chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Sleep terror, Stress, Vaccination site pain
Clinical narrative: Fatigue; Tired; Dragging herself; Distress; Going through a difficult time; headache; sleepless night; loud screaming sounds; Having just three and half hours of sleep; Vaccination site pain; tired; nightmares/Frightening dreams; Vaccination site pain; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams), HEADACHE (headache) and INSOMNIA (sleepless night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Blood pressure, Bipolar disorder (she do not have episodes), Depression (she do not have episodes), Allergy and Rotator cuff tear (right shoulder). Concomitant products included TRIAMTERENE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams) and PAIN IN EXTREMITY (Arm hurts). On 14-Apr-2021, the patient experienced HEADACHE (headache), INSOMNIA (sleepless night), SLEEP TERROR (loud screaming sounds) and INSOMNIA (Having just three and half hours of sleep). On 21-Apr-2021, the patient experienced STRESS (Distress) and MALAISE (Going through a difficult time). On an unknown date, the patient experienced FATIGUE (Fatigue), FATIGUE (Tired) and GAIT INABILITY (Dragging herself). At the time of the report, PAIN IN EXTREMITY (pain in arm), FATIGUE (tired), NIGHTMARE (nightmares/Frightening dreams), HEADACHE (headache), INSOMNIA (sleepless night), SLEEP TERROR (loud screaming sounds), PAIN IN EXTREMITY (Arm hurts), INSOMNIA (Having just three and half hours of sleep), FATIGUE (Fatigue), FATIGUE (Tired), GAIT INABILITY (Dragging herself), STRESS (Distress) and MALAISE (Going through a difficult time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intentional dose omission, SARS-CoV-2 test positive
Clinical narrative: intentional dose omission; Tested positive for COVID after first vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine) and INTENTIONAL DOSE OMISSION (intentional dose omission) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), ALPRAZOLAM (AZOR [ALPRAZOLAM]), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LORAZEPAM (ATIVAN), ALLOPURINOL, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentional dose omission). The patient was treated with Immunotherapy (BAMLAN monoclonal antibodies) for SARS-CoV-2 test positive. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first vaccine) outcome was unknown and INTENTIONAL DOSE OMISSION (intentional dose omission) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       On 09-Jan-2021, the patient went to the hospital and received an antibody infusion and came home the same day after the treatment. Patient was instructed to wait 90 days and start the vaccination series all over again. Patient said the doctor told them their first dose must be repeated.   This case was linked to US-MODERNATX, INC.-MOD-2021-083092, US-MODERNATX, INC.-MOD-2021-083133, US-MODERNATX, INC.-MOD-2021-083104 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Treatment information was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083092:2nd dose US-MODERNATX, INC.-MOD-2021-083104:Wife's 1st dose US-MODERNATX, INC.-MOD-2021-083133:Wife's 2nd dose
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pigmentation disorder, Pruritus
Clinical narrative: itchiness to forearm; rippling to the skin- inside of right arm; pigmentation from wrist to elbow bright red; blotchy redness; stiff neck; headache; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness), MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain) had resolved. At the time of the report, PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red) and RASH MACULAR (blotchy redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment drugs include Benadryl Topical Cream.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Skin disorder
Clinical narrative: itchiness to forearm; rippling to the skin- inside of right arm; pigmentation from wrist to elbow bright red; blotchy redness; stiff neck; headache; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red), RASH MACULAR (blotchy redness), MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck), HEADACHE (headache) and MYALGIA (muscle pain) had resolved. At the time of the report, PRURITUS (itchiness to forearm), SKIN DISORDER (rippling to the skin- inside of right arm), PIGMENTATION DISORDER (pigmentation from wrist to elbow bright red) and RASH MACULAR (blotchy redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment drugs include Benadryl Topical Cream.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fever.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (very high fever). At the time of the report, PYREXIA (very high fever) outcome was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: daughter is underage and received the first dose of the vaccine; sore arm; Minor headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is underage and received the first dose of the vaccine), PAIN IN EXTREMITY (sore arm) and HEADACHE (Minor headache) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is underage and received the first dose of the vaccine) and HEADACHE (Minor headache). 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is underage and received the first dose of the vaccine), PAIN IN EXTREMITY (sore arm) and HEADACHE (Minor headache) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment medications was mentioned.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: As per attached follow up document the drug start date has been corrected from 23- Mar- 2021 to 22--Mar-2021
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: breast milk; sore arms; fatigue; sore back; headache; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk), PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back) and HEADACHE (headache) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.   On 21-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 19-Apr-2021, the patient was diagnosed with PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back) and HEADACHE (headache). On 20-Apr-2021, the patient was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk) and NO ADVERSE EVENT (son has not has side effects.). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk), PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back), HEADACHE (headache) and NO ADVERSE EVENT (son has not has side effects.) outcome was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: 2nd dose given early, 17 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Pain
Clinical narrative: generalized aching; COVID-19; fatigue; headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache) in a 75-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.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache) 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.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-05-2021 contains non-significant information.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (sore arm) 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 INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (sore arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039E21A and 01421A) for COVID-19 vaccination.     Concurrent medical conditions included Depression since 2010 and Diabetes. Concomitant products included ARIPIPRAZOLE (ABILIFY), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and ALPRAZOLAM (ZENAX) for Depression, METFORMIN for Diabetes.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-085244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR from follow up received and outcome of event was resolved
Sex: F
Vaccine: COVID19
Symptoms: Depression, Pain in extremity
Clinical narrative: sore arm; Depression have worsened; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain in extremity and Depression.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened). At the time of the report, PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened) outcome was unknown.            This case was linked to MOD-2021-085231 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: wife is breastfeeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (wife is breastfeeding) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced EXPOSURE VIA BREAST MILK (wife is breastfeeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EXPOSURE VIA BREAST MILK (wife is breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 19-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) 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 medication was reported.    This case was linked to MOD21-080295, MOD-2021-085949 (Parent-Child Link).   See case MOD21-080295,MOD-2021-085949 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: vaccine from the batch effected by temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine from the batch effected by temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not included  Concomitant medicine include Allopurinol  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-085726 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085726:Husband case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; Nausea; chills; headache; Muscle Pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache) and MYALGIA (Muscle Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain). On 15-Apr-2021, DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) 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.   No concomitant medications reported. Patient mentioned that she uses Herbal products for Diabetes and Hypertension.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Dizziness; Nausea; chills; headache; Muscle Pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache) and MYALGIA (Muscle Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain). On 15-Apr-2021, DIZZINESS (Dizziness), NAUSEA (Nausea), CHILLS (chills), HEADACHE (headache), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) 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.   No concomitant medications reported. Patient mentioned that she uses Herbal products for Diabetes and Hypertension.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Facial neuralgia
Clinical narrative: Irritated one side of the face; Swelling of the eyes; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL NEURALGIA (Irritated one side of the face) and EYE SWELLING (Swelling of the eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Eve primrose and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FACIAL NEURALGIA (Irritated one side of the face) and EYE SWELLING (Swelling of the eyes). At the time of the report, FACIAL NEURALGIA (Irritated one side of the face) and EYE SWELLING (Swelling of the eyes) 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.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: outside of 42 day mark; Should have had her second vaccine on 31 Mar 2021; missed her appointment; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (outside of 42 day mark), PRODUCT DOSE OMISSION ISSUE (Should have had her second vaccine on 31 Mar 2021) and PRODUCT DOSE OMISSION ISSUE (missed her appointment) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her appointment). On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (outside of 42 day mark) and PRODUCT DOSE OMISSION ISSUE (Should have had her second vaccine on 31 Mar 2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (outside of 42 day mark), PRODUCT DOSE OMISSION ISSUE (Should have had her second vaccine on 31 Mar 2021) and PRODUCT DOSE OMISSION ISSUE (missed her appointment) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Vomiting
Clinical narrative: she got sick to her stomach; Did not feel good; Threw up once; Was really tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 2 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired). On 06-Mar-2021, ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired) had resolved.            No Concomitant medications were provided by the reporter. No Treatment History was provided by the reporter.   This case was linked to MOD-2021-031902 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information received on 24 May 2021 does not contain any new information
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; mild headache; achy joints-especially hips; very fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips), FATIGUE (very fatigued) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips), FATIGUE (very fatigued) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Migraine, Neck pain, Pain in extremity
Clinical narrative: Migraine; top of shoulder hurting; Sore arm; Neck pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ARTHRALGIA (top of shoulder hurting) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0257321A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX), RIZATRIPTAN BENZOATE (MAXALT) and IBUPROFEN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (top of shoulder hurting). On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, PAIN IN EXTREMITY (Sore arm), NECK PAIN (Neck pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ARTHRALGIA (top of shoulder hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided Patient said she is definitely not receiving second dose due to horrible migraines.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Mixed dose series (first is pfizer, second shot is moderna); This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-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 22-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)). At the time of the report, WRONG PRODUCT ADMINISTERED (Mixed dose series (first is pfizer, second shot is moderna)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Ear pain, Fatigue, Gait disturbance, Muscle spasms
Clinical narrative: Spotting; Bleeding; Cramping; My hips are hurting and difficult to walk; I have had multiple earaches; my fingers are inflamed in joints; I am exhausted and require more sleep than before; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk) and EAR PAIN (I have had multiple earaches) in a 59-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.     Concomitant products included HYDRALAZINE, LOSARTAN, DILTIAZEM and LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, 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 experienced VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk), EAR PAIN (I have had multiple earaches), ARTHRITIS (my fingers are inflamed in joints) and FATIGUE (I am exhausted and require more sleep than before). At the time of the report, VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding) and MUSCLE SPASMS (Cramping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: normal.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-087078.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound pelvis, Vaginal haemorrhage
Clinical narrative: Spotting; Bleeding; Cramping; My hips are hurting and difficult to walk; I have had multiple earaches; my fingers are inflamed in joints; I am exhausted and require more sleep than before; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk) and EAR PAIN (I have had multiple earaches) in a 59-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.     Concomitant products included HYDRALAZINE, LOSARTAN, DILTIAZEM and LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, 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 experienced VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding), MUSCLE SPASMS (Cramping), GAIT DISTURBANCE (My hips are hurting and difficult to walk), EAR PAIN (I have had multiple earaches), ARTHRITIS (my fingers are inflamed in joints) and FATIGUE (I am exhausted and require more sleep than before). At the time of the report, VAGINAL HAEMORRHAGE (Spotting), VAGINAL HAEMORRHAGE (Bleeding) and MUSCLE SPASMS (Cramping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: normal.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-087078.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested Positive for COVID-19). At the time of the report, COVID-19 (Tested Positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.   This case was linked to MOD-2021-089635 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: feeling even worse; miserable right now; tired; dizzy; nauseated; short of breath; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included hydrochlorothiazide.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (soreness). On 22-Apr-2021, the patient experienced FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now). On 17-Apr-2021, PAIN (soreness) outcome was unknown. At the time of the report, FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated), DYSPNOEA (short of breath), FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now) outcome was unknown.            Treatment was reported as tried some motion sickness pills.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feeling even worse; miserable right now; tired; dizzy; nauseated; short of breath; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included hydrochlorothiazide.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (soreness). On 22-Apr-2021, the patient experienced FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now). On 17-Apr-2021, PAIN (soreness) outcome was unknown. At the time of the report, FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated), DYSPNOEA (short of breath), FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now) outcome was unknown.            Treatment was reported as tried some motion sickness pills.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching from head to waist off and on.constant itching from head to waist.worsened itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching from head to waist off and on.constant itching from head to waist.worsened itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BD1A) for COVID-19 vaccination.     Concomitant products included Aller-Tec pill once daily                                      Allergy pill, OMEPRAZOLE, ATENOLOL, ESCITALOPRAM, ROSUVASTATIN and TRAMADOL for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRURITUS (itching from head to waist off and on.constant itching from head to waist.worsened itching). 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.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-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 PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is calling in to find out if he can take an allergy test on the same day as receiving his second shot of the Covid-19 Moderna Vaccine.  No concomitant medications were reported.  No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstrual disorder, Pain in extremity
Clinical narrative: minor headache; minor fatigue; arm soreness lasted 3-4 days.; Has not got menstrual cycle since first dose was administered; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (minor headache), FATIGUE (minor fatigue), PAIN IN EXTREMITY (arm soreness lasted 3-4 days.) and MENSTRUAL DISORDER (Has not got menstrual cycle since first dose was administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 05-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 HEADACHE (minor headache), FATIGUE (minor fatigue), PAIN IN EXTREMITY (arm soreness lasted 3-4 days.) and MENSTRUAL DISORDER (Has not got menstrual cycle since first dose was administered). On 06-Mar-2021, HEADACHE (minor headache) and FATIGUE (minor fatigue) had resolved. On 08-Mar-2021, PAIN IN EXTREMITY (arm soreness lasted 3-4 days.) had resolved. At the time of the report, MENSTRUAL DISORDER (Has not got menstrual cycle since first dose was administered) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-089544 (Patient Link).