chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis C antibody, Lymphadenopathy, Myalgia, Nausea, Pain in extremity
Clinical narrative: Little stomach upset; Arm pain; Fever100.5 to 100.7 after 2nd dose; Severe headache; Severe muscle pain; Joint pain; Fatigue; Nausea; Swelling at site of vaccine; Swollen lymph node under left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache) and MYALGIA (Severe muscle pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L208a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1000 mg and IBUPROFEN ongoing since an unknown date at a dose of 600 mg. At the time of the report, ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm) outcome was unknown and PYREXIA (Fever100.5 to 100.7 after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 100.5 (High) 100.5 F and 100.7 (High) 100.7 F. On 27-Jan-2021, Body temperature: 99 (Borderline) 99 F. On 23-Feb-2021, Hepatitis C antibody: 1.20 (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   This case was linked to MOD-2021-051954.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: This Follow-up was received on 05-MAY-2021 which updated patient demographics.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Little stomach upset; Arm pain; Fever100.5 to 100.7 after 2nd dose; Severe headache; Severe muscle pain; Joint pain; Fatigue; Nausea; Swelling at site of vaccine; Swollen lymph node under left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache) and MYALGIA (Severe muscle pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L208a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1000 mg and IBUPROFEN ongoing since an unknown date at a dose of 600 mg. At the time of the report, ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm) outcome was unknown and PYREXIA (Fever100.5 to 100.7 after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 100.5 (High) 100.5 F and 100.7 (High) 100.7 F. On 27-Jan-2021, Body temperature: 99 (Borderline) 99 F. On 23-Feb-2021, Hepatitis C antibody: 1.20 (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   This case was linked to MOD-2021-051954.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: This Follow-up was received on 05-MAY-2021 which updated patient demographics.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            Patient mentioned that the pharmacist suggested not to use any pain relievers for 10-14 days. His concern is that they use over the counter pain medications for other medical conditions.  No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: Throwing up; Fever; Headache; Whole body aching; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Whole body aching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BUPROPION HYDROCHLORIDE (WELLBUTRIN), GLYCOPYRRONIUM BROMIDE (ROBINUL) and TRIAMTERENE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VOMITING (Throwing up), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Whole body aching). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Mar-2021, VOMITING (Throwing up), PYREXIA (Fever) and MYALGIA (Whole body aching) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       According to the patient, she experienced a horrible reaction, throwing up, fever, headache, and whole body aching. Treatment medication also included nausea medicine.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bled for about 5 minutes) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PROBIOTICS NOS, OMEPRAZOLE and CLOMIPHENE [CLOMIFENE] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced EPISTAXIS (Nose bled for about 5 minutes). At the time of the report, EPISTAXIS (Nose bled for about 5 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Rash, large red itchy blotches on body, medium and smaller blotches on arms and legs.  They have started to subside, but still have numerous itchy red places on body and extremities.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Palpitations
Clinical narrative: Patient's husband called and told me that her wife has headache, pain in site of injection and heat palpitation following  the yesterdays' 2nd Moderna covid 19 vaccine immunization. I told him pain with immunization is a usual side effect of vaccine ,  however for heart palpitation, she may may need see a Doctor , and if necessary need to visit Emergency room.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Burning sensation, Computerised tomogram normal, Electromyogram, Full blood count normal
Clinical narrative: First shot had prickly feelings like someone touching me with a pin.  I was advised I could receive 2nd shot.  Evening of second shot, left toe tingling.  pins and needles developed mainly left side but occasionally the right side.  Feet, legs, arms, fingers.   Muscle weakness also developed.   Also arms burned on biceps.   Things seem to be improving but still have paresthesia that comes and goes.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Muscular weakness, Neuropathy peripheral, Paraesthesia
Clinical narrative: First shot had prickly feelings like someone touching me with a pin.  I was advised I could receive 2nd shot.  Evening of second shot, left toe tingling.  pins and needles developed mainly left side but occasionally the right side.  Feet, legs, arms, fingers.   Muscle weakness also developed.   Also arms burned on biceps.   Things seem to be improving but still have paresthesia that comes and goes.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Needle /syringe was faulty and injection came out of back of needle; pt did not receive dose; Prepared another dose and successfully gave immunization to pt because he did not receive faulty dose
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Heat, swelling, soreness of arm at injection site. Worsening of arthritis symptoms. Arthritis pain symptoms alleviated with OTC Acetaminophen
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Patient presented to Vaccination sit at her scheduled appointment time to receive her 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported that approximately 25-30 minutes after receiving her first Pfizer dose, she experienced tingling in her lips, bilateral cheeks, and left arm from her elbow to her hand. Client she drove home and called DR, and was told to go to urgent care. The client states she decided to wait approximately 4 hours from onset of symptoms before going to urgent care. Client states during that time the tingling in her arm resolved within an hour and the tingling in her lips and cheeks resolved approximately 2 hours after onset. Client states at urgent care they advised her to go home and take claritin. Client reports she drove home and took claritin of unknown strength. She reports she has been feeling well since then and denies following up with her PCP.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Pyrexia
Clinical narrative: Back ache; Chills; Fever; Headache; Joint pain; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (Back ache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-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 03-Feb-2021, the patient experienced BACK PAIN (Back ache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Joint pain). In February 2021, BACK PAIN (Back ache), CHILLS (Chills), HEADACHE (Headache) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The concomitant medications and treatment details were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Patient was fully vaccinated with Pfizer covid 19 vaccine. She received doses on 01/28/2021 and 02/20/2021. She subsequently was infected with Covid 19. Her symptoms started on 8/13/2021. She visited MinuteClinic and tested positive for Covid 19 on 8/15/2021. Health outcome is unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Dyspnoea
Clinical narrative: Chest pain Shortness of pain Fluttering in chest
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Eye swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Patient woke up Tuesday 8/10/21 with rash on face, neck, shoulder, legs, hands and had itching and hives. Patient went to the Dr on Wednesday 8/11/21 and the Dr prescribed patient cream for itching. Then Thursday  8/12/21 the patient had swelling in face and eyes. The patient self treated with calamine lotion and Aveeno wash. The patient started taking Allegra over the counter on Sunday 8/15/21. The patient says their symptoms have gotten better since taking Allegra. The patient has follow up appointment with Dr on Wednesday 8/18/21.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, nausea, fever, body aches, chills,
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eye pain, Eye swelling, Migraine, Ocular hyperaemia
Clinical narrative: Same night of vaccine (3/5/21) - Intense throbbing in left eye socket escalating around 2am followed by blurred vision and a migraine that lasted for at least 3 days. Intermittent pain for the next several months.  June 4th - Severe pain behind both eyes as a result of blood clots followed by swollen & very red eyes and eye lids. Today (8/15/21) - Continued throbbing pain and swelling in left eye. Will follow up with ophthalmologist this week.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thrombosis, Vision blurred
Clinical narrative: Same night of vaccine (3/5/21) - Intense throbbing in left eye socket escalating around 2am followed by blurred vision and a migraine that lasted for at least 3 days. Intermittent pain for the next several months.  June 4th - Severe pain behind both eyes as a result of blood clots followed by swollen & very red eyes and eye lids. Today (8/15/21) - Continued throbbing pain and swelling in left eye. Will follow up with ophthalmologist this week.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Palpitations
Clinical narrative: Frequent heart palpitations one month after vaccine.  Lasted about a month off and on.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have had a really bad rash that comes and goes over various parts of the body, legs, arms, stomach, back hands, feet etc.  started day 7 after vaccine and is still here day 10.  Seems to be the worst these last two days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Dizziness/Lightheadedness; Headache; Sore Arm/Body Aches; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness/Lightheadedness), HEADACHE (Headache), MYALGIA (Sore Arm/Body Aches), CHILLS (Chills) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness/Lightheadedness), HEADACHE (Headache), MYALGIA (Sore Arm/Body Aches), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness/Lightheadedness), HEADACHE (Headache), MYALGIA (Sore Arm/Body Aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Sep-2020 and the estimated date of delivery was 27-Jun-2021. On 19-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 19-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment medications reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was swollen; Injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PRURITUS (Injection site was itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PRURITUS (Injection site was itchy). At the time of the report, VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PRURITUS (Injection site was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Anger, Blood pressure increased, Mood disorder due to a general medical condition
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure), MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION (mood behaviors/Had discussion with sister and it's unusual to hung up the phone), ANGER (short tempered) and AGGRESSION (turned into argumentive/Went into argument to a stranger guy in a store) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included COPD. Concurrent medical conditions included Blood pressure high. Concomitant products included GUANFACINE HYDROCHLORIDE (TENEX) for Blood pressure, POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), HYDROCHLOROTHIAZIDE, VITAMIN B COMPLEX and VITAMIN D NOS for an unknown indication. 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 BLOOD PRESSURE INCREASED (elevated blood pressure), MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION (mood behaviors/Had discussion with sister and it's unusual to hung up the phone), ANGER (short tempered) and AGGRESSION (turned into argumentive/Went into argument to a stranger guy in a store). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure), MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION (mood behaviors/Had discussion with sister and it's unusual to hung up the phone), ANGER (short tempered) and AGGRESSION (turned into argumentive/Went into argument to a stranger guy in a store) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Hypoaesthesia oral, Lip pruritus, Paraesthesia oral, Suppressed lactation
Clinical narrative: Upper lip itch; Drug exposure during breast feeding; 25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk; Injection arm became sore; Lips tingling; Upper lip became numb; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb), LIP PRURITUS (Upper lip itch), VACCINATION SITE PAIN (Injection arm became sore) and SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb) and VACCINATION SITE PAIN (Injection arm became sore). On 16-Mar-2021, the patient experienced SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk). On an unknown date, the patient experienced LIP PRURITUS (Upper lip itch) and EXPOSURE VIA BREAST MILK (Drug exposure during breast feeding). On 15-Mar-2021, PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb) and LIP PRURITUS (Upper lip itch) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm became sore), SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk) and EXPOSURE VIA BREAST MILK (Drug exposure during breast feeding) 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 was breastfeeding. Patient treatment medication included Power pumping, Lactation cookies.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Upper lip itch; Drug exposure during breast feeding; 25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk; Injection arm became sore; Lips tingling; Upper lip became numb; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb), LIP PRURITUS (Upper lip itch), VACCINATION SITE PAIN (Injection arm became sore) and SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb) and VACCINATION SITE PAIN (Injection arm became sore). On 16-Mar-2021, the patient experienced SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk). On an unknown date, the patient experienced LIP PRURITUS (Upper lip itch) and EXPOSURE VIA BREAST MILK (Drug exposure during breast feeding). On 15-Mar-2021, PARAESTHESIA ORAL (Lips tingling), HYPOAESTHESIA ORAL (Upper lip became numb) and LIP PRURITUS (Upper lip itch) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm became sore), SUPPRESSED LACTATION (25% reduction in breast milk/60% reduction in breast milk/50% reduction in breast milk) and EXPOSURE VIA BREAST MILK (Drug exposure during breast feeding) 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 was breastfeeding. Patient treatment medication included Power pumping, Lactation cookies.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Adverse Event due to Special Population (Pregnancy); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Adverse Event due to Special Population (Pregnancy)) in a 34-year-old female patient (gravida 0, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 11-Oct-2020 and the estimated date of delivery was 31-Aug-2021. On 19-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Adverse Event due to Special Population (Pregnancy)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred  on 31-Aug-2021.  On 19-Mar-2021, EXPOSURE DURING PREGNANCY (Adverse Event due to Special Population (Pregnancy)) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: Positive   Action taken with mRNA-1273 in response to the event was not applicable. No concomitant and treatment drug information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Headache, Lymphadenopathy
Clinical narrative: hives; upper arm near the injection site was red; fatigued; lymph nodes swelling in her arm pit and the neck; experienced pain; fever; chills; severe headache for more than 24 hours; full body ache; unable to eat; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat), URTICARIA (hives), PYREXIA (fever), CHILLS (chills) and HEADACHE (severe headache for more than 24 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEEDING DISORDER (unable to eat), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache for more than 24 hours), MYALGIA ( full body ache) and PAIN (experienced pain). On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (upper arm near the injection site was red), FATIGUE (fatigued) and LYMPHADENOPATHY (lymph nodes swelling in her arm pit and the neck). On 12-Mar-2021, the patient experienced URTICARIA (hives). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (unable to eat), URTICARIA (hives), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache for more than 24 hours), MYALGIA ( full body ache), VACCINATION SITE ERYTHEMA (upper arm near the injection site was red), FATIGUE (fatigued), LYMPHADENOPATHY (lymph nodes swelling in her arm pit and the neck) and PAIN (experienced pain) outcome was unknown.            no concomitant medications are provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Urticaria, Vaccination site erythema
Clinical narrative: hives; upper arm near the injection site was red; fatigued; lymph nodes swelling in her arm pit and the neck; experienced pain; fever; chills; severe headache for more than 24 hours; full body ache; unable to eat; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat), URTICARIA (hives), PYREXIA (fever), CHILLS (chills) and HEADACHE (severe headache for more than 24 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEEDING DISORDER (unable to eat), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache for more than 24 hours), MYALGIA ( full body ache) and PAIN (experienced pain). On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (upper arm near the injection site was red), FATIGUE (fatigued) and LYMPHADENOPATHY (lymph nodes swelling in her arm pit and the neck). On 12-Mar-2021, the patient experienced URTICARIA (hives). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (unable to eat), URTICARIA (hives), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache for more than 24 hours), MYALGIA ( full body ache), VACCINATION SITE ERYTHEMA (upper arm near the injection site was red), FATIGUE (fatigued), LYMPHADENOPATHY (lymph nodes swelling in her arm pit and the neck) and PAIN (experienced pain) outcome was unknown.            no concomitant medications are provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Hypoaesthesia, Monoparesis, Peripheral swelling
Clinical narrative: weakness from neck down to knees upon movement; no appetite; numbness in right hand; swelling in hand; no energy; unable to grip anything with right hand; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness from neck down to knees upon movement), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in right hand), PERIPHERAL SWELLING (swelling in hand) and ASTHENIA (no energy) in an 81-year-old male 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 18-Feb-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 an unknown date, the patient experienced ASTHENIA (weakness from neck down to knees upon movement), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in right hand), PERIPHERAL SWELLING (swelling in hand), ASTHENIA (no energy) and MONOPARESIS (unable to grip anything with right hand). At the time of the report, ASTHENIA (weakness from neck down to knees upon movement), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in right hand), PERIPHERAL SWELLING (swelling in hand), ASTHENIA (no energy) and MONOPARESIS (unable to grip anything with right hand) outcome was unknown.             No relevant concomitant medications provided. No relevant treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: minor pain in the arm; little tired; bloating; diarrhea 3 times last night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor pain in the arm), FATIGUE (little tired), ABDOMINAL DISTENSION (bloating) and DIARRHOEA (diarrhea 3 times last night) in a 61-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (minor pain in the arm), FATIGUE (little tired), ABDOMINAL DISTENSION (bloating) and DIARRHOEA (diarrhea 3 times last night). At the time of the report, PAIN IN EXTREMITY (minor pain in the arm), FATIGUE (little tired), ABDOMINAL DISTENSION (bloating) and DIARRHOEA (diarrhea 3 times last night) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment details include, loperamide.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: extreme fatigue; nausea; headache; chills on and off; headache; nausea; fever; extreme fatigue; 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 the first episode of HEADACHE (headache), the first episode of NAUSEA (nausea), PYREXIA (fever), the first episode of FATIGUE (extreme fatigue) and the second episode of FATIGUE (extreme fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced the first episode of HEADACHE (headache), the first episode of NAUSEA (nausea), PYREXIA (fever) and the first episode of FATIGUE (extreme fatigue). On 12-Mar-2021, the patient experienced the second episode of FATIGUE (extreme fatigue), the second episode of NAUSEA (nausea), the second episode of HEADACHE (headache) and CHILLS (chills on and off). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (fever) outcome was unknown. At the time of the report, last episode of FATIGUE (extreme fatigue), the last episode of NAUSEA (nausea), the last episode of HEADACHE (headache) and CHILLS (chills on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warmth down her arm and chest), DIZZINESS (dizziness) and NAUSEA (Nausea) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING HOT (warmth down her arm and chest). On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (Nausea). At the time of the report, FEELING HOT (warmth down her arm and chest), DIZZINESS (dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm was painful; Slept all day; chills; Tiredness; Tiredness; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the first episode of FATIGUE (Tiredness) and the second episode of FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the first episode of FATIGUE (Tiredness), the second episode of FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the last episode of FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.3 (Inconclusive) 99.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Arm was painful; Slept all day; chills; Tiredness; Tiredness; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the first episode of FATIGUE (Tiredness) and the second episode of FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the first episode of FATIGUE (Tiredness), the second episode of FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the last episode of FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.3 (Inconclusive) 99.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Her arm has been red; Swollen; Itchy; Rash 5x7 cm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm has been red), SWELLING (Swollen), PRURITUS (Itchy) and RASH (Rash 5x7 cm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE, HYDRALAZINE, INSULIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (Her arm has been red), SWELLING (Swollen), PRURITUS (Itchy) and RASH (Rash 5x7 cm). At the time of the report, ERYTHEMA (Her arm has been red), SWELLING (Swollen), PRURITUS (Itchy) and RASH (Rash 5x7 cm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication included: Compound Thyroid
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache; A spontaneous report was received from a consumer and concerning a 73 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a persistent headache and worried about a blood clot/thrombosis.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.  Since 03 Mar 2021, the patient had persistent headache for maybe 12-14 days which were not getting better and was worried about a blood clot. No treatment information was provided. The event worried about blood clot was medically significant.  Action taken with mRNA-1273 in response to events was not reported.  The outcome of the event persistent headache was not resolved.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. Headache is consistent with the safety profile of the product.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE BRUISING (Bruising at the Injection Site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-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 03-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at the Injection Site). On 12-Feb-2021, VACCINATION SITE BRUISING (Bruising at the Injection Site) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PRURITUS (Itching) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PRURITUS (Itching). At the time of the report, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PRURITUS (Itching) outcome was unknown. Not Provided          No concomitant medications provided. No treatment drugs were reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27 Apr 2021
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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 relevant concomitant medications reported. No treatment information was provided. This case was linked to MOD-2021-052065.