chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Muscular weakness, Myalgia, Nausea, Neck pain, Paraesthesia
Clinical narrative: neck pain; shoulder pain; whole arm is numb/fingers numb; arm pain; arm very weak; fingers are tingly; Nausea; Sharp back pain/middle back pain; Difficulty walking; I Seemed to be drunk; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sharp back pain/middle back pain), MOBILITY DECREASED (Difficulty walking), FEELING DRUNK (I Seemed to be drunk), NECK PAIN (neck pain) and ARTHRALGIA (shoulder pain) in a 59-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.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    The patient's past medical history included Brain tumour, Heart disorder, Fibromyalgia and Disability.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 17-Mar-2021, the patient experienced BACK PAIN (Sharp back pain/middle back pain), MOBILITY DECREASED (Difficulty walking), FEELING DRUNK (I Seemed to be drunk) and NAUSEA (Nausea). On 25-Mar-2021, the patient experienced NECK PAIN (neck pain), ARTHRALGIA (shoulder pain), HYPOAESTHESIA (whole arm is numb/fingers numb), MYALGIA (arm pain), MUSCULAR WEAKNESS (arm very weak) and PARAESTHESIA (fingers are tingly). The patient was treated with NAPROXEN AMINOBUTANOL at an unspecified dose and frequency and FOSFOMYCIN TROMETAMOL (FOSIROL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Sharp back pain/middle back pain), MOBILITY DECREASED (Difficulty walking), FEELING DRUNK (I Seemed to be drunk), NECK PAIN (neck pain), ARTHRALGIA (shoulder pain), NAUSEA (Nausea), HYPOAESTHESIA (whole arm is numb/fingers numb), MYALGIA (arm pain), MUSCULAR WEAKNESS (arm very weak) and PARAESTHESIA (fingers are tingly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment includes Ibuprofen, Naproxen and Fexeril. concomitant product is not provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: New adverse event is mentioned (middle back pain, arm pain, neck pain,shoulder pain and whole arm is numb)
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: red rash; a little swelling; diarrhea; slight fever; nausea; muscle feel sore; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever) and NAUSEA (nausea) in a male patient of an unknown age 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 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever), NAUSEA (nausea), MYALGIA (muscle feel sore) and FATIGUE (fatigued). At the time of the report, RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever), NAUSEA (nausea), MYALGIA (muscle feel sore) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Swelling
Clinical narrative: red rash; a little swelling; diarrhea; slight fever; nausea; muscle feel sore; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever) and NAUSEA (nausea) in a male patient of an unknown age 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 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever), NAUSEA (nausea), MYALGIA (muscle feel sore) and FATIGUE (fatigued). At the time of the report, RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever), NAUSEA (nausea), MYALGIA (muscle feel sore) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after first dose). The patient was treated with AZITHROMYCIN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details include Z-pak (azithromycin) was prescribed by her doctor on day 3.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Rash, Swelling
Clinical narrative: itchy from elbow to shoulder; little bumps from elbow to shoulder; Swollen from elbow to shoulder; Red from elbow to shoulder; Rash from elbow to shoulder; Sore arm, same arm as injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm, same arm as injection). On 11-Mar-2021, the patient experienced PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder). On 06-Mar-2021, VACCINATION SITE PAIN (Sore arm, same arm as injection) had resolved. At the time of the report, PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: itchy from elbow to shoulder; little bumps from elbow to shoulder; Swollen from elbow to shoulder; Red from elbow to shoulder; Rash from elbow to shoulder; Sore arm, same arm as injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm, same arm as injection). On 11-Mar-2021, the patient experienced PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder). On 06-Mar-2021, VACCINATION SITE PAIN (Sore arm, same arm as injection) had resolved. At the time of the report, PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (Tooth abscess) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced TOOTH ABSCESS (Tooth abscess). The patient was treated with AMOXICILLIN on 18-Mar-2021 for Tooth abscess, at a dose of 10 daysUNK. At the time of the report, TOOTH ABSCESS (Tooth abscess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Thyroid medicine(Unspecified).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Illness, Pyrexia
Clinical narrative: Sick all day; Hurts on every bone.; Fever of 101 Deg F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all day), BONE PAIN (Hurts on every bone.) and PYREXIA (Fever of 101 Deg F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COPD. Concomitant products included MORPHINE, TRAMADOL and GABAPENTIN for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (Sick all day), BONE PAIN (Hurts on every bone.) and PYREXIA (Fever of 101 Deg F). At the time of the report, ILLNESS (Sick all day), BONE PAIN (Hurts on every bone.) and PYREXIA (Fever of 101 Deg F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 (High) 101 Deg F.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itchiness and redness at site of injection; Redness at site of injection; Pain at injection site for 5 days; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness and redness at site of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at injection site for 5 days) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A27A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals (Has anaphylactic (6 days out) after deep injections lidocaine.). Concomitant products included METOPROLOL, CLONIDINE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site for 5 days) and HEADACHE (headache). On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness and redness at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DIPHENHYDRAMINE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchiness and redness at site of injection) had not resolved, VACCINATION SITE ERYTHEMA (Redness at site of injection) and HEADACHE (headache) outcome was unknown and VACCINATION SITE PAIN (Pain at injection site for 5 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash, rash has gotten progressively worse every day; Broke out in hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Broke out in hives) and RASH (Rash, rash has gotten progressively worse every day) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Rash, rash has gotten progressively worse every day). In March 2021, the patient experienced URTICARIA (Broke out in hives). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out in hives) and RASH (Rash, rash has gotten progressively worse every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient reported that about a month after receiving first dose of vaccine, the patient broke out in hives. The patient went to her HCP and was prescribed prednisone. However, the patient did not take prednisone, and alternatively took fexofenadine (Allegra). The patient stated that a month after receiving the first dose on 04-Mar-2021, a rash appeared and the rash had gotten progressively worse every day. The patient was asking if she could receive the second dose of the vaccination after the 28th day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle Ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle Ache). In February 2021, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle Ache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), PAIN (Achy) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), PAIN (Achy) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm hurts), PAIN (Achy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches; Arm soreness; Severe chills; Fever of 100.6F; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Arm soreness), CHILLS (Severe chills), PYREXIA (Fever of 100.6F) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included METRONIDAZOLE and ESTRADIOL (IMVEXXY) for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Arm soreness), CHILLS (Severe chills), PYREXIA (Fever of 100.6F) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Arm soreness), CHILLS (Severe chills), PYREXIA (Fever of 100.6F) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Pyrexia: 100.6 (Inconclusive) fever of 100.6F.         Concomitant also include inflammatory bowel syndrome medications.  Tylenol is used as treatment medication. Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Itchiness throughout the body similar to shingles; Itchiness throughout the body similar to shingles; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itchiness throughout the body similar to shingles) and HERPES ZOSTER (Itchiness throughout the body similar to shingles) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (Itchiness throughout the body similar to shingles) and HERPES ZOSTER (Itchiness throughout the body similar to shingles). At the time of the report, PRURITUS (Itchiness throughout the body similar to shingles) and HERPES ZOSTER (Itchiness throughout the body similar to shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: She was sick; extended length of time between doses; A spontaneous report was received from a consumer concerning herself a 76 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) with extended length of time between doses/inappropriate schedule of vaccine administration, and experienced sick/ malaise.  The patient's medical history was not included. Concomitant medications were not listed.  On 01 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection. Her second dose was due on 02 MAR 2021 but she was sick and didn't receive her second dose until 18 MAR 2021.  On 18 Mar 2021 patient received second dose of their two planned doses of mRNA-1273(batch no: unknown) intramuscularly in the left arm for prophylaxis of covid-19 infection, with extended length of time between doses.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, extended length of time between doses/inappropriate schedule of vaccine administration was considered resolved on 18 Mar 2021. The outcome of the event feeling sick was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot #unknown. 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
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Insomnia, Mental disorder, Nervousness
Clinical narrative: Nervous break down; Agitated; Nervousness; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (Nervous break down), AGITATION (Agitated), NERVOUSNESS (Nervousness) and INSOMNIA (Couldn't sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MENTAL DISORDER (Nervous break down), AGITATION (Agitated), NERVOUSNESS (Nervousness) and INSOMNIA (Couldn't sleep). At the time of the report, MENTAL DISORDER (Nervous break down), AGITATION (Agitated), NERVOUSNESS (Nervousness) and INSOMNIA (Couldn't sleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information reported.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vomiting
Clinical narrative: Start throwing up; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and VOMITING (Start throwing up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], ASPIRIN [ACETYLSALICYLIC ACID], CHOLESTEROL and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MYALGIA (Body ache) and HEADACHE (Headache). On 19-Mar-2021, the patient experienced VOMITING (Start throwing up). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and VOMITING (Start throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Increasing blood pressure systolic up to180 and diastolic up to 100; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increasing blood pressure systolic up to180 and diastolic up to 100) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), AMLODIPINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Increasing blood pressure systolic up to180 and diastolic up to 100). At the time of the report, BLOOD PRESSURE INCREASED (Increasing blood pressure systolic up to180 and diastolic up to 100) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure measurement: 180/100 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.  The reporter states that the patient had  received the second dose of vaccine  and patient had surgery for intestinal blockage in month of  February.   This case was linked to MOD-2021-265347 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received : Patient medical history was added  and the event outcome updated as recovered .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) 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) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 05-Feb-2021, PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. On an unknown date, Antibody test: negative (Negative) Negative a month later of vaccination..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm that same day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm that same day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm that same day). At the time of the report, VACCINATION SITE PAIN (Sore arm that same day) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient wants to go to the dentist and she's going to be administered anesthesia, also probably she's going to be taking some pain medicine afterwards.  Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: diarrhea; feeling lightheaded; nauseas; throwing up; low grade fever; stomach felt tight; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (stomach felt tight), DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas) and VOMITING (throwing up) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach felt tight). On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas), VOMITING (throwing up) and PYREXIA (low grade fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach felt tight), DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas), VOMITING (throwing up) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was included. No treatment details was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea; feeling lightheaded; nauseas; throwing up; low grade fever; stomach felt tight; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (stomach felt tight), DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas) and VOMITING (throwing up) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach felt tight). On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas), VOMITING (throwing up) and PYREXIA (low grade fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach felt tight), DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas), VOMITING (throwing up) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was included. No treatment details was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (Fever - Temperature of 101.9F), HEADACHE (Headache) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030A21A) for COVID-19 vaccination.  Concomitant products included METOPROLOL, LEVOTHYROXINE, ESCITALOPRAM and OMEPRAZOLE for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Pain), PYREXIA (Fever - Temperature of 101.9F), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Pain), PYREXIA (Fever - Temperature of 101.9F), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101.9 (Inconclusive) Temperature of 101.9F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Runny nose; Tested positive for covid19; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and COVID-19 (Tested positive for covid19) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RHINORRHOEA (Runny nose) and COVID-19 (Tested positive for covid19). At the time of the report, RHINORRHOEA (Runny nose) and COVID-19 (Tested positive for covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient did not take any treatment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 60 days past first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (60 days past first dose) in a 43-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (60 days past first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (60 days past first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Aphasia, Dizziness, Toxicity to various agents, Tremor
Clinical narrative: dizziness; blurred vision; shaky; unable to talk on the phone; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LITHIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Toxicity to various agents: 1.7 (High) 1.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received on 27-Jul-2021 included no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: dizziness; blurred vision; shaky; unable to talk on the phone; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LITHIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIZZINESS (dizziness), VISION BLURRED (blurred vision), TREMOR (shaky), APHASIA (unable to talk on the phone) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Toxicity to various agents: 1.7 (High) 1.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received on 27-Jul-2021 included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Pain
Clinical narrative: Body ache; Fever (101.9); Chills; Headache; Muscle ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), MYALGIA (Muscle ache), PYREXIA (Fever (101.9)) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (prior covid-19 infection) in September 2020. Concurrent medical conditions included Lupus erythematosus.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and HEADACHE (Headache). On 18-Mar-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever (101.9)) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), MYALGIA (Muscle ache), PYREXIA (Fever (101.9)), CHILLS (Chills) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature increased: 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Body ache; Fever (101.9); Chills; Headache; Muscle ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), MYALGIA (Muscle ache), PYREXIA (Fever (101.9)) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (prior covid-19 infection) in September 2020. Concurrent medical conditions included Lupus erythematosus.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and HEADACHE (Headache). On 18-Mar-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever (101.9)) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), MYALGIA (Muscle ache), PYREXIA (Fever (101.9)), CHILLS (Chills) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature increased: 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Myalgia, Nausea, Vomiting
Clinical narrative: Bedridden; body aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedridden), MYALGIA (body aches), NAUSEA (Nausea) and VOMITING (Vomiting) in a 46-year-old female patient 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 BEDRIDDEN (Bedridden), MYALGIA (body aches), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, BEDRIDDEN (Bedridden), MYALGIA (body aches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment medicines includes anti-nausea medication.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash erythematous
Clinical narrative: Red egg-sized rash; Very itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red egg-sized rash), PRURITUS (Very itchy) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache). On 19-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red egg-sized rash) and PRURITUS (Very itchy). On 10-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red egg-sized rash) and PRURITUS (Very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment Information Provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A lot of pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot of pain in her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (she had a hysterectomy six weeks ago.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (A lot of pain in her arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A lot of pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Red/pinkish circle around the injection site that lasted several weeks; Soreness around the site for several days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the site for several days) and VACCINATION SITE ERYTHEMA (Red/pinkish circle around the injection site that lasted several weeks) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2(Z?)04) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the site for several days). On 12-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red/pinkish circle around the injection site that lasted several weeks). On 27-Feb-2021, VACCINATION SITE PAIN (Soreness around the site for several days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red/pinkish circle around the injection site that lasted several weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.