chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site discharge
Clinical narrative: a small amount or a couple of drops dripped back out from the injection site on the arm; 2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCHARGE (a small amount or a couple of drops dripped back out from the injection site on the arm) and INCORRECT DOSE ADMINISTERED (2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE DISCHARGE (a small amount or a couple of drops dripped back out from the injection site on the arm) and INCORRECT DOSE ADMINISTERED (2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL). On 18-Mar-2021, VACCINATION SITE DISCHARGE (a small amount or a couple of drops dripped back out from the injection site on the arm) and INCORRECT DOSE ADMINISTERED (2 droplets that was about an inch dripped out before it stopped and it seemed to be less than 0.4mL) 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Therapeutic response unexpected
Clinical narrative: Blood pressure has been better than its ever been; Headaches started the day after; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches started the day after) and THERAPEUTIC RESPONSE UNEXPECTED (Blood pressure has been better than its ever been) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Thrombus. Concurrent medical conditions included Hypertension. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headaches started the day after). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Blood pressure has been better than its ever been). At the time of the report, HEADACHE (Headaches started the day after) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 117/78 (Inconclusive) blood pressure 117/78.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medicine includes asprin For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia, Vomiting
Clinical narrative: sick as a dog; FEVER OF 103; VOMITING; FELT LOUSY FOR 2 DAYS; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), PYREXIA (FEVER OF 103), VOMITING (VOMITING) and FATIGUE (FELT LOUSY FOR 2 DAYS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick as a dog), PYREXIA (FEVER OF 103), VOMITING (VOMITING) and FATIGUE (FELT LOUSY FOR 2 DAYS). At the time of the report, ILLNESS (sick as a dog), PYREXIA (FEVER OF 103), VOMITING (VOMITING) and FATIGUE (FELT LOUSY FOR 2 DAYS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nausea, Somnolence
Clinical narrative: Sleepy; Dizzy; Weak; Head in the cloud; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), DIZZINESS (Dizzy), ASTHENIA (Weak), FEELING ABNORMAL (Head in the cloud) and NAUSEA (Nausea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SOMNOLENCE (Sleepy), DIZZINESS (Dizzy), ASTHENIA (Weak), FEELING ABNORMAL (Head in the cloud) and NAUSEA (Nausea). At the time of the report, SOMNOLENCE (Sleepy), DIZZINESS (Dizzy), ASTHENIA (Weak), FEELING ABNORMAL (Head in the cloud) and NAUSEA (Nausea) outcome was unknown.            No concomitant and treatment medication information was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Decreased appetite, Dizziness, Dysstasia
Clinical narrative: sore arm; didn't have any energy; nauseous; head hurt; temperature was 99.8°F; low blood sugar; very dizzy; could hardly stand up; weak felt she couldn't function; achy all over; didn't felt too much like eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (didn't felt too much like eating), BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy) and DYSSTASIA (could hardly stand up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, PANTOPRAZOLE, EZETIMIBE, RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DECREASED APPETITE (didn't felt too much like eating). On 16-Mar-2021, the patient experienced BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), ASTHENIA (weak felt she couldn't function), PAIN (achy all over), NAUSEA (nauseous), HEADACHE (head hurt) and PYREXIA (temperature was 99.8°F). On 17-Mar-2021, the patient experienced ASTHENIA (didn't have any energy). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Mar-2021, DECREASED APPETITE (didn't felt too much like eating) had resolved. On 16-Mar-2021, BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), ASTHENIA (weak felt she couldn't function), PAIN (achy all over), NAUSEA (nauseous), HEADACHE (head hurt) and PYREXIA (temperature was 99.8°F) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (didn't have any energy) outcome was unknown.            Treatment included paracetamol   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; didn't have any energy; nauseous; head hurt; temperature was 99.8°F; low blood sugar; very dizzy; could hardly stand up; weak felt she couldn't function; achy all over; didn't felt too much like eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (didn't felt too much like eating), BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy) and DYSSTASIA (could hardly stand up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, PANTOPRAZOLE, EZETIMIBE, RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DECREASED APPETITE (didn't felt too much like eating). On 16-Mar-2021, the patient experienced BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), ASTHENIA (weak felt she couldn't function), PAIN (achy all over), NAUSEA (nauseous), HEADACHE (head hurt) and PYREXIA (temperature was 99.8°F). On 17-Mar-2021, the patient experienced ASTHENIA (didn't have any energy). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Mar-2021, DECREASED APPETITE (didn't felt too much like eating) had resolved. On 16-Mar-2021, BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), ASTHENIA (weak felt she couldn't function), PAIN (achy all over), NAUSEA (nauseous), HEADACHE (head hurt) and PYREXIA (temperature was 99.8°F) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (didn't have any energy) outcome was unknown.            Treatment included paracetamol   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Pain of skin, Skin discomfort
Clinical narrative: right arm really started hurting which was throbbing; Skin under armpit feels dull after 1st dose; Shooting pain on skin after 1st dose; Arm feels heavy after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm really started hurting which was throbbing), SKIN DISCOMFORT (Skin under armpit feels dull after 1st dose), PAIN OF SKIN (Shooting pain on skin after 1st dose) and LIMB DISCOMFORT (Arm feels heavy after 1st dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right arm really started hurting which was throbbing), SKIN DISCOMFORT (Skin under armpit feels dull after 1st dose), PAIN OF SKIN (Shooting pain on skin after 1st dose) and LIMB DISCOMFORT (Arm feels heavy after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right arm really started hurting which was throbbing), SKIN DISCOMFORT (Skin under armpit feels dull after 1st dose), PAIN OF SKIN (Shooting pain on skin after 1st dose) and LIMB DISCOMFORT (Arm feels heavy after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Tylenol and Aleve.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not provided. Treatment information does not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Inflammation, Pain
Clinical narrative: Horrible inflammation; Severe pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Horrible inflammation) and PAIN (Severe pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gouty arthritis, Osteoarthritis, Baker's cyst and Chondrocalcinosis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Horrible inflammation) and PAIN (Severe pain). The patient was treated with PREDNISONE for Osteoarthritis flare up, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLAMMATION (Horrible inflammation) and PAIN (Severe pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) High c-reactive protein in blood..    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported. Patient stated that she received Cortisone injection in the knee on 01-Feb-2021. Patient had severe swollen right leg due to Osteoarthritis Flare-up on an unknown date. She stated that she had this problem in Oct, Nov and Dec of 2020.She also reported that she took second dose of Moderna vaccine on an unknown date. Patient stated that swelling was due to osteoarthritis and pseudogout  and not due to Moderna vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Added patient demographics (age and DOB). New events swollen legs and severe pain with event outcome as unknown. The treatment drug Tylenol was added. On 18-May-2021: Added patient medical history information as reported. Patient took second dose with very limited information was added. On 22-Jul-2021: The event Swollen legs removed.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash, Swollen tongue
Clinical narrative: Severe rash on their left arm; Slight swelling under their tongue; Tingling on their lip; This spontaneous case was reported by a physician and describes the occurrence of SWOLLEN TONGUE (Slight swelling under their tongue), PARAESTHESIA ORAL (Tingling on their lip) and RASH (Severe rash on their left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 048A21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE for Antacid therapy.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced SWOLLEN TONGUE (Slight swelling under their tongue) and PARAESTHESIA ORAL (Tingling on their lip). On 14-Feb-2021, the patient experienced RASH (Severe rash on their left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, SWOLLEN TONGUE (Slight swelling under their tongue) and PARAESTHESIA ORAL (Tingling on their lip) had resolved. On 18-Feb-2021, RASH (Severe rash on their left arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling cold, Illness, Muscular weakness
Clinical narrative: legs were so weak she had to  crawl to the bathroom; freezing to death; dizziness; deathly ill; ached all over; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill) and MYALGIA (ached all over) in a 54-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.     Concurrent medical conditions included Rheumatoid arthritis and Diabetes.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill), MYALGIA (ached all over) and PYREXIA (fever of 102 ). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill), MYALGIA (ached all over) and PYREXIA (fever of 102 ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: legs were so weak she had to  crawl to the bathroom; freezing to death; dizziness; deathly ill; ached all over; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill) and MYALGIA (ached all over) in a 54-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.     Concurrent medical conditions included Rheumatoid arthritis and Diabetes.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill), MYALGIA (ached all over) and PYREXIA (fever of 102 ). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill), MYALGIA (ached all over) and PYREXIA (fever of 102 ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pruritus, Injection site rash
Clinical narrative: there was a bruise on injection site; On 9th Day, she noticed some rash on side of injection site; On 8th day, patient felt itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (there was a bruise on injection site), INJECTION SITE PRURITUS (On 8th day, patient felt itching at injection site) and INJECTION SITE RASH (On 9th Day, she noticed some rash on side of injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MWA) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LANSOPRAZOLE (PREVACID), MELOXICAM and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE PRURITUS (On 8th day, patient felt itching at injection site). On 11-Mar-2021, the patient experienced INJECTION SITE BRUISING (there was a bruise on injection site) and INJECTION SITE RASH (On 9th Day, she noticed some rash on side of injection site). On 12-Mar-2021, INJECTION SITE BRUISING (there was a bruise on injection site) had resolved. At the time of the report, INJECTION SITE PRURITUS (On 8th day, patient felt itching at injection site) and INJECTION SITE RASH (On 9th Day, she noticed some rash on side of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: leg cramps; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (leg cramps) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced MUSCLE SPASMS (leg cramps) and PAIN IN EXTREMITY (sore arm). On 15-Feb-2021, MUSCLE SPASMS (leg cramps) had resolved. On 17-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided by the reporter. Treatment medication includes "flu pill' for people with high blood pressure.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Left arm ached and was sore; Extreme shortness of breath; No appetite; Had a fever of 99.7; Fatigued; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Left arm ached and was sore), DYSPNOEA (Extreme shortness of breath), DECREASED APPETITE (No appetite), PYREXIA (Had a fever of 99.7) and FATIGUE (Fatigued) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 18-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 (Left arm ached and was sore), DYSPNOEA (Extreme shortness of breath), DECREASED APPETITE (No appetite), PYREXIA (Had a fever of 99.7) and FATIGUE (Fatigued). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm ached and was sore), DYSPNOEA (Extreme shortness of breath), DECREASED APPETITE (No appetite), PYREXIA (Had a fever of 99.7) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Pyrexia: 99.1 (abnormal) 99.1.     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 provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: Circle is warm; 1.5 inch diameter red circle; feeling more tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Circle is warm), INJECTION SITE ERYTHEMA (1.5 inch diameter red circle) and FATIGUE (feeling more tired than usual) 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 No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE WARMTH (Circle is warm), INJECTION SITE ERYTHEMA (1.5 inch diameter red circle) and FATIGUE (feeling more tired than usual). At the time of the report, INJECTION SITE WARMTH (Circle is warm), INJECTION SITE ERYTHEMA (1.5 inch diameter red circle) and FATIGUE (feeling more tired than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle; Muscle pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle) and VACCINATION SITE PAIN (Muscle pain at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, SIMVASTATIN, ZOLPIDEM TARTRATE (AMBIEN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle) and VACCINATION SITE PAIN (Muscle pain at the injection site). On 10-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle) had resolved. At the time of the report, VACCINATION SITE PAIN (Muscle pain at the injection site) had not resolved.            Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-019004 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received from the primary reporter: The reporter address was added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Hypertension
Clinical narrative: Unusual high blood pressure; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Unusual high blood pressure), CHILLS (Chills) and FATIGUE (Tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BENAZEPRIL, AMLODIPINE and POTASSIUM 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HYPERTENSION (Unusual high blood pressure), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, HYPERTENSION (Unusual high blood pressure), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 149/94 mmHg (High) 149/94 and 120/71 mmHg (normal) 120/71.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Pyrexia
Clinical narrative: Cough , Chest congested cough; Fever 100F in one ear, 101F in another; Headache, congested; Chill; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough , Chest congested cough), PYREXIA (Fever 100F in one ear, 101F in another), HEADACHE (Headache, congested) and CHILLS (Chill) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced COUGH (Cough , Chest congested cough), PYREXIA (Fever 100F in one ear, 101F in another), HEADACHE (Headache, congested) and CHILLS (Chill). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (Cough , Chest congested cough), PYREXIA (Fever 100F in one ear, 101F in another), HEADACHE (Headache, congested) and CHILLS (Chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity
Clinical narrative: feels a bean size lymph node near her neck; right shoulder feels like it's tearing and pulling; super arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (super arm soreness), ARTHRALGIA (right shoulder feels like it's tearing and pulling) and LYMPHADENOPATHY (feels a bean size lymph node near her neck) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (super arm soreness). On 18-Mar-2021, the patient experienced ARTHRALGIA (right shoulder feels like it's tearing and pulling). On an unknown date, the patient experienced LYMPHADENOPATHY (feels a bean size lymph node near her neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (super arm soreness) had resolved. At the time of the report, ARTHRALGIA (right shoulder feels like it's tearing and pulling) had not resolved and LYMPHADENOPATHY (feels a bean size lymph node near her neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Back pain.   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) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included high blood pressure medications and injections in spine for back pain.  No treatment information was provided.  It was reported that after receiving both doses of the vaccine the patient was feeling better. Every 6 months, the patient was receiving injections in the spine in order to heal back pain and since received the vaccine the patient was feeling great.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273 (lot/batch: 030M20A) with no associated AEs reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my legs, up past my knees,it's bad,it's a rash on my hands too; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my legs, up past my knees,it's bad,it's a rash on my hands too) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Rash.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on my legs, up past my knees,it's bad,it's a rash on my hands too). At the time of the report, RASH (rash on my legs, up past my knees,it's bad,it's a rash on my hands too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was not provided by the reporter. Treatment medication includes antibiotics.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hypoaesthesia, Lymphadenopathy, Pyrexia
Clinical narrative: headache; fever; numbness in armpit; redness in armpit; swollen lymph node in armpit; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in armpit), ERYTHEMA (redness in armpit), LYMPHADENOPATHY (swollen lymph node in armpit), HEADACHE (headache) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in armpit), ERYTHEMA (redness in armpit) and LYMPHADENOPATHY (swollen lymph node in armpit). On 17-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 18-Mar-2021, HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, HYPOAESTHESIA (numbness in armpit), ERYTHEMA (redness in armpit) and LYMPHADENOPATHY (swollen lymph node in armpit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Muscle spasms, Pain in extremity
Clinical narrative: weird side effect; She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a; she feels that her muscle is contracting/pulsating; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (weird side effect), PAIN IN EXTREMITY (She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a) and MUSCLE SPASMS (she feels that her muscle is contracting/pulsating) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE EVENT (weird side effect), PAIN IN EXTREMITY (She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a) and MUSCLE SPASMS (she feels that her muscle is contracting/pulsating). At the time of the report, ADVERSE EVENT (weird side effect), PAIN IN EXTREMITY (She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a) and MUSCLE SPASMS (she feels that her muscle is contracting/pulsating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EAR PAIN (Aching behind their right ear), NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired) and MYALGIA (Every inch of their body ached) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LUTEIN [XANTOFYL] for Macular degeneration and Prophylaxis, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired), MYALGIA (Every inch of their body ached) and PYREXIA (fever of 102.1°F). On 19-Mar-2021, the patient experienced EAR PAIN (Aching behind their right ear). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. On 18-Mar-2021, NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired), MYALGIA (Every inch of their body ached) and PYREXIA (fever of 102.1°F) had resolved. At the time of the report, EAR PAIN (Aching behind their right ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 degree fahrenheit (High) Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-220917 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EAR PAIN (Aching behind their right ear), NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired) and MYALGIA (Every inch of their body ached) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LUTEIN [XANTOFYL] for Macular degeneration and Prophylaxis, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired), MYALGIA (Every inch of their body ached) and PYREXIA (fever of 102.1°F). On 19-Mar-2021, the patient experienced EAR PAIN (Aching behind their right ear). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. On 18-Mar-2021, NASOPHARYNGITIS (Extremely cold), HEADACHE (Headache), FATIGUE (very very tired), MYALGIA (Every inch of their body ached) and PYREXIA (fever of 102.1°F) had resolved. At the time of the report, EAR PAIN (Aching behind their right ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 degree fahrenheit (High) Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-220917 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Lethargy, Vaccination site swelling
Clinical narrative: COVID fog/weird reactions; feeling lethargic; arm is swollen at the injection site; severe headache; cold chills all night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID fog/weird reactions), LETHARGY (feeling lethargic), VACCINATION SITE SWELLING (arm is swollen at the injection site), HEADACHE (severe headache) and CHILLS (cold chills all night) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047N21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (COVID fog/weird reactions), LETHARGY (feeling lethargic), VACCINATION SITE SWELLING (arm is swollen at the injection site), HEADACHE (severe headache) and CHILLS (cold chills all night). At the time of the report, FEELING ABNORMAL (COVID fog/weird reactions), LETHARGY (feeling lethargic), VACCINATION SITE SWELLING (arm is swollen at the injection site), HEADACHE (severe headache) and CHILLS (cold chills all night) 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.   Patient states that he has been having severe headaches, feeling lethargic with COVID fog. He also experienced cold chills all night yesterday. He says that he started experiencing the reactions yesterday, 18MAR2021, in the afternoon after receiving the shot.  Patient also says that his arm is swollen at the injection site since right after receiving the vaccine. He does mention having COVID in Oct-2020 and says that his current symptoms feel very similar to when he had COVID
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site (Right) arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site (Right) arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 024A20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Liver transplant.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (Right) arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 20-Jan-2021, VACCINATION SITE PAIN (Pain at injection site (Right) arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine has been reported by reporter.