chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling cold, Joint swelling, Pruritus
Clinical narrative: Felt cold/chilly; Swollen, stiff, red knuckles and joints; Sensitive to the temperature; Swollen, stiff, red knuckles and joints; Tired; Itchy and hot again; Rash around the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints) and TEMPERATURE INTOLERANCE (Sensitive to the temperature) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site). On 19-Jan-2021, the patient experienced PRURITUS (Itchy and hot again). On an unknown date, the patient experienced FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints), PRURITUS (Itchy and hot again), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not provided.   Treatment include hot compress on the site to keep the vaccine flowing and cold compress on the site for when she was itchy.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow up received and it contain information about patient contact information updated and patient demographics updated and new events were added. On 04-Aug-2021: Non-sig follow up; patient's street address provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature intolerance, Vaccination site erythema, Vaccination site mass, Vaccination site rash, Vaccination site warmth
Clinical narrative: Felt cold/chilly; Swollen, stiff, red knuckles and joints; Sensitive to the temperature; Swollen, stiff, red knuckles and joints; Tired; Itchy and hot again; Rash around the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints) and TEMPERATURE INTOLERANCE (Sensitive to the temperature) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site). On 19-Jan-2021, the patient experienced PRURITUS (Itchy and hot again). On an unknown date, the patient experienced FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints), PRURITUS (Itchy and hot again), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not provided.   Treatment include hot compress on the site to keep the vaccine flowing and cold compress on the site for when she was itchy.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow up received and it contain information about patient contact information updated and patient demographics updated and new events were added. On 04-Aug-2021: Non-sig follow up; patient's street address provided.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Paraesthesia, Rib fracture
Clinical narrative: shocks on the ribs; patient fell from the bed; broken rib; A spontaneous report was received from a consumer concerning a 96 years-old, male patient who experienced shocks on the ribs: paraesthesia.  The patient's medical history included a fall from bed on 31 Jan 2021 which resulted in broken left rib. Products known to have been used by the patient, within two weeks prior to the event, included dabigatran etexilate mesilate, furosemide sodium, cilostazol, levothyroxine, simvastatin, Tamsulosin, finasteride, and losartan.  The patient received their first of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly, in the left arm on 02 Feb 2021 for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient started to feel little shocks on the ribs on the right side. The reporter wanted to know if the shocks were normal side effects. Treatment for the event included Tylenol.  Action taken with mRNA-1273 was unknown.  The outcome of event shocks on the ribs, was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema
Clinical narrative: Triangle raise red mark; Hurting very slightly at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: arm got hard and sore at the injection site; sore at the injection site; A spontaneous report was received from a (Consumer) concerning a  71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20/Jan/2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 20/Jan/2021, The patient experienced the events list (verbatims) with seriousness criteria. Moderna Customer Care. Case Number Patient states she received her first dose of the Moderna Covid-19 vaccine yesterday and her arm got hard and sore at the injection site and she wants to know if she can put ice at the site. Patient is a 71 year old female who received the vaccine in her left arm. She has not taken anything yet and takes Calcium, Biotin, Stool Softener, Collagen Powder. Consent for safety to follow-up was received and also to have this call documented. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  unknown outcomes: At the time of this report, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was unknown>.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM ACETATE for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Jul-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she learned she was pregnant on 03-Nov-2020. Her due date reported to be 12-Jul-2021. She reported her pre-pregnancy weight as 165 lbs and current weight as 170 lbs.    Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination complication
Clinical narrative: side effects; Headache; chills; bodyache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache). At the time of the report, VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Genetic counselling, Maternal exposure during pregnancy, Pregnancy test, Puncture site haemorrhage, Ultrasound uterus normal
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 09-Nov-2018 and Miscarriage on 01-Jun-2020. Concurrent medical conditions included Pregnancy since 25-Aug-2020. Concomitant products included VITAMIN D NOS, IRON, PARACETAMOL (TYLENOL) and CALCIUM MEFOLINATE (L METHYLFOLATE) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 04-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. In November 2020, Genetic counselling: ok normal. In November 2020, Puncture site haemorrhage: failed Failed. In November 2020, Ultrasound uterus normal: ok ok.     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 had Live full-term birth on 09NOV2018 and  had  Miscarriage one 01JUN2020.  patient took Tylenol 7times in pregnancy. 2nd dose is schedule on 2-feb-2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Myalgia
Clinical narrative: Pregnant; Headache; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and MYALGIA (Sore arm) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy since 12-Nov-2020. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE DR) for Anxiety depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Nov-2020 and the estimated date of delivery was 10-Aug-2021. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and MYALGIA (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and MYALGIA (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.   Treatment information not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-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 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment history was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm at the injection site). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine present, Chills, Fatigue, Pyrexia
Clinical narrative: Blood in Urine; Chills; High fever; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-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 BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded  No Concomitant Medicines were provided No Treatment medicines were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-076605 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient Demographics updated. Added four New Events Arthralgia, Fatigue, Chills, Pyrexia. Added Details of Second dose. Action taken with the drug was Updated from Unknown to No Change.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-076605:First dose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: maternal exposure during pregnancy; Sore arm  after getting the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm  after getting the vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm  after getting the vaccine). On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm  after getting the vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Vaccination area was red; Sore left arm; Vaccination area was burning; Vaccination area looks like rash; Vaccination area was Itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Vaccination area was red), INJECTION SITE PAIN (Sore left arm), INJECTION SITE PAIN (Vaccination area was burning), INJECTION SITE RASH (Vaccination area looks like rash) and INJECTION SITE PRURITUS (Vaccination area was Itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Vaccination area was red), INJECTION SITE PAIN (Sore left arm), INJECTION SITE PAIN (Vaccination area was burning), INJECTION SITE RASH (Vaccination area looks like rash) and INJECTION SITE PRURITUS (Vaccination area was Itchy). At the time of the report, INJECTION SITE ERYTHEMA (Vaccination area was red), INJECTION SITE PAIN (Sore left arm), INJECTION SITE PAIN (Vaccination area was burning), INJECTION SITE RASH (Vaccination area looks like rash) and INJECTION SITE PRURITUS (Vaccination area was Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Erythema, Pruritus
Clinical narrative: Red bumps in different places in breast; Red bumps in different places in arm of injection; Itchy bumps; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Red bumps in different places in breast), ERYTHEMA (Red bumps in different places in arm of injection) and PRURITUS (Itchy bumps) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, Pain, Leg cramps and Sleep disorder. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), ATENOLOL and AMLODIPINE BESILATE, VALSARTAN (AMLORTAN) for Blood pressure high, METFORMIN for Diabetes, TIZANIDINE for Leg cramps, TRAMADOL and GABAPENTIN (GABAPEN) for Pain, TEGAFUR (RESURGE) for Sleep disorder, THYROID (ARMOUR THYROID), VITAMIN B COMPLEX, PROTEIN and MAGNESIUM for an unknown indication.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced BREAST MASS (Red bumps in different places in breast), ERYTHEMA (Red bumps in different places in arm of injection) and PRURITUS (Itchy bumps). At the time of the report, BREAST MASS (Red bumps in different places in breast), ERYTHEMA (Red bumps in different places in arm of injection) and PRURITUS (Itchy bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Black out/couldn't remember anything for days; A spontaneous report was received from a consumer who was also a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a black out and couldn't remember anything for days/amnesia.  The patient's medical history included allergies to industrial chemicals, glaucoma, and diabetes. Concomitant product use was not provided by the reporter.  On 23 Jan 2021, approximately one day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 013L20A) intramuscularly for prohylaxis of COVID-19 infection.  On 24 Jan 2021, the patient reportedly experienced a black out and was unable to remember anything for days. In the early morning hours on 29 Jan 2021, the patient's memory returned but he was reportedly still unable to remember "silly" things such as how to go to a restaurant. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events of black out and inability to remember anything for days were considered resolved on 28 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site it was red; injection site it was swollen; injection site it was hard; injection site it was itchy; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), VACCINATION SITE ERYTHEMA (injection site it was red), VACCINATION SITE SWELLING (injection site it was swollen), VACCINATION SITE INDURATION (injection site it was hard) and VACCINATION SITE PRURITUS (injection site it was itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome. Concurrent medical conditions included Penicillin allergy and Hypertension.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (pain). On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site it was red), VACCINATION SITE SWELLING (injection site it was swollen), VACCINATION SITE INDURATION (injection site it was hard) and VACCINATION SITE PRURITUS (injection site it was itchy). At the time of the report, PAIN (pain), VACCINATION SITE ERYTHEMA (injection site it was red), VACCINATION SITE SWELLING (injection site it was swollen), VACCINATION SITE INDURATION (injection site it was hard) and VACCINATION SITE PRURITUS (injection site it was itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was reported.  Treatment drugs was not reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Product dose omission issue, Vaccination site discomfort, Vaccination site pain, Vaccination site pruritus
Clinical narrative: did not get the second shot, was told by three separate doctors no to get due to; intermittently, she would be tired, but then she would get over it; it's almost to my elbow/wide area, probably 3 inches; burning and itching started on my arm; burning and itching started on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (it's almost to my elbow/wide area, probably 3 inches), PRODUCT DOSE OMISSION ISSUE (did not get the second shot, was told by three separate doctors no to get due to), VACCINATION SITE PRURITUS (burning and itching started on arm), FATIGUE (intermittently, she would be tired, but then she would get over it) and VACCINATION SITE PAIN (burning and itching started on my arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (burning and itching started on arm) and VACCINATION SITE PAIN (burning and itching started on my arm). On 21-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (it's almost to my elbow/wide area, probably 3 inches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot, was told by three separate doctors no to get due to) and FATIGUE (intermittently, she would be tired, but then she would get over it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site reaction, at a dose of 1 dosage form and CORTISONE for Vaccination site reaction, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOMFORT (it's almost to my elbow/wide area, probably 3 inches) and VACCINATION SITE PRURITUS (burning and itching started on arm) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get the second shot, was told by three separate doctors no to get due to), FATIGUE (intermittently, she would be tired, but then she would get over it) and VACCINATION SITE PAIN (burning and itching started on my arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No concomitant medications were reported.  The patient needed to put ice and cortisone on it in order to sleep.  The patient did not get the second shot. It was reported that the patient was told by three doctors no to get due to reaction.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Telephone contact report (TCR) was received. Action taken was updated. Additional event was added.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pallor, Pruritus, Swelling
Clinical narrative: Raised bump; Itchy; Blanched; Rash below the injection site 2x2 in/Rash got bigger/Rash got flatter and paler; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Raised bump), PRURITUS (Itchy), PALLOR (Blanched) and INJECTION SITE RASH (Rash below the injection site 2x2 in/Rash got bigger/Rash got flatter and paler) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING (Raised bump), PRURITUS (Itchy), PALLOR (Blanched) and INJECTION SITE RASH (Rash below the injection site 2x2 in/Rash got bigger/Rash got flatter and paler). On 14-Jan-2021, SWELLING (Raised bump) had resolved. On 18-Jan-2021, PRURITUS (Itchy), PALLOR (Blanched) and INJECTION SITE RASH (Rash below the injection site 2x2 in/Rash got bigger/Rash got flatter and paler) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Head discomfort, Myalgia
Clinical narrative: she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after; chills; fatigue; sore muscles; aches; head stuffiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HEAD DISCOMFORT (head stuffiness), CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Cirrhosis of liver. Concomitant products included INSULIN GLARGINE (LANTUS), LOSARTAN, CARVEDILOL, LOVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, MECLIZINE HCL, CALCIUM, PROBIOTICS NOS, MULTIVITAMINS [VITAMINS NOS], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), IPRATROPIUM BROMIDE, AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), SODIUM CHLORIDE (SALINE NASAL SPRAY), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), SIMETHICONE, ZINC and DICLOFENAC SODIUM (DICLOFENAC 1A PHARMA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (aches), HEAD DISCOMFORT (head stuffiness), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (sore muscles). On an unknown date, the patient experienced CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after). At the time of the report, PAIN (aches), HEAD DISCOMFORT (head stuffiness), CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (sore muscles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On follow up patient mentioned that she is totally fine now.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received on 20-APR-2021,Patient said she was doing fine and refused to disclose further contact details and refused further FU.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after; chills; fatigue; sore muscles; aches; head stuffiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HEAD DISCOMFORT (head stuffiness), CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Cirrhosis of liver. Concomitant products included INSULIN GLARGINE (LANTUS), LOSARTAN, CARVEDILOL, LOVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, MECLIZINE HCL, CALCIUM, PROBIOTICS NOS, MULTIVITAMINS [VITAMINS NOS], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), IPRATROPIUM BROMIDE, AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), SODIUM CHLORIDE (SALINE NASAL SPRAY), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), SIMETHICONE, ZINC and DICLOFENAC SODIUM (DICLOFENAC 1A PHARMA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (aches), HEAD DISCOMFORT (head stuffiness), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (sore muscles). On an unknown date, the patient experienced CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after). At the time of the report, PAIN (aches), HEAD DISCOMFORT (head stuffiness), CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (sore muscles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On follow up patient mentioned that she is totally fine now.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received on 20-APR-2021,Patient said she was doing fine and refused to disclose further contact details and refused further FU.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007320A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 04-Feb-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haematoma, Vaccination site pain
Clinical narrative: Blood clot at site of injection; Soreness and tenderness at her arm of injection; A spontaneous report (United States) was received from a consumer concerning a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness and tenderness at her arm of injection and a blood clot at site of injection.  The patient's medical history was not provided. Concomitant product use was not provided.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 11M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Feb 2021, after the administration of vaccine, the patient experienced soreness and tenderness at her arm of injection. On 05 Feb2021, she also got a blood clot at the site of injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of these events, soreness and tenderness at her arm of injection and a blood clot at site of injection were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: 23 weeks pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and received the vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink a week) on 20-Sep-2020 and Marijuana use (rare (1 use a month)) on 15-Aug-2020. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Nausea, PRENATAL FORMULA [ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FERROUS FUMARATE;FISH OIL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;ZINC OXIDE] for Pregnancy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Aug-2020 and the estimated date of delivery was 31-May-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and received the vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2020, Pregnancy test: positive (Positive) Positive. On 12-Mar-2021, Blood glucose: negative (Negative) negative for gestational diabetes. On 19-Apr-2021, Ultrasound foetal: normal (normal) normal 34 week ultrasound- 29th percentile in weight.         Genetic testing was carried on 09-Sep-2020-Negative Down Syndrome, Edwards  Symdrome, Trisomy 13   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Dose 2, Lab data , Con meds & med history info added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: called to register for the pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (called to register for the pregnancy registry) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination.     Previously administered products included for an unreported indication: substance use (Marijuana -Prior use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FERROUS SULFATE and LAMOTRIGINE for an unknown indication.    On 02-Feb-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 13-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (called to register for the pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (called to register for the pregnancy registry) 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 Treatment medications was provided by the reporter. Patient reported use of substance  Marijuana prior use.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Internal review on 27-Jul-2021 resulted in updates to the pregnancy details.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Skin reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: inflammation; really hot; delayed reaction; intensely itching at the site; red; swollen/ area was the size of a grapefruit in circumference; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (inflammation), VACCINATION SITE WARMTH (really hot), SKIN REACTION (delayed reaction), VACCINATION SITE PRURITUS (intensely itching at the site) and VACCINATION SITE ERYTHEMA (red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation), VACCINATION SITE WARMTH (really hot), SKIN REACTION (delayed reaction), VACCINATION SITE PRURITUS (intensely itching at the site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen/ area was the size of a grapefruit in circumference). At the time of the report, INFLAMMATION (inflammation) had resolved and VACCINATION SITE WARMTH (really hot), SKIN REACTION (delayed reaction), VACCINATION SITE PRURITUS (intensely itching at the site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen/ area was the size of a grapefruit in circumference) was resolving. 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.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: inflammation; really hot; delayed reaction; intensely itching at the site; red; swollen/ area was the size of a grapefruit in circumference; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (inflammation), VACCINATION SITE WARMTH (really hot), SKIN REACTION (delayed reaction), VACCINATION SITE PRURITUS (intensely itching at the site) and VACCINATION SITE ERYTHEMA (red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation), VACCINATION SITE WARMTH (really hot), SKIN REACTION (delayed reaction), VACCINATION SITE PRURITUS (intensely itching at the site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen/ area was the size of a grapefruit in circumference). At the time of the report, INFLAMMATION (inflammation) had resolved and VACCINATION SITE WARMTH (really hot), SKIN REACTION (delayed reaction), VACCINATION SITE PRURITUS (intensely itching at the site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen/ area was the size of a grapefruit in circumference) was resolving. 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.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.