chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted COVID-19 Virus after first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Contracted COVID-19 Virus after first shot) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID-19 Virus after first shot). At the time of the report, COVID-19 (Contracted COVID-19 Virus after first shot) 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.   No concomitant medications were provided. No treatment medications were provided. This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred on unknown day and month after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable since only information about the first dose was disclosed. Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred on unknown day and month after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable since only information about the first dose was disclosed. Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses for boosters instead of half doses.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided  Caller stated that patients first dose was a JNJ dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave full doses (0.5ml) for boosters instead of half doses (0.25ml); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave full doses (0.5ml) for boosters instead of half doses (0.25ml)). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diarrhea (patient had diarrhea, it was bad), abdominal discomfort (patient had waves come over abdomen/started in one side and then went to the other side), pain in extremity (sore arm) and pyrexia (patient must have had fever, but didn't control the temperature) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025D21A) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient experienced  diarrhea (patient had diarrhea, it was bad), abdominal discomfort (patient had waves come over abdomen/started in one side and then went to the other side), pain in extremity (sore arm) and pyrexia (patient must have had fever, but didn't control the temperature). On Oct 25, 2021, diarrhea (patient had diarrhea, it was bad), abdominal discomfort (patient had waves come over abdomen/started in one side and then went to the other side) and pyrexia (patient must have had fever, but didn't control the temperature) resolved. At the time of the report, pain in extremity (sore arm) outcome: unknown. The patient took blood pressure medication as concomitant. No treatment information reported. This case linked to MOD-2021-364473 (patient link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Date of refrigeration was reported as 07 May 2021.   This case was linked to MOD-2021-364375 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weight has gone down 10 lbs.; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight has gone down 10 lbs.) 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.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced WEIGHT DECREASED (Weight has gone down 10 lbs.). At the time of the report, WEIGHT DECREASED (Weight has gone down 10 lbs.) outcome was unknown.            Patient received flu shot last week after receiving both the doses of Moderna COVID-19 vaccine and experienced cough, chills and felt tired the entire week after. Patient was still coughing a little and had this reaction which was not over yet. It was also reported that the patient never had a reaction to the flu shot before. It was reported that the patient was unsure about the timelines of weight loss but she thinks that that it happened over a course of 2 years. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Myalgia, Pruritus, Pyrexia
Clinical narrative: Chills; fevers; Injection site arm ached; Body aches; Was in bed for 2 days; Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), CHILLS (Chills), PYREXIA (fevers) and VACCINATION SITE PAIN (Injection site arm ached) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Allergy (Patient takes Loratadine 10mg daily for allergy issues.). Concomitant products included LORATADINE for Allergy, PREDNISONE for Rheumatoid arthritis, OXYCODONE, VENLAFAXINE, EZETIMIBE (ZETIA), VITAMIN D NOS, POLYCARBOPHIL CALCIUM (FIBER), D-MANNOSE and ZOLEDRONIC ACID for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). In 2021, the patient experienced BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), PYREXIA (fevers), VACCINATION SITE PAIN (Injection site arm ached) and MYALGIA (Body aches). At the time of the report, BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), CHILLS (Chills), PYREXIA (fevers), VACCINATION SITE PAIN (Injection site arm ached) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes vitamins used for unknown indication.  No treatment information was reported by the reporter.   This case was linked to MOD-2021-364248 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; fevers; Injection site arm ached; Body aches; Was in bed for 2 days; Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), CHILLS (Chills), PYREXIA (fevers) and VACCINATION SITE PAIN (Injection site arm ached) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Allergy (Patient takes Loratadine 10mg daily for allergy issues.). Concomitant products included LORATADINE for Allergy, PREDNISONE for Rheumatoid arthritis, OXYCODONE, VENLAFAXINE, EZETIMIBE (ZETIA), VITAMIN D NOS, POLYCARBOPHIL CALCIUM (FIBER), D-MANNOSE and ZOLEDRONIC ACID for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). In 2021, the patient experienced BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), PYREXIA (fevers), VACCINATION SITE PAIN (Injection site arm ached) and MYALGIA (Body aches). At the time of the report, BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), CHILLS (Chills), PYREXIA (fevers), VACCINATION SITE PAIN (Injection site arm ached) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes vitamins used for unknown indication.  No treatment information was reported by the reporter.   This case was linked to MOD-2021-364248 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Eczema cleared up by 90 percent.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Eczema cleared up by 90 percent.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 032B21A and 939906) for COVID-19 vaccination.     Concurrent medical conditions included Eczema (Severe eczema on her scalp, neck, eye brows and facial cheeks.).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Eczema cleared up by 90 percent.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Eczema cleared up by 90 percent.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.  Patient stated that she was unsure if the improvement started after the first or second vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Somnolence
Clinical narrative: Cold; Sleepy/slept all day; Chilly; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), SOMNOLENCE (Sleepy/slept all day) and CHILLS (Chilly) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NASOPHARYNGITIS (Cold), SOMNOLENCE (Sleepy/slept all day) and CHILLS (Chilly). At the time of the report, NASOPHARYNGITIS (Cold), SOMNOLENCE (Sleepy/slept all day) and CHILLS (Chilly) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Patient sat in her chair, covered up with blankets and slept all day.   This case was linked to MOD-2021-364868 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-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 MASS (A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.). At the time of the report, VACCINATION SITE MASS (A lump in the arm/noticed several days after the 1st dose, several inches (3 inches) below the injection site/: smooth, oblong, 2 inches/ it has not gone away and is at the injection site on the left arm.) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication were reported. No treatment medication were reported.  Patient stated that It doesn't hurt or itch, no rash. It was not an allergic reaction. It has been more than a week and has not gone away or diminished in size. It smooth and oblong in shape, about 2" by 3". She know for a fact that it was not there before.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Patient demographics were updated. On 28-Oct-2021: Follow up contains non significant information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: a minor headache for part; I had soreness in site of injection for a couple days (1st dose); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had soreness in site of injection for a couple days (1st dose)) and HEADACHE (a minor headache for part) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (I had soreness in site of injection for a couple days (1st dose)) and HEADACHE (a minor headache for part). At the time of the report, VACCINATION SITE PAIN (I had soreness in site of injection for a couple days (1st dose)) and HEADACHE (a minor headache for part) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient stated after first dose had soreness in site of injection for a couple days and a minor headache for part of the day   This case was linked to MOD-2021-364550 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Headache, Lethargy, Off label use, Product storage error
Clinical narrative: lethargy; sore arm/the same symptoms; headache/the same symptoms; stored in the refrigerator 4 days too long; Not immunocompromised; full dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised), ACCIDENTAL OVERDOSE (full dose), LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09O21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Oct-2021, the patient experienced OFF LABEL USE (Not immunocompromised), ACCIDENTAL OVERDOSE (full dose) and PRODUCT STORAGE ERROR (stored in the refrigerator 4 days too long). On an unknown date, the patient experienced LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Oct-2021, ACCIDENTAL OVERDOSE (full dose) and PRODUCT STORAGE ERROR (stored in the refrigerator 4 days too long) had resolved. At the time of the report, OFF LABEL USE (Not immunocompromised) had resolved and LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lethargy; sore arm/the same symptoms; headache/the same symptoms; stored in the refrigerator 4 days too long; Not immunocompromised; full dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised), ACCIDENTAL OVERDOSE (full dose), LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09O21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Oct-2021, the patient experienced OFF LABEL USE (Not immunocompromised), ACCIDENTAL OVERDOSE (full dose) and PRODUCT STORAGE ERROR (stored in the refrigerator 4 days too long). On an unknown date, the patient experienced LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Oct-2021, ACCIDENTAL OVERDOSE (full dose) and PRODUCT STORAGE ERROR (stored in the refrigerator 4 days too long) had resolved. At the time of the report, OFF LABEL USE (Not immunocompromised) had resolved and LETHARGY (lethargy), VACCINATION SITE PAIN (sore arm/the same symptoms) and HEADACHE (headache/the same symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: had a little lump; it was hot to the touch; arm hurt; it's itchy; has a rash/rash is 3 inches wide in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (had a little lump), VACCINATION SITE WARMTH (it was hot to the touch), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE PRURITUS (it's itchy) and VACCINATION SITE RASH (has a rash/rash is 3 inches wide in the vaccination site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (had a little lump), VACCINATION SITE WARMTH (it was hot to the touch), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE PRURITUS (it's itchy) and VACCINATION SITE RASH (has a rash/rash is 3 inches wide in the vaccination site). At the time of the report, VACCINATION SITE MASS (had a little lump), VACCINATION SITE WARMTH (it was hot to the touch), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE PRURITUS (it's itchy) and VACCINATION SITE RASH (has a rash/rash is 3 inches wide in the vaccination site) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment given as Put Cold on affected area.   This case was linked to MOD-2021-364966.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Slight Neck Pain; sore arm; shoulder slight pain; slight fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Slight Neck Pain), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (shoulder slight pain) and PYREXIA (slight fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Slight Neck Pain), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (shoulder slight pain) and PYREXIA (slight fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Slight Neck Pain) and ARTHRALGIA (shoulder slight pain) had resolved and PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. Patient was stated that after 3 weeks he had recovered from slight neck and shoulder ache. Patient had stated that he will going to take Pfizer on 18-AUG as Second dose
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was just a little tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was just a little tired.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (I was just a little tired.). At the time of the report, FATIGUE (I was just a little tired.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received moderna vaccine after J&J vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received moderna vaccine after J&J vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received moderna vaccine after J&J vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received moderna vaccine after J&J vaccine) had resolved.            No concomitant medication information was provided. No treatment medication information was provided. As they heard on the news the J&J was not as effective and so then they got two full doses of Moderna COVID-19 vaccine as well.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Everything else (medicine) leaked down on her arm,Received 0.125mL; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Everything else (medicine) leaked down on her arm,Received 0.125mL) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and AMLODIPINE for Blood pressure, VITAMIN D [VITAMIN D NOS], CALCIUM and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .125 ml. On 24-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Everything else (medicine) leaked down on her arm,Received 0.125mL). On 24-Oct-2021, ACCIDENTAL UNDERDOSE (Everything else (medicine) leaked down on her arm,Received 0.125mL) had resolved.            No medical history was reported by the reporter. No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses for boosters instead of half doses.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients were given 0.5 milliliter as booster dose instead of 0.25 milliliter. Concomitant medications were not provided. Treatment information is not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: Feeling achy; Soreness at injection site; Feel ing very tired; Very bad headache/mild haedache right now; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling achy), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Feel ing very tired), HEADACHE (Very bad headache/mild haedache right now) and NAUSEA (Nauseous) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PAIN (Feeling achy), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Feel ing very tired), HEADACHE (Very bad headache/mild haedache right now) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Feeling achy), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Feel ing very tired), HEADACHE (Very bad headache/mild haedache right now) and NAUSEA (Nauseous) had not resolved.            No concomitant medication was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], ZINC, SELENIUM and Turmeric for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced 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) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported taking Tylenol liquid children's for symptoms. Patient also reported having blood titers antibodies checked 3 weeks ago and they are over 10. It is reported as patient takes 20 mg once a day simvastatin to lower cholesterol and also healthy supplements for immunity   This case was linked to MOD-2021-364741 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea
Clinical narrative: period type Nausea feeling; 1st dose on 26-May-2021 and 2th dose on 9-June-2021; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (period type Nausea feeling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-May-2021 and 2th dose on 9-June-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Anxiety, Blood pressure high, Asthma and Penicillin allergy.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-May-2021 and 2th dose on 9-June-2021). On an unknown date, the patient experienced NAUSEA (period type Nausea feeling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Nausea, at a dose of UNK dosage form. On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-May-2021 and 2th dose on 9-June-2021) had resolved. At the time of the report, NAUSEA (period type Nausea feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-364860 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment details not provided. The vials expired on 8-OCT-2021 and were left in the refrigerator past that date.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses for boosters instead of half doses.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Pyrexia
Clinical narrative: fever of 101.9F; booster dose given at 0.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (booster dose given at 0.5 ml) and PYREXIA (fever of 101.9F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 014M20A and 012M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (booster dose given at 0.5 ml). On 26-Oct-2021, the patient experienced PYREXIA (fever of 101.9F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 25-Oct-2021, ACCIDENTAL OVERDOSE (booster dose given at 0.5 ml) had resolved. At the time of the report, PYREXIA (fever of 101.9F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 101.9f (High) Fever.         The patient is not immunocompromised. No concomitant medications were reported
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye pain, Headache, Myalgia
Clinical narrative: Eyes ache/ eyes hurt to turn; Eyelids are puffy; Itchy; Injection site being the biggest problem; Chills; Headache; Body aches; Temperature of 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem) and CHILLS (Chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Temperature of 100 degrees F). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in October 2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Temperature of 100 degrees F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: high (High) 100 degree Fahrenheit.         Patient received the booster shot and felt sick. He stated that he used to take a statin before receiving the Moderna Vaccines.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pruritus, Pyrexia, Vaccination site reaction
Clinical narrative: Eyes ache/ eyes hurt to turn; Eyelids are puffy; Itchy; Injection site being the biggest problem; Chills; Headache; Body aches; Temperature of 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem) and CHILLS (Chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Temperature of 100 degrees F). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in October 2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PAIN (Eyes ache/ eyes hurt to turn), PERIORBITAL SWELLING (Eyelids are puffy), PRURITUS (Itchy), VACCINATION SITE REACTION (Injection site being the biggest problem), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Temperature of 100 degrees F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: high (High) 100 degree Fahrenheit.         Patient received the booster shot and felt sick. He stated that he used to take a statin before receiving the Moderna Vaccines.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received a full 3rd dose and is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received a full 3rd dose and is not immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a full 3rd dose and is not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (received a full 3rd dose and is not immunocompromised) had resolved.            no concomitant and treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Nonsignificant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was expired to 13 patients./Expired vaccine was expired to 9 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Significant Follow up; start date for vaccination given
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment was received by the patient.   This case was linked to MOD-2021-365019 (Patient Link).