chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain returned and felt like someone was jabbing the arm with a knife; Pain spread to clavicle area; Unbearable arm pain; Severe pain in right arm/ arm felt heavy and painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in right arm/ arm felt heavy and painful), PAIN IN EXTREMITY (Pain returned and felt like someone was jabbing the arm with a knife), PAIN (Unbearable arm pain) and PAIN (Pain spread to clavicle area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in right arm/ arm felt heavy and painful). On 20-Feb-2021, the patient experienced PAIN (Unbearable arm pain). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain returned and felt like someone was jabbing the arm with a knife) and PAIN (Pain spread to clavicle area). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of 400 mg. On 23-Feb-2021, PAIN IN EXTREMITY (Severe pain in right arm/ arm felt heavy and painful) and PAIN (Unbearable arm pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain returned and felt like someone was jabbing the arm with a knife) and PAIN (Pain spread to clavicle area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site warm to touch; Injection site red; Injection site sore; Injection site itchy; Injection site swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, INJECTION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness
Clinical narrative: weakness in legs; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs) and FATIGUE (fatigue) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 04-Feb-2021, the patient experienced FATIGUE (fatigue). On 05-Feb-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs). On 05-Feb-2021, FATIGUE (fatigue) had resolved. On 06-Feb-2021, MUSCULAR WEAKNESS (weakness in legs) had resolved.            No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Duration of AE, Patient stated that events were  only present for 24 hours and denied email.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headachy; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headachy) and FATIGUE (Tired) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced HEADACHE (headachy) and FATIGUE (Tired). On 31-Dec-2020, HEADACHE (headachy) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he has had a rash from injection site on the outside of his arm to his elbo; This spontaneous case was reported by a consumer and describes the occurrence of RASH (he has had a rash from injection site on the outside of his arm to his elbo) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM, TRAZODONE, GABAPENTIN, CARVEDILOL, NITROGLYCERIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]), LISINOPRIL, MELATONIN and SALBUTAMOL (SALBUTEROL) for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (he has had a rash from injection site on the outside of his arm to his elbo). At the time of the report, RASH (he has had a rash from injection site on the outside of his arm to his elbo) outcome was unknown.            patient took blood thinner and glaucoma drops as concomitant medications The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Tender knot at the site of injection; sore at the site of injection; Red knot at the site of injection; Itchy knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Tender knot at the site of injection), VACCINATION SITE PAIN (sore at the site of injection), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE MASS (Tender knot at the site of injection), VACCINATION SITE PAIN (sore at the site of injection), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection). At the time of the report, VACCINATION SITE MASS (Tender knot at the site of injection), VACCINATION SITE PAIN (sore at the site of injection), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Soreness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and PYREXIA (Slight fever) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Soreness) and PYREXIA (Slight fever). At the time of the report, PAIN (Soreness) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: soreness in his arm; body pain; muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm), PAIN (body pain) and MYALGIA (muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in his arm), PAIN (body pain) and MYALGIA (muscle aches). At the time of the report, PAIN IN EXTREMITY (soreness in his arm), PAIN (body pain) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication details were not reported. The patient declined follow-up.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Laid in bed; Nausea immediately after injection, nausea continues; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Laid in bed) and NAUSEA (Nausea immediately after injection, nausea continues) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (Nausea immediately after injection, nausea continues). On 15-Feb-2021, the patient experienced MALAISE (Laid in bed). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (Laid in bed) outcome was unknown and NAUSEA (Nausea immediately after injection, nausea continues) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified acid reflux medication.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Diarrhoea, Dizziness, Lethargy
Clinical narrative: deyhdrated; lethargic; weak; very severe dizziness; diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very severe dizziness), DEHYDRATION (deyhdrated), DIARRHOEA (diarrhea), LETHARGY (lethargic) and ASTHENIA (weak) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage 1. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage 2. On 23-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, the patient experienced DIZZINESS (very severe dizziness). On 02-Mar-2021, the patient experienced LETHARGY (lethargic) and ASTHENIA (weak). On an unknown date, the patient experienced DEHYDRATION (deyhdrated). At the time of the report, DIZZINESS (very severe dizziness), DEHYDRATION (deyhdrated), DIARRHOEA (diarrhea), LETHARGY (lethargic) and ASTHENIA (weak) outcome was unknown.            Concomitant medications were not reported. The patient received unspecified medication as a treatment for dizziness.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Received only 0.3 ml instead of the full 0.5 ml of the vaccine; Syringe malfunctioned; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Received only 0.3 ml instead of the full 0.5 ml of the vaccine) and SYRINGE ISSUE (Syringe malfunctioned) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 ml. On an unknown date, the patient experienced UNDERDOSE (Received only 0.3 ml instead of the full 0.5 ml of the vaccine) and SYRINGE ISSUE (Syringe malfunctioned). At the time of the report, UNDERDOSE (Received only 0.3 ml instead of the full 0.5 ml of the vaccine) and SYRINGE ISSUE (Syringe malfunctioned) 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.   Concomitant medication was not reported. Treatment medication was not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101.2F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.2F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A211A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (Fever of 101.2F). At the time of the report, PYREXIA (Fever of 101.2F) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 101.2 (High) 101.2 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Arm Pain; Rash; Welts - All Over Body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), RASH (Rash) and URTICARIA (Welts - All Over Body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Allergy (unspecified). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), RASH (Rash) and URTICARIA (Welts - All Over Body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, Urticaria and Pain in extremity, at an unspecified dose and frequency and HYDROCORTISONE ACETATE (CORTIZONE-10 [HYDROCORTISONE ACETATE]) ongoing since an unknown date for Rash, Urticaria and Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm Pain), RASH (Rash) and URTICARIA (Welts - All Over Body) 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Limb discomfort, Lip swelling, Pain, Pyrexia
Clinical narrative: Left Rotator Cuff Hurt; Unable to lift up her left arm; Swollen Lips; Swollen Face; Fever 100.8 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Left Rotator Cuff Hurt), LIMB DISCOMFORT (Unable to lift up her left arm), LIP SWELLING (Swollen Lips), FACE OEDEMA (Swollen Face) and PYREXIA (Fever 100.8 F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic angioedema.    On 18-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN (Left Rotator Cuff Hurt), LIMB DISCOMFORT (Unable to lift up her left arm), LIP SWELLING (Swollen Lips), FACE OEDEMA (Swollen Face) and PYREXIA (Fever 100.8 F). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) ongoing since an unknown date for Face oedema, Lip swelling, Limb discomfort and Pain, at an unspecified dose and frequency. On 19-Jan-2021, LIP SWELLING (Swollen Lips) and FACE OEDEMA (Swollen Face) had resolved. On 24-Jan-2021, PAIN (Left Rotator Cuff Hurt), LIMB DISCOMFORT (Unable to lift up her left arm) and PYREXIA (Fever 100.8 F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: 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 EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive.         No concomitant medication were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Musculoskeletal discomfort, Myositis, Product dose omission issue
Clinical narrative: Only had one Moderna vaccine back in January; Myositis; Arm was swollen, hot, rash; Terrible pain up shoulder and down back; Arm was swollen, hot, rash; arm was swollen; Shoulder and back are weak; Strange horizontal dark colored bump on left arm by injection site; Asthma attack, lungs started to tighten and wheezing; This spontaneous case was reported by a nurse and describes the occurrence of ASTHMA (Asthma attack, lungs started to tighten and wheezing), MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January) and MYOSITIS (Myositis) in a 72-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 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 ASTHMA (Asthma attack, lungs started to tighten and wheezing). On 13-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), ARTHRALGIA (Terrible pain up shoulder and down back), VACCINATION SITE RASH (Arm was swollen, hot, rash) and VACCINATION SITE SWELLING (arm was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January), MYOSITIS (Myositis) and VACCINATION SITE WARMTH (Arm was swollen, hot, rash). At the time of the report, ASTHMA (Asthma attack, lungs started to tighten and wheezing), MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January), MYOSITIS (Myositis), ARTHRALGIA (Terrible pain up shoulder and down back) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown and VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), VACCINATION SITE WARMTH (Arm was swollen, hot, rash) and VACCINATION SITE RASH (Arm was swollen, hot, rash) had not 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.   Concomitant medication details were not reported.  Treatment included antibiotics and inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Events and outcome of events. On 13-Jul-2021: Follow up received included no new information; 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Only had one Moderna vaccine back in January; Myositis; Arm was swollen, hot, rash; Terrible pain up shoulder and down back; Arm was swollen, hot, rash; arm was swollen; Shoulder and back are weak; Strange horizontal dark colored bump on left arm by injection site; Asthma attack, lungs started to tighten and wheezing; This spontaneous case was reported by a nurse and describes the occurrence of ASTHMA (Asthma attack, lungs started to tighten and wheezing), MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January) and MYOSITIS (Myositis) in a 72-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 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 ASTHMA (Asthma attack, lungs started to tighten and wheezing). On 13-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), ARTHRALGIA (Terrible pain up shoulder and down back), VACCINATION SITE RASH (Arm was swollen, hot, rash) and VACCINATION SITE SWELLING (arm was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January), MYOSITIS (Myositis) and VACCINATION SITE WARMTH (Arm was swollen, hot, rash). At the time of the report, ASTHMA (Asthma attack, lungs started to tighten and wheezing), MUSCULOSKELETAL DISCOMFORT (Shoulder and back are weak), PRODUCT DOSE OMISSION ISSUE (Only had one Moderna vaccine back in January), MYOSITIS (Myositis), ARTHRALGIA (Terrible pain up shoulder and down back) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown and VACCINATION SITE MASS (Strange horizontal dark colored bump on left arm by injection site), VACCINATION SITE WARMTH (Arm was swollen, hot, rash) and VACCINATION SITE RASH (Arm was swollen, hot, rash) had not 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.   Concomitant medication details were not reported.  Treatment included antibiotics and inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Events and outcome of events. On 13-Jul-2021: Follow up received included no new information; 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.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm at injection site; itchy at injection site; Arm at injection site is red; Swelling at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE ERYTHEMA (Arm at injection site is red), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE ERYTHEMA (Arm at injection site is red), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (itchy at injection site). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE ERYTHEMA (Arm at injection site is red), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed with "Nethyl Prednisolone" 4 mg for her hip. Treatment medication was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site hypersensitivity, Pain in extremity, Pruritus, Rash
Clinical narrative: itching; swollen; red; It was 3.5 inches long and 2.5 inches wide; rash; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red) and INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Feb-2021, the patient experienced PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red), INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red), INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included cold compress and hydrocortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter contact information was updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: itching; swollen; red; It was 3.5 inches long and 2.5 inches wide; rash; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red) and INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Feb-2021, the patient experienced PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red), INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red), INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included cold compress and hydrocortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter contact information was updated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: shakes; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) and PYREXIA (Fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 25-Jan-2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced TREMOR (shakes) and PYREXIA (Fever). At the time of the report, TREMOR (shakes) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored incorrectly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored incorrectly) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored incorrectly). On 01-Mar-2021, PRODUCT STORAGE ERROR (Vaccine was stored incorrectly) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-041703, MOD21-041814 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up received include no new information.; Reporter's Comments: This report refers to a case of product storage error  for mRNA-1273, lot # 025A21A  with no associated AEs.; Sender's Comments:  MOD21-041703:crosslinked MOD21-041814:crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchiness around the injection site; Redness around the injection site; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Neck pain. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, PREGABALIN (LYRICA) for Neck pain.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness around the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated she stopped taking the Lyrica for neck pain because it was not working. Patient reported she had a big red circle around her injection site. The patient rubbed alcohol on it and took a Tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Dizziness, Fatigue, Heart rate increased, Myalgia
Clinical narrative: Concerned about getting 2nd vaccine; Fast heart rate; Muscle ache; Fatigue; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), COVID-19 IMMUNISATION (Concerned about getting 2nd vaccine), HEART RATE INCREASED (Fast heart rate), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M024) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Hay fever.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), MYALGIA (Muscle ache) and FATIGUE (Fatigue). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Concerned about getting 2nd vaccine). At the time of the report, DIZZINESS (Dizziness), COVID-19 IMMUNISATION (Concerned about getting 2nd vaccine), HEART RATE INCREASED (Fast heart rate), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications not provided Treatment information not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Called and reporter declined further follow-up
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: Temperature 95-96°F; Got the first shot of the vaccine and tested positive for COVID the same day; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got the first shot of the vaccine and tested positive for COVID the same day) and PYREXIA (Temperature 95-96°F) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (Got the first shot of the vaccine and tested positive for COVID the same day). On an unknown date, the patient experienced PYREXIA (Temperature 95-96°F). At the time of the report, COVID-19 (Got the first shot of the vaccine and tested positive for COVID the same day) and PYREXIA (Temperature 95-96°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 95-96 (Inconclusive) Temperature 95-96°F. On 26-Feb-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient got the mRNA-1273 Moderna vaccine on 26-Feb-2021 and a few hours later got a swab test for COVID-19 because patient was scheduled for leg surgery on 01-Mar-2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Myalgia, Vaccination complication
Clinical narrative: Just not right; Sweating; Weakness; did not want to get out of bed; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Just not right), MYALGIA (Achiness), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness; did not want to get out of bed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION (Just not right), MYALGIA (Achiness), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness; did not want to get out of bed). At the time of the report, VACCINATION COMPLICATION (Just not right), MYALGIA (Achiness), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness; did not want to get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient received vaccine at 01:24 PM on 09-Feb-2021 and waited for the allotted 15 minutes. At 10PM, the evening of 09-Feb2-021 the patient went to bed and woke between 1-2AM experiencing achiness, sweating, just not right. The patient experienced weakness all day on 10-Feb-2021. Her symptoms eventually subsided towards the evening. She did not expect the symptoms at that time. The patient was not 100%, but better. On 11-Feb-2021 the patient was still not herself, but planned on showering, washing hair and getting up and out. She felt like she can though. The patient did house chores, which she could care less for, she just felt weakened.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dehydration, Myalgia, Pruritus
Clinical narrative: Dehydration; Itching all over; Upper back pain; Rash here and there; Chills; Body ache/ muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), PRURITUS (Itching all over), BACK PAIN (Upper back pain), RASH (Rash here and there) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included DENOSUMAB (PROLIA) and METOPROLOL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DEHYDRATION (Dehydration), PRURITUS (Itching all over), BACK PAIN (Upper back pain), RASH (Rash here and there), CHILLS (Chills) and MYALGIA (Body ache/ muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Chills, Myalgia and Upper back pain, at an unspecified dose and frequency. On 27-Feb-2021, DEHYDRATION (Dehydration), PRURITUS (Itching all over), BACK PAIN (Upper back pain), RASH (Rash here and there), CHILLS (Chills) and MYALGIA (Body ache/ muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Dehydration; Itching all over; Upper back pain; Rash here and there; Chills; Body ache/ muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), PRURITUS (Itching all over), BACK PAIN (Upper back pain), RASH (Rash here and there) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included DENOSUMAB (PROLIA) and METOPROLOL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DEHYDRATION (Dehydration), PRURITUS (Itching all over), BACK PAIN (Upper back pain), RASH (Rash here and there), CHILLS (Chills) and MYALGIA (Body ache/ muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Chills, Myalgia and Upper back pain, at an unspecified dose and frequency. On 27-Feb-2021, DEHYDRATION (Dehydration), PRURITUS (Itching all over), BACK PAIN (Upper back pain), RASH (Rash here and there), CHILLS (Chills) and MYALGIA (Body ache/ muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; temperature; body ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (temperature) and MYALGIA (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 NAUSEA (Nausea), PYREXIA (temperature) and MYALGIA (body ache). At the time of the report, NAUSEA (Nausea), PYREXIA (temperature) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: upper left arm , where received the vaccine , is swollen; Hot upper left arm; Itchy upper left arm; Very painful upper left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (upper left arm , where received the vaccine , is swollen), FEELING HOT (Hot upper left arm), PRURITUS (Itchy upper left arm) and PAIN IN EXTREMITY (Very painful upper left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (upper left arm , where received the vaccine , is swollen), FEELING HOT (Hot upper left arm), PRURITUS (Itchy upper left arm) and PAIN IN EXTREMITY (Very painful upper left arm). At the time of the report, PERIPHERAL SWELLING (upper left arm , where received the vaccine , is swollen), FEELING HOT (Hot upper left arm), PRURITUS (Itchy upper left arm) and PAIN IN EXTREMITY (Very painful upper left arm) outcome was unknown.            No concomitant medications were reported. Treatment details were not provided.