.     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 21-Jul-2021: Non significant followup added. TCR form appended.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-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 SARS-COV-2 TEST POSITIVE (Positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. No Treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Arm swollen like an egg; localized feeling of hot; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen like an egg), FEELING HOT (localized feeling of hot) and PRURITUS (Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 01120A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen like an egg), FEELING HOT (localized feeling of hot) and PRURITUS (Itchy). On 31-Jan-2021, PERIPHERAL SWELLING (Arm swollen like an egg), FEELING HOT (localized feeling of hot) and PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included an antihistamine, not otherwise specified.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm; Dizzy; Face is flushed; Nauseous; Face is tingling; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), FLUSHING (Face is flushed), PARAESTHESIA (Face is tingling) and NAUSEA (Nauseous) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-1900, the patient experienced PARAESTHESIA (Face is tingling). On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), FLUSHING (Face is flushed) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), FLUSHING (Face is flushed), PARAESTHESIA (Face is tingling) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-045076 (E2B Linked Report).; Sender's Comments:  MOD21-045076:Crosslinked case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Right arm sore). On 11-Feb-2021, VACCINATION SITE PAIN (Right arm 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.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Just so tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Just so tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Just so tired). At the time of the report, FATIGUE (Just so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.     Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Nausea
Clinical narrative: mid section pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (mid section pain), CHILLS (chills) and NAUSEA (nausea) in a male 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 ABDOMINAL PAIN (mid section pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN (mid section pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine injected into the skin, not in the muscle; A spontaneous report was received from a consumer concerning a 73-year-old, female patient  who reported that vaccine was injected into the skin, not into the muscle (incorrect route of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 4 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: 0127A21A) for prophylaxis of COVID-19 infection.  The patient stated that the vaccine was not injected into the muscle but into the skin.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, vaccine injected into the skin, not in the muscle (incorrect route of product administration) was considered as recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 0127A21A) with no associated AEs reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: there's a fiery type feeling on injection site; itchy; Red around injection site,redness after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (there's a fiery type feeling on injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (Red around injection site,redness after the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN, APREMILAST (OTEZLA), VIVISCAL ADVANCED HAIR HEALTH and VITAMIN D3 for an unknown indication.   On 01-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 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (there's a fiery type feeling on injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (Red around injection site,redness after the injection). At the time of the report, VACCINATION SITE WARMTH (there's a fiery type feeling on injection site) and VACCINATION SITE PRURITUS (itchy) outcome was unknown and VACCINATION SITE ERYTHEMA (Red around injection site,redness after the injection) had resolved.            she did not have any reaction with her first dose. No treatment taken.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received, event outcome has changed.; Sender's Comments: This case concerns a 71-year-old female with nonserious unexpected events of vaccination site warmth, and expected vaccination site erythema and vaccination site pruritus. Event onset 7 days after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pregnancy, Pregnancy test
Clinical narrative: Injection site arm soreness; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy) and INJECTION SITE PAIN (Injection site arm soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 18-Aug-2020 and the estimated date of delivery was 25-May-2021. On 18-Aug-2020, the patient experienced PREGNANCY (Pregnancy). On 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site arm soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The delivery occurred  on 25-May-2021, which was reported as Unknown.  At the time of the report, PREGNANCY (Pregnancy) and INJECTION SITE PAIN (Injection site arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2020, Pregnancy test: positive.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash on her right arm; red rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy, red rash on her right arm) and RASH ERYTHEMATOUS (red rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetic, Hypertension, Thyroid disorder NOS, Acid reflux (esophageal) and Penicillin allergy. Concomitant products included METFORMIN, HYDRALAZINE, PANTOPRAZOLE, RIVAROXABAN (XARELTO), LEVOTHYROXINE, PRAVASTATIN and SOTALOL for an unknown indication.    On 25-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy, red rash on her right arm) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH PRURITIC (Itchy, red rash on her right arm) and RASH ERYTHEMATOUS (red rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product include "magnoxside".  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Sleep disorder
Clinical narrative: arm hurt a little bit; Very tired; slept a lot; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (Very tired) and SLEEP DISORDER (slept a lot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (Very tired) and SLEEP DISORDER (slept a lot). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit), FATIGUE (Very tired) and SLEEP DISORDER (slept a lot) outcome was unknown.            This case was linked to MOD-2020-036191, MOD-2021-034961 (E2B Linked Report).; Sender's Comments:  MOD-2020-036191: MOD-2021-034961: