chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: Felt increasingly weak; chills; headache; cough; runny nose; body ached so bad; had no taste for anything; CONGETSTED; RUNNY NOSE; constipated; Fever progressed; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated) and PYREXIA (Fever progressed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated), PYREXIA (Fever progressed), CHILLS (chills) and HEADACHE (headache). On 16-Jan-2021, the patient experienced ASTHENIA (Felt increasingly weak). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 16-Jan-2021, COUGH (cough), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated), PYREXIA (Fever progressed), ASTHENIA (Felt increasingly weak) and CHILLS (chills) had resolved. On 17-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99f (normal) 99F. On 16-Jan-2021, Body temperature (Unknown-high): 104°f (High) 104°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Felt increasingly weak; chills; headache; cough; runny nose; body ached so bad; had no taste for anything; CONGETSTED; RUNNY NOSE; constipated; Fever progressed; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated) and PYREXIA (Fever progressed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated), PYREXIA (Fever progressed), CHILLS (chills) and HEADACHE (headache). On 16-Jan-2021, the patient experienced ASTHENIA (Felt increasingly weak). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 16-Jan-2021, COUGH (cough), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated), PYREXIA (Fever progressed), ASTHENIA (Felt increasingly weak) and CHILLS (chills) had resolved. On 17-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99f (normal) 99F. On 16-Jan-2021, Body temperature (Unknown-high): 104°f (High) 104°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). On 15-Jan-2021, VACCINATION SITE PAIN (injection site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experiencing side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 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 VACCINATION COMPLICATION (Experiencing side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing side effects) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: woke up with positional vertigo; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo positional. Concurrent medical conditions included Hashimoto's thyroiditis, Penicillin allergy, High cholesterol and Breast cancer aggravated. Concomitant products included LEVOTHYROXINE and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ESCITALOPRAM OXALATE (ESCITALOPRAN) and PRENATAL VITAMINS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Feb-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) 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 treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot
Clinical narrative: having sensation in right hip that is hot; burning sensation in my hip joints; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (having sensation in right hip that is hot) and ARTHRALGIA (burning sensation in my hip joints) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PANTOPRAZOLE, VITAMINS NOS, GABAPENTIN and GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced FEELING HOT (having sensation in right hip that is hot) and ARTHRALGIA (burning sensation in my hip joints). On 19-Jan-2021, FEELING HOT (having sensation in right hip that is hot) and ARTHRALGIA (burning sensation in my hip joints) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: itch at the injection site; raised bumps at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (itch at the injection site) and INJECTION SITE MASS (raised bumps at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by the reporter.     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 INJECTION SITE PRURITUS (itch at the injection site) and INJECTION SITE MASS (raised bumps at the injection site). At the time of the report, INJECTION SITE PRURITUS (itch at the injection site) and INJECTION SITE MASS (raised bumps at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, SARS-CoV-2 test
Clinical narrative: stomach ache; She tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache) and COVID-19 (She tested positive for Covid-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 immunization.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, the patient experienced COVID-19 (She tested positive for Covid-19). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) for Adverse event, at an unspecified dose and frequency. On 16-Jan-2021, ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown. At the time of the report, COVID-19 (She tested positive for Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     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.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.. Based on the current available information and temporal association between the use of the product and the start date of abdominal pain upper, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: burning, stinging pain on my eyebrow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (burning, stinging pain on my eyebrow) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced INJECTION SITE PAIN (burning, stinging pain on my eyebrow). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (burning, stinging pain on my eyebrow) was resolving. Burning , stinging pain on her eyebrow 2 days post injection. On 27-DEC-2020, it moved into her eyeballs and up the left side of her face and top of her head and a little bit in her left arm, but only on the left side. No visible rash or burn. It peaked that week. On 19-JAN-2021, it comes and goes sometimes in her eyebrow, but most of that resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Rash papular
Clinical narrative: raised rash, about 4 inches; Injection site warmth; It itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised rash, about 4 inches), INJECTION SITE WARMTH (Injection site warmth) and INJECTION SITE PRURITUS (It itches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced RASH PAPULAR (raised rash, about 4 inches), INJECTION SITE WARMTH (Injection site warmth) and INJECTION SITE PRURITUS (It itches). At the time of the report, RASH PAPULAR (raised rash, about 4 inches), INJECTION SITE WARMTH (Injection site warmth) and INJECTION SITE PRURITUS (It itches) outcome was unknown. rash is about 4 inches      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Covid 19 Positive (Sore throat); Redness near the injection site; Swelling near the injection site; Tenderness near the injection site; A hot sensation near the injection site; Case reference number MOD-2021-009528 is a spontaneous case report sent by a Physician on 19-JAN-2021 00:00:00 , which refers to a Female aged 57 Years .  The patients past medical history included: No adverse event   . .  On 31/DEC/2020  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  9 days later,  the patient developed Injection site redness,swelling, tenderness, warmth,Sore throat.The patient experienced the following serious criteria:. The eventual diagnosis made on was Injection site erythema . .   The patient was treated for the event with Monoclonal antibodies ,Antibiotics  .The action taken for Moderna COVID-19 Vaccine was  Unknown . The Physician did not declare any relatedness between Redness near the injection site and Moderna COVID-19 Vaccine.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for Safety Update narratives and signal review) Brief 3 line summary of above for Council listing: Report Source- Physician,  Age- 57 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment- Monoclonal antibodies,Antibiotics  Diagnosis\Outcome- Covid 19 Positive (Sore throat) - Unknown,A hot sensation near the injection site - Unknown,Tenderness near the injection site - Unknown,Swelling near the injection site - Unknown,Redness near the injection site - Unknown.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 positive (sore throat), is assessed as unlikely related.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Gait disturbance, Myalgia
Clinical narrative: could barely walk; when he puts pressure on right leg it now hurts from knee to buttocks; chills; muscle aches; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes and Peanut allergy. Concomitant products included CHLORIDE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site reaction
Clinical narrative: Sore arm; had the Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (had the Moderna arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (had the Moderna arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (had the Moderna arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information On 14-Apr-2021: Event And Email ID updated
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site hard; Injection site,  swelled up; Injection site, it red; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Injection site hard), INJECTION SITE SWELLING (Injection site,  swelled up), INJECTION SITE ERYTHEMA (Injection site, it red) and INJECTION SITE PAIN (Injection site sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INDURATION (Injection site hard), INJECTION SITE SWELLING (Injection site,  swelled up), INJECTION SITE ERYTHEMA (Injection site, it red) and INJECTION SITE PAIN (Injection site sore). At the time of the report, INJECTION SITE INDURATION (Injection site hard), INJECTION SITE SWELLING (Injection site,  swelled up), INJECTION SITE ERYTHEMA (Injection site, it red) and INJECTION SITE PAIN (Injection site sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was included.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pregnancy (Live full term birth on May 2017). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FOLIC ACID for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 29-Mar-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh month of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported positive pregnancy test  JUL2021 and due date is  29 Mar2021 There is discrepancies  between positive pregnancy test  & due date. Patient reported live full-term child birth on MAY2017. Concomitant medications prenatal vitamins, folic acid. Treatment medications were not provided This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Urticaria from shoulder to elbow; Arm warm to the touch; Arm swollen; severe itching; Left upper arm - red; Arm was sore; Arm was bruised/little discolored; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE BRUISING (Arm was bruised/little discolored), URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE SWELLING (Arm swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy and Constipation chronic. Concomitant products included LINACLOTIDE (LINZESS) and MACROGOL 3350 (MIRALAX) for Constipation, BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Arm was bruised/little discolored) and VACCINATION SITE PAIN (Arm was sore). On 14-Jan-2021, the patient experienced URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PRURITUS (severe itching) and VACCINATION SITE ERYTHEMA (Left upper arm - red). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) at a dose of 10 mg and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 09-Jan-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. On 19-Jan-2021, VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE PRURITUS (severe itching) had resolved. On 20-Jan-2021, VACCINATION SITE BRUISING (Arm was bruised/little discolored), URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch) and VACCINATION SITE ERYTHEMA (Left upper arm - red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE SWELLING (Arm swollen) to be possibly related. No further causality assessments were provided for VACCINATION SITE BRUISING (Arm was bruised/little discolored), URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE PRURITUS (severe itching) and VACCINATION SITE ERYTHEMA (Left upper arm - red).    This case was linked to MOD-2021-076807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Added patient demographics, stop date of events. Updated the concomitant medications and event outcome.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Urticaria from shoulder to elbow; Arm warm to the touch; Arm swollen; severe itching; Left upper arm - red; Arm was sore; Arm was bruised/little discolored; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE BRUISING (Arm was bruised/little discolored), URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE SWELLING (Arm swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy and Constipation chronic. Concomitant products included LINACLOTIDE (LINZESS) and MACROGOL 3350 (MIRALAX) for Constipation, BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Arm was bruised/little discolored) and VACCINATION SITE PAIN (Arm was sore). On 14-Jan-2021, the patient experienced URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PRURITUS (severe itching) and VACCINATION SITE ERYTHEMA (Left upper arm - red). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) at a dose of 10 mg and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 09-Jan-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. On 19-Jan-2021, VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE PRURITUS (severe itching) had resolved. On 20-Jan-2021, VACCINATION SITE BRUISING (Arm was bruised/little discolored), URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch) and VACCINATION SITE ERYTHEMA (Left upper arm - red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE SWELLING (Arm swollen) to be possibly related. No further causality assessments were provided for VACCINATION SITE BRUISING (Arm was bruised/little discolored), URTICARIA (Urticaria from shoulder to elbow), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE PRURITUS (severe itching) and VACCINATION SITE ERYTHEMA (Left upper arm - red).    This case was linked to MOD-2021-076807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Added patient demographics, stop date of events. Updated the concomitant medications and event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Concomitant products included ROSUVASTATIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: hot; bright red; round spot around the injection site; itching; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE DISCOLOURATION (round spot around the injection site), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (bright red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, FLUOXETINE, BUSPIRONE and LAMOTRIGINE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (round spot around the injection site) and INJECTION SITE PRURITUS (itching). On 17-Jan-2021, the patient experienced INJECTION SITE WARMTH (hot) and INJECTION SITE ERYTHEMA (bright red). On 18-Jan-2021, INJECTION SITE PRURITUS (itching) had resolved. On 19-Jan-2021, INJECTION SITE DISCOLOURATION (round spot around the injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (hot) and INJECTION SITE ERYTHEMA (bright red) 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: Abdominal discomfort, Malaise, Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), ABDOMINAL DISCOMFORT (Arm was sore) and MALAISE (Arm was sore) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 17-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Arm was sore). On 19-Jan-2021, the patient experienced MALAISE (Arm was sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore) and MALAISE (Arm was sore) outcome was unknown and ABDOMINAL DISCOMFORT (Arm was sore) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Arm felt heavy; Arm felt tingly/ Also felt this around her face; Arm felt numb/ Also felt this around her face; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 information was provided.  No concomitant medication was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 19 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: TCR form was attached. email ID was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Headache, Limb discomfort, Malaise
Clinical narrative: coughing up thick brown/reddish phlegm; everything tasted like salt; not well; Headache; Arm really sore; Metallic Taste in Mouth; Lost appetite; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm) and DYSGEUSIA (everything tasted like salt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), MALAISE (not well) and HEADACHE (Headache). On 19-Jan-2021, the patient experienced PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm) and DYSGEUSIA (everything tasted like salt). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qd and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm), DYSGEUSIA (everything tasted like salt), MALAISE (not well) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Fallow up received and treatment medication Zithromax and new events were added On 05-Aug-2021: Follow up  received and reporter address were updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: coughing up thick brown/reddish phlegm; everything tasted like salt; not well; Headache; Arm really sore; Metallic Taste in Mouth; Lost appetite; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm) and DYSGEUSIA (everything tasted like salt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), MALAISE (not well) and HEADACHE (Headache). On 19-Jan-2021, the patient experienced PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm) and DYSGEUSIA (everything tasted like salt). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qd and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm), DYSGEUSIA (everything tasted like salt), MALAISE (not well) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Fallow up received and treatment medication Zithromax and new events were added On 05-Aug-2021: Follow up  received and reporter address were updated.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Hurt for 2 days; Ache; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt for 2 days), PAIN (Ache) and FATIGUE (Felt tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN (Hurt for 2 days), PAIN (Ache) and FATIGUE (Felt tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Ache, at an unspecified dose and frequency. At the time of the report, PAIN (Hurt for 2 days), PAIN (Ache) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment medication aspirin was taken for all events.   No concomitant medication was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: major fatigue; headache; nausea; vomit; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomit), FATIGUE (major fatigue), HEADACHE (headache) and NAUSEA (nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VOMITING (vomit) and NAUSEA (nausea). On an unknown date, the patient experienced FATIGUE (major fatigue) and HEADACHE (headache). On 19-Jan-2021, VOMITING (vomit) and NAUSEA (nausea) had resolved. At the time of the report, FATIGUE (major fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Peripheral swelling
Clinical narrative: pain in the joint; pinch nerve pain; arm is swollen; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (pain in the joint), PAIN (pinch nerve pain) and PERIPHERAL SWELLING (arm is swollen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06l20a) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ARTHRALGIA (pain in the joint), PAIN (pinch nerve pain) and PERIPHERAL SWELLING (arm is swollen). The patient was treated with IBUPROFEN at a dose of UNK, bid. At the time of the report, ARTHRALGIA (pain in the joint), PAIN (pinch nerve pain) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; CHILLS; soreness of arm; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (CHILLS), PAIN IN EXTREMITY (soreness of arm), NAUSEA (Nausea) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (CHILLS), PAIN IN EXTREMITY (soreness of arm), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (CHILLS), PAIN IN EXTREMITY (soreness of arm), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm got red, swelling, bruising, itchy; Arm got red, swelling, bruising, itchy; Arm got red, swelling, bruising, itchy; Arm got red, swelling, bruising, itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm got red, swelling, bruising, itchy), VACCINATION SITE SWELLING (Arm got red, swelling, bruising, itchy), VACCINATION SITE BRUISING (Arm got red, swelling, bruising, itchy) and VACCINATION SITE PRURITUS (Arm got red, swelling, bruising, itchy) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm got red, swelling, bruising, itchy), VACCINATION SITE SWELLING (Arm got red, swelling, bruising, itchy), VACCINATION SITE BRUISING (Arm got red, swelling, bruising, itchy) and VACCINATION SITE PRURITUS (Arm got red, swelling, bruising, itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Arm got red, swelling, bruising, itchy), VACCINATION SITE SWELLING (Arm got red, swelling, bruising, itchy), VACCINATION SITE BRUISING (Arm got red, swelling, bruising, itchy) and VACCINATION SITE PRURITUS (Arm got red, swelling, bruising, itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site bruising
Clinical narrative: left arm was swollen; wide ring on her left arm, a bruise with a red ring around it; patch of redness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of   in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given a topical cream for treatment.  No concomitant medication was provided.