chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate decreased, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she was shaking like a druggy), HEART RATE DECREASED (heart rate at 44), FATIGUE (wiped out) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (she was shaking like a druggy), FATIGUE (wiped out) and HEADACHE (headache). On 21-Mar-2021, the patient experienced HEART RATE DECREASED (heart rate at 44). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 19-Mar-2021, TREMOR (she was shaking like a druggy) and FATIGUE (wiped out) had resolved. On 21-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, HEART RATE DECREASED (heart rate at 44) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnant patient received the 1st Moderna covid-19 vaccination; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (complication of shoulder dystocia upon delivery and live, full-term birth.) and Pregnancy. Concurrent medical conditions included Drug allergy (Sulfa), Rash lupus-like (Lupus- NOS) since 01-Feb-2020, Drug allergy (Ceclor), Drug allergy (Bactrim) and Drug allergy (cephalosporins - rash). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ASPIRIN [ACETYLSALICYLIC ACID] for Pregnancy, HYDROXYCHLOROQUINE for Rash lupus-like, VITAMIN D NOS for Vitamin D deficiency.   On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Nov-2020 and the estimated date of delivery was 24-Aug-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Ultrasound foetal: normal (normal) 12 week US. On 03-Mar-2021, Ultrasound foetal: normal (normal) 20 Week Ultrasound.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test was 24-Dec-2020. The patient has an established prenatal care. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received contains non-significant information.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Body temperature, Cough, Oropharyngeal pain, Pain
Clinical narrative: Aches; Sore Throat; Was in Bed 3 days; Arm was really sore; Bad cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough). At the time of the report, PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102f (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome updated.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Aches; Sore Throat; Was in Bed 3 days; Arm was really sore; Bad cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough). At the time of the report, PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102f (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: severe pain from her neck to the top of her arm; severe pain from her neck to the top of her arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm). At the time of the report, NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: 9 cm area erythema; hot to the touch at the injection site; itching at the injection site; red at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) (oral) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (topical) at a dose of 0.1 percent. At the time of the report, ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) 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.   No concomitant medication were provided.  Treatment medication included Bactrom and triamcinolone acetonide 0.1 % topical cream.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Panic reaction
Clinical narrative: having shortness of breath; Doing a great deal of coughing; Really panicking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking). At the time of the report, DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-Jun-2021 contains significant information. Changed outcome of the event from unknown to recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: Hard time sleeping; Didnt feel good; Feeling sick; Arm started hurting, right arm also started hurting; Feeling very tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting) and FATIGUE (Feeling very tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A 028L20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included GABAPENTIN, SPIRONOLACTONE, FUROSEMIDE, OMEPRAZOLE, FOLIC ACID, VITAMIN B12 NOS, POTASSIUM, ELDERBERRY [SAMBUCUS NIGRA], GARLIC [ALLIUM SATIVUM], TURMERIC [CURCUMA LONGA RHIZOME], CALCIUM, MAGNESIUM, LACTULOSE and UBIDECARENONE (COQ 10) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), HEADACHE (Headache) and CHILLS (Chills). 20-Mar-2021, the patient experienced FATIGUE (Feeling very tired). The patient was treated with TRAMADOL at an unspecified dose and frequency and Manual therapy (cold packs on arm) for Pain in extremity. At the time of the report, INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), FATIGUE (Feeling very tired), HEADACHE (Headache) and CHILLS (Chills) was resolving.            This case was linked to US-MODERNATX, INC.-MOD-2021-054246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054246:patient link, 1st dose case
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Hard time sleeping; Didnt feel good; Feeling sick; Arm started hurting, right arm also started hurting; Feeling very tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting) and FATIGUE (Feeling very tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A 028L20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included GABAPENTIN, SPIRONOLACTONE, FUROSEMIDE, OMEPRAZOLE, FOLIC ACID, VITAMIN B12 NOS, POTASSIUM, ELDERBERRY [SAMBUCUS NIGRA], GARLIC [ALLIUM SATIVUM], TURMERIC [CURCUMA LONGA RHIZOME], CALCIUM, MAGNESIUM, LACTULOSE and UBIDECARENONE (COQ 10) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), HEADACHE (Headache) and CHILLS (Chills). 20-Mar-2021, the patient experienced FATIGUE (Feeling very tired). The patient was treated with TRAMADOL at an unspecified dose and frequency and Manual therapy (cold packs on arm) for Pain in extremity. At the time of the report, INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), FATIGUE (Feeling very tired), HEADACHE (Headache) and CHILLS (Chills) was resolving.            This case was linked to US-MODERNATX, INC.-MOD-2021-054246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054246:patient link, 1st dose case
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Headache
Clinical narrative: Affected heartbeat (the next morning).; Swollen throat--not too much; Difficulty breathing--not gasping for air,; Unable to sleep; Headache; Joint pain; Nausea; Muscle pain; Fever of 101.3; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (December 2020). Concurrent medical conditions included Lung scarring (Due to COVID-19 in December2020). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LATANOPROST, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and DORZOLAMIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills). On 28-Feb-2021, the patient experienced HEART RATE IRREGULAR (Affected heartbeat (the next morning).). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) Units not reported, Fever confirmed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Insomnia, Myalgia, Nausea, Pharyngeal swelling
Clinical narrative: Affected heartbeat (the next morning).; Swollen throat--not too much; Difficulty breathing--not gasping for air,; Unable to sleep; Headache; Joint pain; Nausea; Muscle pain; Fever of 101.3; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (December 2020). Concurrent medical conditions included Lung scarring (Due to COVID-19 in December2020). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LATANOPROST, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and DORZOLAMIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills). On 28-Feb-2021, the patient experienced HEART RATE IRREGULAR (Affected heartbeat (the next morning).). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) Units not reported, Fever confirmed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Affected heartbeat (the next morning).; Swollen throat--not too much; Difficulty breathing--not gasping for air,; Unable to sleep; Headache; Joint pain; Nausea; Muscle pain; Fever of 101.3; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (December 2020). Concurrent medical conditions included Lung scarring (Due to COVID-19 in December2020). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LATANOPROST, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and DORZOLAMIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills). On 28-Feb-2021, the patient experienced HEART RATE IRREGULAR (Affected heartbeat (the next morning).). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) Units not reported, Fever confirmed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Musculoskeletal stiffness, Nausea, Pruritus
Clinical narrative: skin infection; Itchiness; Hotness; Stiff shoulders; Swelling; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling) and HEADACHE (Headache) in a 53-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.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), METFORMIN, LISDEXAMFETAMINE MESILATE (VYVANSE), COLECALCIFEROL (VIT D [COLECALCIFEROL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), TIOTROPIUM BROMIDE (SPIRIVA) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced SKIN INFECTION (skin infection). The patient was treated with DICLOFENAC at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache), NAUSEA (Nausea) and SKIN INFECTION (skin infection) 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.   The patient's medical history was not provided. Treatment details included Diclofenac, Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: fallow up information received on 05-apr-2021 updated the outcome of the event skin infection from( unknown to unknown)
Sex: F
Vaccine: COVID19
Symptoms: Skin infection, Swelling
Clinical narrative: skin infection; Itchiness; Hotness; Stiff shoulders; Swelling; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling) and HEADACHE (Headache) in a 53-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.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), METFORMIN, LISDEXAMFETAMINE MESILATE (VYVANSE), COLECALCIFEROL (VIT D [COLECALCIFEROL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), TIOTROPIUM BROMIDE (SPIRIVA) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced SKIN INFECTION (skin infection). The patient was treated with DICLOFENAC at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache), NAUSEA (Nausea) and SKIN INFECTION (skin infection) 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.   The patient's medical history was not provided. Treatment details included Diclofenac, Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: fallow up information received on 05-apr-2021 updated the outcome of the event skin infection from( unknown to unknown)
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to her face cream; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to her face cream) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to her face cream). At the time of the report, HYPERSENSITIVITY (Allergic reaction to her face cream) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE ERYTHEMA (red swatch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 14-Apr-2021, the patient experienced ORAL HERPES (fever blister(cold sore)). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (very sore arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product was none.  Treatment included as tylenol and ice pack
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE ERYTHEMA (red swatch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 14-Apr-2021, the patient experienced ORAL HERPES (fever blister(cold sore)). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (very sore arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product was none.  Treatment included as tylenol and ice pack
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Bone pain, Myalgia, Night sweats, Vaccination complication
Clinical narrative: Bone pain; Vivid dreams; vaccination related malaise; Night sweat; Vaccination  site erythema; Vaccination site swelling; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat) and VACCINATION SITE ERYTHEMA (Vaccination  site erythema) in a 78-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.     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 BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination  site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia). At the time of the report, BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination  site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information received
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Bone pain; Vivid dreams; vaccination related malaise; Night sweat; Vaccination  site erythema; Vaccination site swelling; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat) and VACCINATION SITE ERYTHEMA (Vaccination  site erythema) in a 78-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.     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 BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination  site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia). At the time of the report, BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination  site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information received
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Dose administered at day 20; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement
Clinical narrative: serious joint pain in shoulder in the same arm as injection, left non-dominant arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure (high).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Mar-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 ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm). At the time of the report, ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Have not received second dose within 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days) 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.    In January 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Insomnia, Limb discomfort
Clinical narrative: Increased bleeding during period; Itching; Vaginal dryness; Vaginal pain; Difficulty sleeping; Circular pattern; Sharp pain; Tendon pain; Bump on underarm; Arm pain; Tirdness; Headache; Nausea; Throwing up; Arm swelling; Not being able to lift up arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain) and TENDON PAIN (Tendon pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), LIMB DISCOMFORT (Not being able to lift up arm) and VOMITING (Throwing up). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Tirdness), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced MASS (Bump on underarm). On 16-Mar-2021, the patient experienced PAIN (Sharp pain), TENDON PAIN (Tendon pain) and RASH (Circular pattern). On 17-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 22-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness) and VULVOVAGINAL PAIN (Vaginal pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain), TENDON PAIN (Tendon pain), INSOMNIA (Difficulty sleeping), HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness), VULVOVAGINAL PAIN (Vaginal pain), LIMB DISCOMFORT (Not being able to lift up arm), RASH (Circular pattern), FATIGUE (Tirdness), VOMITING (Throwing up), HEADACHE (Headache) and NAUSEA (Nausea) 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 concomitant medications were reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Increased bleeding during period; Itching; Vaginal dryness; Vaginal pain; Difficulty sleeping; Circular pattern; Sharp pain; Tendon pain; Bump on underarm; Arm pain; Tirdness; Headache; Nausea; Throwing up; Arm swelling; Not being able to lift up arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain) and TENDON PAIN (Tendon pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), LIMB DISCOMFORT (Not being able to lift up arm) and VOMITING (Throwing up). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Tirdness), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced MASS (Bump on underarm). On 16-Mar-2021, the patient experienced PAIN (Sharp pain), TENDON PAIN (Tendon pain) and RASH (Circular pattern). On 17-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 22-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness) and VULVOVAGINAL PAIN (Vaginal pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain), TENDON PAIN (Tendon pain), INSOMNIA (Difficulty sleeping), HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness), VULVOVAGINAL PAIN (Vaginal pain), LIMB DISCOMFORT (Not being able to lift up arm), RASH (Circular pattern), FATIGUE (Tirdness), VOMITING (Throwing up), HEADACHE (Headache) and NAUSEA (Nausea) 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 concomitant medications were reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Tendon pain, Vomiting, Vulvovaginal dryness
Clinical narrative: Increased bleeding during period; Itching; Vaginal dryness; Vaginal pain; Difficulty sleeping; Circular pattern; Sharp pain; Tendon pain; Bump on underarm; Arm pain; Tirdness; Headache; Nausea; Throwing up; Arm swelling; Not being able to lift up arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain) and TENDON PAIN (Tendon pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), LIMB DISCOMFORT (Not being able to lift up arm) and VOMITING (Throwing up). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Tirdness), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced MASS (Bump on underarm). On 16-Mar-2021, the patient experienced PAIN (Sharp pain), TENDON PAIN (Tendon pain) and RASH (Circular pattern). On 17-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 22-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness) and VULVOVAGINAL PAIN (Vaginal pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain), TENDON PAIN (Tendon pain), INSOMNIA (Difficulty sleeping), HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness), VULVOVAGINAL PAIN (Vaginal pain), LIMB DISCOMFORT (Not being able to lift up arm), RASH (Circular pattern), FATIGUE (Tirdness), VOMITING (Throwing up), HEADACHE (Headache) and NAUSEA (Nausea) 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 concomitant medications were reported